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China pharmacopoeia is a civil code which is to ensure pharmaceutical quality and protect people's drug safety and effectiveness. Drug standards are consist of two parts, the pharmaceutical standards and medical standards. Medical standards include four contents, such as prescription, function and indications, usage and dosage and attentions. This paper summarized the revised contents of medical standards and suggested some propositions.

Li C.,China Pharmaceutical University | Sun C.,China Pharmaceutical University | Li S.,China Pharmaceutical University | Han P.,Chinese Pharmacopoeia Commission | And 6 more authors.
International Journal of Nanomedicine | Year: 2014

In order to limit the adverse reactions caused by polysorbate 80 in Taxotere®, a widely used formulation of docetaxel, a safe and effective nanocarrier for this drug has been developed based on micelles formed by a new class of well-defined polyoxyethylene sorbitol oleate (PSO) with sorbitol as the matrix in aqueous solution. The physicochemical properties of the amphiphilic surfactant and the resulting micelles can be easily fine-tuned by the homogeneous sorbitol matrix and pure oleic acid. Composition, critical micelle concentration, and entrapment efficiency were investigated by ultraviolet visible spectroscopy, matrix-assisted laser desorption/ionization time-of-flight mass spectrometry, fluorospectrophotometry, and high-performance liquid chromatography. In vitro and in vivo evaluation revealed that PSO had exceptionally low hemolysis and histamine release rates compared with commercial polysorbate 80. Moreover, the tumor targeting delivery of PSO was investigated by in vivo imaging in S180 tumor-bearing mice. The results suggest that this novel delivery system, PSO, provides an acceptable alternative to polysorbate 80 for delivery of docetaxel. Further, due to the hypoallergenic nature of PSO, the mechanism of pseudoallergy caused by the polyoxyethylene nonionic surfactant was investigated. Based on in vitro cell analysis, it was assumed that the initial contact of polyoxyethylene nonionic surfactant with mast cells provoked pseudoallergy via polyamine receptor-mediated endocytosis. © 2014 Li et al.

Gao H.,Chinese Institute of Materia Medica | Gao H.,National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines | Wang Z.,Chinese Institute of Materia Medica | Wang Z.,National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines | And 2 more authors.
Frontiers of Medicine in China | Year: 2011

Traditional Chinese medicine (TCM) has been widely used for the prevention and treatment of various diseases for a long time in China. Due to its proven efficacy, wide applications, and low side effect, TCM has increasingly attracted worldwide attention. However, one of the biggest challenges facing the clinical practice of TCM is the uncontrollable quality. In this review, the progress of the development and the current status of quality standard as well as new quality control techniques introduced in Chinese Pharmacopoeia (2010 edition), such as liquid chromatography hyphenated mass spectrometry (LC-MS), fingerprint, quantitative analysis of multicomponents by single-marker (QAMS), thin layer chromatography bio-autographic assay (TLC-BAA), and DNA molecular marker technique, are briefly overviewed. © Higher Education Press and Springer-Verlag Berlin Heidelberg 2011.

Guo Z.-P.,Chinese Pharmacopoeia Commission
Chinese Journal of New Drugs | Year: 2015

Pharmacopoeia of the People's Republic of China (Chinese Pharmacopoeia, Ch.P.) 2015 was officially published by China Food and Drug Administration (CFDA) in June 5, 2015, and will be put into effect in December 1, 2015. This review gave the general introduction of the revision in Ch.P.2015 Vol. Ⅲ and interpreted the comparison between Ch.P. 2015 Vol.Ⅲ and European Pharmacopoeia (EP)/British Pharmacopoeia (BP), U.S. Pharmacopoeia (USP), Japanese Pharmacopoeia (JP). The impact and significance of new edition Ch.P. Vol.Ⅲ to the bio-pharmaceutical industry are noted as well. ©, 2015, Chinese Journal of New Drugs Co. Ltd. All right reserved.

Guo Z.-P.,Chinese Pharmacopoeia Commission
Chinese Journal of New Drugs | Year: 2014

The generic names identify the active pharmaceutical ingredients, and also are the main contents of drug standardization. The normalized generic name is a unique name recognized and is important for the clear identification, safe prescription and dispensing of medicines to patients. Biological products are one category of drugs, and the policies for the nomenclatures of biological products have some characteristics compared with those for the generic names. This review presented the profile and specialty of Chinese approved drug name (CADN) and WHO INN (International Nonproprietary Names) for biotherapeutics, the existing challenges facing the nomenclature of SBP, and the proposal to improve the system of CADN for biotherapeutics as well.

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