The Development of Chinese Medicinal Materials and Decoction Pieces Industry: Problems and Countermeasures

WANG Jian-sheng, TIAN Li-juan

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The Development of Chinese Medicinal Materials and Decoction Pieces Industry: Problems and Countermeasures

WANG Jian-sheng, TIAN Li-juan

Objective Toanalyze the problems in the development of Chinese medicinal materials and decoction pieces industry and to suggest the countermeasures. Methods Main factors that hinder the development of Chinese medicinal materials and decoction pieces industry were summarized through literature review and information collection. Results and Conclusion There are some problems in the development of Chinese medicinal materials and decoction pieces industry, especially in the areas of plantation and slices processing. Faking medicinal materials and decoction pieces are another serious problem. The development trend of Chinese medicinal materials and decoction pieces industry is good, though, it still needs the government’s guidance and policy support.

Chinese medicinal material; decoction piece; problem; countermeasure

Since the founding of new China, great importance has been attached to the work of traditional Chinese medicine by the CPC Central Committee and State Council, Chinese medicine industry has made remarkable achievements. With the vigorous development of traditional Chinese medicine, Chinese medicinal materials and slices face unprecedented opportunities. China Food and Drug Administration and State Administration of Traditional Chinese Medicine have introduced a series of regulations and laws to standardize the market for many years so that the situation of planting, harvesting, processing of Chinese medicine material and slices have been greatly improved. The raise of Chinese traditional medicines profile in domestic and abroad made the demand of Chinese medicinal materials and slices increase greatly. But due to resource scarcity and rising prices, many problems arose, such as excessive excavation, fake medicinal materials and illegal operation which directly affect the quality of Chinese medicinal materials and slices.

By analyze the problems in the development of Chinese medicinal materials and slices, we find the effective resolution to guarantee safety in medication for patients.

1 The main problems in the development ofChinese medicinal materials and slices

With the increasing use of Chinese medicinal materials and slices, the long-term unplanned excavation and the change of natural environment, wild herbal resources have been in a state of contradiction between protection and utilization of wild herbal resources is more and more obvious.

According to the authorities, in the late 1980s, liquorices resources were 60% less than the 50s’, musk resources were reduced by 70%. The destruction of otherresources of Chinese medicinal materials and sliceswas very serious. Such asGecko, Chinese caterpillar fungus, magnolia bark, eucommia bark, amur corktree bark, milk vetch root, ephedra, unibract fritillary bulb, Ginseng, huoshan mountaindendrobium herb and medicinal dendrobium herb,. It is hard to get some wild herbals. More than 100 kinds of wild Chinese medicinal plants are classified as rare and endangered species, including ginseng, liquor rice, noble dendrobium stem herb, Sichuan fritillary bulb and snow lotus,[1, 2].

Under the pressure of resources scarcity or the utilization of new resources, Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the 2010 editionof“Pharmacopoeia”) modified some of the source of Chinese medicinal materials and slices. For example, the 2000 edition of “Pharmacopoeia” contained Sichuan fritillary, bulb, tendrileaf fritillary bulb, unibract fritillary bulb, przewalsk fritillary bulb and delavay fritillary bulb and classified them as Songbei, Qingbei and Lubei separately according to their characters. In addition to the above wild herbs, two cultivating fritillarias, titled Taipai fritillary bulb and Wabu fritillary bulb were added to the current “Pharmacopoeia”.For another example, the 2000 version of “Pharmacopoeia” contained only loddiges dendrobium herb, eye shaped dendrobium herb, glodenflower dendrobium herb, medicinal dendrobum herb and noble dendrobium stem herb for the source of caulis dendrobii. But the current “Pharmacopoeia” recorded the cultivated noble dendrobium stem herb, yellow-bow dendrobium herb and eye shaped dendrobium herb which had the approximate characteristic of the same species, making the plant source of caulis dendrobii more widely[3, 4].

China Food and Drug Administration definedfamous-region drugs in the Good Agricultural Practices ofChinese medicinal materials (trial) (hereinafter referred to as GAP) as traditional Chinese medicinal materials with specific germplasm, region and special production technology and processing method.

LI Shi-zhen of the Ming dynasty talked about the nature of the medicinal materials, pointing out that the characteristics of medicines vary a lot as the change of origins. In the “Compendium of Materia Medica” He emphasized the importance of origins. Due to the excessive excavation, wild resources decrease greatly. The lack of policy support, high cost of cultivation, low yield and less artificial planting made the varieties of famous-region drug fewer and fewer.

There were 1142 species of medicinal resources in Hebei province in the 70s, but only about 1000 species today. The harvest of divaricate aposhnikovia root, gentian root, bupleurum root and thin leaf milkwort root was about 1000 tons in the late 80s. Due to the current serious resources depletion, these wild herbs have run out[5].

Hangzhou dwarf lily turf is one of the eight famous Chinese herbs in Zhejiang. It is white and big with soft and glutinous figure. It tastes sweet with pleasant fragrance. But due to the three years growing cycle, high planting cost and low yield, Hangzhou dwarf lily turf has been replaced by Sichuan dwarf lily turf which grows up in two years with high yield. Hangzhou white paeony root, Yuqian large head atractylodes rhizome is on the verge of extinction too as their planting areas decline.

With the raise of price and large use of traditional Chinese medicine, the number of Chinese medicinal materials planting has increased. But due to the lack of scientific guidance, some herbals were sowed in wrong places without taking the soil environment and climate conditions into consideration. Furthermore, the use of chemical fertilizers and auxin lead to degeneration and mutation of some varieties. In addition, the artificial breeding of new varieties has lead to the chaos of varieties of Chinese medicinal materials. Honeysuckle flower, one of the famous Chinese medicinal materials, is used for reducing intense heat and eliminating heat toxics. TAO Hong-jing described it as a vine and it is evergreen even in winter, so it got the name Rendong. LI Shi-zhen wrote in Compendium of Materia Medica: “when the flowers bloom, the petals are white; after two or three days, they become yellow. The white and yellow flowers mix together and it is called honeysuckle flower.” Honeysuckle flower should be a kind of vine plants with white and yellow flowers.But today, the green honeysuckle flower occupies the market. Wildcommon anemarrhena rhizome and red sage root are small and thin with dark color, the artificial anemarrhena rhizome and red sage root are big and thick. Their slices are big with white color and their traits are obviously different from the wind ones. What is more, the main component content is significantly lower than the wild types. Furthermore, wild divaricate saposhnikovia root is light and light yellow with earthworms head, and the planted divaricate saposhnikovia root is heavy and dark yellow, without earthworms’ head[6, 7].

Due to their different application parts, Chinese medicinal materials growth cycle and harvest season are also different according to their own characteristics. But in order to reduce the cost, many Chinese medicinal materials in the market now are collected without following the growth cycle and harvest season.

For example, white mulberry branch and mulberry leaf are two kinds of Chinese medicinal materials. According to the requirement, white mulberry branch should be green ramulus of mulberry, mulberry leaf should be yellow and they can be harvested after the frost. Now thick and yellow color branch, green mulberry leaf often appear on the market. The buds of Honeysuckle and Sophora should be used in medicine instead of blooming flowers.Immature bitter orange and Citron fruit are all from Citrus aurantium L. Immature bitter orange refers to the immature fruit with 0.5~2.5 cm in diameter and it is commonly known as goose eye immature bitter orange.Citron fruit is nearly mature fruit with 4.5~6 cm in diameter. Ginseng should be excavated in autumn after 5~6 years. Now in the market, most ginsengs are of 2~3 years. Because the growth cycle is short, its curative effect is significantly reduced[8].

In order to standardize Chinese medicinal materials planting, on April 17, 2002, China Food and Drug Administration issued “Good Agriculture Practice of Chinese Medicinal Materials (trial)” (hereinafter referred to as GAP), which would come into effect on June 1, 2002. In order to ensure the progress of the GAP, on September 19, 2003, China Food and Drug Administration has issued “Notice about distributing GAP Certification Administrative Measures (trial) and GAP Certification Examination Evaluation Standard (trial)”, but this has not been operational yet.

Because of small and scattered planting areas, at present, most of the farmers or cooperative cultivate Chinese medicinal materials without GAP certification. By mid-march 2013, only about 60 varieties of medicinal, 113 companies and 61 Chinese medicinal materials production base have gotten the national certification. However, China has about 360 kinds of commonly used varieties of Chinese medicinal materials. In order to increase production and reduce costs, the soil environmental assessment was not made before planting and the use of pesticides and fertilizers lead to the serious problem of heavy metal and pesticide residues which affected the quality of Chinese medicinal slices. Heavy metal and pesticide residues not only spoil the international reputation of Chinese traditional medicine, but also hinder the overseas sales. It impairs the health of Chinese who use traditional Chinese medicine for a long-term. Although we recognize that heavy metal and pesticide residue problem, we do not have enough solutions to it. In the current Pharmacopoeia, only 6 kinds of medicinal herbs, astragals root, honeysuckle flower, American ginseng, white paeony root, liquorice and red sage rootare requested to do poisonous and harmful elements inspection of lead, cadmium, arsenic, mercury and copper. The tests for pesticide residues are also far behind the developed countries[9, 10].

While processing Chinese medicinal materials, medical herb growers adopt different method to dry them. Most of the medicinal materials dry out in the sun. If the weather is bad, drying will not be on time and some herbs will become moldy. Due to the high price and maintenance cost for the drying equipment, herb growers can’t afford or reluctant to buy it. So sulfur fumigation process is adopted to prevent insect and dry the materials with bright color.

The “Chinese Pharmacopoeia” of 2005 edition cancelled sulphur fumigation process for herbs. The National Pharmacopoeia Committee released “Chinese medicinal materials and slices SO2residue detection limit draft” in 2011. It required that 11 kinds of Chinese medicinal materials such as Chinese yam, achyranthes, and pilose asiabell root whose SO2residue should be 400 mg/kg or less; SO2residue on other Chinese medicinal materials and slices should be 150 mg/kg or less. Because there are no proper Chinese medicinal materials and slices drying, processing and insect-resistant method to replace sulfur fumigation, the problem still occurs[11, 12].

Although China is cracking down on manufacturing fake and inferior drugs, due to the increase in the price of Chinese medicinal materials and slices in recent years, some unscrupulous traders use various means of adulteration and fraud that seriously affect the quality of Chinese medicinal materials and slices.

Bupleurum root is the medicinal part. However, some unscrupulous traders mixed the ground part with the root. The stigma of west Safflower is the medicinal part but it is mixed with stylus. Common macrocarpium fruit is used as the medicine without getting rid of its nut. Yunnan spiny jujube seed is taken as spiny jujube seed. Orange magnolia vine fruit is used as Chinese magnolia vine fruit. Spiny jujube branches and other tree branches with spine are used as Chinese honey locust spine.

Wooden rods, metals and coating metal powder are inserted into cordyceps.Rehmannia root is mixed with soil;Cattail pollen is mixed with starch; Alum is added to stachyurus pith to increase the weight. The following Chinese medicinal materials and slices such as pangolin scales, safflower, grifola, blackberry rhizome, cortex dictamni, saffron crocus stigma, magnolia bark, honeysuckle flower, chaenomeles fruit, dried longan, leech, black snake, bugbane rhizome, divaricate saposhnikoviaroot, notopterygium, rhizoma, dodder and bulrush are usually mixed with some sundries.

Pigment is added to some Chinese medicinal materials and slices with colors. Common dyeing medicinal materials and slices include smoked plum, red sage root,safflower, cinnabar, dragon’s blood，sharp leaf galangal fruit，root of Baikal skullcap, cattail pollen, fleece flower root, madder, solomoseal rhizome, wine cistanche, arnebia root，honeysuckle flower, Chinese corktree bark, amur corktree bark, barberry wolfberry fruit, fruit of glossy privet, root of common monkshood, root of Himalayan teasel, saffron crocus stigma and natural indigo,.

Some unscrupulous businessmen take extracted Chinese medicinal materials and slices as normal one and sell them in the market after processing. Such as the stem of suberect spatholobus, astragalus, safflower, red sage root, ginseng, ballonflower root, Sichuan fritillary bulb and corktree bark,[13].

China Food and Drug Administration issued the notice about promoting Chinese medicinal slices categories GMP implementation on October 26, 2004. It required all Chinese medicinal slices production enterprises should produce under the condition of GMP “since January 1, 2008. On February 1, 2008 it issued another notice about strengthening Chinese medicinal slices production supervision and Management, From January 1, 2008, enterprises that did not get the medicine GMP certificate of Chinese medicinal slices shall not engage in production and business operation. The notice standardized the production enterprises and eliminated a batch of small production units. But the current production scale is still small. There is not a big competitive brand. Enterprises have simple production equipment with low technology...Production standard is not unified. Some processing is in accordance with the Pharmacopoeia standard, but most of the processing is based on local Chinese medicinal slices processing specifications which cannot be taken as the national standard or international one[14].

On February 3, 2009, China Food and Drug Administration issued guiding principles about protection of TCM variety, putting forward concrete opinions to the personnel engaged in the work of Chinese medicinal materials and slices. Requirements, working in the field of Chinese medicinal materials and slices acceptance personnel shall have technical secondary school or above, major in Chinese Materia Medica Or have Chinese Materia Medica of professional and technical titles at or above the intermediate level; Engaged in Chinese medicinal materials and slices maintenance work, personnel should have technical secondary school or above, major in Chinese Materia Medica or have Chinese Materia Medica of professional and technical titles at or above the primary level. Direct acquisition of Chinese medicinal materials, inspection personnel shall have Chinese Materia Medica of professional and technical titles at or above the intermediate level.

But personnel engaged in Chinese medicinal material and slice production, processing, scope is wide, quantity is big, and education level is relatively low, especially in the planting, circulation pharmaceutical professionals. Many people engaged in the processing production also are not pharmaceutical professionals, restricting the development of Chinese medicinal slices.

Most hospitals have small storage space, however, the dispensing and storage of Chinese medicinal materials and slices take big space. Under the situation of separation of clinic from pharmacy, Hospitals are unwilling to invest to improve equipment and facilities; they even want to have the pharmacy trusteeship. Some western medical hospitals are ready to cancel the TCM pharmacy.

2 The countermeasures

On October 30, 1987, the State Drug Administration issued a list of 76 kinds of national wild medicinal species which included 43 species of traditional Chinese medicine. Tiger, leopard, antelope and deer were regarded as the first level protection. Pangolin scales, coral snake, tokay, licorice root and ginseng were taken as a secondary level protected species. Unibract fritillary bulb, acanthopanax, root of baikalskullcap, divaricate saposhnikovia root, sharpleaf galangal fruit, medicinal dendrobum herb and common macrocarpium fruit were taken as a tertiary protected species. The protection of wild species would affect the quality of Chinese medicinal materials and slices. In the long run, it is necessary to carry out the protection for the survival of species.

The government should invest more in the research of traditional Chinese medicine resources, the development of new resources and their alternatives. Tiger bone, rhino horn and other valuable medicinal herbs have been prohibited. The use of artificial bones and artificial bezoars, musk, buffalo horn would ease the contradiction between supply and demand, although their curative effect need to be further validated.

Based on the survey, we can determine the authentic Chinese medicinal materials resources by setting policy to protect them. Governments at all levels should increase investment and subsidies in Chinese medicinal materials cultivation and enlarge planting area. Their visibility can be increased by applying plant protection of geographical indication and registering trademark brand[15].

We should focus on cultivating high quality variety and expanding the planting areas to reduce the GAP certification cost. We should give scientific guidance to herbs growers so that the small-scale production of the individual plantation can be expanded, to the social collective mass production.

Sulfur fumigation has been widely used in Chinese medicinal material processing since the early 20th century[16].Research on new methods of pest control and pollution free pesticide should be done actively. Study on the pros and cons of sulfur fumigation should be done as well so that we can control sulfur content in Chinese medicinal slices. Research on the new method of drying should be enacted. We suggest that the Pharmacopoeia (2015 edition) should change the description of the characteristics of Chinese medicinal materials and slices caused by sulfur fumigation.

The Drug Administration Law has clear provisions on Punishment for the production and sale of counterfeits in chapter 9. Article seventy four states that people who have the production and sales of counterfeit drugs should pay a fine five times as much as the value of illegal production and sale. Their drug approval documents must be revoked and factories shall be ordered to shut down. Their pharmaceutical production license can be cancelled if the case is serious. If the case constitutes a crime, criminal responsibility shall be investigated according to law. The relevant departments at all levels should strengthen the supervision and inspection to clear out the production and sale of counterfeit drugs.

To formulate a unified national Chinese medicinal slice processing standard and dispensing procedure standard, we should strengthen research on the standardization of processing techniques, and the use of equipments[17].

In recent years, various provinces and cities have introduced new Chinese medicinal slice processing standard, but the national Chinese medicinal slice processing standard is still the old version issued in 1988 by China’s Ministry of Health. In order to adapt to the new situation, a unified national Chinese medicinal slice processing standard must be formulated as soon as possible, at the same time common standards for processing accessories must be formulated as well. There is no unified national Chinese medicinal slice dispensing procedure standard due to the dispensing procedure standard written by various provinces and cities according to their respective situation. Therefore, one unified standard must be made as soon as possible.

We should raise the barrier to entry by lifting staff quality at all levels. People who are engaged in Chinese medicinal materials and slices should have professional quality. Quality management and inspection personnel should have a relevant professional qualification with certain degree. For the non pharmaceutical professionals engaged in Chinese medicinal material planting should master the relevant policies and regulations and professional knowledge. They must gain the related certificates after assessment so that they can work on the relevant field.

We should study the current situation of TCM pharmacy in themedical institutions to find out an effective method to solve the contradiction and guarantee the quality of Chinese medicinal slices.

We should provide storage space and maintenance equipment for Chinese medicinal slice. Normal temperature stroage, cool and cold storage must be provided respectively according to the characteristics of Chinese medicinal materials and slices. Necessary measures for dehumidification, dry prevention, insects control and rat proof should be adopted.

Pharmacy staff treatment, working conditions and wonderful environment should be improved. The present situation of the pharmacy can be changed reasonably.

Good staff structure can guarantee the quality of Chinese medicinal materials and slices. The increase of clinic patients and the limited dispensing staff increase personnel’s work load. The daily overload affects the dispensing quality of Chinese medicinal slices.

In recent years, with the help of good policy and CDFA norms, Chinese medicinal material and slice industry has increased year by year. On April 21, 2009, the State Council put forward several opinions about promoting the development of Chinese medicine. To carry out the medical and health system reform is the key to building a well-off society in China in the Twelfth Five Year Plan period. The industry of Chinese medicinal material and slice should seize the opportunity and overcome the difficulties to develop fast.

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Author’s information: TIAN Li-juan, Associate professor. Major research areas: National drug policies, pharmacy regulations, rational use of drugs. Tel: 024-24517422, E-mail: tianlijuan_8@126.com.