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Chinese patent medicine (CPM) is an important part of traditional and Chinese medicine (TCM). Its quality has direct impact on the safety and effectiveness of clinical use. The quality standard is the pivotal approach to guarantee the quality of CPM. Due to the complex material basis, multitudinous quality influencing factors and unveiled active ingredients, dose-effect relationship and action mechanism, the investigation on quality standard faces many difficulties. This paper surveys the current quality status of CPM and the general situation of CPM standards. At present, the dosing problem has the crucial impact on the quality of CPM. The current quality standard system of CPM is confirmed and the limitations are indicated. Based on the above analysis, the principles and considerations on investigation of quality standard are proposed as follows: ① Adhere to safety as the bottom line, strengthen the risk-control ability of the standard of CPM; ② Adhere to theory of TCM and comprehensive quality, improve the integrative control level of the CPM standard; ③ Emphasize technological development and innovation, promote the quality control competence of CPM standard; ④ Facilitate planning and coordination, optimize the management of the CPM standard system; ⑤ Reinforce investigation on evaluation method, develop grade evaluation standard, accelerate high-quality development of CPM. Finally, the future perspective on investigation of CPM quality standard is prospected.
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Aim: Improper personal hygiene can facilitate the transmission of the pathogenic microorganisms found in environment and on people抯 hands via food to humans. The present study was undertaken to investigate the microbiological quality of different street food and determining the antibiotic susceptibility of the isolated microorganisms. Study Design: Collection of food samples for isolation of Pathogenic Microorganisms, to identify them by using Biochemical test, molecular test (16sr RNA typing), Antibiotic susceptibility was done by using different antibiotics against the isolates. Place and Duration of Study: Food samples were collected from street vendors of Sainkpuri area, work was done from December 2020 to April 2021 at Microbiology Department, St. Francis College for Women, Hyderabad. Methodology: Five samples of street food were collected in sterilized bottles, tested for the presence of microorganisms by following standard microbiological method used for isolation of microorganisms. The organisms were identified by carrying out various biochemical test according to Bergey抯 Manual of Systematic Bacteriology. The Molecular characterization was done based on 16sr RNA typing. Determining the sensitivity of the isolates against different Antibiotics by employing Kirby Bauer technique. Results: The organisms isolated from Manchuria and Ragada samples: Lactobacillus delbrueckii; Lactobacillus casei, Klebsiella pneumonia, Enterococcus faecalis and Vibrio spp respectively; Samosa and bonda: Staphylococcus aureus, Lactobacillus delbrueckii and Pantoea dispersa; Pani puri water: Staphylococcus aureus and Providencia vermicola. Antibiotic susceptibility tests showed that most of the isolated microorganisms were sensitive to Ciproflaxin. Conclusion: Hence the quality of street food is found to be low due to following factor: lack hygiene conditions in the food preparation, ingredients may also affect quality of the food, and presence of air borne microorganisms in the surrounding areas of service points.
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OBJECTIVE@#This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device.@*METHODS@#This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020.@*RESULTS@#The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance.@*CONCLUSIONS@#It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.
Subject(s)
Indicators and Reagents , Marketing , Reference StandardsABSTRACT
Summarize the quality status and variety quality change characteristics of the sampling products through the Summary and analysis, according to the results of the national medical device supervision and inspection in 2019. Put forward suggestions on the development of the medical device industry and supervisory measures. Thereby, further improve the level of the medical device and ensure the safety use of medical device.
Subject(s)
Equipment and Supplies , Industry , Reference StandardsABSTRACT
Calculus Bovis is the dry gall-stone of Bos taurus domesticus Gmelin, which is the most precious traditional Chinese medicine for its incomparable therapeutic effects. In vitro cultured Calculus Bovis,cultured Calculus Bovis and artificial Calculus Bovis are developed as the substitutes of Calculus Bovis. The Chinese Pharmacopoeia 2015 edition includes 89 Chinese patent drugs containing cow-bezoar and its substitutes. In this paper, the standards of Calculus Bovis and its substitutes in 89 Chinese patent drugs were reviewed to provide suggestions and reference for improving the relative standards. The qualities of Calculus Bovis and its substitutes of several Chinese patent drugs were summarized and analyzed based on the quality research of these drugs in recent years to offer suggestions for the revision of quality standards of relevant drugs and regulatory policy.
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With the rapid development of traditional Chinese medicine (TCM) in China as well as the implementation of the four most strict requirements, the quality of Chinese medicinal materials and decoction pieces had beem improved in recent years, however new problems and challenges were occurred. All the data of Chinese medicinal materials and decoction piece in special inspection,supervision test and evaluation inspection of drug administration department to were summarized and analyzed evaluate and analyze of the quality of Chinese medicinal materials and decoction pieces in 2017. On this basis, the relevant quality control strategies and suggestions were put forward for the relevant departments of China Food and Drug Administration to formulate and implement regulatory measures, furthermore to improve drug standards, and ensure the safety of medication.
Subject(s)
China , Drugs, Chinese Herbal , Reference Standards , Medicine, Chinese Traditional , Product Surveillance, Postmarketing , Quality ControlABSTRACT
OBJECTIVE:To evaluate the quality of sampling drugs of Hubei province,and to provide reference for drug enter-prises and supervision department. METHODS:The data obtained by Hubei Institute for Food and Drug Control about provincial drug sampling and testing from 2013 to 2015 were summarized,the overall quality and unqualified items were statistically analyzed according to current standard. RESULTS & CONCLUSIONS:The number of total sampling batches was 7721 and that of the un-qualified batches was 333 (4.3%) during 2013-2015. Most of the unqualified samples came from distribution units (2.8%-9.0%) and medical institutions (5.2% -11.7%). Among all sample types, the herbal medicine has the highest unqualified rate (12.1%-37.4%),with the largest number of unqualified items(content determination,supplement inspection item,property,resid-ual amount of sulfur dioxide,ash content). The quality of pharmaceutical preparations is relatively stable,and the unqualified items correlated with drug types and dosage forms. The current issues of provincial drug sampling and testing are the variety of standard levels,unreasonable sampling resource allocation and the low level of the industry. Supervision department is proposed to readjust drug standard,reasonably plan sampling and testing process and strengthen production source controlling.
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The chemical components reached 138 types in Eucommia ulmoides, including mainly lignans, iridoids, phenylpropanoids, flavonoids, polysaccharides, gutta-percha, and antifungal protein. Modern pharmacological actions included lowering blood pressure, enhancing immunity function, reducing blood fat, lowering blood sugar, protecting liver, cholagogic, diuresis, protecting nerve cells, regulating bone metabolism, tonifying kidney and so on. Research progress on E. ulmoides was reviewed in the fields of chemical components, pharmacological actions and quality status. The quality status analysis found that some E. ulmoides on sale was not up to the pharmacopoeia standard, and processing methods have effect on the quality for E. ulmoides.
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Non-standardized planting, breeding, harvest and original process of Chinese herbal medicines, illegal dye addition and weight gain of Chinese medicine decoction pieces, and illegal production and business of counterfeit decoction pieces, all these seriously influence the quality and safety of Chinese medicinal materials and decoction pieces. In the year of 2013, a market quality surveillance project of Chinese medicinal materials and decoction pieces was carried out by the China Food and Drug Administration. This paper is a summary and analysis of the project, with the hope to reflect current situation of the quality of Chinese herbal medicines and decoction pieces.