| Object:As the develop of State Administration of Traditional Chinese Medicine "about small packing Chinese native medicine tablets ready for decoction use small packaging pilot",small package Chinese medicinal slices have been widely used in medical institutions, particularly in the trend of the production industrialization.Due to there is no unified standard for the enterprise to set,the small package production process and quality of traditional Chinese medicinal slices quality are uneven.Small package is not conductive to the standardization of the Chinese medicinal slices.This study take the research of the small packing TCM slices quality control and main problems in the key process of production and usage to carry out the "the study of small package of Chinese herbal medicinal slices microwave drying production process and the load difference".Aimed at setting reasonable microwave process parameters, such as temperature,frequency conversion speed and material thickness for different categories of small packing TCM slices small package.At the same time, different specifications of the small packing TCM slices filling quantity,formulate feasible limits, filling quantity in a unified production operation and testing standards were ussed to provide theoretical basis for the production, use and regulation, improve product quality and ensure drug safety and effectiveness. Methods:1.The technology research of small packing TCM slices in microwave drying and sterilizationStudy the production line of small package Chinese native TCM slices tunnel microwave drying.Through an experiment to determine the influence index of microwave drying factors and levels, including temperature, Frequency conversion speed and material thickness.Taking the L9 (34) Drthogonal experiment method, examing each slices properties, moisture content, content (or extract) and bacteria, mould and the change of the microbial limits before and after the microwave drying process.Comparing the the primary and secondary influence of small package on the quality of the TCM slices, selecting the most important factors in the combination of a higher level and combining production cost controlto make different categories (according to the different medicinal part:root and rhizome, fujiki class, leather, flower, fruit, seeds, leafy) the best microwave drying sterilization process parameters.2 The filling quantity differences research of small package TCM slicesAccording to the request of State Administration of Traditional Chinese Medicine in small TCM slices,commonly used for different specifications of the small package such as 3gã€6gã€9gã€10gã€12gã€15gã€20gã€30g, picking 50 packs each kind of TCM slices randomly.Each bales of slices was measured by electronic balance, recording error rate, the average error rate and the load distribution difference results through the analysis of mathematical statistics Reference to "Chinese pharmacopoeia" to make filling quantity difference limit standard of TCM slices small package.Results:1.Parameters of microwave drying sterilization process Tunnel microwave drying sterilization process can effectively control the water and the growth of microorganisms in TCM slices. The main component content did not change significantly before and after microwave All kinds of slices tunnel microwave process parameters optimization scheme is shown in table 1.Table 1 Microwave process parameters optimal method of Various pieces2.Content uniformity limitThe load difference of Chinese medicine pieces of Small package varies with the change of drug regulation, the greater the amount of loading, the load difference is smaller. The load difference limit of each drug regulation is shown in table 2.Table 2 load difference limit table of Chinese medicine pieces of SmallConclusion:As the new development direction of traditional Chinese medicine,small packing TCM slices has become one of the main products of TCM enterprises. Because of its gas impermeability, package cause slices are more likely to spoil.Microwave drying sterilization technology was applied to small package production,small packing TCM slices is convenient to operate, fast drying speed, uniform, the advantages of the slices is easy to save, effectively solves the small package of TCM slices quality variation problem.Closely with the production practice, this study made the tunnel microwave drying sterilization process parameters, production conditions, operating norms, small packaging to ensure that the quality of the TCM slices, At the same time it can effectively control the cost of production.On the other hand,small packing TCM slices quality testing main routine index of difference of this study is to formulate unified the load limit of reference, guarantee the accuracy of the clinical dosage, ensuring the safety of medication for small package of TCM slices, providing theory basis for production, use and regulation and has strong )racticability and guidance. |