Standard herbal extracts refer to the extracts produced by normalized manufacturing techniques in accordance with certain quality standards. The extracts must be manufactured on the basis of four principles, namely, normalized manufacturing process of raw medicinal materials, normalized manufacturing process of extracts, standardized control over the quality of raw medicinal materials, and standardized control over the quality of extracts.
Herbal extracts refer to a kind of Chinese medicinal herb product derived by extracting, separating, and processing Chinese medicinal herb materials or Chinese herbal compound prescriptions with the aid of advanced techniques, and such extracts have explicit drug effects and comply with strict quality standards. As a new product modality appearing in the international natural medicine and health product market, it is extensively applied to natural health products and becomes a principal raw material of botanic preparations. Herbal extracts, according to the nature, diversify into four types: single Chinese herb extracts (derived by different extraction methods) like lucid ganoderma, ginseng, ginkgo leaf, siraitiae fructus, mesona chinensis benth etc.; compound herbal extracts like Buzhong Yiqi Decoction, Four Ingredients Soup, Pills of Six Ingredients with Rehmannia, Qibao Meiran Mini-Pills etc.; Chinese medicinal herb ingredients like ginkgo biloba extract, ginkgolide, soy isoflavone, ganoderan, cordycepin etc.; derivatives of herbal extracts, for example, isatin from indigo naturalis, which is inconclusive.
Generally, the chemical components of standard herbal extracts refer to an active components group constituted by multiple pharmacological active substances in appropriate proportions. It is characterized by multiple components of Chinese medicinal herbs and special effects of Chinese medicinal herb materials and compound prescriptions. In addition, it has an advantage in quality control.
Traditional extraction methods (decocting, reflux, impregnation, percolation, etc.) have several defects in terms of reserving effective components and removing noneffective components, including great loss of effective components, long period length, complex working procedures, low extraction efficiency, etc. For more than ten years, many new technologies and methods have been applied to extraction of Chinese medicinal herbs, which enables herb extraction to conform to the theory of traditional Chinese medicine and increases absorption rate and purity of effective ingredients.
Herbal extracts have high requirements on manufacturing conditions and technologies. Many advanced extracting, separating, purifying and desiccating equipment and technologies have been applied to manufacturing herbal extracts, which greatly enhances the technical level and equipment level of Chinese pharmaceutical engineering.
Chinese herbal extracts are mostly exported. Such situation may be related to the disagreements on herbal extracts in the field of traditional Chinese medicine in China. In this field, many people think herbal extracts are quite different from Chinese medicinal herb decoction pieces and such extracts even cannot be regarded as traditional Chinese medicine. They believe that subtle chemical reactions occur when Chinese medicinal herbs are being decocted, but herbal extracts do not have the same effect when being mixed. In fact, Guangdong Yifang Pharmaceutical Co., Ltd. has proved in its research on drug granules made of Chinese medicinal herbs that herbal extracts can maintain most properties of Chinese medicinal herbs. As technologies are improved and active ingredients of Chinese medicinal herbs are found, preliminary standards conforming to the characteristics of Chinese medicinal herbs and also accepted worldwide will be formulated definitely in the near furfure according to the standards of Chinese medicinal herb materials recorded in Chinese Pharmacopoeia. In addition, the standards will be improved constantly to follow the development law of botanical drugs.
The standards of herbal extracts are relatively backward. With the implementation and promotion of the drug standard improvement program in China, a national drug standards system has been established preliminarily. Along with the accelerated construction of drug regulation informatization, the drug standards control will be more normative and perfect.
The standardization of herbal extracts, however, is relatively backward due to following reasons: (1) Unestablished standards. Herbal extracts are important raw materials to produce Chinese patent medicines. According to statistics, 29.8% of Chinese patent medicines use herbal extracts as raw materials, but a part of extracts lacks national standards. Due to the absence of legal standards, production and operation have to follow the standards given by customers or enterprises in most situations, and product delivery shall be subject to quality terms stipulated in the contract. Therefore, diverse quality testing methods of the product result in a confusing situation. (2) Inadequate standards. Standards covering all items are essential for effectively controlling the quality of herbal extracts. The standards for some herbal extracts were enacted a long time ago and thus they are incomplete in terms of standard items. For example, some early-stage standards of herbal extracts lack maximum pesticide residue limits and heavy metal measurement items. Some lack auxiliary material standards and others lack microbial limit tests. (3) Inconsistent standards. There are a large number of standards of herbal extracts, and they differ from each other in terms of naming, production method, description, inspection, etc. Some herbal extracts have the same name but different production methods, for example, scutellaria baicalensis. It has been recorded in the 2010 edition of Chinese Pharmacopoeia and Chinese Patent Drug for 12 times, but there are great differences when referring to key process parameters that may affect the quality, including “whether add the alum solution or not”, “final PH value before desiccation”, “solution for cleaning crude product”. Given such circumstances, confusion may occur during manufacturing and use. (4) Varying standard levels. Herbal extracts approved in the manner of new drugs or recorded in Chinese Pharmacopoeia indicate a high level of standards, while the extracts gained by other means may be defective due to problems such as under-developed techniques and lack of core technologies. Many manufactures of herbal extracts are small-sized enterprises and they do not have advanced techniques and strong production abilities. These enterprises barely optimize and research manufacturing techniques for products and thus fail to engage in the in-depth product development. The low manufacturing and technical threshold of herbal extracts results in disordered market competition. (5) Non-updated standards. There are no approaches to evaluate the implementation status of the standards of herbal extracts, some of the standards are “formulated without elimination”. Many standards have been used for many years without updating or revising. Therefore, there is an urgent need to establish an elimination system for standards.
In China, herbal extracts are mostly used in the field of health food, including all kinds of preparations, capsules, tablets, oral solutions, health wines, etc. In abroad, these extracts are mainly applied to the development and usage of botanical drugs. There is a tendency to apply them in the manufacturing of dietary supplements, cosmetics, health cigarettes, feed additives, etc.
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