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Pharmacopoeia of The People's Republic of China 2010

Pharmacopoeia of The People's Republic of China 2010
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Name: Pharmacopoeia of The People's Republic of China 2010
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Serial Number: 9780119207798
Manufacturer Name: Pharmacopoeia Commission of the People's Republic of China
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Pharmacopoeia of The People's Republic of China 2010 Pharmacopoeia of The People's Republic of China 2010

9780119207798, PHARMACOPOEIA OF The People's Republic of China, chinese medicine, chinese medical book, acupuncture, moxibustion, traditional chinese medicine, acupuncture book, chinese medicine, chinese medicine and acupuncture

  • ISBN: 9780119207798
  • Hardcover 3 Copies of English Edition (Volume I/II/III) 220mm X 300mm 3382 pages
  • Publisher: Chemical Industry Press, Published: 01 Aug 2011
  •  
    FREE SHIPPING  within the continental US.
     
     
    This latest English edition of the Pharmacopoeia of the People's Republic of China (known as Chinese Pharmacopoeia 2010 or in abbreviation as ChP 2010) has been prepared in accordance with the principles and requirements recommended by the Ninth Pharmacopoeia Commission and accomplished with the effort made by Commission members and its Secretariat and with collaborated support of relevant institutions and organizations. The draft text has been reviewed and approved by the Executive Committee of the Pharmacopoeia Commission. This is the ninth edition of Chinese Pharmacopoeia since the founding of the People's Republic of China.
     
    • ISBN: 9780119207798
    • ISBN: 0119207796
    • Hardcover 3 Copies of English Edition (Volume I/II/III) 220mm X 300mm   3382 pages
    • Author: Pharmacopoeia Commission
    • Published: 01 Aug 2011,     Publisher: Chemical Industry Press
    Contents
    Membership of the 9th Pharmacopoeia Commission of the People's Republic of China............III
    Editorial Board of Pharmacopoeia of the People�s Republic of China (2010) Volume II.........VII
    Preface....................................................................................VIII
    History of the Pharmacopoeia of the People's Republic of China...............................XI
    New Admissions...............................................................................XX
    Omissions or Adjustments included in Volume II (2005 Edition)..............................XXIV
    General Notices.............................................................................XXV
    Monographs Part I.............................................................................1
    Monographs Part II.........................................................................1295
    Appendices..................................................................................A-1
    Index.......................................................................................I-1


    Preface

    Chinese Pharmacopoeia 2010 is published in three volumes, and contains up to 4567 monographs with 1386 new admissions. In Volume I , it contains monographs of Chinese crude drugs and the prepared slices, vegetable oil/fat and its extract, the patented Chinese traditional medicines, single ingredient of Chinese crude drug preparations etc, it has 2165 monographs with 1019 new admissions (439 articles of the prepared slice) and 634 revised; Volume II deals with monographs of chemical drugs~ antibiotics, biochemical preparations. radiopharmaceuticals and excipients for pharmaceutical use, contains 2271 monographs with 330 new admissions and 1500 revised; Volume III contains biological products, has 131 monographs with 37 new admissions and 94 revised.

    The number of articles in Appendices of this edition is much varied. There are 14 new admissions and 47 revised, in Volume I . There are 15 new admissions and 69 revised in Appendices of Volume II. There are 18 new admissions and 39 revised in Appendices of Volume III. Appropriate monographs common to all three volumes are presented in each volume respectively in a harmonized and unified form.

    The main changes in the revision of this edition of Chinese Pharmacopoeia are as follows:

    Monographs adopted in this edition of Chinese Pharmacopoeia are significantly increased in comparison with previous editions. The scope of monographs adopted in this edition has been expanded actively, and covers basically the catalogue of national essential medicines. Numbers of new admissions and revised monographs are significantly increased in comparison with previous editions. Numbers of omissions or adjustments are 36 monographs of previous edition due to standards imperfect s, no product for years and adverse drug reactions.

    Applications of contemporary techniques of analysis is further enhanced and stressed in this edition. In addition to articles of new technologies and new methods contained in the appendices such as guidelines of ion chromatography, nuclear magnetic resonance spectroscopy and Raman spectrometry, applications of contemporary techniques of analysis is further enhanced and stressed in monographs. In Volume I , a number of monographs adopted some new techniques, of liquid chromatography-mass spectrometer, DNA molecular markers identification, thin layer chromatography-bioautography in order to improve sensitivity and specificity. In Volume II , ion chromatography and high performance capillary electrophoresis are adopted, determination of total organic carbon and conductimetric method are used for purified water and water for injection. In Volume III, methods of test in vitro are used to determine activity and potency of biological products instead of animal testing methods. virus inactivation verification with much higher sensitivity is adopted.

    The guarantee of pharmaceutical safety is further strengthened. In addition to articles contained in the general notices and appendices to intensify general requirements for safety tests. items of safety test are also increased and improved significantly in monographs. In the general notices, the monographs of drug substances for injection from human and animal origin should have requirements of production. In the general requirements for preparations. preparations for eye are demanded according to requirements of sterile preparations, adhesive plasters must meet hygienic standard, and preparations of eye drops and intravenous infusions should have items of osmotic molar concentration. In the appendices, tests of hernolysis and gathering and tests of the effectiveness of antimicrobial agents have been acceded to appendices. In Volume I, the requirements of limits of heavy metals and hazardous elements have been formulated in Chinese medicine injections, tests of heavy metals and hazardous elements also are adopted in monographs of pediatric drugs and long-term drugs, aflatoxin inspections are used to easy moldy semen persicae and almonds. In Volume II , controls in related substances and polymers are further strengthened, tests for residual solvents, bacteriostats, antioxidants, osmotic pressure, bacterial endotoxins and sterile processes are increased. In Volume III, production processes of biological products must strictly control use of antibiotics, additive precrva1ives in products are restricted, controls in residual solvents. impurities and residual endotoxins are strengthened.

    The controllability and effectiveness of drug quality are further improved. In addition to articles of newly admitted or revised test methods or guidelines contained in appendices, items of effectiveness are also increased and improved significantly in monographs. In Volume I, owing to the added methods of inductively coupled plasma-atomic emission spectrometry and ion chromatography and the revised methods of atomic absorption spectrometry and heavy metal tests, a test system of heavy metals and hazardous elements is perfected. There has been a tremendous increase in methods of characteristic identifications to traditional Chinese medicines. The characteristic identification by thin layer chromatography is used for most Chinese medicines except mineral drugs, the characteristic tests for effective constituents of Chinese medicines are established in quality control. In Volume II, assays and potency assays adopt more characteristic methods of high pressure liquid chromatography, the dissolution tests are added to the majority of oral solid dosage forms, and the use of content uniformity test is expanded to specifications of 25mg. In Volume III, quality requirements of raw materials are more stringent, test items and the method arc more scientific and rational.

    The contents of drug standards are scientific and normative. In order to meet the needs of drug supervision and administration, the general requirements of pharmaceutical excipients are added in the general requirements for preparations; the method of visible particles determination is revised the respect of sampling requirements, test frequency and time, etc.; the inspection method of insoluble particles integrates operations in the further. In Volume I, Latin names of Chinese medicinal herbs have been regulated and revised; the general notices specifically state that Chinese medicinal decoction should used slices. Chinese medicinal decoction slices have been assigned their properties, actions andindications, usage and dosage in monographs concerned.

    Encouraging technical innovation, actively participating in international coordination. This edition actively promotes independent innovation, according to Chinese medicine theory and Chinese medicines complexity, the establishment of chromatographic fingerprints can reflect the overall characteristics of traditional Chinese medicine in order to ensure stable quality and uniformity. At the same time, this edition also actively introduces the requirements and limitations of pharmaceutical impurity control and sterility test from the international coordination organizations.

    In addition, this edition also reflects the concepts of the wild resource protection and sustainable development of traditional Chinese medicines, with reference to traditional Chinese medicine resources and protection of rare and endangered the relevant international conventions and agreements, no additional endangered wild medicinal herbs and actively guide manual planting and breeding scarce resources development. The pharmacopoeia also actively promotes the green standards, to use less toxic, less polluted materials and to save resources, protect the environment, adopt simple and practical detection method.

    In the organizational work and scientific management new approach is adopted for editing the pharmacopoeia. The research tasks of pharmacopoeial standards were carried out for the first time in the form of research project assignments~ it gave clear responsibilities and obligations, and clarified work tasks, research goals, indicators for performance appraisal and progress schedule. In the process of compiling pharmacopoeia, we convened for the first time the participation of all members of the working conference to study and solve pharmacopoeial problems. We introduced the weekly system of progress of the scientific mission to report the progress of the undertaking unit, the common problems and improvement requirements so as to promote effectively the progress and quality.

    In the compilation work of the pharmacopoeia the members played an important role in expertise and technology. We fully mobilized social resources to participate enthusiastically and forwardly in the compilation work, played the coordinating role of the organizations and provided also an important guarantee for the standard work through various channels and ways to raise special funds.

    Pharmacopoeia as the code to ensure the quality of medicines shall maintain scientific, advanced, normative and authoritative characteristics to solve problems of quality and safety of the drug and improve the level of pharmaceutical standards. We also use the international advanced technology and experience for reference to reflect the current level of pharmaceutical industry, clinical medicine and inspection technology, it will play an important role in improving the quality of drugs actively and will further expand and improve our pharmacopoeia international influence.


    Pharmacopoeia Commission of the People's Republic of China  (August 2010)

       

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