Research On Preparation And Quality Standard Of Lixuekang Soft Capsule

Lixuekang soft capsule is developed based on Lixuekang granules, which is composed of raw Panax notoginseng and extractions from Rhizoma bletillae, Rhizoma imperatae, Nodus nelumbinis rhizomatis. Lixuekang soft capsule is used in clinic for the treatment of Thrombocytopenia. In this study, the optimal preparation process and quality standards of LIxuekang soft capsule were investigated to overcome many shortcomings of Lixuekang granules and improve the bioavailability and quality standards of the formulation, which is very important for clinical application.In this thesis, the yield rates of ethyl acetate extraction proportion and dry extract were used as indexes to optimize the parameters of water extraction process of Rhizoma imperatae and Nodus nelumbinins rhizomatis by orthogonal design. Aqueous extract sedimentation with alcohol was also used as the index of ethyl acetate extraction proportion.The optimal process is:Rhizoma imperatae and Nodus nelumbinins rhizomatis were decocted 2 hours with 10-fold volume water by 3 times. The filtrate was concentrated to the relative density of 1.10 (75～80℃measured), and added ethanol into extraction until the alcohol content reached 50% under stirring, then desposited for 24 hours. The supernatant solution was collected and concentrated to the relative density of 1.15 (55～60℃measured). Because aqueous extract of Rhizoma bletillae is very glutinous, its extraction and purification was proceeded alone. The optimal decocted process of Rhizoma bletillae was lhours with 10-fold water by 3 times. The filtrate was concentrated to the relative density of 1.20～1.22 (75 80℃measured), then added ethanol into extraction until the alcohol content reached 60%. After stirred, it was desposited for 24 hours. The supernatant solution was collected and concentrated to the relative density of 1.15 (55～60℃measured); Raw Panax notoginseng was crushed into powder and added to based on the formulation indication. According to stability of the suspension system, excipients of soft capsules and granularity of dry extraction were selected. The amount of PEG400 was investigated on the basis of liquidity of the suspension system and granularity of dry extraction. 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= 2:1.2:2, with a melting temperature of 70℃.TLC technique is utilized to identify qualitatively the Panax notoginseng, Rhizoma bletillae, Rhizoma imperatae and Nodus nelumbinis rhizomatis. Moreover, the HPLC technique is used to determine notoginsenoside R1, ginsenoside Rgland ginsenoside Rb1, and their linear equation are proposed by using the external standard method. The results displayed that ginsenoside Rgl, ginsenoside Rbl and notoginsenoside R1 linear relationship were well in the range of Y=84397X+75745, R2=0.9986; Y=57176X-187.1, R2=0.9988;Y 12264X-1478.9, R2=0.9990, respectively. The recovery rates of Lixuekang soft capsule were 98.12%, RSD1.12; 98.30%, RSD 1.03 and 98.35%, RSD 1.30 This method is simple, reproducible, and can be used as a quality control route for Lixuekang soft capsule. The total content of notoginsenoside R1, ginsenoside Rg1and ginsenoside Rb1 in Lizuekang soft capsule was above 8.5mg/g.Stability is well exhibited by performing the 12-months stability tests in normal temperature on three batches of samples.In conclusion, in this study the preparation technique of Lixuekang soft capsule has been optimized and an effective quality control method has been proposed as well.