The departure of Chinese medicine decoction pieces processing machinery standardization

A few days ago, the National Technical Committee on Pharmaceutical Equipment Standardization Technical Committee established in Hangzhou, Zhejiang Province. The committee is responsible for the preparation and preparation by the Zhejiang Provincial Bureau of Quality and Technical Supervision. The National Pharmaceutical Equipment Standardization Technical Committee is in charge of business guidance. After the establishment, it will be responsible for the net system, infiltration, cutting, cooking, and frying, roasting, calcining, quenching, flying, boring and baking. The national standard system revision work in the field of machinery and equipment such as frosting, crushing, drying, and packaging.

According to industry experts, at present, TCM Decoction Piece Machinery has been widely used in more than 6,000 Chinese medicine plants, decoction pieces, and health products plants in the Chinese medicine pretreatment workshop or decoction workshop. However, in view of the overall situation, China's decoction machine machinery is relatively Pharmaceutical equipment is still in an embarrassing situation of low standards, especially the lack of high-level national standards. The establishment of the Technical Committee for Chinese Medicine Processing Machinery of the National Pharmaceutical Equipment Standardization Technical Committee will open the prelude to the standardization process of Chinese Herbal Pieces Machinery.

Big problems in small industries

“In the pharmaceutical field in China, the market share of TCM decoction pieces is small, and compared with chemical drugs and proprietary Chinese medicines, it can only be considered as a “little brother.” The lack of high-level national standards in concoction machinery is a big problem that plagues TCM decoction pieces. "The National Pharmaceutical Equipment Standardization Technical Committee Secretary General of the Technical Committee of Chinese Medicinal Processing Machinery, Xiaojie Ming, Director of Hangzhou Chunjiang Automation Research Institute, said.

Taking the weakest link frying and moxibustion machinery in the traditional Chinese medicine decoction processing machine as an example, many old equipment fire sources cannot be adjusted and the temperature cannot be controlled. Some advanced microwave fryers are rarely used. For another example, for some mineral medicines, precious drugs, and special-purpose Chinese herbal medicines, traditional methods such as waterflies and plutonium are used in a very small amount of processing and are not suitable for the production of large-scale, industrialized Chinese medicine pieces, but hammer hammers are now commonly used. Ball mill type, flow type and other mechanical equipments do not have national standards in terms of powder particle size, powder extraction rate, effective ingredient preservation, etc., and these devices are also incapable of helping Chinese herbal medicines with strong thermal sensitivity, low melting point, and easily destroyed components.

Xiao Jieming pointed out that there are many reasons for the lack of standardized machine tools for making tablets. First of all, this is related to the late start of the modernization of traditional Chinese medicine decoction pieces, thin foundation, and complex production methods. Although the production of TCM decoction pieces goes back to ancient times, before the liberation, people used manual methods such as hand-picking, pool-scouring, hand-cutting, sun-burning, smoke-curing, smoky-smoke, sulfur-fumigant, and grind-powdered powders to process the decoction pieces. Until the mid-50s of the last century, people introduced the semi-mechanized embryonic form for the first time in the cutting process of traditional Chinese medicine decoction pieces. It was not until 1973 that Zhoukou, Shanghai, Tianjin, and Changchun had four Chinese herbal medicine machinery factories.

In addition, this is also related to the specificity of the production of Chinese Herbal Pieces and the lack of technical specifications for processing. Chinese herbal medicines must be processed, that is, they can be made into pieces of raw materials before they can be used as medicine or decoction. This is a feature of traditional Chinese medicine. At present, China's administrative standards for the production of TCM decoction pieces are relatively sound, including GMP, GAP, Chinese Pharmacopoeia, national concoction specifications, and local concoction specifications. On the other hand, there is no corresponding organization to formulate standards in the process and management of the concocted arts. The production organization standards are more freely exerted by the enterprises, that is, the technology management standards are not sound enough, resulting in the failure of convergence between the administration and production organizations.

This convergence does not appear to be the need for Chinese medicine processing based on experience to manually control and master the concocted process and the quality of the pieces, such as the "Chinese Pharmacopoeia" or the concocted specifications on the description of infiltration: medicine permeability, soft and hard moderate, do not hurt the water, soak a moment , boring; description of the frying process: slow fire fry until slightly yellow, Wuhuo fry until coke color; description of calcined: fire to red, crunchy, crisp ... entrance is not for the degree, etc., very general, It is difficult to quantify and refine, which directly leads to difficulties in the production of decoction processing equipment and the production of decoction pieces.

Standardization is imperative

According to relevant industry experts, there are currently six types of traditional Chinese medicine decoction processing machinery used in China, namely net medicinal machinery for medicinal herbs, infiltration softening machinery, cutting machinery, artillery, machinery, drying machinery, and special processing machinery for Chinese herbal medicines. These machines have developed rapidly in recent years. Taking the artillery machinery as an example, as the research efforts of various Chinese medicine machinery factories are relatively large, the actual performance of such machinery has basically satisfied the requirements of the “Chinese Pharmacopoeia”, and the completion of fry, bran fry, charcoal, and preserves , accessories fry, etc., and has been intuitively judged from experience to digital display intelligent control type. However, on the whole, the degree of modernization of decoction processing machinery remains low.

"If a worker wants to do good, he must first sharpen his tools." Xiao Jieming believes that the existing technology of the deli piece processing machinery obviously cannot meet the needs of modernization of the Chinese medicine industry. For example, the “fried yellow, fried coke, and fried charcoal” of the Chinese medicine described in the Chinese Pharmacopoeia can only be grasped by the eyes and experience of the pharmacists. These descriptions of the quality requirements of the decoction pieces are the result of traditional processing methods. He said: “The processing technology of decoction pieces determines the quality standards of concocted decoction pieces, and the level of deli piece machines restricts the use of concocting techniques. Therefore, we attach importance to and strengthen the modernization of deli piece-making machinery and design according to the processing technology requirements. The development of various types and specifications of processing machinery and the formulation of corresponding national standards are the top priorities for the development of the current Chinese Herbal Pieces industry."

According to Dong Chunliang, secretary general of the China Pharmaceutical Machinery Industry Standardization Technical Committee, the standardization of China's TCM decoction pieces began in the 1980s and was later affected by the adjustment of state institutions and the reform of the economic management system. The gap between the requirements of equipment and GMP is large, and the situation of “dead standard (standard void)” also appears. It does not adapt to the needs of WTO and market economic order. In 2003, the former State Economic and Trade Commission approved the establishment of the China Pharmaceutical Machinery Industry Standardization Technical Committee, in order to speed up the revision of standards, promote the improvement of corporate quality, and promote the implementation of standards, so that the standardization of the deli piece of machinery has improved. Up to now, 8 officially approved standards for the processing of Chinese Herbal Piece Processing Machinery have been implemented. During the “11th Five-Year Plan” period, the revised standards for the deli piece of machinery will be increased.

Xiao Jieming introduced that this time, relying on the establishment of the National Pharmaceutical Equipment Standardization Technical Committee of Hangzhou Chunjiang Automation Research Institute, the technical committee of the Chinese medicine confectionery machinery was composed of 8 experts from the Chinese medicine concoction equipment manufacturing enterprises, 9 experts from the Chinese Herbal Piece Company, and universities and research institutes. There are 11 experts, 3 experts in medical design institutes, and 5 experts from testing organizations, superior standard committees, and administrative departments. This is the first professional standardization technical committee in the field of Chinese medicine processing, which fills the gap in the development and revision of technical management standards in the field of Chinese medicine processing. In light of the vacancy situation in the process and management technology standards for the concocted arts, the sub-committee will study and formulate the process and management standards closely related to the processing equipment while mainly formulating the national standards for Chinese medicine concoction machinery, so that equipment and process standardization will be synchronized.

Relevant experts believe that the establishment of the Technical Committee for Chinese Medicine Processing Machinery of the National Pharmaceutical Equipment Standardization Technical Committee has opened the prelude to the standardization process of Chinese Herbal Processing Machines and will promote the development of the slice processing machinery and even the entire deli piece production industry.