Chinese Pharmacopoeia Commission

Beijing, China

Chinese Pharmacopoeia Commission

Beijing, China
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Cheng Y.-Y.,Zhejiang University | Qian Z.-Z.,Chinese Pharmacopoeia Commission | Zhang B.-L.,Tianjin University of Traditional Chinese Medicine | Zhang B.-L.,Chinese Academy of Sciences
Zhongguo Zhongyao Zazhi | Year: 2017

The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating phar-maceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated.


Xiong Y.,China Pharmaceutical University | Shen Y.,China Pharmaceutical University | Li H.,Chinese Pharmacopoeia Commission | Sun C.,China Pharmaceutical University | And 2 more authors.
Biomaterials | Year: 2012

A cisplatin-loaded nanoconjugate, poly(γ, l-glutamic acid)-citric acid-cisplatin [γ-PGA-CA-CDDP], as a tumor-targeted drug delivery system with sustained release capacity was successfully synthesized and characterized, and its antitumor activity was evaluated. The particle size (107 ± 6.3 nm) and average molecular weight (66 kDa) were determined by dynamic light scattering (DLS) and gel permeation chromatography (GPC), respectively. The nanoconjugate delivery system released platinum in a sustained manner in PBS at 37 °C with an initial burst release during the first 8 h and 50% cumulative release within 48 h. Both in-vitro and in-vivo studies showed that the toxicity of γ-PGA-CA-CDDP nanoconjugate significantly decreased by comparison to that of unconjugated CDDP. The maximum tolerated dose (MTD) of γ-PGA-CA-CDDP nanoconjugate was about 38 mg/kg versus 8 mg/kg for CDDP. No apathy or acute adverse reactions were observed in γ-PGA-CA-CDDP nanoconjugate groups while mice expressed apathy at all dose levels with CDDP treatment. In ICR mice, the area under the curve and total body clearance values for γ-PGA-CA-CDDP nanoconjugate were 9-fold and one-twentieth of the values for CDDP, respectively. With the aid of near-infrared fluorescence (NIRF) imaging system, it was demonstrated that γ-PGA-CA-CDDP nanoconjugate gradually accumulated at the tumor site within 15 min postinjection and exhibited prolonged retention for more than 8 h. In H22-implanted mice, γ-PGA-CA-CDDP showed a significantly higher antitumor activity versus CDDP. These results reveal that γ-PGA-CA-CDDP nanoconjugate with improved stability, reduced toxicity and prolonged in-vivo retention time holds great potential in terms of clinical application to cancer therapy. © 2012 Elsevier Ltd.


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.


Deng J.,East China University of Science and Technology | Wang F.,Chinese Pharmacopoeia Commission | Yan W.,East China University of Science and Technology | Zhu J.,East China University of Science and Technology | And 4 more authors.
Chemical Communications | Year: 2012

A highly enantioselective organocatalytic protocol for conjugate addition of new nucleophilic carbonylmethyl 2-pyridinylsulfone to enals has been developed in good yields and with high enantioselectivities. The resulting Michael adducts are versatile building blocks for a variety of organic transformations. © 2012 The Royal Society of Chemistry.


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.


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.


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

Biological products are a complexity of multiple active ingredients the structure is not easy to identify. Process variation is very easy to cause the product character parameter changes, which influences the quality monitoring of the products, product safety and effectiveness. Compared with the standards of general drugs, the quality standards of biological products have unique characteristics. This review presented the profile and specialty of the national quality standard system of biological products.


Ren Y.-M.,Chinese Pharmacopoeia Commission | Zhang S.-B.,Chinese Pharmacopoeia Commission
Chinese Journal of Biologicals | Year: 2014

The management of drug name is of an important significance, of which the standardization is the key to strengthening the surveillance of drugs and protecting the public health. The current General Principles of Nomenclature of Biologicals is complicated, which needs to be further standardized. This paper reviews the principles, advances and problems in nomenclature of therapeutic biotherapeutics in China.


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.


Zhang W.,Chinese Academy of Sciences | Zhang R.-X.,Chinese Academy of Sciences | Li J.,Chinese Academy of Sciences | Liang F.,Chinese Academy of Sciences | Qian Z.-Z.,Chinese Pharmacopoeia Commission
Zhongguo Zhongyao Zazhi | Year: 2013

Through systemically sorting and studying literature of Chinese medicine, this article pointed out that leech used by the traditional Chinese medicine in ancient time has the features of small, living in water, able to suck blood of animal and people. The species of leeches having these features were Hirudo nipponia Whitman, H. pulchra Song, Poecilobdella nanjingensis sp. Nov., P. manillensis (Lesson) and P. hubeiensis Yang, which were not fully coincidence with the species recorded in Chinese Pharmacopeia of 2010 edition. We suggests that species of leech in Chinese Pharmacopeia be revised: H. nipponica Whitman should be kept, P. manillensis (Lesson) should be added in, Whitmania pigra Whitman and W. acranulata Whitma should be temporarily reserved, and H. pulchra Song, P. nanjingensis sp. Nov., and P. hubeiensis Yang should be considered.

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