| Xiangshayangwei Soft Capsule was recorded in "Drug Standard (20th edition)"of the Chinese medicine preparations compiled by the Ministry of Health, People's Republic of China, which is composed of 14 kinds of Traditional Chinese Medicines (TMC) including amomum villosum, orange peel, nutmeg, patchouli etc.Xiangshayangwei Soft Capsule has the effects of the warm neutral stomach. It was used in clinic for not thinking of the diet, the vomitive acid water, the completely stuffy of stomach cavity, and tired limbs. The clinical practice proved its favorable curative effect and its widespread usage. Due to the existing defective extraction technique and the relatively low quality control standard, the xiangshayangwei soft capsules are easy to disintegrate, dissolve, stratify, and leak during storage. In this thesis, the new soft capsule pouch skin fabric's various components, the composition and the matrix allocated proportion were investigated in order to improve the solubility and stability of Xiangshayangwei soft capsule. Moreover, its quality control was also studied with aim to improve the stability, safety and effectiveness of the drug.The HPLC method was used to determine the contents of magnolol and honokiol in Xiangshayangwei soft capsule. The orthogonal testing method was utilized for optimizing the extraction process of essential oil in radix aucklandiae, fructus amomi, pericarpium citri reticulatae, fructus amomi rotundus and herba pogostemonis. Such optimized process is to soak these meterials in water with a volume that is 10 times more than them for 2 hours, then to distill them for 7 hours by steam. Atractylodes, Poria, Pinellia (system), Cyperus rotundus (vinegar), Jujube, Citrus aurantium (fried), Magnolia officinalis (ginger), Licorice, Ginger were added in the way that they are 10,8,6 times the volume of 80% ethyl alcohol, in order to determine the optimal extraction technique.80% ethyl alcohol was used to extract these meterials for 2 times, first time, adding 10 times the amount of extraction for 2 hours, the second time, adding 8 times the amount of extraction for 1 hour. Experimental results showed that this method is applicable for large-scale manufacturing.Proportioning experiments of supplementary materials are conductedin order to determine the prescription of Xiangshayangwei soft capsule. The soft capsules are manufactured by encapsulating the suspension that is made of the extracted and auxiliary materials. Each capsule contains a total mass of magnolol and honokiol not less than 1.0 mg. In order to determine the optimal composition for capsule shells, orthogonal tests are carried out to explore the effects of the ratio of gelatin to glycerin, the ratio of water to gelatin, and the melt temperature. The observed optimal composition is:gelatin:glycerin:water=2:1:2, with a melt temperature of 70℃.TLC technique is utilized to identify qualitatively the Fructus Amomi, Herba Pogostemonis, Pericarpium Citri Reticulatae and Citrus Aurantium. Moreover, the HPLC technique is used to measure the magnolol and honokiol, and the linear equations of magnolol and honokiol are proposed by using the external standard method:magnolol RSD 0.38%, average recovery 98.04%, honokiol RSD 1.41%, average recovery 99.00%. It is shown that this method is simple, reproducible, and can be used as a quality control route for Xiangshayangwei soft capsule.Stability is well exhibited by performing both accelerated and the long-term stability tests on three batches of samples.In sum, in this study the preparation technique of Xiangshayangwei soft capsule has been optimized and an effective quality control method has been proposed as well. By doing so, the stability of the product has been shown to be improved, which provides a theoretical and experimental guide for large-scale manufacturing. |
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