| Objective: To study the extraction and purification process of Swertimarin and the preparation process of the soft capsule,and to make a preliminary study on the quality of the preparation according to the requirements of soft capsule in Chinese Pharmacopoeia(2015 Edition),to draft the quality standard of Swertimarin Soft Capsules,and to make a preliminary pharmacodynamic evaluation.In order to obtain a new soft capsule preparation with mature technology and definite effect,and to provide reliable experimental data for the preclinical study of Swertimarin Soft Capsules.Methods: 1.HPLC method was used to detect Swertimarin content,and the pretreatment process of raw materials in the production process was determined by the content determination of Swertimarin in various parts of the green leaf gall;2.Ultrasonic extraction method was compared with reflux extraction method,and the extraction method was selected,and the extraction conditions were optimized by orthogonal experiment;3.The extraction solution was used to The pure Swertimarin was purified by high pressure preparative liquid chromatography;4.The best preparation technology of soft capsule was selected;5.The Swertimarin in the preparation was qualitatively identified by TLC with reference to the reference substance,and the content of Swertimarin in the preparation was determined by HPLC;6.The effect on acute liver injury of mice and rats was studied Pharmacodynamic evaluation of STZ induced renal injury.Results: the pre-treatment technology for the extraction of Swertia mileensisa lanceolata,the liquid-phase purification technology for the ultrasonic extraction and high-pressure preparation of Swertimarin,the forming technology for the soft capsule preparation,the quality standards for the APIs and preparations were established,and the preliminary pharmacodynamic evaluation was carried out.Conclusion: Swertimarin Soft Capsules is a new drug for the treatment of liver injury. |
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