Microbial Limit Test Research Articles

Freeze-dried wafers containing sesame oil for alleviation of dry mouth

A dry mouth is a condition with significant morbidity. Conventional saliva substitutes are expensive, short-lived, and prone to contamination. This study presents a Freeze-Dried Sesame Oil Emulsion Saliva Substitute (FD-SOESS), which combines the advantages of sesame oil through a freeze-drying process and assesses its effectiveness. High-speed homogenization (HSH) as well as high-pressure homogenization (HPH) techniques were employed to fabricate the FD-SOESS. The formulations that underwent the additional HPH step demonstrated improved physical properties, such as lower viscosity and faster redispersion times, compared to HSH alone. The optimized formulation (F11) possessed a near neutral pH of 6.67 and rapid re-dispersibility that was <141.5 s), which is acceptable for oral administration. Additionally, the FD-SOESS formulation revealed heterogeneous porous structures with a layered arrangement of different pore sizes, and the resulting formulation had low moisture content (2.76 %). The formulation met the microbial limit test. The antioxidant IC₅₀ of sesamin was found to be 0.318 μM. Furthermore, it was not toxic to periodontal cells at 50 μg/mL or 100 μg/mL. Human periodontal cell lines subjected to scratch and treated with FD-SOESS demonstrated notable migration that achieved complete wound closure within two days. The administration of FD-SOESS led to a notable elevation in the mucus concentrations found in the saliva samples of all participants. Overall, the results indicated that FD-SOESS is a highly promising alternative to saliva and may improve oral health for individuals suffering from dry mouth.

Physicochemical Properties, Heavy Metal and Pesticide Contaminations, and Microbial Limit Tests of Cannabis Oral Drops

Cannabis, a medicinal herb renowned for its therapeutic potential, is utilized in the treatment of various ailments, including the stimulation of appetite in cancer patients. In Thailand, the predominant dosage form is oral drops; however, the absence of robust quality control measures for these products poses significant health risks to patients. The primary objectives of this study were to formulate and evaluate cannabis oral drops, with a comprehensive evaluation encompassing physicochemical properties such as appearance, pH, Δ9-tetrahydrocannabinol, and cannabidiol contents. Furthermore, heavy metals (specifically arsenic, cadmium, and lead), pesticides (including pyrethroids, organochlorines, organophosphates, and carbamates), and microbial contaminations (Staphylococcus aureus, Clostridium spp., and Salmonella spp.) were evaluated. The results revealed that the optimal formulation, comprising cannabis extract derived from supercritical carbon dioxide fluid, vitamin E acetate, and medium-chain triglyceride oil, exhibited a pH of approximately 4.0, a Δ9-tetrahydrocannabinol content of approximately 27 mg/mL, and a cannabidiol content of approximately 9 mg/mL. Furthermore, there were no heavy metals or pesticides detected. Microbial limit tests demonstrated the absence of Staphylococcus aureus, Clostridium spp., and Salmonella spp. In conclusion, this endeavor successfully achieved the development of high-quality cannabis oral drops, showcasing the potential for safe and therapeutic use.

Quality of medicines for Cardio-Vascular Diseases (CVDs) in the Ethiopian border with Kenya: The case of enalapril maleate and furosemide tablet quality in Borena and Gedeo zones.

Hypertension (HTN), a cardiovascular disease (CV), is a major public health challenge. Therefore, the quality of drugs used to treat it has become a major concern. Enalapril and furosemide are among the drugs prescribed to manage hypertension. Hence, this study is aimed at evaluating the quality of different brands of enalapril and furosemide tablets available in the Gedeo and Borena zones, southern Ethiopia. Thirteen generic brands of enalapril maleate (5 mg) and furosemide (40 mg) tablets were evaluated for visual defects, in vitro dissolution test, weight variations, friability, hardness, and disintegration tests. The analysis of active pharmaceutical ingredient (API) content was performed by high performance liquid chromatography (HPLC). Out of 55 samples, 7 (12.73%) failed to comply with the criteria for visual inspection; otherwise, all samples passed the identification test. Except for one brand of each of enalapril maleate and furosemide, all passed the dissolution test. The assay value showed that all enalapril maleate samples were within the limits of United States Pharmacopoeia (USP), 2020. Additionally, except for two batches, all furosemide samples were within the USP and British Pharmacopoeia (BP), 2020 standards. Out of 55 samples, 8% (2/25) and 6.67% (2/30) of enalapril maleate and furosemide tablets failed the uniformity of dosage units test per the USP-2020, respectively. All samples passed the disintegration test, and selected furosemide samples passed the microbial limit tests. However, 36% (9/25) and 20% (6/30) of enalapril maleate and furosemide samples failed to pass hardness test. Generally, from the total samples, 50.91% (28/55) were substandard (did not meet the specifications failing any one or more parameters assessed). The studied drugs circulating in the market did not meet some of the needed quality specifications. This could have brought a risk of reduced efficacy due to the distribution of poor quality medicines in the area.

Microbiological acceptance criteria, specifications of herbal drugs and herbal drug preparations in various pharmacopoeias: a global scenario.

A pharmacopoeia is a compendium of guidelines and criteria for drug quality. It was established by a national or regional entity and has legal significance. This applies to administration of drugs in a particular nation or region. In this study, the differences and similarities of microbiological acceptance criteria, specifications for microbial enumeration of herbal drugs and herbal drug preparations in 14 national and international pharmacopeias were investigated. It was found that 12 pharmacopeias have given separate microbial limits for total aerobic microbial count (TAMC) and total yeast and mold count (TYMC), and a list of specified microorganisms for which acceptance criteria are defined. However, similarities were noticed in Ph.Eur, Ph. Helv and, BP. Salmonella, and Escherichia coli are the most common pathogens specified for herbal preparations in which boiling water is added prior to use and for internal use in all Pharmacopoeias because they serve as indicators of potential contamination. From this study, it can be concluded that the differences in microbial limit tests and their acceptance criteria as specified in the various pharmacopoeias need to be harmonized. It will become a more convenient option for global drug manufacturers to import/export herbal drugs, and this would also eliminate the burden of performing various analytical methods and comply with different microbial acceptance criteria set by various pharmacopoeias. The comparative data obtained from this study will be used to develop strategies for revisions of pharmacopoeias in a harmonized manner with respect to microbiological acceptance criteria, specifications for microbial enumeration of herbal drugs and herbal drug preparations.

Suitability of Culture Broth and Conditions for Escherichia coli Growth and Gas Production as a Test for Food Additives in EC Broth

The growth and gas production test for Escherichia coli in the microbiological examination of food additives is stipulated in the ninth edition of Japan's Specifications and Standards for Food Additives (JSFA) and described as a part of the "Confirmation Test for Escherichia coli" in "Microbial Limit Tests" in the same manuscript. The growth and gas production test for E. coli indicated that the positive or negative of "gas production and/or turbidity" in EC broth should be confirmed after incubating at 45.5±0.2℃ for 24±2 h. If both gas production and turbidity are negative, the culture is additionally incubated up to 48±2 h to determine E. coli contamination. The internationally referenced Bacteriological Analytical Manual of the U.S. FDA had revised the incubation temperature in tests for coliforms and E. coli from 45.5±0.2℃ to 44.5±0.2℃ in 2017. Therefore, we conducted research in anticipation of this temperature change being reflected in the microbiological examination of the JSFA. We used seven EC broth products and six food additives across eight products that are available in Japan in order to compare the growth and gas production at temperatures of 45.5±0.2℃ and 44.5±0.2℃ of E. coli NBRC 3972, which is designated as the test strain in JSFA. Both with/without food additives, the number of EC broth products in which medium turbidity and gas production by the strain were positive in three out of three tubes at all test times was greater at 44.5±0.2℃ than at 45.5±0.2℃. These results suggest that the growth and gas production test for E. coli could be more appropriately conducted by incubation at 44.5±0.2℃ in the "Confirmation Test for Escherichia coli" for E. coli in the JSFA in comparison to 45.5±0.2℃. Furthermore, there were differences in the growth and gas production of E. coli NBRC 3972 depending on the EC broth product used. Therefore, the importance of "Media growth promotion test" and "Method suitability test" in the ninth edition of the JSFA should be emphasized.

Study on Applicability of Microbial Limit Test for Xiangju Tablets

Study on Applicability of Microbial Limit Test for Xiangju Tablets

Evaluation of the Pharmaceutical and Microbial Safety, as well as the Reliability, of Some Natural Pharmaceutical Products Available in Iraq.

The use of natural pharmaceutical products (NPPs) for the treatment or prevention of diseases is continuously increasing. The ease of obtaining them without professional observation, as well as the incorrect popular belief that natural products are completely safe, increase the possibility of harmful and toxic effects of such products. In this study, some of the widely sold NPPs in Iraqi markets were evaluated for their pharmaceutical and microbial legibility to be consumed by humans. The evaluation includes organoleptic properties, foreign matters, loss on drying, water content, total ash percentage, heavy metal tests, aflatoxins, as well as microbial limit tests. The results revealed that some of the evaluated products were contaminated with heavy metals, lead, mercury, and cadmium. Additionally, pathogenic bacterial growth, including Salmonella species and E. coli, was detected. A high percentage of loss on drying and water content was detected in some of the tested products. All tested samples showed negative results for aflatoxins. Some of the evaluated products were pharmaceutically and/or microbiologically unacceptable and not safe to be consumed by humans. Serious and fast measures must be taken by the Drug Regulatory Authority of Iraq to issue more rigorous standards for the quality of NPPs with continuous monitoring and control of the marketed NPPs.

Quality of Oral Drug Formulations of Artemisinin-Based Combination Therapy Sold in Katsina State, Nigeria

There are increasing reports of substandard antimalarial drugs, and these have been a severe under-recognised public health problem especially in developing countries. For this reason, 21 samples of different brands of artemisinin-based combination therapies (ACTs) comprising of artemether/lumefantrine and artesunate/amodiaquine oral drug formulations that are available on sale in different hospital pharmacies and patent medicine stores in Katsina State, Nigeria were evaluated for microbial and chemical qualities. Microbial limit test (MLT) and assay for the content of the active pharmaceutical ingredients (APIs) using standard high performance liquid chromatography (HPLC) procedures were carried out as described in the official monograph of the United States Pharmacopoeia (USP) and the International Pharmacopoeia (IP). The results obtained had indicated that all the ACTs oral drug preparations were free from microbial contamination except one sample of artesunate-amodiaquine showing viable total combined yeasts/moulds count (TYMC) of 1.0 x 101 colony forming units (CFU)/g. All the samples complied with the USP and IP criteria for the microbiological quality of non-sterile oral dosage forms. On the other hand, 10 (47.6%) out of the 21 samples met the specific chemical quality standards. Moreover, 8 (57.1%) and 3 (42.9%) of the artemether/lumefantrine and artesunate/amodiaquine had active ingredient outside the set pharmacopoeial limit and, therefore, were none compliant to the IP specifications for percentage content. The presence of substandard ACTs may lead to possible therapeutic failure from the use of such kind of formulations, facilitate the development and spread of drug-resistance. There is the need for effective government regulation and adequate enforcement on the production, distribution and sales of good quality medicines.

Microorganism Determination of 10 Proprietary Chinese Medicines for Children by Plate Culture or Membrane Filtration.

Objective This study attempted to verify the applicability of the microbial limit test (plate culture and membrane filtration) for 10 proprietary Chinese medicines for children. Methods In this study, we collected 10 proprietary Chinese medicines for children as study objects and performed plate culture and membrane filtration to calculate the colony-forming unit (cfu) of microorganisms in these medicines and verify its applicability in objectionable microorganisms. Results It was found that the recovery rate of microorganisms including Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger ranged from 70% to 150%. This verification was performed by plate culture or membrane filtration. Inspection for objectionable microorganisms (Escherichia coli, Salmonella paratyphi B, and bile salt-tolerant Gram-negative bacteria) was applicable for most medicines. Conclusion Microbial limit test is feasible for the determination of microorganisms in 10 proprietary Chinese medicines for children.

Liquisolid Orodispersible Tablets of Valeriana officinalis L. Root Extraction: Formulation, Development and Evaluation

Background: Valerian root extract is used in traditional medicine to treat sleep disorders. According to previous studies, sedative effects are related to the presence of valerenic acid. Formulating orodispersible tablets (ODTs) is an effective and cost-benefit technique for accelerating drugs' therapeutic effects. This study aimed to formulate ODTs of valerian root extract and evaluate their properties. Materials and Methods: Valerian root was extracted by percolation in 70% ethanol. The solubility of valerenic acid was investigated in various liquid carriers. The extract was uniformly dispersed in the selected carrier (Tween 80), then mixed with other excipients, and compressed into tablets. Fourteen formulations with different amounts of sodium starch glycolate (SSG, as a super disintegrant) and camphor (as a sublimating agent) were prepared. The physicochemical properties of the ODTs, drug release rates, and microbial limit tests (MLTs) were studied. Results: Both SSG and camphor accelerated tablet disintegration rates and their composition showed a synergistic effect (P&lt;0.05). The infrared spectroscopy revealed no chemical interaction between formulation components. The MLTs confirmed that a limited number of microbial colonies were grown in the liquid medium, and no pathogen growth occurred in the specific culture media. Conclusion: The results revealed that Valerian ODT's physicochemical properties were significantly improved compared to conventional tablets. The technique can be utilized for other poorly watersoluble pharmaceuticals.

FORMULATION, EVALUATION, AND IN VIVO ANTI-INFLAMMATORY AND ANTI-ARTHRITIC ACTIVITIES OF MORINGA GRANULES

Objective: Consumption of crude natural products like plants and herbs for mitigation or treatment of illnesses usually accompanied with inconsistent therapeutic effects because of poor solubility and low bioavailability of active phytochemical(s) in addition to product instability. To overcome all of above mentioned drawback ethanol extract of Moringa oleifera leaf was formulated as standardised solid dosage form.&#x0D; Methods: Different types of materials as an adsorbent, surfactant and other necessary excipients were tested to be use in formulation of Moringa granules utilising wet granulation method. The formulated Moringa granules was then evaluated for organoleptic properties and physical characteristics, in vitro dissolution test, compatibility, drug content, heavy metal tests and microbial limit tests. Additionally, the in vivo anti-inflammatory against Carrageenan-induced paw oedema and anti-arthritic activity against CFA-induced arthritis were also assessed.&#x0D; Results: 95% ethanol extract of M. oleifera leaves was successfully formulated as standardised granules for oral administration utilising simple and low-cost techniques. Dissolution rate for the marker compounds was increased by an average of 1.076 fold. Animal groups given the prepared Moringa granules showed an improvement in the anti-inflammatory activity and the anti-arthritic activity compared to animal groups given crude extract at the same dose level. Additionally, all the treatment groups showed a significant difference at P&lt;0.05 and P&lt;0.01 compared to control group.&#x0D; Conclusion: To the best of our knowledge, this work was the first to use gum Arabic in the formulation of a standardised botanical pharmaceutical dosage form of M. oleifera crude extract. Additionally, formulation of Moringa granules apparently improves the drug release profile and bioactivity compare to Crude Moringa extract.

Preliminary screening method of Escherichia coli in oral drugs by visual LAMP technology

According to Chinese Pharmacopoeia, Escherichia coli should not be detected in oral drugs. In this study, a visual LAMP method for rapid detection of Escherichia coli was developed to replace the traditional microbial limit test method. Methods Four specific primers (FIP, BiP, F3, B3) for loop mediated isothermal amplification were designed by using uidA gene of Escherichia coli, and calcein-Mn2+ dye was added to the system to establish a visual loop mediated isothermal amplification detection method for Escherichia coli Finally, the visual LAMP system was used to detect the presence of E.coli and the sensitivity of the system in drugs. Results The specificity of the optimized system was good, using this system to detect 10 different strains, the results showed that only Escherichia coli genome appeared, the system turned green, the other systems were brown yellow; the detection limit of gradient dilution Escherichia coli was 102 CFU/mL by LAMP. Visual LAMP was used to detect the oral drugs sold in the market and not passed the test of the drug administration, and no E.coli was detected, but the oral drugs that were artificially contaminated with E.coli were visualized by LAMP. The color detection limit of the system in oral drugs was 1.8×102 CFU/mL. Conclusion The visual LAMP detection system can be used for the preliminary detection of oral drugs containing Escherichia coli.

Why it’s time to strengthen and widen the microbial test panel

The testing of culture media, and conducting microbiological method suitability studies, disinfectant efficacy studies, Antimicrobial Effectiveness Test (or Preservative Efficacy Test) and associated activities, requires the use of a test panel of microorganisms. These organisms need to be representative of the intended application and be of a suitable range in order to demonstrate that a low level of viable cells can be recovered without any indication of the inhibition of growth or excessive growth-promotion (typically defined as the recovery of between 50 to 200% of the challenge count). This activity provides the basis for the release of culture media or for verifying that a method is suitable for recovering any microorganisms that might be present in a product sample. This approach has been established for several decades and in many cases the types of organisms selected for the panel are drawn from guidance presented in the major pharmacopeia. The test panels of organisms recommended by compendia along with specific standards are in place to allow for reproducibility between laboratories. In the case of most standards (such as the disinfectant efficacy norms), these are designed to be multi-industry. Hence the presented organisms may or may not be suitable for the intended application. In addition, with the compendia, all too often the organisms recommended for, say, the Microbial Limit Test method verification, are applied to the release of all culture media used for all activities, be that the test for sterility or for the recovery of organisms from water systems. Not only is this inappropriate – for the microbiologist should be reviewing the panel and deciding upon the appropriate organisms – the recommended panels have not kept pace with improvements with our understanding of the types of microorganisms likely to cause contamination. Take, for example, the inclusion of Salmonella in the panel for the recovery of so-called ‘objectionable microorganisms’ for use with the Microbial Limits Test ¹. To my knowledge and based on discussions with microbiologists over a couple of decades, no Salmonella has ever been recovered from a raw material. Equally the selection, especially in relation to the testing of culture media used for cleanroom environmental monitoring, has not moved forwards with the findings from the human microbiome project and the depth of species richness found on the human skin microbiome. The argument that the test panel quoted in the compendia is representative and thus if culture media release testing can recover such organisms then it can reasonably be assumed that any other similar organisms can be recovered does not really hold up. Unless, that is, the only concern is with the recovery of non-fastidious mesophilic organisms. Instead, I maintain that in terms of the appropriate panel, this should be based on: • What is currently being recovered, and • What should theoretically be recovered.

Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’

Background: the assessment of microbiological quality of medicinal products is one of control stages in medicinal products saft, because the holder of a manufacturing authorization must drug so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. Objective: To assess microbial limit test for hospital preparation ‘compound alum powder’. Methods: The results of strain culture and analysis were used to evaluate the drug quality of ‘compound alum powder’. The objective is ‘compound alum powder’ (approval number: Z20140229) was made by the First Affiliated Hospital of Jinan University. Their batch numbers include: 201019, 200818, 200701. Validation tests were carried out in accordance with the standards of the Chinese Pharmacopoeia (2020 edition). Three parallel independent validations were conducted to calculate the recovery rate of each test bacterium and investigate whether each test bacterium was detected in the control bacterial inspection. Result: The recovery ratio of the total number of aerobic bacteria, molds and yeast in the control group was in the range of 0.5 ~ 2, and the results of the control group were positive, and the results of each control group met the requirements. The results show that the membrane filtration method is suitable for the microbial limit test of ‘compound alum powder’. Conclusion: this microbial limit test method control and ensure the quality of drug production by solving the problem of interference of antimicrobial components in drugs. It can eliminate the bacteriostasis of boric acid, phenol and alum.

Establishment of a Method to Allow Microbial Limit Testing of Iodine-containing Preparations

Background: Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on the therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Iodine can inhibit and kill microorganisms in pharmaceutical preparations. The risk of microbial contamination of cellular products can be reduced when cultured in the presence of iodine. This however, may impact the sensitivity of microbiological tests. Iodine-containing Preparations does not guarantee sterility but may just reduce the proliferation rate of microorganisms, microbiological testing of medicinal products remains obligatory. Thus, an appropriate method to test for microbial contamination of iodine-containing products has to be validated. Objective: To establish a method that would allow microbial limit testing of four iodine-containing preparations (concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin). Methods: To specifically determine the degree of contamination in the four in-house iodine preparations, sodium thiosulfate was used to reduce the iodine molecules to iodide ions, thereby eliminating the intrinsic antibacterial property of the preparations. Then, the suitability of this method was evaluated according to the regulations for non-sterile microbial limit tests. Results: The neutralization method effectively eliminated the interference of the antibacterial iodine component, rendering the control bacteria detectable. The recovery ratio of the test strains met the required standards. Conclusion: The neutralization method with sodium thiosulfate as the iodine neutralizer is suitable for microbial limit testing of concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin, with the results being accurate and reliable.

Pharmacognostic studies on Zingiber officinale roscoe

Zingiber officinale (Ginger), one of the best-known spices, is highly esteemed for its pleasant, aromatic odour and warm, pungent taste. It is widely used in dried, preserved and green forms. It is widely used for flavoring a great variety of foods and in several nations for its medicinal properties. Ayurvedic texts report several medicinal applications of ginger in India. Ginger is considered a tonic for the digestive tract, stimulating digestion and toning the intestinal muscles. Ginger preparations are clinically useful to alleviate osteoarthritis or other pain; it also exerts in vitro antioxidative, antitumorigenic and immunomodulatory effects and is an effective antimicrobial and antiviral agent. Keeping all these points in a view in the present study aims at standardization of Zingiber officinale by pharmacognosy approach. Physicochemical and microbial limit test results revealed that parameters were found to be within the permissible limits. The microscopic and anatomical studies characters were unique. Further, phytochemical screening exhibited the presence of secondary constituents and TLC profiling of the samples illustrated bands when observed in visible light, under UV and also when sprayed with reagen.

Development of Lidocaine-Loaded Dissolving Microneedle for Rapid and Efficient Local Anesthesia.

Lidocaine is a local anesthetic agent used in the form of injection and topical cream. However, these formulation types have limitations of being either painful or slow-acting, thereby hindering effective and complete clinical performance of lidocaine. Dissolving microneedles (DMNs) are used to overcome these limitations owing to their fast onset time and minimally invasive administration methods. Using hyaluronic acid and lidocaine to produce the drug solution, a lidocaine HCl encapsulated DMN (Li-DMN) was fabricated by centrifugal lithography. The drug delivery rate and local anesthetic quality of Li-DMNs were evaluated using the pig cadaver insertion test and Von Frey behavior test. Results showed that Li-DMNs could deliver sufficient lidocaine for anesthesia that is required to be utilized for clinical level. Results from the von Frey test showed that the anesthetic effect of Li-DMNs was observed within 10 min after administration, thus confirming fast onset time. A toxicity test for appropriate clinical application standard was conducted with a microbial limit test and an animal skin irritation test, showing absence of skin irritation and irritation-related microorganisms. Overall, Li-DMN is a possible alternative drug delivery method for local anesthesia, meeting the requirements for clinical conditions and overcoming the drawbacks of other conventional lidocaine administration methods.

Topical green tea formulation with anti-hemorrhagic and antibacterial effects.

Objective(s):Potentially preventable death from uncontrolled hemorrhage clearly indicates the importance of simple, fast and efficient ways to achieving hemostasis. The aim of this study was to develop a topical formulation of green tea extract for reducing bleeding that can be helpful in hemorrhage control.Materials and Methods:Hydroalcoholic extract of green tea was isolated from Camellia sinensis and formulated in polyvinyl alcohol (PVA) to achieve two concentrations of 2% and 4% v/v. Folin-Ciocalteau assay was used to determine the total amount of tannins in extract. Rheological behavior of solutions was investigated by measuring viscosity at shear rates of 0–200 sec−1. Quantitative and qualitative microbial limit tests and minimum inhibitory concentration (MIC) assay were done. The effect of formulations on bleeding time was evaluated in an animal model. Results:The total amount of tannin in green tea extract was 3.8% w/w and addition of green tea significantly increased the viscosity of PVA. The results of MIC assay showed that PVA could not inhibit the growth of bacteria, while, 716 µg/ml of green tea and 2860 µg/ml of green tea/PVA 4% inhibited the growth of Staphylococcus aureus and Pseudomonas aeruginosa. In an animal study both 2% and 4% formulations were able to stop hemorrhage approximately at an equal time compared with tranexamic acid (TXA) 50 mg/ml as a control and the lowest bleeding time was 6.4±0.51 sec for green tea/PVA 4%.Conclusion:Based on our results, the topical formulation of green tea extract in PVA has a great potential for anti-hemorrhage applications.

Characterization and antimicrobial study of Trinakantamani (Amber) Pishti.

Background:Trinakantamani Pishti (TMP) is a cardio-tonic (Hridya), styptic (Rakta Stambhaka), astringent (Kashaya) formulation frequently used in varieties of bleeding disorders such as bloody diarrhea (Raktatisaara), Raktarsha (bleeding piles), and disorders of excessive menstruation (Atyartava). Still, no published data is available regarding its characterization.Aim:To generate a fingerprint for raw and processed TMP using sophisticated instrumental techniques to assess antimicrobial activity of TMP.Materials and methods:Three samples of TMP were prepared using the standard reference method. Characterization of TMP was carried out by Fourier-transform infrared spectroscopy (FTIR), energy dispersive X-ray analysis (EDEX) with scanning electron microscopy, powder X-ray diffraction (XRD). Antibacterial activity was carried out by the well-diffusion method.Results:Analysis by scanning electron microscope revealed maximum particle size <5 μm and <3 μm in the raw sample and TMP, respectively. Minimum particle size in TMP ranges from 1 to 2 μm and 701 nm. EDEX analysis shows carbon and oxygen as major constituents while Na, Mg, Ca, Si, Fe, and S were present in traces. XRD pattern indicates the amorphous nature of the drug, while FTIR analysis reveals the presence of functional groups such as O–H, CO2, C = O, C-N, N–H. Heavy metals, total microbial count, and microbial limit test were found to be under permissible limits. Anti-microbial study against tested pathogens Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Salmonella typhimurium did not show any effect of TMP.Conclusion:The results of EDEX study showed that Pishti samples have the small particle size i.e., 701nm than the raw i.e., 1-2 μm, which may facillitate absobtion of drug into the body. All heavy metals in the samples were within the permissible limit. Carbon, hydrogen and oxygen are the chief elements of drug which confirms similarity to the Amber, Since the present work is the first published literature on characterization and anti-microbial study on TMP, the outcome can be considered as fingerprint for the drug prepared using the mentioned reference method.

Pharmacognstic evaluations of Persea americana mill

The ripe Persea Americana or avocado fruits consists of the hard peel, the pulp with a butter-like consistency and a peculiar nutty flavour, and the seed. The fruit is eaten as salad flavoured with pepper, salt or sugar. It is also used in soups and ice-cream. Avocado oil obtained by pressing the dried pulp, has a heavy consistency, a week odour and a taste reminiscent of hazelnuts. It commands high price and is valued for use in cosmetic preparations and as a high grade salad oil. It is also used in superior quality soaps and in pharmaceuticals. The meal left after the extraction of oil from the pulp is also used as an animal feed or as manure. In the present study the parameters viz., physicochemical, Organoleptic, TLC and Microbial limit tests are studied to standardise this plant by pharmacognosy.