Study On Preparation Process And Quality Standard Of Gan Shu Ke Li

Objective:To study mainly Ganshu particles from Clinical empirical formula. To Change dosage form for the medicinal instead of granules to overcome disadvantages of traditional decoction, such as not easy to decoct, taste bitter, not easy to store and carry, etc, but to give full play to the advantages of modern preparation-granules, such as taste good, easy to carry and save, etc. to provide theoretical guidance and practice data for the further development of the preparation.Methods:1. In the process of extraction technology research of raw materials of Ganshu particle,7herbs were studied by literature. According to physical and chemical properties of effective component of medicinal materials, ethanol refluxing extraction and water decoction easy to mass production were taken respectively, using the orthogonal design, the optimal process was studied.2. In the study of Ganshu particle molding process, the main factors influencing granules for drying, granulating was inspected to optimize the best granulating process.3. In the compound quality control of Ganshu particle, the TLC method was used to identify the characteristics of angelica dahurica, honeysuckle, dandelion, radix bupleuri and radix ophiopogonis, and total flavonoids content was determined by uv spectrophotometry, Imperatorin and Cynaroside content was determined by HPLC.4. In terms of detection, heavy metal content in the granules was determined by atomic absorption method, pesticide residue in granular was detected by gas chromatography and electron capture detector, and according to the "Chinese pharmacopoeia" granules under comparison to test the related parameters of granules, limit indicators was established.Results:1. raw materials extraction technology of Ganshu particle identified as:honeysuckle, dandelion and dwarf lilyturf were soaked with12times amount of water for40minute, were decocted2times with0.5hours every time, then decoction fluid was concentrated on stress to the relative proportion of1.15to1.2for aside. Radix bupleuri, radix angelicae, semen coicis and chrysanthemum reflux extracted10times amount of70%ethanol for2times with each time1hour, then after recycling of ethanol extract, decoction fluid was concentrated on stress to the relative proportion of1.15to1.2for aside.2. the optimize granulating process was that the raw material was extracted for extractum, the extractum was driedunder reduced pressure, the next process was crush, through100mesh sieve, mixed according to1:1with the lactose, add85%ethanol, granulat, dry, granulation.3. in Quality control, the TLC method was established to identify the characteristics of angelica dahurica, honeysuckle, dandelion, radix bupleuri and radix ophiopogonis, the method was rapid with strong specificity, in the uv detector determination method of total flavonoids, linear regression equation was A=12.221C-0.0091, r=0.9992, with rutin minimum total flavonoids content in the prescribed granules shall not be less than4%; in high performance liquid chromatography (HPLC) determination of the imperatorin method, linear regression equation was y3×106x-17724, r=0.9999, the linear range was0.011648～0.17472u g, with the minimum imperatorin content in granules of each bag was not less than0.65mg. in high performance liquid chromatography (HPLC) determination of the Cynaroside method, linear regression equation was y1.5E+7x-44275,r2=0.9998,the linear range was0.011646～0.17469u g, with the minimum imperatorin content in granules of each bag was not less than0.42mg.4. Detecting heavy metals in granules determined by atomic absorption method was far less than the limited scope of the provisions of the state, so not into standards. Test of the granules of related indicators meet to the "Chinese pharmacopoeia" under regulation, therefore, the standard of Chinese pharmacopoeia were carried out.Conclusion:Pilot scale test show that preparation process of Ganshu particles is stable, feasible and can meet the production requirements. This study is determined the quality of the control scheme to be a quick, accurate, real control Ganshu particles quality, it meets the requirements of quality control of this preparation, to ensure that the drug is safe and effective. This study provides the theoretical support and practical reference forclinical medicinal decoction traditional transform Chinese medicine tomodern drug granules.