Research progress of new products of traditional Chinese medicine based on ancient classic prescriptions

Gao Shuwei, Qiu Zhidong, Zhao Yan, Gao Yingxin, Xu Wei, Jia ailing, Li sining, dongxuelian

Changchun University of traditional Chinese medicine Lanzhou heshengtang Pharmaceutical Co., Ltd

Table 1 relevant laws and regulations issued by the state from 2008 to 2019  

1.2 domestic research progress of classic famous prescriptions

In recent years, classic famous prescriptions have made a difference in many fields, such as in the field of Gynecology, for irregular menstruation[2], menopausal syndrome[3]And problems during pregnancy can adjust the treatment[4]In pediatrics, the treatment of tic disorder in children[5]There are also successful cases of sleepwalking in children[6]Gastrointestinal diseases have also been effective[7]From 2013 to 2016, many drugs developed from classic famous prescriptions came into the market in China, such as Wuling tablets and capsules developed from Wuling powder, and Xiaoer Feire Kechuan oral liquid made from Baihu Decoction and Maxing Shigan decoction[8]It can be seen that in recent years, China has made some remarkable achievements in the development of classic famous prescriptions, but there are also problems such as fierce competition in categories and limited sales. At the same time, the universities of traditional Chinese medicine all over the country have also successively explored the classic famous prescriptions. Among them, Nanjing and Beijing University of traditional Chinese medicine have established the school of classical prescriptions; The International Classical Prescriptions class of Guangzhou University of traditional Chinese medicine has become a brand for overseas promotion of Classical Prescriptions[9]In addition, the emergence of a large number of scholars studying classical prescriptions has also provided a better guarantee for the development of classical prescriptions in China. It is believed that the development projects of classical prescriptions in China will achieve better results in the next few years.

1.3 international research progress of classic famous prescriptions

At present, 29 countries and regions have recognized the theory of traditional Chinese medicine, and nearly half of them have included traditional Chinese medicine in national health insurance. The development status of the international market of traditional Chinese medicine is optimistic. Since 2010, China has successively listed Chinese patent medicines on the international market, including Tongxinluo capsules from Yiling pharmaceutical and Danning tablets from Shanghai and Huang pharmaceutical. However, compared with Japan and South Korea, the market share of Chinese patent medicine is still small. . Japan's Tsumura Hanfang Pharmaceutical Co., Ltd. ranks first. According to statistics, its market size has reached 112.3 billion yen in 2017. Its market revenue for Chinese patent medicine with South Korea is much more than that of China[10]Therefore, as the country of origin of traditional Chinese medicine, it is urgent to develop the cause of traditional Chinese Medicine Guided by classic prescriptions.

2.1 based on the medicinal materials themselves

2.1.1 determination of medicinal material base

The base of traditional Chinese medicine includes the varieties of traditional Chinese medicine and the parts used for medicine. According to the compendium of Materia Medica, "the rise and decline of ancient and modern drugs are different". In the long history, the change of the name of medicinal materials, artificial cultivation, distribution of origin and other factors have led to the change of some base of medicinal materials. Therefore, whether the origin of the medicinal materials mentioned in ancient prescriptions is consistent between ancient and modern needs us to consult ancient books for textual research. [11], zhaojiachen[12]According to the research of scholars such as the Tang Dynasty and previous records, there is no mention of citrus aurantium. According to the research, the main base of citrus aurantium and citrus aurantium in this period was trifoliate orange. In the song and Ming Dynasties, citrus aurantium L. and citrus aurantium L. were the two plants of citrus, and in the Ming Dynasty, it was believed that the quality of citrus aurantium L. was higher than that of citrus. Chinese Pharmacopoeia (2015 Edition) stipulates that citrus aurantium is the dried immature fruit of Rutaceae lime and its cultivated varieties. It can be seen that in the process of historical development, ancient Chinese doctors have found great differences between different species, so the medicinal materials used are also different. Therefore, in the current study, the drugs recorded in the prescriptions of different periods need to be strictly textual research, in order to determine the correct prescription to ensure the exact curative effect.

2.1.2 changes in the origin of medicinal materials

. Phellodendron amurense is mainly distributed in Northeast and North China. Phellodendron amurense in Song Dynasty, Ming and Qing Dynasties has always been a genuine medicinal material in Sichuan[13]After the Republic of China, Phellodendron amurense started to circulate in the market, but it is still better to use Phellodendron amurense. Nowadays, Phellodendron amurense and Phellodendron amurense are included separately in Chinese Pharmacopoeia (2015 Edition)[14]According to the survey, among the prescriptions involved in the catalogue of ancient classic famous prescriptions (the first batch), liquorice, Rehmannia glutinosa and ginseng lamp have changed in origin to varying degrees[15].

2.1.3 issues related to animal protection and reasonable substitution of animal drugs in shortage

According to the selection scope and principles of the list of ancient classic famous prescriptions, the selection of classic famous prescriptions should not involve the first-class protected animals of the list of wild animal medicinal materials under national key protection[16]Therefore, all the 100 classic prescriptions involved in the published catalogue of ancient classic prescriptions (the first batch) are plant prescriptions. However, many classic famous prescriptions contain rare and resource scarce medicinal materials, so it is necessary to find alternatives. Although the prescriptions containing animal medicinal materials have not been selected in the current list of classic famous prescriptions, the use of animal medicinal materials is also a direction worthy of research and consideration once there are prescriptions that perform well and conform to the general environment in the future research work.

2.2 ancient and modern differences in prescription dose

There have been many units of measurement in the historical development, such as cent, money, Liang, Jin, liter, etc. it is particularly important to clarify the differences between the units of measurement in each stage and modern times and find out the conversion rules between them[17]The reason why the dosage is inconsistent between ancient and modern times is that the dosage recorded in the ancient prescription is the dosage before processing, and different processing methods naturally have different effects on its quality. Xulipeng et al[18]The experimental study found that when the live leech was placed on the tile and baked by fire, its mass loss was about 80%. In addition, heliqing[19]In the study of treatise on Febrile Diseases and synopsis of the golden chamber, many non quantitative units of measurement have been noticed. Such as large as palm, big as sour jujube and other quasi measurement units, square inch dagger, money dagger and other measurement units. [20]In 2017, these units were refined, such as one coin dagger equals 1 ml, three fingers rub is 1.6 ml, etc. In view of the divergent conclusions, we should find a more accurate statement in combination with the clinical situation, and refer to the works circulated in various ages for analogy analysis.

2.3 selection and processing of decoction pieces

Traditional Chinese medicine believes that "anyone who uses drugs must be first shot", and the processing of drugs is an important link in the application of traditional Chinese medicine. With the development of history, the processing methods of decoction pieces are also changing. Take Pinellia ternata as an example[21], including vinegar, fire, ginger, medicine juice, boiling and many other methods[22]However, the Pharmacopoeia only contains four kinds of Pinellia ternata, Rhizoma Pinelliae, Rhizoma Pinelliae, and Rhizoma Pinelliae qingensis, and other processing methods are disappearing. Shi Zheng et al[23]The study found that Pinellia Houpu decoction, which originated from the synopsis of the golden chamber, requires repeated Decoction washing or Decoction of pinellia, which is different from the processing method of the current edition of the Pharmacopoeia. It is believed that repeated Decoction washing is no longer suitable for the development of classic famous prescriptions under contemporary conditions, while the principle of processing and detoxification of ginger Pinellia is similar, so it is suggested to use ginger Pinellia instead of the original prescription. It can be seen that the processing methods of decoction pieces in some prescriptions are very similar to those in the current Pharmacopoeia, that is, they can replace the cumbersome and ancient processing methods in the past, while those not included in the Pharmacopoeia need to refer to local processing specifications[24]。

2.4 process research

According to the traditional preparation method, the preparation process of the classic prescription was studied, and the consistency evaluation research was carried out with the reference of the material standard and the index component content, fingerprint, etc. According to the industrialization process, the extraction, concentration, drying and molding process parameters were established to realize the transformation from traditional preparation method to modern production process, and form the classic standard particles equivalent to traditional preparations. However, among the 100 prescriptions in the catalogue of ancient classic famous prescriptions (the first batch), 23 kinds of medicinal materials containing volatile oil are involved[25]Due to the limitation of the ancient technology level, there is no relevant record of its separate extraction, while the contemporary technology level is developing rapidly. Nowadays, there are many extraction methods such as steam distillation, headspace solid-phase microextraction (HS-SPME Technology)[26]Therefore, it is also worth investigating whether the medicinal materials containing volatile oil need to be extracted separately when they are formulated.

2.5 protection of intellectual property rights during the development of classic famous parties

In recent years, many countries have carried out research and development on the basis of China's classic famous prescriptions and applied for relevant patents[27]In 2001, a Japanese company applied to the United States for a patent for the treatment of ulcerative colitis, requiring the protection of four compounds with Paeonia lactiflora as the active ingredient, and was authorized[28]Japan has made the classical prescriptions of traditional Chinese medicine into Chinese medicine and applied for more than 200 patents for classic prescriptions of traditional Chinese medicine, and its products occupy 80% of the world market[29]It can be seen that many classic famous resources in China have been preempted by the United States, Japan and other countries. In order to stop losing the wisdom of traditional Chinese medicine and compete in the international market, China must pay attention to the property protection of classic famous prescriptions.

. 1) Restore the classics: the project clarifies the composition of classical prescriptions, medicinal materials, medicinal parts, dosage basis and processing methods, and solves the common and difficult problems of ancient medical books. 2) In terms of reproducing Classics: the project is based on the preparation method recorded in ancient books, defines the conditions and instruments for decocting drugs according to ancient methods, and solves relevant problems in the preparation of corresponding physical objects. 3) In terms of inheriting Classics: Based on the equivalence of ancient and modern preparations and the theory of drug property transmission, the project studies and designs the processing, extraction, concentration, drying and molding processes of classical prescriptions, and solves the key technical problems of traditional to modern transformation. 4) Verify the classic aspect: establish the equivalence evaluation system between standard particles and traditional preparations, and solve the quality effect consistency problem of ancient and modern preparations. 5) Canonical aspects: to establish the quality evaluation and control of key links in the whole process of medicinal materials decoction pieces material benchmark preparations.

The development of classic famous prescriptions in China is at a steady stage of improvement. The development of classic famous prescriptions is conducive to the development of Chinese patent medicine. The development strategy of traditional Chinese medicine should be established based on the theory of traditional Chinese medicine and guided by the classic famous prescriptions of traditional Chinese medicine. Therefore, how to accurately construct the literature research traceability system, prepare the corresponding real objects consistent with the standard decoction, reasonably transform the ancient pharmaceutical to modern production, establish the quality and efficiency consistency evaluation method and the whole process quality evaluation system are the key problems to be solved urgently in the study of classical Chinese medicine. .

Copyright notice: the article is from the Journal of Changchun University of traditional Chinese medicine 2021,37 (03)
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