Pharmaceutical Standards Research Articles

Evaluasi Kelengkapan Resep Rawat Jalan Terhadap Standar Pelayanan Farmasi di Upt Puskesmas Ibrahim Adjie Kota Bandung

The importance of reviewing prescriptions to realize medication safety in pharmaceutical services. Good Pharmacy Practice (GPP) where the professional relationship between doctors and pharmacists is in the form of prescriptions as part of the representative quality of pharmaceutical service standards. The purpose of this study was to determine the percentage of administration on prescription completeness based on 3 aspects; administration, pharmaceutical and clinical to the percentage of pharmacy service standards at UPT. Ibrahim Adjie Health Center in Bandung City is adjusted to the PERMENKES RI No. 74 of 2016. This type of research is qualitative non-experimental descriptive observational with prospective data collection using a check list form to find out whether or not they fulfill each other in a recipe. This study was conducted in July 2021 with 150 samples of prescriptions for adult patients aged 26-45 years. The percentage of results from administrative screening was 10.6% or as many as 16 complete prescriptions due to not fulfilling the patient's address, SIP and doctor's initials. The percentage of pharmaceutical screening aspects obtained 58.6% or as many as 88 prescriptions that meet. The percentage of clinical screening showed 3.3% or as many as 5 prescriptions. Meanwhile, the results of the conformity of pharmaceutical services as a whole according to the applicable regulation of the Minister of Health indicate that there are no mutually fulfilling aspects in 1 prescription sheet. So the evaluation of this research needs to be done communication in increasing awareness between doctors and pharmacists in prescribing services as representatives of applicable service standards.

GAMBARAN PENERAPAN PELAYANAN FARMASI KLINIK DI PUSKESMAS

Clinical pharmacy services are part of the pharmaceutical service standards at the puskesmas, aiming to improve therapeutic outcomes and ensure the patient's quality of life. The study aimed to determine the suitability of 7 aspects of pharmaceutical services with pharmaceutical service standards in the application of clinical pharmacy at the puskesmas. This research is an observational study using a survey method. The study was conducted at 31 Puskesmas in Bone Bolango and Pohuwato districts, Gorontalo Province, in May-August 2021. The pharmaceutical staff in charge of pharmaceutical services is the population in this study. The total sampling technique was used in sample selection. This research instrument is a checklist compiled based on pharmaceutical service standards at the puskesmas—collected data utilizing observation and interviews with respondents. Did analysis descriptively. The results showed that assessment and prescription services and drug information services were suitable, while the other five elements were poor.

Pharmacognostic Evaluation and Establishment of Quality Parameters of Leaves of Prosopis cineraria

The present work focus to evaluate the physicochemical and preliminary phytochemical studies on the leaves of Prosopis cineraria (L.) Druce (family: Fabaceae). The plants resources which are used in pharmaceutical formulation standardization was evaluated on the basis of various organoleptic properties, physical characteristics, and physico-chemical properties. Different Physicochemical parameters ash values, extractive values, loss on drying, foreign matter, fluorescence analysis, pH, TLC and HPLC were evaluated. Macroscopically seeds the total ash, acid insoluble ash and water soluble ash were found to be 7.06%, 3.14%, and 69.3% w/w respectively. Hexane, ethyl acetate, ethanol and water soluble extractive values (hot)were 4.865 %, 19.092 %, 12.19%, 24.82%w/w respectively. The pH of 1% and 10% aqueous solution was found to be 6.4 and 6.8 respectively. Primary phytochemical screening indicated the existence of sterols, tannins, flavonoids, amino acids, glycosides, phenolic compounds, carbohydrates, saponins and alkaloids. Thin layer chromatographic studies also had been done on ethanolic and hexane extracts. HPTLC fingerprinting is a valuable method for the quantitative determination of phytochemicals present herbal medicine. HPTLC fingerprinting Showing the presence of Gallic acid in ethonolic extract.Rf value calculated and repoted.in plant organoleptic and physico-chemical properties changed due to geographical diversity and time of collection of sample. The present work therefore, attempts to report necessary pharmacognostical and standardization parameters the leaves of Prosopis cineraria (L.) Druce (family: Fabaceae) which will help to identify and development of the drug.

Evaluation of Repeated Dose (Sub Chronic) Toxicity Study of Shilasindur Prepared by Two Different Methods Along with Its Characterization and Antimicrobial Activity

Introduction: Rasaushadhies (metal and mineral) preparations are unique preparations that include Bhasma, herbo-mineral preparations and Kupipakwa rasayana hold a significant place in Ayurvedic pharmaceutics. Nearly 70 % of formulations include a combination of one or more metallic/mineral with several herbs which have a supporting role in improving efficacy, relieving symptoms of the disease and to achieve long and healthy life. Shilasindur is a one of the Kupipakwa rasayana containing mercury, sulphur and arsenic disulphide and indicated in skin disorders, respiratory tract disorders and other infectious diseases.
 Aim and Objectives: Evaluation of repeated dose (Sub chronic) toxicity study of Shilasindur along with its characterization and antimicrobial activity.
 Materials & Methods: Shilasindur will be prepared in three batches as per classical reference and by using Electric Muffle furnace. The prepared formulation will be assessed with Organoleptic characters, physicochemical parameters and ICP – AES (Inductively coupled plasma atomic emission spectroscopy), FTIR (Fourier-transform infrared spectroscopy), XRD (X-Ray Diffraction). Sub chronic toxicity study will be carried out according to the OECD guidelines 408 and 452 as well as CCRAS guidelines of safety and toxicity. Epsilometer test (E-test) will be used to check antimicrobial activity of Shilasindur.
 Results: The analytical parameters will be assessed to establish the pharmaceutical standardization. Toxicity study will be done in three doses to ensure its safety. Statistical analysis will be done by applying unpaired t-test and ANOVA test.
 Conclusion: If significant positive results obtained in this work then it will be a valuable contribution and evidence that the drug Shilasindur is safe for consumption at treatment doses.

The Effect of Natural Therapies in Combination with Usual Care for Depression: A Narrative Review

Introduction: Major depressive disorder (MDD) is the most common and debilitating form of depression with a 12-month prevalence of 4.7% and a lifetime prevalence of 11.2% in Canada. Various classes of antidepressants are commonly used treatments for MDD; however, high failure rates occur due to adverse events and discontinuation of use. Non-drug and alternative interventions are commonly sought by people when drug treatment fails. The purpose of this investigation was to analyze the evidence on the effect of natural therapies in combination with pharmaceutical standard of care for the management of MDD Methods: The following inclusion criteria were defined before conducting the literature search: 1) population of adults with major depressive disorder, 2) intervention of lavender, folic acid or acupuncture, combined with standard treatment, 3) comparison group of a placebo, standard treatment or natural therapy used alone, 4) changes to Hamilton Depression Rating Scale (HAM-D) as the primary outcome. PubMed, APA PsycARTICLES and Google scholar were used for the research. The articles were limited to randomized clinical trials (RCTs), and systematic reviews with meta-analyses. The different therapies were used as key words in the literature search. Results: The literature search for ‘lavender’ yielded 214 studies, of which 3 RCTs met the criteria. ‘Folic acid’ yielded 680 studies of which 2 RCTs and 1 systematic review with meta-analysis met the criteria. ‘Acupuncture’ yielded 2240 studies of which 2 RCTs and 2 systematic reviews with meta-analyses met the criteria. Only the RCTs not summarized in the systematic reviews and meta-analyses were summarized in this review. Discussion: All ten studies using natural interventions showed a statistically significant decrease in the mean score change versus comparison groups, however, the magnitude of the effect varied between the studies. Sample sizes were small and there was significant heterogeneity between studies. Conclusion: Evidence suggests that natural therapies can be used adjunctively to the pharmaceutical care of MDD, however, the overall research quality is low and substantial heterogeneity exists between studies. Further, additional research using more rigorous methodologies and standardized interventions is needed.

EVALUASI KESESUAIAN PENYIMPANAN OBAT DI SALAH SATU APOTEK KOTA CIMAHI

Storage is one of the main factors in the maintenance of drug quality by storing properly and in accordance with standards, if it is not done will cause the quality of the drug is not guaranteed during storage in pharmacies. This study aims to find out how to store drugs and how much percentage of suitability of drug storage systems in one of Cimahi City Pharmacies Based on the Technical Instructions for Pharmaceutical Service Standards in Pharmacies in 2019. Research methods use descriptive observation and evaluation using checklist table sheets. Drug storage in one of Cimahi City Pharmacies is stored based on dosage form, therapeutic class, stability and alphabetically with a dispensing system using the FEFO system. Drug storage systems in pharmacies in accordance with the Technical Instructions of Pharmaceutical Service Standards are 86.36% while those that are not in accordance with the Technical Instructions of Pharmaceutical Service Standards which amount to 13.64% include adjacent LASA or NORUM storage, recording on less than optimal stock cards and the absence of backup electricity. The conclusion of this study shows that there are still those who are not in accordance with the Technical Instructions of Pharmaceutical Service Standards.

Modern Strategies for the Diversification of the Supply of Natural Compounds: The Case of Alkaloid Painkillers.

Plant-derived natural compounds have been used for treating diseases since prehistorical times. The supply of many plant-derived natural compounds for medicinal purposes, such as thebaine, morphine, and codeine, is primarily dependent on opium poppy crop harvesting. This dependency adds an extra risk factor to ensuring the supply chain because crops are highly susceptible to environmental conditions. Emerging technologies, such as biocatalysis, might help to solve this problem by diversifying the sources of supply of these compounds. Here we review the first committed step in the production of alkaloid painkillers, the production of S-norcoclaurine, and the enzymes involved. The improvement of these enzymes can be carried out experimentally by directed evolution and rational design strategies, supported by computational methods, to create variants that produce the S-norcoclaurine precursor for alkaloid painkillers in heterologous organisms, meeting the pharmaceutical industry standards and needs without depending on opium poppy crops.

Manajemen Perencanaan, Pengadaan, dan Pengendalian Obat di Instalasi Farmasi Rumah Sakit

Background: Several hospitals in Indonesia have shown drug vacancies, drug delays, and minimal budgets in drug procurement. The availability of drugs is also influenced by the value of the hospital BOR which fell during the Covid-19 pandemic. The purpose of this research is to analyze the implementation of Permenkes No. 72 of 2016 on the management of planning, procurement, and control of drugs at the pharmacy installation of the GMIM Pancaran Kasih General Hospital, Manado. Methode: This a qualitative research. The research was carried out on March-July 2020. The research location is at the pharmacy installation of the GMIM Pancaran Kasih General Hospital, Manado. This study took 5 informants. Data analysis used content analysis from in-depth interviews, direct observation of documents and comparing with theories in the literature. This study uses validation with source triangulation techniques and methods. Result: The results showed that the planning, procurement and control of drugs at the General Hospital of GMIM Pancaran Kasih is in accordance with the Regulation of the Minister of Health of the Republic of Indonesia No. 72 of 2016 concerning Pharmaceutical Service Standards in Hospitals. It was also found that the e-purchasing system as a whole did not work well because the facilities and infrastructure were inadequate. Conclusion: That can be concluded that the implementation of Minister of Health Regulation No. 72 of 2016 on the management of planning, procurement, and control of drugs at the pharmacy installation of the General Hospital GMIM Pancaran Kasih Manado has been going well. However, it is necessary to add human resources in the pharmaceutical field.

Implementasi Sistem Informasi Akuntansi Persediaan Obat-Obatan Pada Rumah Sakit PKU Muhammadiyah Gamping Sleman-D.I. Yogyakarta

This study aims to analyze the accounting information system for drug supplies at PKU Muhammadiyah Gamping Hospital. The employed research method was descriptive qualitative research. Data sources were from secondary and primary data. Based on the results of the study, it can be concluded that the accounting information system for drug supplies at PKU Muhammadiyah Gamping Hospital has been running well because the existing system can provide the required information. However, there are still weaknesses; namely, the physical activity is not maximal; the warehouse stock card does not include an expiration date. In addition, the hospital has not made 4 copies of an official report on the drug disposal following the Minister of Health Regulation (Permenkes) Number 73 of 2016 concerning Pharmaceutical Service Standards in Pharmacies.

Pharmaceutical Standardization of Palasha Kshara (Alkali Extract of Butea monosperma Lam.) Prepared from Two Combinations

Introduction: Standardization in herbal pharmaceuticals is needed in order to ensure their quality and acceptability of final medicament prepared from them. There are many plants have been suggested in the compendia for Kshara (alkali extract) preparation. Acharya Bhavamishra coined the name of plant Palasha (Butea monosperma Lam.) as Kshara Shresta means the one which is best of all Kshara. Generally all parts of plant together (Panchanga) have been suggested to be used for Kshara preparation in the texts. But considering the unavailability of all parts of the Palasha throughout the year this study has been designed to standardize the Palasha Kshara prepared from two combinations.
 Aim and Objectives: Pharmaceutical and analytical standardization of Palasha Kshara PK-1 and PK-2 prepared from two combinations.
 PK-1 is the Palasha Kshara prepared from combination of ashes of roots, stems, leaves, flowers and fruits.
 PK-2 is the Palasha Kshara prepared from combination of ashes of roots, stems and leaves.
 Observation and Results: The total yield percentage of PK-1 and PK-2 were 20.757% and 4.067% respectively. Both PK-1 and PK-2 were found alkaline in nature having ph value of 10.44 and 10.47 respectively. The ICPAES study of both PK-1 and PK-2 reveals maximum amount of potassium in them (41.65% and 47.51% respectively.) Heavy metals such as arsenic, lead, mercury, and cadmium were not detected or were found to be within acceptable ranges. The XRD study reveals presence of more functional groups in PK-2 than PK-1. The observed crystallanity of PK-1 was more (87.5%) than PK-2 (84.6%).
 Discussion and Conclusion: Two varieties of Palasha Kshara were made in this study using two different combinations of ashes. This was an attempt to identify the need of Kshara prepared from all five parts of Panchanga) over the Kshara prepared from three parts (roots, stems and leaves) and standardize them pharmaceutically and analytically.

Evaluation of Comparative Dermal Toxicity and Efficacy of Aargwadhadi Oil and Aargwadhadi Ointment

Introduction: Skin diseases are among the most common of all health illness in recent years, In Ayurveda, management of skin diseases includes internal and external administration. External administration includes various topical applications However, herbal medicines are not completely safe from adverse effects and develop irritation, rashes, redness and burning sensation on the skin as observed in recent researches.“Hence there is a requirement of a safe drug which should be economical & affordable for all. Hence present study is undertaken to study dermal toxicity profile Aargwadhadi oil and Aargwadhadi ointment in an experimental animal and make available safe and efficient drug to the human being.
 Aim and Objective: Pharmaceutical development, standardization and evaluation of acute, sub-acute dermal toxicity and efficacy of a Aargwadhadi oil and Aargwadhadi ointment and compare efficacy and safety of Aargwadhadi oil and Aargwadhadi ointment.
 Materials and Methods: Aargwadhadioil and Aargwadhadi Ointment will be prepared as per classical reference and it will be converted into ointment form. Analytical study for standardization of Aargwadhadi oil and Aargwadhadi ointment will be done. Evaluation of Acute and sub-acute dermal toxicity study in experimental animals of both dosage forms as well, efficacy study of Aargwadhadi oil and Aargwadhadi ointment on animal model of vitiligo will be done.
 Observations and Results: Observation will be done on the basis of assessment criteria evaluation of control group and experimental group will be noted. Results will be drawn on the basis of observations and applying suitable tests. It will be noted and presented in form of table, charts, graphs etc.
 Conclusion: Conclusion of the study will be drawn accordingly from the recorded observations, analysis of data.

Evaluation of Drug Procurement with the E-Phurchasing System on the Availability of Drugs at the Pharmacy Installation of the Central Aceh Regency Health Office 2021

The purpose of the study was to evaluate drug procurement with the E-Purchasing system on the availability of drugs at the Pharmacy Installation of the Health Office of Central Aceh Regency. The research design used qualitative research methods through in-depth interviews accompanied by direct observation (observation). Informants of the Head of the Health Office, the Head of the Pharmacy Installation of the Health Office, the Planning and Finance Subdivision of the Health Office, the drug management officer at the Health Office and the health center drug management officer were 2 people. Data analysis is presented in the form of a text (content analysis). The results of the research on the availability of drugs at the Pharmacy Installation of the Aceh Tengan District Health Office have not been maximized, the process of ordering drugs by E-purchasing and Non-E-purchasing is in accordance with PMK No. 63 of 2014, but the fulfillment time is not in accordance with the 2014 Pharmaceutical Service Standards. The budget provided for the drug procurement process by e-purchasing is not sufficient. The conclusion of this study is that the availability of drugs in the Pharmacy Installation of the District Health Office of Central Aceh Regency has not been maximized. This drug vacancy is caused by the number of drugs that are not all realized, the time of drug delivery by the distributor.

STUDY OF PHARMACEUTICAL INVENTORY CONTROL SYSTEM IN SEVERAL PHARMACIES IN KARANGASEM, BALI

The control of pharmaceutical products is one of the pharmaceutical services at the Pharmacy that is regulated in Permenkes RI No. 73 of 2016. The pharmacy control of each pharmacy must always apply the principles stated in the Good Pharmacy Practice (GPP) guidelines. GPP is a pharmaceutical practice that responds to the needs of people who use pharmacist services to provide optimal and evidence-based care. This study aims to determine the system of one of the pharmaceutical service standards, namely the control of pharmaceutical products in several pharmacies in Karangasem, Bali. This type of research is observational descriptive. Data retrieval is carried out in a retrospective manner related to the pharmaceutical product control system in the form of an order or procurement, dispensing, and handling system. Most pharmacies are researched to apply the same control system in the procurement and spending of pharmaceutical products. Only the pharmaceutical product system for handling parts has a slight difference in each pharmacy.

Pharmaceutical Preparation and Standardization of Swarna Vanga and Its Clinical Efficacy as Adjuvant to Reduce Adverse Effects of Chemotherapy with Special Reference to Its Rasayana Property

Abstract: Cancer is most dreadful disease affecting mankind. Many innovative healing modalities and hundreds of cancer treatments have resulted from extensive research. With chemotherapy and radiotherapy, surgical excision is the oldest and most tested method. This leads to therapy problems, poor health, and a decline in quality of life, all of which necessitate treatment discontinuation. Anorexia, diarrhoea, nausea, vomiting, and mucositis can all be caused by psychological causes. The anorexiacachexia syndrome is the most common cause of death among cancer patients. Cancer cachexia is characterised by metabolic, hormonal, and cytokine abnormalities that lead to progressive wasting. Swarna Vanga is a Kupipakwa Rasayana mentioned in Rasatarangini. Chemically it is stannous sulphide containing Shuddha Parad, Shuddha Vanga, Shuddha Gandhak, Shuddha Navasadar. Till today, no study has been carried out using Swarna Vanga for its Rasayana and Balya properties. Hence an attempt was given to study the pharmaceutical preparation, standardization and clinical efficacy of the drug in reducing adverse effects of chemotherapy with special reference to its Rasayana property through this dissertation. Thus the present study entitled “Pharmaceutical preparation and standardization of Swarna Vanga and its clinical efficacy as adjuvant to reduce adverse effects of chemotherapy with special reference to its Rasayana property” was carried out. Keywords: Swarna Vanga, adjuvant, Rasayana, cancer, chemotherapy, adverse effects, standardization.

PHARMACEUTICAL STANDARDIZATION OF AGNIKUMARA RAS

Bhaishajya Kalpana is an integral part of Ayurveda which deals with the process of preparation of single and com- pound formulations. The preparation of drugs can be classified into two groups, primary and secondary. Vati is a popular secondary preparation in Ayurvedic pharmaceutics. It is a solid dosage form that is produced and marketed in the field of pharmaceutics. This is because of the advantages like it can be swallowed easily without any irritation, handy and fixation of dosage becomes easier. Agnikumara Ras is one such formulation mentioned in Basava- rajeeyam pradhama prakarana indicated in Peenasa, Jwara, ama and Pratishyaya. Agnikumara ras contains Shud- dha Vatsanabha, Maricha, Mustha, Kushta and Vacha. The pharmaceutical procedures adopted in this study are Shodana, Churna nirmana, mardana and preparation of vati of Agnikumara ras. Till now, no research work has been carried out to standardize the method of preparation Agnikumara Ras. Therefore, the present study has been planned to standardize the method of preparation of Agnikumara ras according to the method explained in the classics. Keywords: Agnikumara ras, Shodana, Churna nirmana, pharmaceutical standardization.

Discriminative and quantitative analysis of norepinephrine and epinephrine by surface-enhanced Raman spectroscopy with gold nanoparticle suspensions.

Surface-enhanced Raman spectroscopy (SERS) is a powerful analytical technique capable of increasing the Raman signal of an analyte using specific nanostructures. The close contact between those nanostructures, usually a suspension of nanoparticles, and the molecule of interest produces an important exaltation of the intensity of the Raman signal. Even if the exaltation leads to an improvement of Raman spectroscopy sensitivity, the complexity of the SERS signal and the numbers of parameters to be controlled allow the use of SERS for detection rather than quantification. The aim of this study was to develop a robust discriminative and quantitative analysis in accordance with pharmaceutical standards. In this present work, we develop a discriminative and quantitative analysis based on the previous optimized parameters obtained by the design of experiments fixed for norepinephrine (NOR) and extended to epinephrine (EPI) which are two neurotransmitters with very similar structures. Studying the short evolution of the Raman signal intensity over time coupled with chemometric tools allowedthe identification ofoutliers and their removal from the data set. The discriminant analysis showed an excellent separation of EPI and NOR. The comparative analysis of the data showed the superiority of the multivariate analysis after logarithmic transformation. The quantitative analysis allowed the development of robust quantification models from several gold nanoparticle batches with limits of quantification of 32µg/mL for NOR and below 20µg/mL for EPI even though no Raman signal is observable for such concentrations. This study improves SERS analysis over ultrasensitive detection for discrimination and quantification using a handheld Raman spectrometer.

Pharmaceutical Standardization and Drug Dosage Modification of Laghu Sudarshan Churna with Comparative Assessment of its Antipyretic and Analgesic Activities in Albino Rats

Introduction: Laghu Sudarshan Churna is a Churna mentioned by Yogratnakar indicated in the treatment of all types of Jwara and its action is Tridoshanashak. Fever is bodys natural defense mechanism against infectious agents which can damage the tissue. Some studies have suggested that raising temperature may be harmful. Therefore, in clinical practices in which fever associated risk benefits, antipyretic treatment is necessary.
 Aim and Objective: Drug dosage modification and pharmaceutical standardization of Laghu Sudarshana Churna to Laghu Sudarshana Vati with comparative Assessment of its Antipyretic & Analgesic activities in albino rats.
 Materials and Methods: To evaluate antipyretic & analgesic activities of test drugs the most commonly employed method to induce fever in animals is brewers yeast induced pyrexia, Tail flick test & Hot plate test for analgesic in animal models.
 Observation and Results: Observation will be done on the basis of Physicochemical & Organoleptic characteristics of Laghu Sudarshan churna & Laghu Sudarshan vati. Results will be drawn on the basis of observations & applying suitable test. It will be noted & presented in the form of table, charts & graphs etc.
 Conclusion: If this Antipyretic & Analgesic study is successful then this data will be used in another clinical study for intervention of Antipyretic & Analgesic studies, as it is Herbal medicine so it will show no any toxic effect in animal models. Hence, it will be easily used in humans also.

Implementasi Standar Pelayanan Kefarmasian di Apotek Kupang

According to applicable standards, pharmaceutical services strongly support the role of pharmacists in realizing quality pharmaceutical services to protect patients and the community and provide legal certainty for pharmaceutical personnel. This study aims to evaluate the implementation of pharmaceutical service standards in pharmacies by pharmacists in Kupang City. This study uses a quantitative descriptive approach. Data were collected using a questionnaire adapted from Regulation of the Minister of Health Number 73 of 2016 concerning Pharmaceutical Service Standards in Pharmacies. The population in this study were all pharmacies in Kupang City, totaling 90 pharmacies based on data from the Health Service, with valid pharmacy permits. Respondents are pharmacists who have a valid practice license in pharmacies and are willing to participate in the survey. A total of 66 respondents returned the questionnaire, and 64 were declared complete and qualified for analysis. Data were analyzed using univariate analysis with SSPS 25. The results showed that 53.75% of pharmacies in Kupang City had implemented pharmaceutical service standards in pharmacies by Regulation of the Minister of Health Number 73 of 2016, while 46.25% have not implemented service standards properly. Pharmacies that manage pharmaceutical preparations, medical equipment, and disposable medical equipment (BMHP) according to standards are 66.1%, and clinical pharmacy services are 41.4%. The conclusion shows that pharmaceutical service standards in pharmacies have not been carried out optimally by pharmacists in Kupang City.

Standardization and Phytochemical screening of Carica papaya seeds

The present work focus to evaluate the physicochemical and preliminary phytochemical studies on the seeds of family Caricaceae. The plants resources which are used in pharmaceutical formulation standardization was carried out on the basis of organoleptic properties, physical characteristics, and physico-chemical properties. Different Physicochemical parameters ash values, extractive values, loss on drying, foreign matter, fluorescence analysis, and pH were evaluated. Macroscopical characteristics and Physicochemical parameters like total ash, acid insoluble ash and water soluble ash were found to be 83.7%, 71.7% and 61.5% w/w respectively. Hexane, ethyl acetate, ethanol and water soluble extractive values (hot)were 7.6%, 11.6%, 27.4%, 37.5%w/w respectively. The pH of 1% and 10% aqueous solution was found to be 3.57 and 3.78 respectively. Preliminary phytochemical screening showed the presence of Tannins, Proteins and amino acids, Glycosides, Phenolic compounds, Carbohydrates, Saponins, Alkaloids and Flavonoids. Thin layer chromatographic studies also had been done on ethanolic and hexane extracts. HPTLC fingerprinting is a valuable method for the quantitative determination of phytochemicals present in plant extract. These studies aim to investigating referential information for correct identification and standardization of this plant secondary metabolites.

Standardization of the Pharmaceutical Substance of the Drug LCS-1208

Introduction. Indolocarbazole derivatives are of increasing scientific interest for practical oncology. A number of N-glycosides, indolo[2,3-a] carbazole under the laboratory code LCS, were synthesized in the laboratory of chemical synthesis of the National Medical Center of Oncology named after N.N. Blokhin. Currently, one of the most promising compounds in this class is LCS-1208, a representative of the arabinoside class of indolo [2,3-a]pyrrolo[3,4-c]carbazole-5,7-dione. According to the mechanism of biological action, LCS-1208 is a protein kinase C inhibitor and is of great interest for the treatment of malignant neoplasms.Aim. chemical and pharmaceutical standardization of the pharmaceutical substance LCS-1208.Materials and methods. Laboratory samples of pharmaceutical substance LCS-1208. Methods of investigation: gravimetry, spectrophotometry, polarimetry, high-performance liquid chromatography (HPLC), high-resolution nuclear magnetic resonance (NMR) spectroscopy and infrared (IR) spectroscopy.Results and discussion. The quality assessment of LCS-1208 was carried out according to the indicators adopted in the XIV edition of the State Pharmacopoeia of the Russian Federation for quality control of pharmaceutical substances. LCS-1208 - orange amorphous powder, odorless; soluble in dimethylsulfoxide (DMSO) and dimethylformamide (DMF); very slightly soluble in 95 % ethyl alcohol and practically insoluble in water. The authenticity of the substance is confirmed by NMR and IR spectra, as well as electronic absorption spectra. The values of the specific optical rotation of LCS-1208 (1 % solution in DMF) are placed in the range from +58° to +61°. All the studied samples of the substance were free of inorganic impurities, sulphate ash, heavy metals and contained no more than 1.0 % water, determined by the K. Fischer titration method. The content of possible related impurities in the substance LCS-1208 and the content of the main active substance were determined by HPLC. The studied laboratory series of the pharmaceutical substance LCS-1208 contained no more than 1.0 % of any single and no more than 3 % of the total unidentified impurities. The content of the main active substance was more than 97 %.Conclusion. As a result of the work carried out, quality criteria and parameters were selected and methods for their determination were developed, which allow to adequately assess the quality and standardness of the pharmaceutical substance LCS-1208.