Common Chinese medicine adulteration means and compliance analysis

According to incomplete statistics, a total of 172 drug GMP certificates were withdrawn in 2016. Among them, Chinese medicine and beverage enterprises GMP certificate recovery 79, accounting for 46% of the total recovery. It can be seen that the hard-hit areas of flying inspection are still Chinese medicine tablets enterprises. At the beginning of this year, CFDA organized a special spot check on Chinese medicine tablets for varieties found in daily supervision, and published the results of spot checks, involving 93 pharmaceutical tablets production enterprises there is fraud, including well-known pharmaceutical companies.
harm of Chinese medicine adulteration is not only that the amount of medicine is not enough, the drug is not correct, reduces the treatment or invalidity, but also that the drug is prone to toxic side effects. Because of the toxic side effects of impurities themselves, they can cause other diseases to patients. More importantly, it seriously affects the reputation of Chinese medicine and the development of Chinese medicine. According to the CFDA and provincial and municipal drug regulatory agencies and special inspection arrangements for Chinese medicine, in order to help Chinese medicine tablets, Chinese medicine preparations production enterprises understand the new regulatory situation, grasp the identification of the authenticity of Chinese medicine, the author talks about the current market common Chinese medicine adulteration means and compliance analysis. 8 common doping means 1. Weight doping: that is, mixed with talcum powder, gypsum powder, cement, sediment, inoromic salts and other impurities, in order to increase the weight of medicinal herbs, and not easy to find out.
different types of medicinal herbs doped with different characteristics:
flowers, fruits, seeds and other small varieties easily mixed with other colors, similar shape impurities; Gold and silver flowers, red flowers, chrysanthemums wet with water and add their color similar to yellow, red or white bean powder, sediment and so on.
root herbs, whole grasses, fruits with sulfates, salt, sugar soaked after drying to achieve aggravating purposes. For example: through grass, etc. with sulfates or sugar soaked weight gain. The identification method of white herbs is to place the above herbs in the sun, and the line of sight zero angle of view, it can be seen that the surface of the medicinal herbs have crystall reaction, taste a sour feeling can be determined.
powdered block root herbs are mixed with talcum powder. The starch content of several varieties, such as white herring, smallpofic pollen and yams, is high, and there will be hanging powder on the surface after the slice, adding talcum powder is a common seepage phenomenon. To identify whether talc powder is added, as long as the hand into the Chinese medicine drink tablets to take out the hands feel slippery feeling, and the hand aimed at the bright place, talc powder particles will have reflective points.
animal medicinal herbs, with silt, coagulation gel and other substances into the abdomen of animal medicinal herbs, or do not remove the animal medicinal herbs internal organs, in order to achieve aggravating purposes. Such as winter worm summer grass nails, wire; Purple River car doped with protein starch.
2. Shape-like adulteration: doping with medicinal herbs that are similar in appearance or of the same family. For example
: the heron: with the northeast heron, the shrill ear impersonation;
: Posing with co-greening and pricking grass;
- Tiger bones: posing with cow bones;
x Western ginseng: posing with white slugs, ginseng artifacts;
x melons: posing with water melons;
x kernels: posing with grass beads;
sandalwood: posing with flat cypress wood, sprayed with "sandalwood perfume";
half summer: half summer with water half summer impersonation;
x cinnamon: posing with yin;
x yams: posing with ginseng potatoes;
x Chuanbei: posing with small Zhebei or mussava.
3. Dyeing pseudo-mixing: some similar-looking but different-colored plant slices are dyed with counterfeit genuine drinks, and other substances are processed to forge medicinal herbs. Staining doping is divided into dyeing fraud, dyeing doping, dyeing to sub-charge 3 kinds of conditions.
dyeing fake: dyeing some plant slices that look similar but have different colors to fake genuine drinks. For example: dye iron red other plant roots dyed after posing as Dansan, dye iron black sweet potatoes dyed after posing as Ho Shou Wu, with scarlet to dye other mineral powders impersonated as water fly zhu sand, with the root part of the white swastice dyeing processed into Sichuan Wu, grass wu and so on.
dyeing doping: other impurities that are stained in the genuine. For example: red flowers mixed with gold orange II. Dyed red building materials; Pu Huang, Huang Lian mixed with gold amine O dyed yellow calcium carbonate powder; Artificial bovine yellow is mixed with several dyes, such as gold amine O, golden orange II. mixed with dyed calcium carbonate, silicate powder.
dyeing to the next best: the poor quality of drinks dyed to improve the appearance, increase the price. For example: after extracting the active ingredients, the yellow cypress was dyed and the appearance was improved to impersonate the new yellow cypress; Other origin of the color is not bright Dansan with pigment dyeing after posing as Shandong Dansan; Yanhuso, with gold amine O dyeing after sale.
4. Pure processing products doped pseudo: choose the appropriate material plus adhesive molding, posing as genuine drink tablets.
common pure processing doping counterfeits are the following:
into the cooked medicinal herbs.
some illegal traders recycled extracted Chinese herbs, cut into drinks to dry and then sold again, such as yellow cypress, five miso, armor, three seven, even. The extracted ingredients of ginseng, western ginseng sprayed into the flavor. The extracted sedum is aggravated with talcum powder or sulfate before dyeing.
addition, there are Chinese medicines containing volatile oils. Extracted herbs, most of the color is lighter, the texture is lighter, fragile, only weak original herbs have a special aroma. Such as large musk, incense, ginseng, wood incense, red flowers, ginseng, white art, white sulches and other varieties.
method: composition analysis, detection of the effective composition content of drink tablets can clearly grasp its fraud; Appearance odor, observe the color of the drink section, smell, taste.
forgery.
often used in expensive and resource-scarce Chinese herbs. Common are: using potatoes to forge hemp, using yellow-chain snakes to impersonate money white flower snakes, using ordinary fine yellow sand or talc powder to impersonate sea sand, using cow bones to forge tiger bones, using buffalo horns to forge rhino horns, using the roots of white storks to dye into Sichuan Wu, grass, with potato chips molded dyeing to make white appendages, with sweet potato cloaks processed into what head; Use flour to crush the block into irregular block-shaped mixture into the mould, plastic through the mold to create a look imitation of the roller.
5. Retouching doping: by beautifying the appearance of the medicinal tablets, to cover up the bad appearance of the herbs themselves, and even to the second-best. For example, cooked ground, making the first black glue attached to the surface.
. Shoddy counterfeiting: volatile medicinal herbs with oil immersion or oil steaming method aggravated and with inferior filling, with false and true purposes. For example, insect-infed or fragranceless sandalwood is soaked in oil or steamed with oil, and after frying with oil, it pretends to be sourdent.
7. Non-medicinal parts of the doping: the use of the same medicinal non-medicinal parts posing as medicinal sites, or did not remove non-medicinal parts. For example, the mountain juju doped fruit handle core, gold and silver flowers mixed with too many leaves and twigs, mulberry leaves contain too many twigs.
8. Ingredients doping: put some ingredients up, apply them to counterfeits, avoid qualitative testing, or add weight to other ingredients. For example, small juice immersed in yellow bark trees filled with yellow cypress, otters, paraphernalu, earthworms, whole scorpions and other salt. Se6 aspects to eliminate adulteration
Chinese herbal medicine, Chinese medicine tablets and traditional Chinese medicine is China's traditional Medicine industry's three pillars, and Chinese herbal medicine is Chinese medicine tablets and traditional Chinese medicine raw materials, the compliance of Chinese medicine is more important. In the flight inspection or spot check of Chinese medicine enterprises, more or less there will be fake and inferior herbs, raw materials testing unqualified, insufficient content and other problems, the root cause is the phenomenon of adulteration of Chinese medicine, therefore, to put an end to adulteration phenomenon is urgent. We can start from the following aspects:
1. Strict screening of raw material suppliers. In the raw material supplier audit to carry out qualification check, the origin supplier, Chinese herbal medicine professional market supplier or planting nature supplier to carry out on-site audit, audit planting site, storage environment, initial processing, etc. , all raw material suppliers should sign a quality assurance agreement, clear raw material quality requirements, Packaging requirements, transportation requirements, quality responsibilities of both sides, etc., high-quality suppliers to ensure the compliance of materials,
2. good Chinese herbal medicine procurement, acceptance, strict training and assessment of buyers, inspectors, buyers, inspectors to be effective Identify the authenticity of Chinese medicine used, familiar with the origin of Chinese herbal medicines, planting years, harvesting seasons, drug use sites, etc., master the characteristics of Chinese herbal medicines
Familiar with the identification, inspection, content determination and other test operations of Chinese herbal medicines and correctly judge the test results, it is more important to seek truth from facts, the source of samples, sample distribution, sample processing, inspection operation, such as truthful records, objective analysis, to ensure the reliability of
; 4. Play the role of QA, do a good job in material supplier audit work, material procurement, acceptance, inspection and other aspects of the work to play a supervisory role, material release play a guarantee role
Review and analysis of the situation, raw material quality, deviation, rejection, change, etc., and find that the non-conformity is handled in a timely manner,
6. Make a good record of the process of purchasing, accepting, inspecting and storing the maintenance of Chinese medicine, as well as the processing record of the problems found, and maintain the reliability of the data. (Medical Economics)