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New Pharmacopoeia wrapped up highlighting drastic revision of TCM standards
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| 2009-12-18 |
The compilation of Chinese Pharmacopoeia 2010 edition is finished on schedule and the execution work will be followed gradually. It’s learned that an increase of 42% of new drugs has been collected in the Pharmacopoeia, and 69% are revised drugs, which is the biggest modification among all the versions. It is a mainly solution to the long-standing problems of lack of national standards and low level of quality control for Chinese medical oral tablets and commonly used pharmaceutical excipients.
Totaling 4615 varieties
Compared with the Pharmacopoeia of 2005 edition, the new Pharmacopoeia adds up 1358 new varieties, totaling 4615 varieties and establishing a complete pharmaceutical standard system including a full range of Chinese herbal medicine, Chinese medical oral tablets, Chinese medicine, chemicals, pharmaceutical excipients and biological products, which covers all drugs in the National Essential Drug List.
According to Zhou Fucheng, Deputy Secretary-General of Pharmacopoeia Commission, Volume 1 of Chinese Pharmacopoeia 2010 edition has collected a total of 2136 drugs including herbs, oral tablets, plant oils and extracts, set prescriptions and single flavor preparations, among which 990 are newly added and 612 revised; Volume 2 has collected a total of 2348 drugs including chemicals, antibiotics, biochemical drugs, radioactive pharmaceuticals and pharmaceutical excipients, among which 340 are newly added and1500 revised; Volume 3 has collected a total of 131 biological products including 28 newly added ones and 103 revised ones.
The Appendix to the Pharmacopoeia also sees dramatic changes, where Volume 1 adds 14 drugs and amends 54 ones; Volume 2 adds 15 and amends 70; Volume 3 adds 18 and amends 38.
Ending the era where TCM is hard to distinguish
Subject to its own characteristics and the impact of historical problems, the standard-setting for the traditional Chinese medicine (TCM) has always been difficult. Nevertheless, TCM has been the most drastic revised section in the Pharmacopoeia of this edition.
“TCM products collected in the Pharmacopoeia of 2010 edition basically cover the Essential Drug List of 2009 edition." said Qian Zhongzhi, Director of TCM Standard Division, Pharmacopoeia Commission.
According to Qian zhongzhi, TCM volume of the Pharmacopoeia of 2010 edition has had a comprehensive check and review of the collecting methods of the original standards (including the proposed new drugs and all the amended varieties in 2005 edition) for the first time, which has greatly improved the overall level of the quality standards and make them more systematical, feasible and normative.
"We shall make no ‘patches’ for the standards revision and achieve balanced development, making an overall improvement of their effectiveness and safety, and meanwhile reflecting the distinct orientation of sustainable development of TCM." said Qian Zhognzhi. TCM volume of the Pharmacopoeia 2010 edition makes a comprehensive supplement and improvement of the general inspection items such as impurities, gouache, ash, acid insoluble ash and relevant substances in the standards that may affect the quality and safety of TCM, he said. It is reported that the 2005 edition contains various inspection items totaling 1465 while the 2010 edition adds new inspection items adding up to 1868.
It is reported that proprietary authentication in line with the characteristics of TCM has been substantially increased in the 2010 edition in terms of effectiveness. Chemical color or precipitation reactions and spectral identifying method are no longer used in the standards for Chinese medicine. Highly specific examined items such as micro-powder identification and TLC technology are added. For example: in the Pharmacopoeia of 2005 edition, the content mensuration requirement of coptis is based on thin-layer chromatography of berberine in coptis, which requires berberine content is not less than 3.6%. However, as berberine has a large number of distribution in a variety of plants, its objectivity and specificity as the only determination indicator are poor, while the Pharmacopoeia of 2010 edition uses HPLC method in a multi-measurement assessment, making the controllable composition of berberine, jatrorrhizine, table berberine, berberine alkali and palmatine reach 10%, which reflect the activity relationship of coptis different from cortex phellodendri on the whole.
In terms of safety, TCM is focused on stepping up the control on heavy metals, aflatoxin and residual organic solvents, and completely bans benzene as solvent. All the analysis methods concerning benzene are revised.
"The new pharmacopoeia adopts new technologies such as liquid chromatography-mass spectrometry limit and quantitative technique, DNA molecular identification technique, TLC- biological self-display technology and biometrics for the problems which fails to be solved by the conventional analysis methods.” said the assessors participating in the conference. For example, the new version of the pharmacopoeia adopts DNA molecular identification technique for snake medicine, which is the first time the technology is used in the standards of traditional Chinese medicine.
In fact, safety, effectiveness and innovation have also been further strengthened in Volume 2 and Volume 3 of the Pharmacopoeia. The modern analytical instrumentation such as HPLC and IR has been more widely used; Volume 3 incorporating the first bacterial polysaccharide conjugate vaccine and replacing the same types of non-purified vaccines by purified vaccines reflect advances in production technology.
"It is fair enough to say that in terms of quality standards of TCM, we have basically brought the era where even the immortal God would find it difficult to distinguish 'pills, powders, pastes or pellets’ to an end." Qian Zhongzhi also revealed that five standards for TCM including andrographis paniculata, centella asiatica, cinnamon, ganoderma lucidum, artemisia annua are intended to be incorporated into the United States Pharmacopoeia as the first international China-US mutual recognized standards
Source: Medicine Economic News
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