Sunday, January 27, 2013

Chinese medicinal materials and decoction pieces management: Should be transfer extensively to and standardize

Chinese medicinal materials and decoction pieces management: Should be transfer extensively to and standardize
Heilongjiang Province the intersection of Hegang and municipal the intersection of food and medicines supervise the intersection of administration bureau and deep and vast the intersection of hall and military military peak extensive to manage, sow hidden danger first issue sword: These regulations about Chinese medicinal materials, traditional Chinese medicine decoction pieces are had and can be found out from " law of medicine management ", our country has not managed Chinese medicinal materials, traditional Chinese medicine decoction pieces like other medicines yet at present. Manage extensive, the threshold is low, drawback of forcing strength to be bad etc. existing. Article 10 of " law of medicine management " stipulates: Besides process of preparing Chinese medicine of traditional Chinese medicine decoction pieces, the production technology that medicines must be sanctioned according to national medicines standard and the State Council pharmaceuticals administration department is produced, it must be intact and accurate to produce the record. The medicines manufacturing enterprise changes production technology of influencing the quality of medicines, must submit to the former department of approval and verify and sanction. Traditional Chinese medicine decoction pieces must be concocted according to the national medicines standard; The national medicines standard has no one that stipulate, must concoct according to the process of preparing Chinese medicine norm that the pharmaceuticals administration department of the people's government of province, autonomous region and municipality directly under the Central Government make. Article 21 stipulates: The market of country trade in urban and rural areas can sell Chinese medicinal materials, the State Council is except the cases otherwise stipulated. The market of country trade in urban and rural areas can't sell medicines beyond Chinese medicinal materials, but hold the medicines retailer of " medicines business liscence " in the fixed range, can set up an office on the market of country trade of urban and rural areas and sell medicines beyond Chinese medicinal materials. Article 47 stipulates: The management of folk conventional crude drugs of provincialism, is made together with the State Council traditional Chinese medicine administrative department by the State Council pharmaceuticals administration department. Article 103 stipulates: Planting, collection and management raised of Chinese medicinal materials, are stipulated separately by the State Council. State Pharmaceutical Inspection Administration issued " standardard management of quality of production of Chinese medicinal materials " (GAP) in June of 2002 ,But not forced enterprises to implement, not big to enterprise's engagement. Above-mentioned reason cause the intersection of market and the intersection of variety and confused, the intersection of quality and low of imitation and poor quality current situation that medicines emerge in an endless stream, Chinese medicinal materials of our country and decoction pieces of traditional Chinese medicine. The quality criteria no reunification two: Chinese medicinal materials, traditional Chinese medicine decoction pieces quality criteria are not unified, unstandard. The folk conventional crude drugs all parts of provincialism are different, cause the variety to be confused, hard to tell whether it is true or false. Chinese medicinal materials sold on the market are basically all traditional Chinese medicine decoction pieces. The standard that decoction pieces was carried out was " Chinese pharmacopoeia " in the past. What " Chinese pharmacopoeia " is described in properties are distinguished is all original crude drugs, so the unable accurate norm while describing properties. Our province the intersection of traditional Chinese medicine and the intersection of decoction pieces and test it carries out standards to be until " whether Heilongjiang Province traditional Chinese medicine concocts the norm " accurate mostly now. It's time to concoct the norm and was made in 1991, only simple properties described, it is unable to judge to meet some decoction pieces with low quality whether its inherent quality was qualified. Some crude drugs distinguish method to be simple, variety numerous such as the intersection of Sichuan and bulb of fritillary, and culture make a variation variety to be complicated these years, only micro- to distinguish starch of bulb of fritillary one similar on the whole under pharmacopoeia distinguish, it is very difficult to distinguish the true and false. And for example, honeysuckle is recorded only for the bud of Radix Ophiopogonis or flower in bloom for the first time in 2005 edition " Chinese pharmacopoeia ", call red the intersection of gland and Radix Ophiopogonis in 1991 edition " whether Heilongjiang Province traditional Chinese medicine concoct norm ", mountain silver flower, Mao HuaZhu bud or flower turn on for the first time of Radix Ophiopogonis can be regarded as the honeysuckle and used as medicine. Local standard conflict with " the the intersection of Chinese and pharmacopoeia " obviously, let at the basic level the intersection of administrator and kind assurance while examining specifically. So the standard norm is a problem to be solved urgently. Purchase and sell the field question and does not lack of the question three: Misapplication. A lot of personnel engaged in the work of traditional Chinese medicine lack the professional knowledge that traditional Chinese medicine distinguished, the name or description, property of Chinese medicinal materials especially recorded to the pharmacopoeia are not mastered, use crude drugs with close name, efficiency with by mistake. Regard wide Herba Lysimachiae as Herba Lysimachiae is fragrant to add skin, regard as the Wu Chia Pee, regard the north beans root as root of subprostrate sophora,etc. for instance. The variety is confused. There are a lot of crude drugs confused variety on the market at present, there are more false products. The false product of for instance sour jujube kernel has Yunnan to sting dates, the sand garden son's false product is Radix Astragali,etc., papaya's false product glazed leather papaya, small papaya, the one's own -proof false product is root of fangji of Hanzhong, wooden root of fangji,etc.. It is false to mix. It is substantially as mixing the brick in the sea Jinsha it is detailed powder,it must mix pistil, corn at safflowers west, lotus must,etc. impurity. The decoction pieces specification standard treats the norm according to the regulation about traditional Chinese medicine decoction pieces of " law of medicine management ", traditional Chinese medicine decoction pieces must be concocted according to the national standard. There is not a standard one in the country, concoct the norm to concoct according to the place. Cut national decoction pieces, make or concoct the rules the standard general rule not completely unified yet at present can be depended on. The specification substantially as cutting and making traditional Chinese medicine and drinking to each, silks, each, various concoct and fry standard craft,etc. made with adjuvants. Even existing fixed standard now has greater differences. If " whether Heilongjiang Province traditional Chinese medicine concocts the norm " 1991 edition regulations: Traditional Chinese medicine cut make flake thickness under the 1mm extremely, flake 1~2mm, thick slice 2~5mm, short pieces of 8~12mm, grow in the Section 20~25mm. And " the the intersection of Chinese and pharmacopoeia " crude drugs concoct the general rule stipulate: Flake thickness under the 0.5mm very much, flake 1~2mm, thick slice 2~4mm, short sections of 5~10mm, grow pieces of 10~15mm, it is obvious how large the difference is. And often the intersection of honey and too much bulk of sticking with decoction pieces that honey make, or honey so little that distinguish honey make while being difficult. These problems need solving as soon as possible too. Propose the intersection of country and relevant clause in " the law of medicine management " make, supplement, revise, put on an equal footing crude drugs and decoction pieces as other medicines, improve and produce and manage the entry threshold. Traditional Chinese medicine decoction pieces uses medicine as the Chinese medicine prescription, should be according to the medicines regulation at present, implement a variety, a name, one and concoct craft norm and quality criteria. In concrete operation, should change the current situation relying mainly on local standard at present progressively, make traditional Chinese medicine decoction pieces carry out the transition to the whole country and seek unity of standard finally. It is notably different to concoct the craft to all parts, certain ones that used the foundation are the same as a decoction pieces, while making the national standard, should distinguish in the name according to the actual conditions, and keep separately. Be wild, daily concoct norm and quality criteria, the large principle after wanting the family in line with being easy first and difficult later, first to be wild, daily first after planting in unison, the norm, unify progressively step by step. Propose the following varieties authorize and concoct craft norm and quality criteria preferably: --28 toxic decoction pieces of crude drugs, the intersection of grass and dark, the intersection of Sichuan and dark, tuber of pinellia, white Radix Aconiti Lateralis Preparata, cinnabar,etc.. --" the Seventh Five-Year Plan Period " , " the Eighth Five-Year Plan Period " 40 kinds of decoction pieces in the national brainstorm subject, such as Radix Astragali, Chinese angelica, prepared rhizome of rehmannia, rhizome of large-headed atractylodes, fragrant enclosing, thick Piao, sesame oil,etc.. --" the the intersection of Chinese and pharmacopoeia " and the intersection of Ministry of Public Health and a commonly used one in " whether national traditional Chinese medicine concoct norm ", concoct the craft, define unified variety basically of editor. --Fermented product,etc. needs traditional Chinese medicine decoction pieces processed specially. --Had already listed in and made Make " variety for producing the standardard management of quality " of Chinese medicinal materials. To the inherent quality criteria of decoction pieces, can consult " Chinese pharmacopoeia's " Chinese medicinal materials standard to give completely. Encourage setting up fingerprint atlas based on genuine crude drugs. According to the medicines requirement, standardize the decoction pieces packaging of traditional Chinese medicine. Reform the decoction pieces packaging of traditional Chinese medicine, realize the decoction pieces packaging standardization. Promote the improvement of Chinese medicinal materials and traditional Chinese medicine decoction pieces quality criteria, implement GAP in an all-round way.

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