Edition Of Pharmacopoeia Research Articles

Validation of the UV Spectrophotometric Method for Determining the Content of Ranitidine HCl Tablets in HCl

Introduction: Ranitidine HCl tablets are widely available in the market. Ensuring the proper levels of active ingredients is crucial for ensuring the quality of medications. Objective: To find a reliable method for measuring the levels of Ranitidine HCl tablets in acidic solvents that meet validation standards, and to explore valid methods using ultraviolet spectrophotometry in acidic solvents. Methods: UV spectrophotometry with a UV detector at maximum wavelength was used. Two solvents were employed: 0.10 N HCl and 0.15 N HCl. Method validation included tests for linearity, accuracy, repeatability, precision, and selectivity. Results: The maximum wavelengths detected for each solvent were 225 nm and 226 nm, respectively. Validation results indicate excellent linearity, accuracy, and precision within the ranges of 0.9984 - 0.9998; 99.6% - 100.7%; 0.427% - 0.861%; 0.518% - 0.952%. The selectivity test yielded positive outcomes. The average Ranitidine HCl tablet levels were 98.2% for PT. Hexpharm Jaya and 98.4% for PT. Mutifa Medan, meeting the standards of the Indonesian Pharmacopoeia Edition VI. Conclusion: The method using a 0.10 N solvent for determining Ranitidine HCl tablet levels meets validation requirements and is suitable for practical application.

Quality and potency of government-subsidized antibiotics in hospitals Jakarta, Indonesia

Several pharmaceutical companies have long complained that the price of medicines that win the e-catalogue tender is too low, in some cases even below the cost of production. However, it should not be a concern that only pharmaceutical products with regulation of Indonesian food and drug (BPOM) distribution licenses are eligible for the price tender, as they are of good quality. This study aims to determine the quality and potency of three antibiotic drugs based on their highest utilization (DU 90%) in pneumonia patients at two hospitals, A (ceftriaxone, azithromycin tablet) and B (ceftriaxone, levofloxacin infusion) compared to brand name. The quality of the samples was evaluated following the Indonesian Pharmacopoeia 6th Edition (FI-VI). Antibiotic potency was assessed using the Plate-Cylinder Method with K. pneumonia from human and S. pneumonia ATCC 10015 as the test bacteria evaluated following CLSI. All samples meet the criteria of FI-VI antibiotic content, weight uniformity, dissolution. Antibiotic potency all samples test S.pneumonia and K.pneumonia were sensitive but ceftriaxone test with K.pneumonia was resistance. All antibiotic tablets and injections studied met the requirements of the Indonesian Pharmacopoeia Edition 6 for active medicinal ingredient content, dosage weight uniformity, and dissolution. All drugs from hospitals (INN) have lower antibiotic potency than branded drugs. This highlight the importance of conducting microbiological testing on antibiotic preparations.

PENGARUH VARIASI WAKTU PANEN TERHADAP KADAR FLAVONOID TOTAL DAUN KUMIS KUCING (Orthosiphon aristatus (Blume) Miq.)

Harvest time influences the formation of optimal active compound content in the areal parts in plant. It is known that differences in harvest time can affect the quality and quantity of traditional plant. Flavonoids are known to be active metabolites in Orthosiphon aristatus with a wide range of bioactivity. This research aims to determine the best harvest time for Orthosiphon aristatus leaves in order to obtain optimal simplicia quality. Plants were harvested in in the morning (06.00-07.00 WIB), in the afternoon (12.00-13.00 WIB) and in the evening (17.00-18.00 WIB). The picked leaves are then sorted, washed and dried using a drying oven before each simplicia is extracted. Extraction uses a maceration technique with 96% ethanol solvent. The simplicia and extracts obtained were analyzed for organoleptic, yield, drying loss and qualitative and quantitative analysis of total flavonoid compounds. Qualitative identification of flavonoids used dilute NaOH, Wilstater Cyanidin, and AlCl3 reagents, while for quantification total flavonoid levels were measured using UV-Vis spectrophotometry as Quercetin Equivalent. The difference in harvest time did not affect the organoleptic properties of leaves. The drying loss of simplicia meets the requirements in the Indonesian Herbal Pharmacopoeia Edition II (less than 10% w/w). The highest yield of simplicia (23.8% w/w) and extract (11.3% w/w) was produced during the harvest time of 12.00-13.00 WIB, followed by harvesting at 17.00-18.00 and 06.00-07.00 WIB. All extracts contain flavonoids, while the total flavonoid content in each extract showed significant differences. The highest total flavonoid content (4.423+0.029 mgQE/g extract) was related at the harvest time of 17.00-18.00 WIB and the lowest value (4.331+ 0.026 mgQE/g extract) was recorded at the harvest time of 06.00-07.00 WIB. Our findings in Orthosiphon aristatus, may pave the route towards the optimization of quality and quantity by selecting the best harvesting time of the plants.

ANALISIS KADAR PARASETAMOL GENERIK DIBANDINGKAN BERMEREK DAGANG

Paracetamol is a substance that can reduce the fever (antipyretic) and relieve the pain (analgesic). Analysis of the levels of generic and branded paracetamol tablets was carried out to determine whether the levels of the active substance in the preparations met the requirements or not by using the High Performance Liquid Chromatography method. The paracetamol quantitative test obtained the results of the levels in sample A = 94.306%, sample B = 99.986%, sample C = 95.296% and sample D = 94.904%. These results indicate that the level of the active substance paracetamol in each sample still meets the requirements of the Indonesian Pharmacopoeia Edition IV, namely not less than 90% and not more than 110%. Statistical analysis using the t-student test, the results of t-count < t-table (0.026 < 2.35) at a significant level of 5%, with the conclusion that there is no significant difference between generic paracetamol and branded paracetamol were analyzed using High Performance Liquid ChromatographyIV, namely not less than 90% and not more than 110%. Statistical analysis using the t-student test, the results of t-count < t-table (0.026 < 2.35) at a significant level of 5%, with the conclusion that there is no significant difference between generic paracetamol and branded paracetamol were analyzed using High Performance Liquid Chromatography.

Validasi Metode dan Penetapan Kadar Sirup Kering Cefadroxil dengan Metode FTIR-ATR

Cefadroxil is a broad-spectrum bactericidal antibiotic belonging to the first group of cephalosporins produced by the fungus Cephalosporium acremonium. This study aims to validate the method and determine the concentration of cefadroxil dry syrup using FTIR-ATR. The method used is FTIR-ATR with aquabides as a solvent. Parameter Validation of the analysis method carried out includes linearity, accuracy, precision, Limit of Detection (LOD) and Limit of Quantification (LOQ). The results of the linearity test show a value of r = 0.999 which indicates linear. The accuracy obtained is 97 - 105.5%. Precision with an Relative Standard Deviation (RSD) value of 0.54%, LOD of 469.72 µg/mL and LOQ of 1423.6 µg/mL. The results of determining the levels of cefadroxil dry syrup with three samples, namely sample A 100.2%; sample B 100.5%; sample C 100.1%. Based on the research results, it can be concluded that the FTIR-ATR method is valid and the sample concentration complies with the provisions of the Indonesian Pharmacopoeia Edition VI, namely the concentration of cefadroxil in dry syrup preparations is not less than 90% and not more than 120%.

Assay of Diphenhydramine HCl in Syrup by High Performance Liquid Chromatography

Cough is a natural response from the respiratory tract by increasing the clearance of secretions and particles from mucus, irritants, foreign particles, and microbes, so that it can act as a body defense. One way that can be done to relieve cough symptoms is to use symptomatic drugs. Diphenhydramine HCl is an antihistamine that belongs to the first generation H1 receptor antagonist (H1 blocker) group which has sedative and anti-allergic properties. Diphenhydramine HCl is used to treat sneeze, runny nose, watery eyes, itches, skin rashes, and other cold symptoms or other allergies. Diphenhydramine HCl is also used to treat motion sickness and to induce sleep. The purpose of this study was to determine the contents of diphenhydramine HCl syrup sold in the market. This test uses the High Performance Liquid Chromatography (HPLC) method with acetonitrile as a mobile phase; water; triethylamine (50;50;0.5). The results obtained the average content of Diphenhydramine HCl 102.5%. So it can be concluded that the cough medicine sample meets the requirements because the contents are not less than 90% and not more than 110% based on the Indonesian Pharmacopoeia Edition VI 2020.
 Keywords: Cough, Diphenhydramine HCl, High Performance Liquid Chromatography (HPLC)

Formulasi tablet hisap ekstrak etanol daun kemangi (Ocimum sanctum L.) dengan variasi konsentrasi bahan pengikat gelatin

Basil leaves (Ocimum sanctum L.) contain secondary metabolites as inhibitors of the growth of pathogenic microbes in the mouth, so they can be used as lozenges. The choice of binder in the formulation is very important, because it can affect the physical properties of the tablet. The purpose of this study was to determine the content of secondary metabolites in basil leaf extract and determine the best formula for lozenges of ethanol extract of basil leaves based on variations in gelatin binding agents. Basil leaves were extracted using the sonication method with 96% ethanol solvent and subjected to phytochemical screening (test tube and TLC). Tablets were formulated using the wet granulation method with variations of gelatin in formula 1 (5%), formula 2 (7.5%), and formula 3 (10%). The physical properties of the granules are evaluated and compressed. The resulting tablets were evaluated for physical properties. The results showed that basil leaves contained compounds belonging to the class of flavonoids, saponins and tannins. The results of the granule flow time test for formula 1 and 2 did not meet the requirements, formula 3 met the requirements for the Indonesian Pharmacopoeia Edition III. The angle of repose, settling, and granule water content tests (formula 1, 2, and 3) met the requirements of the Indonesian Pharmacopoeia Edition III. The results of tablet evaluation in the weight uniformity test for formulas 1, 2, and 3 were 257 mg ± 0.226; 248 mg ± 0.068 and 253 mg ± 0.157. Tablet hardness test of 3.721 kg ± 0.268; 4.221 kg ± 0.929 and 6.636 kg ± 1.035. Tablet friability test of 3.4% ± 0.152; 1.1% ± 0.264 and 0.9% ± 0.1. The disintegration time test was 7.6 minutes ± 2.452; 11 minutes ± 2.154 and 18.6 minutes ± 4.016. From this study it can be concluded that the ethanol extract of basil leaves has secondary metabolites of flavonoids, saponins and tannins. Variations in gelatin binder affect the physical properties of the tablet, where the concentration of gelatin binder is best in formula 3 (10%).

System optimization and validation to improve thin-layer chromatography of roselle calyces (Hibiscus sabdariffa L.) required by the Indonesian Herbal Pharmacopoeia Edition II

Context: Roselle (Hibiscus sabdariffa L.) is one of the traditional crude drugs monographed in the Indonesian Herbal Pharmacopoeia Edition II (IHP II). As per IHP II requirements, a TLC pattern should be used in its authentication. However, the TLC system described for this purpose does not produce a clear reference chromatogram, often leading to inconclusive results. Aims: To develop and validate TLC systems of H. sabdariffa calyces for a better-quality chromatogram than those listed in the IHP II, thereby facilitating crude drugs authentication. Methods: To optimize TLC for H. sabdariffa, sixteen systems, differing in stationary phase, mobile phase composition, and/or visualization reagent were tested. The TLC system was then validated using several parameters such as analyte stability during chromatography, analyte stability in the extract solution and on the TLC plate, stability of the derivatization result, and precision on a plate as well as intermediate precision. Results: Two systems (I and II) were successfully designed and applied to evaluate H. sabdariffa quality. System I used Si gel 60 F254 for the stationary phase, ethyl acetate-formic acid-glacial acetic acid-water (100:11:11:2) for the mobile phase, H. sabdariffa’s ethanol extract (5%, 20 µL) for the test solution, cyanidin 3-O-glucoside (100 ppm, 4 µL) as a reference, no derivatization, and detection with visible light. System II combined Si gel 60 F254 for the stationary phase, ethyl acetate-formic acid-glacial acetic acid-toluene-water (80:11:11:20:19), H. sabdariffa’s ethanol extract (5%, 20 µL) for the test solution, chlorogenic acid (1000 ppm, 2 µL) and caffeic acid (50 ppm, 2 µL) as references, the visualizing reagent NP/PEG, and investigation under 366 nm UV light. Conclusions: Both systems are simple but have good stability and precision, thus facilitating H. sabdariffa calyx authentication and paving the way for developing content analysis methods for H. sabdariffa markers.

Interaction between Chinese medicine and digoxin: Clinical and research update.

Background: Digoxin is one of the most widely and commonly used cardiac drug, which plays an irreplaceable role in treating heart failure and arrhythmia. The 2010 Edition of Pharmacopoeia of the People's Republic of China stipulates that the effective range of digoxin plasma concentration is 0.5-2.0ng/mL and it is toxic at plasma concentration >2ng/mL. Its effective plasma drug concentration is close to the toxic concentration, and large individual differences in the effects of the drug have been observed. It is often used in combination with other drugs, but drug interactions have a great impact on the plasma concentration of digoxin and lead to adverse reactions (ADRs), such as poisoning. Most of the reported drug interactions are with Western drugs. However, there are many combinations of traditional Chinese medicine (TCM) and Western drugs, TCM interacting with digoxin comprises monomer components, single medicines, and Chinese patent medicines. Aim of the study: We aimed i) to provide an overview of the TCM formulations affecting the pharmacology of digoxin and their mechanisms of action and ii) to provide a theoretical reference for the safe and rational use of digoxin in combination with TCM in clinical practice and to avoid ADRs. Methods: A literature search of electronic databases, including PubMed, MEDLINE, Cochrane Library, Web of Science, China National Knowledge Infrastructure, and WANFANG Data, was performed to search for articles published between 1 January 1960, and 1 August 2022. Search terms used included "digoxin," "traditional Chinese medicine," "Chinese patent medicine," and "adverse reactions" and their combinations. Results: A total of 49 articles were obtained, including clinical reports, pharmacological experiments and in vitro experiments. The mechanisms of action affecting the pharmacology of digoxin are complex. TCM formulations may affect the pharmacology of digoxin in vivo by influencing gastrointestinal motility or gastric juice pH, regulating P-glycoprotein levels, exerting cumulative pharmacological effects, and enhancing the sensitivity of the heart to digoxin. Although studies have shown that some TCM formulations interact with digoxin, they may be influenced by the complexity of the composition and the pharmacological effects of the TCM, the sensitivity of digoxin concentration determination methods, etc. The results of existing studies are controversial and further in-depth studies are required. Conclusion: Combinations of digoxin and TCM formulations are commonly used. This article serves as a reference to understand the interactions between TCM formulations and digoxin to avoid the occurrence of ADRs and improve the efficacy and safety of digoxin.

PENETUAN KADAR ZAT AKTIF PADA FLUOCINOLONE ACETONIDE CREAM DENGAN METODE SPEKTROFOTOMETRI UV- VIS

Fluocinolone Acetonide Cream is a topical medication used to treat itching, redness, dry skin, crusting, inflammation, and discomfort of various skin conditions. This research was conducted to determine the levels of the active substance contained in Fluocinolone Acetonide Cream. Testing the levels of active substances is carried out to ensure the levels of active substances are in accordance with predetermined requirements. The side effect of the active substance is that if the drug has excess levels of the active substance it will endanger the drug user and if there is a deficiency of the active substance, the drug will not have any reaction. at a wavelength of 200-300 nm and the maximum wavelength of the Fluocinolone Acetonide Cream test is 238. The test results for determining the levels of active substances in the sample are 98.99% and 99.14% where the specifications used are between 90% - 110%. These results indicate that the sample levels fall within the specifications established by Pharmacopoeia edition I and II 2009.

Small regions as key sources of traditional knowledge: a quantitative ethnobotanical survey in the central Balkans

BackgroundStarting from the idea that unexplored areas may yield new and different ethnobotanical information, we performed a survey of traditional uses of plants in two neighboring districts situated in east Serbia (Bor and Aleksinac), both lacking in previous ethnobotanical reports, but characterized by an interesting history and culture, together with some specific features. In this study, we hypothesized that such small and specific areas could be of high ethnobotanical importance.MethodsSemi-structured interviews were used with 155 informants. Relative cultural importance (RCI) indices, such as the frequency of citation (FC), relative frequency of citation (RFC), relative importance index (RI), informant consensus factor (ICF-FIC), use value (UV), fidelity level (FL) and Jaccard index (JI), were calculated, and principal coordinate analysis (PCoA) was performed.ResultsIn this study, 2333 use-reports and 114 plants were recorded. Of the 101 medical herbs, 33 are included in the European Pharmacopoeia Edition 8.0. The most frequently used mode of preparation was as an infusion (50.0%), while leaf (44.7%) was the most used plant part. The highest FC and RFC values were recorded for Hypericum perforatum L. (13.1 and 0.2, respectively), while the highest RI was documented for Urtica dioica L. (1.0). ICF and FL indices showed important differences among selected groups of informants. The PCoA showed three homogeneous plant groups. Plants were mostly used for the treatment of digestive (49.1%), circulatory (41.2%) and respiratory system disorders (35.1%). Thirty-seven (32.5%) herbs were used for human nutrition, 14 (12.3%) in veterinary medicine, 17 (14.9%) in rituals and ethnoculture, while 24 (21.0%) for miscellaneous purposes. The highest degree of similarity was determined with studies conducted in close proximity. Four species are new to Balkan ethnobotany. New uses for some well-known plants are highlighted.ConclusionThe study indicated that small and specific areas in the Balkans may be an important reservoir of ethnobotanical knowledge.

ACUTE TOXICITY TEST OF ETHANOL EXTRACT OF SUNGKAI LEAF (Peronema canescens Jack) IN WHITE MICE (Mus musculus)

Sungkai (Peronema canescens) is a type of plant that can be used in traditional medicine in Jambi, Indonesia. The purpose of the study was to determine the value of LD50 from the results of the acute toxicity test of LD50 ethanol extract of Sungkai leaves (Peronema canescens) in male and female white mice (Mus musculus). This research method is experimental research in the laboratory used 50 mice comprising 25 males and 25 females which are divided into 5 groups, normal control (Na-CMC 1%), ethanol extract (625 mg/kg body weight), ethanol extract (1,250 mg/kg body weight), ethanol extract (2,500 mg/kg body weight) and ethanol extract (5,000 mg/kg body weight). The test preparation is administered orally through the gastric sonde and is administered only once in 24 hours. The Indonesian Pharmacopoeia Edition III method was used to calculate the value of LD50 in this study. The results of the acute toxicity test of LD50 Sungkai leaf ethanol extract are included in the safe category in the male animal group. In the group of female animals, an LD50 value of 6.50 mg/kg body weight was got. They include it in the category of very toxic and dangerous for the group of female animals. On the data on the ratio of organ weights in each research organ. Only in the male group, there was no noticeable difference (P>0.05) in each organ, but in the female group of animals, there were noticeable differences (p<0.05) in the heart, liver, lungs, kidneys, and stomach organs.

Isoniazid Microencapsulation With HPMCP HP-50 and HPMCP HP-55 (2:3) Coating Using Solvent Evaporation Method

The combination formulation of TB drugs may cause interactions if these drugs are given simultaneously. Rifampin (RIF) decomposes in the stomach when given concurrently with isoniazid (INH), which results in a decrease in the bioavailability of RIF. The purpose of this study is to make INH microcapsules using HPMCP HP-50 and HP-55 coatings to prevent these interactions. The process of making INH: HPMCP HP-50 and HP-55 (2:3) microcapsules was done by using solvent evaporation method. The entrapment efficiency of INH: HPMCP HP-50 and HP-55 (2:3) were 83.21% and 91.57%, respectively. The dissolution test of INH: HPMCP HP-50 and HP-55 microcapsules met the requirements of the Indonesian Pharmacopoeia Edition V. The FTIR test showed that the microcapsules didn’t change the chemical composition of isoniazid or the coating on the microencapsulation so that it was concluded that no chemical reaction or decomposition occurred before and after the formation of the microcapsules. Scanning Electron Microscopy (SEM) showed a spherical microcapsule surface morphology and the active substance was well coated for INH: HPMCP HP-50 (2:3), while for INH: HPMCP HP-55 (2:3) the surface of the microcapsules was round but hollow. This study produces microcapsules that can provide a delayed release effect, so it is expected that INH: HPMCP HP-50 and HP-55 (2:3) microcapsules can be released in the intestines without interacting with RIF.

Antioxidant of Effervescent Tablet Formulated from Combination of Secang Wood and Red Ginger Extracts

Secang wood has strong antioxidant properties because it contains phenolic compounds such as flavonoids and brazilin. Also, red ginger has antioxidant derived from nonvolatile phenolic compounds. Until now, there has been no use of a combination of secang wood extract and red ginger specifically for the manufacture of effervescent tablets. The purpose of this study was to formulate an effervescent tablet by doing combination of secang wood and red ginger extracts with using various concentrations of citric and tartaric acids. The formulations conducted were three acid sources of 20%, 25%, 30%, using wet granulation. The evaluation subjected to the formulas included the physical properties of the granules, such as the water content and flow properties of the granules. Meanwhile, the evaluation performed to the tablet included the hardness test, tablet friability, weight uniformity, dissolution time, and acidity (pH). The analysis was carried out in accordance with the requirements of the Indonesian Pharmacopoeia Edition III and BPOM. The results obtained are effervescent tablet with an acid variation of 20% with physical quality values of water content of 2.91% and granule flow properties of 6.03 s. Meanwhile, the physical quality requirements of effervescent tablets were tablet hardness of 4.02 kp; tablet friability 0.46%; weight uniformity 0.132%; 71 s dissolution time; and 6.4 degrees of acidity.

Isoniazid Microencapsulation With HPMCP HP-50 and HPMCP HP- 55 (2:3) Coating Using Solvent Evaporation Method

The combination formulation of tuberculosis drugs may cause interactions if these drugs are given simultaneously. Rifampin (RIF) decomposes in the stomach when given concurrently with isoniazid (INH), which results in a decrease in the bioavailability of RIF. The purpose of this study is to make INH microcapsules using HPMCP HP-50 and HP-55 coatings to prevent these interactions. The process of making INH: HPMCP HP-50 and HP-55 (2:3) microcapsules was done by using solvent evaporation method. The entrapment efficiency of INH: HPMCP HP-50 and HP-55 (2:3) were 83.21% and 91.57%, respectively. The dissolution test of INH: HPMCP HP-50 and HP-55 microcapsules met the requirements of the Indonesian Pharmacopoeia Edition V. The FTIR results showed that there was no change either in the chemical composition of isoniazid or in the coating of the microencapsulation. Scanning Electron Microscopy (SEM) showed the active substance was well coated. This study produces microcapsules that can provide a delayed release effect, so it is expected that INH: HPMCP HP-50 and HP-55 (2:3) microcapsules can be released in the intestines without interacting with RIF.

Development and evaluation of a 3D printing protocol to produce zolpidem-containing printlets, as compounding preparation, by the pressurized-assisted microsyringes technique

Insomnia is a chronic disorder with a mean prevalence ranged from 6% to 15% worldwide. The usual pharmacologic treatment for insomnia has been benzodiazepines and barbiturates. More recently, z-drugs were introduced in the therapeutic arsenal to maximize benefits and minimize treatment damage. Zolpidem tartrate, whose primary indication is for sleep initiation problems, is conventionally used at a recommended dose of 5 mg for women as well as elderly patients (<65 years-old) and 10 mg for non-elderly men. However, it was demonstrated that the dose of zolpidem should be adjusted according to the gender, age, condition of the patient and the presence of polypharmacy to decrease the occurrence of adverse events. Faced with the therapeutic limitations inherent to marketed products, magistral preparations offer medical and legal alternatives to mass treatment. The use of a semi-automatic technique, with standardized protocol, such as 3D printing should be advantageously implemented as an alternative to standard compounding procedures.In this work, the pressure-assisted microsyringes method was selected as it allows the tridimensional printing, and so the customization of the dose, by easily extruding a viscous semi-liquid material, called “slurry”, through a syringe at room temperature. It has been demonstrated that this methodology allows obtaining printlets that responded to the zolpidem-containing tablets monograph of the US pharmacopoeia Edition 42. The compounding preparations proposed in this work therefore have the same criteria of requirements as a commercial form.

Historical and medical-pharmaceutical aspects of the creation of a pharmacopeia

The article presents a historical analysis of the works of ancient authors related to the standardization and use of medicinal products underlying their prescriptions, as well as the Antidotaria, Dispensatoria, Ricettaria, and other publications that became the basis of modern pharmacopoeia. Based on the results of the analysis of literary sources on the history of medicine and pharmacy, issues of the standardization and regulation of prescription of medicinal products have always been given special importance in various societies and cultures. The chronology of the collections of prescriptions of medicinal products and then the establishment of a pharmacopoeia indicates the great need for pharmaceutical information for healthcare, determines the stages of development of pharmaceutical science, production, pharmaceutical and medical practice, and standardization and state regulation of medical and pharmaceutical activities. Particular attention is paid to the history of the creation of the first editions of the Russian pharmacopoeia. From physicians, herbalists, and greenery workers, practical information on the treatment of diseases in Russia was then translated, added to the official editions of the pharmacopoeia, and adopted at the state level. The significant contribution of domestic scientists is reflected, thanks to which the domestic pharmacopoeia not only did not yield to foreign counterparts but in some cases even surpassed them, contributing to the development of the countrys healthcare. The role of the staff of the Imperial MedicalSurgical (Military Medical) Academy, who actively participated in the development of various editions of the national state pharmacopoeia during the XIXXXI centuries, is emphasized.

Aplikasi Metode Penetapan Kadar Rutin Parasetamol PT. Kimia Farma, Tbk Secara HPLC pada Sediaan Tablet Generik dan Bermerek di Medan

Paracetamol is a drug that is analgesic and antipyretic, which is produced as a generic or branded drug. The research objective was to determine the quality based on paracetamol levels in generic and branded tablet preparations circulating in Medan. The research used HPLC Alliance e2696 UV / Visible Detector 2489, Column µ Bondapak TMC-18: 10 µm 125A 3.9x300 mm, UV-Vis Spectrophotometer Agilent 8453. The method used was a routine assay method for paracetamol PT. Kimia Farma. The results showed that the paracetamol content in the tablet dosage was 97.05% - 106.04%, according to the Indonesian Pharmacopoeia Edition V, not less than 90% and not more than 110%.

An analytical method for alkaloids of Coptis chinensis based on mixed-mode surface electrostatic exclusion/reversed-phase chromatography

A mixed-mode chromatographic method based on surface electrostatic exclusion and reversed-phase chromatography was established for the determination of alkaloids present in Coptis chinensis. The effects of two mobile phase additives, formic acid and acetic acid, on retention, peak shape and selectivity of the alkaloids in Coptis chinensis were investigated using the self-made C18HCE column. Acetic acid (0.1%, v/v) used as the additive was found to be optimum for effective separation of the main alkaloids present in Coptis chinensis. The main chromatographic peaks of Coptis chinensis were recognized by the established method and references, which were coptisine, epiberberine, columbamine, jatrorrhizine, berberine and palmatine, respectively. With reference to the content determination method of Coptis chinensis in the 2015 edition of pharmacopoeia, the linear relationship of berberine in the range of 0.5-100 mg/L was good, the correlation coefficient was 0.9996, and the average recovery was 93.74%. The contents of alkaloids in Coptis chinensis in different batches of Hubei and Chongqing were determined. The method is simple, reliable and accurate, and can be used as reference for separation and analysis of other basic compounds.

Pharmacokinetic Comparisons of Typical Constituents in Curcumae Rhizoma and Vinegar-Processed Curcumae Rhizoma after Oral Administration to Rats.

The Raw Curcumae Rhizoma (R-CR), included in the Chinese Pharmacopoeia Edition 2015, is a well-known Chinese herbal medicine. However, the vinegar-processed Curcumae Rhizoma (V-CR) is used more widely than R-CR. The pharmacokinetics comparison of R-CR and V-CR after oral administration to rats is poorly understood. A novel method, rapid resolution liquid chromatography-tandem mass spectrometry (RRLC-MS) coupled with a sensitive, specific, and convenient microdialysis sampling method, free from endogenous interference was developed in this research. The extracts of R-CR and V-CR were administered orally to each group of rats. The blood and liver microdialysis probes were positioned within the jugular vein toward the right atrium and the median lobe near the center of the liver, respectively. Then, a double-peak phenomenon was observed in the concentration-time curves of curdione in R-CR group, while it was not observed in V-CR group. The liver-to-blood distribution ratio of curdione in V-CR group increased significantly (P < 0.05) compared to that of R-CR group. However, compared with V-CR group, the pharmacokinetic parameters of curcumol exhibited no statistically significant differences from those of R-CR group. These results indicate that vinegar-processed procedure has influence on the pharmacokinetic process of Curcumae Rhizoma in/ns. RRLC-MS coupled with microdialysis system could be used to evaluate the pharmacokinetics of typical constituents in Curcumae Rhizoma after oral administration.