Research on the Preparation and Quality Standard of Chaihuang Soft Capsule
|Keywords||Chaihuang soft capsule Orthogonal test Preparation Process Quality standards|
Firewood yellow soft capsule for the national drug standards the Chinese medicine Narikata preparations Book 10 containing such varieties , by Chaihu skullcap extract composition , clearing and anti-inflammatory effect for respiratory tract infections , cold and fever . But the existing firewood yellow soft capsule formulation process is not reasonable and lower existing standards can not effectively control the quality of products , resulting in its products prone to disintegration or dissolution retardation , layering and leakage during storage . This topic by exploring a new type of soft capsules capsule of each component of the composition of the skin , soft capsule composition and matrix ratio , in order to improve the the soft capsule Chaihuang solubility and stability problems ; their quality control , in order to improve the stability of the drug , safety and effectiveness. Subject to the saikosaponin indicators of a dry paste was the HPLC method the determination of saikosaponin a content by Orthogonal Test out the Bupleurum the best water extraction and alcohol precipitation process ; Bupleurum plus 8 times the amount of water , extracted for 2 hours, and boiling water 2 times ; concentration of 50% in the alcohol precipitation . The test results show that the method is suitable for large-scale production . Content materials ratio experiment , to determine the prescription Chaihuang soft capsules made of concretes with excipients , after the extracted suspended like soft capsule content , pressed into a soft capsule . Each capsule containing baicalin amount of not less than 70.0mg. Gelatin , glycerin , water and gelatin ratio of sol temperature as a factor in the inspection , the orthogonal experiment , soft capsule capsule shell consists of gelatin : glycerol : water = 2:1:2 , sol temperature of 70 ° C . TLC. The qualitative identification Bupleurum preparations . HPLC determination of baicalin content in the formulation , application of the external standard method , establish linear equations baicalin , baicalin RSD = 1.3% , with an average recovery rate of 98.90% . The method is simple and feasible method with good reproducibility, control method can be used as quality of Chaihuang soft capsule . Three batches retention samples at room temperature visits six months of initial stability test , good stability . In short , through the preparation process on the soft capsule Chaihuang conducted , Quality Standard and stability studies , preferably out of the reasonable preparations molding process , the establishment of effective quality control methods , to improve the stability of the product , we reached the intended purpose .