In recent years, the quality problems in the field of Chinese herbal medicine and decoction pieces are quite prominent. In order to promote the healthy development of the industry, the authoritative experts invited the authoritative experts to trace the source of the key issues such as quality and inspection standards of Chinese herbal medicines and processed pieces, and find the crux of the problem, and put forward constructive suggestions for reference by the industry and regulatory practitioners.

Chinese herbal medicine and decoction pieces are an important part of Chinese medicine. They are the source of Chinese medicine industry and the material basis for the development of Chinese medicine. Strengthening the management of Chinese herbal medicines and pieces, ensuring the quality and safety of Chinese herbal medicines and pieces, is of great significance for maintaining public health, promoting the sustained and healthy development of Chinese medicine industry and promoting the prosperity of Chinese medicine. Relevant departments of the state have put forward the plan for the development of Chinese herbal medicines, and have strengthened the supervision over the quality of Chinese herbal medicines and pieces. However, in recent years, various inspection and sampling tests have been carried out by the state and provincial and municipal drug regulatory departments. The quality problems in the field of Chinese herbal medicine and decoction pieces are still outstanding. In particular, the State Administration recently announced the quality of the products and units of Chinese herbal pieces with high quality.

In order to promote the healthy development of the industry, this newspaper invited authoritative experts to trace the source of the key issues such as quality and testing standards of Chinese herbal medicines and processed pieces, find the crux, and put forward constructive suggestions for reference by the industry and regulatory practitioners.

Since 2013, the State Food and drug administration has launched the special action of "two dozen and two construction", all local governments and drug administration departments have intensified the market supervision, making the professional market of Chinese herbal medicines improved in many aspects.

At the same time, along with the continuous expansion and upgrading of the industrialization and marketization of Chinese medicine, Chinese herbal medicine industry has gradually formed a Chinese herbal medicine industry with the main link of Chinese herbal medicine planting and breeding, primary processing and specialized market, and has also formed a large number of Chinese herbal medicine Pieces Enterprises that have been certified and begun to take shape through GMP. However, there are still some problems in the quality of Chinese herbal medicines and Chinese herbal medicines due to the shortage of resources, the expanding market demand, the long industrial chain, the imperfect production technology and norms, and the weak sense of quality of the employees. The author combines daily inspection practice and common problems to make suggestions to communicate with you.

In the past 2013~2016 years, the national drug quality sampling inspection showed that the overall pass rate of Chinese herbal medicines and processed pieces were 64%, 68%, 75%, 77%, respectively, and the pass rate increased year by year and steadily improved. However, compared with other medicines, the failure rate of Chinese herbal medicines and Chinese herbal medicines is still high. The problems are mainly manifested in the following aspects:

Counterfeit fake or adulterated counterfeit goods

The adulteration of counterfeit products into genuine or genuine adulteration products is mainly concentrated on varieties with fewer genuine sources and scarce resources, mostly belonging to similar varieties or similar names and similar characters. 问题较突出的有：以野皂角刺或日本皂角刺冒充皂角刺;以大菟丝子冒充菟丝子;薯蓣科其他品种如参薯、山薯冒充山药;零余子染色冒充延胡索;木防己、汉防己冒充防己;非药典品种的青蛙输卵管冒充蛤蟆油;赤链蛇幼蛇冒充金钱白花蛇;虎掌南星或水半夏冒充半夏;伊贝母、平贝母冒充川贝母;湖北贝母冒充浙贝母;藏柴胡、锥叶柴胡等冒充柴胡;黄花白及、华白及、小白及等冒充白及;朝鲜白头翁、委陵菜等冒充白头翁;沙苁蓉冒充肉苁蓉;益智仁冒充砂仁;槲寄生冒充桑寄生等。

Two, too many impurities such as non medicinal parts.

Excessive use of non medicinal parts in Chinese herbal medicines and pieces is one of the main reasons leading to failure. The more prominent varieties were Bupleurum chinense and asarum and so on, which were mixed with more aboveground parts; saponins, uncaria, Cynanchum paniculate mixed with most stems; Morinda officinalis xylem had a larger proportion; Cornus officinalis had too many cores; peony bark and Polygala tenuifolia did not go to wood core. In addition, some species are mixed with sediment and other impurities, such as Coptis chinensis mixed with a lot of soil; silkworm has a lot of lime; the soil of earthworm is not removed; frankincense and myrrh are mixed with a large number of bark and silt; and there are a lot of silt in the woodlouse worm's viscera.

Three, confused goods problem

Some varieties of local medicinal materials are mixed with the Chinese Pharmacopoeia, which are mixed with the source and the name, such as the mixture of jujube kernel and sour jujube; mixed with Radix Acanthopanacis and Radix Acanthopanacis; the mixture of wood and Sichuan; the mixture of patchouli and patchouli; the mixture of Chinese yam and Chinese yam; the mixture of Cortex Acanthopanacis and cortex phellomis, the mixture of Ophiopogon japonicus and Radix lophadi; the substitution of rhizome bean with root; the mixture of papaya and papaya; the mixture of Herba Ophiopogon and Herba papyrrhizae; mixture of Herba glehsiae and Herba Lysimachia; mixture of valleys and oryzae. Herbal pieces with similar appearance or similar names are often mixed. In addition, the phenomenon of mixed use of pharmacopoeia is serious. The main varieties are: Radix Puerariae and pueraria lobata mixed; Honeysuckle mixed with Flos Lonicerae; mixed fruit of Schisandra chinensis and Fructus schisandrae chinensis; mixed use of Phellodendron amurense and Phellodendron amurense.

Four, illegal staining problem

It is a serious offence to dye the inferior medicinal materials with organic dyes. The main varieties are safflower, saffron, Salvia miltiorrhiza, Schisandra chinensis, Fructus schisandrae chinensis, cinnabar, dragon's blood, pollen cattail, corydalis, Dendrobium, Jiang Huang, Scutellaria baicalensis, Rhizoma Coptidis, Phellodendron amurense, Phellodendron amurense, Fructus Mume, indigo naturalis, Rehmannia glutinosa, Radix Polygoni multiflori and so on. The pigments and dyes found are acid red 73, carmine, erythrin, lemon yellow, Jin Cheng, gold amine O, Sudan red IV, 808 scarlet, Sudan red I, Sudan red IV, 808 scarlet, malachite green, iron black and so on. The purpose of dyeing is often to cover adulteration, poor quality, mildew, weight gain or changes in character caused by extraction, so as to increase sales. For example, in the 320 batch of safflower inspection conducted in 2015, 20% of the samples were stained with pigments, and 4 samples were detected at the same time. The reason for this may be that Chinese medicinal materials are mostly collected and processed by individuals, and there are many circulation links. Therefore, a batch of Chinese herbal medicines are often collected from multiple channels. Because organic dyes are mostly toxic and even carcinogenic and teratogenic, the dyeing behavior of medicinal materials is not only a fraud, but also increases the safety risk and must be severely punished. The State Food and drug administration has issued a series of supplementary testing methods for illegal dyeing problems found in the market. It has been applied to market supervision and effectively cracked down on illegal dyeing.

Five, the problem of malicious weight gain driven by interests.

In order to pursue economic interests, some illegal elements use inorganic salts, silt and other substances to increase the weight of medicinal materials and slices. The most prominent problems are earthworm, pangolin, scorpion, hippocampus, sea dragon, Gekko, leech, woodlouse worm, Bombyx Silkworm, placenta, and chicken gallbladder, and Cordyceps sinensis, hainjinsha, Puhuang, red ginseng, cortex butris, Polyporus, Cuscuta chinensis etc.

Six, Sulphur Fumigation problem

Sulphur fumigated herbs are mostly for moisturizing, gaining weight, improving appearance and increasing sales. The most serious types of excessive sulfur fumigation are yam, Yuzhu, Curcuma, Fritillaria thunbergii, Fritillaria, lily, dangshen, angelica, Paeonia lactiflora, Rhizoma Atractylodis Macrocephalae, Pueraria lobata, Gastrodia elata, lilyturf, Radix et Rhizoma et Radix et Rhizoma et Radix and so on. Studies have shown that a large number of widely used sulfur fumigation will not only affect the quality of herbs and pieces, but also cause harm to human health. In recent years, with the strengthening of supervision, from the national sampling test, no matter the variety or quantity, Sulphur Fumigation has been reduced, and even in some areas, the implementation of sulfur free herbal medicine and processed slices and fresh processing has been welcomed by the public. It is suggested that some new technologies for processing and storing medicinal materials should be popularized.

Seven, storage is not standardized resulting in moth and mildew.

Due to improper storage conditions, some species were found to be moth eaten and mouldy during the examination. Some of them were more serious, such as coix seed, Morinda officinalis, Radix et Rhizoma Panax, Radix Alpinia, Radix Codonopsis, ginseng, Radix Isatidis, Cyperus rhizome and so on. In addition, there is a phenomenon of pesticide abuse in the storehouse in order to prevent the production of insects. For example, it is found that the pesticide residue of woodlouse worm is over standard and aflatoxin exceeds the standard.

Eight, planting and breeding is not standardized, resulting in poor quality.

Due to the blind cultivation of wild or non native medicinal materials, there are serious problems in the quality of some Chinese medicinal materials due to the fact that pesticides and growth regulators are widely used in the cultivation process, the cultivation methods are not standardized, and the soil quality of cultivated land is different. The rhizome of Pinellia ternata cultivated with small stalks rather than spheroid (wild products), the characteristics of cultivated Pinellia ternata are similar to that of the southern palm of the tiger palm; the cultivated materials of Salvia miltiorrhiza Bunge are shallower than the wild skin, and the section is not purple brown or even white like, hard and tanshinone content descends obviously; Radix Polygoni Multiflori, Radix Ophiopogonis, Codonopsis pilosula, Radix Sophorae Flavescentis, Angelica sinensis and other varieties, due to the use of growth regulators, the growth of the medicinal materials in a relatively short period of time has resulted in a change in morphology, which is totally out of line with the varietal characters collected in the current Pharmacopoeia. Now found

Nine, others

In addition to the above common quality problems, there are other kinds of quality problems. Although these problems are not very common, they also affect the quality of medicinal herbs. First, the extracted residues are treated and circulated again. The varieties found are Gastrodia elata, Magnolia officinalis, Rhizoma Atractylodis, Rhizoma Corydalis, safflower, Phellodendron chinense, Paeonia lactiflora pall, Atractylodes macrocephala and so on. Two, it is not processed according to the standard of processing. If Pinellia ternata was processed without licorice, ginger could not be identified as ginger ingredients; phellodendron bark and Eucommia ulmoides were not removed; coarse cinnabar was not removed by water flying method, but directly crushed into very fine powder; the processed pieces of Polygonum multiflorum and Rehmannia glutinosa liq. Were often processed poorly; the toxic tablets such as aconite and Radix Aconiti Preparata were processed too much, and the toxic ingredients of these pieces were effective ingredients.

(source: Chinese herbal medicine net)