Study On The Preparation Technology And Quality Standard For The Ease Soft Capsules

The traditional Chinese medicine is precious cultural heritage of the Chinese nation. And the long history of its clinical applications has proved its excellent curable effects. But because the preparation craft is backward, the traditional Chinese medicine exist some shortages such as it's larger oral dose and unstable quality. These reality existence problem has seriously restricted the traditional Chinese medicine curative effect further display as well as a more widespread clinical practice ,caused the traditional Chinese medicine to be unable to move towards the world medicine mainstream market.In view of this, this research has carried on the beneficial attempt in this aspect .we take the ease pill as the object of study, utilize the new method, the new technology to carry on the craft reform to it, optimize the dosage-form, and use the modern analysis method to carry on the quality control, make every effort to explore the feasible method of the traditional Chinese medicine modernization.The formula of the ease pill comes from 《Tai Ping Hui Min He Ji Ju Fang》 and recored in various edition "Pharmacopoeia", It has the function to relieve the stagnancy of vital energy in liver,to benefit the function of the spleen ,to replenish blood and to regulate menstruation.It's used for stagnancy of liver,and deficiency of blood,manifesting costal pain,headache,dizziness,lasstitude,loss of appetite,irregular menstruation.This research takes the content of saikoside A , peoniflorin, ferulaic acid, glycyrrhizic acid as the determination index, takes HPLC as the examination method, uses the Homogeneous design to optimize the ease pill extraction craft. And takes the Homogeneous design adsorption rate, the desorption rate, the biggest adsorptive capacity and so on as the inspection index, screens Homogeneous design which is suitable, carries on to the effective component concentrated, auxiliary results in the ease pill soft capsule in this foundation by the polyethylene glycol 400 systems, and hasconducted the preliminary study to its quality standard. And the RP-HPLC analytical method has been developed for determinate content of the active principles of the capsules with UV-DAD as the detector.The method was proved to be simple,precise and reproduciable.lt is especially practicable for rapid analysis to control product quality.This research,under the guidance of the traditional Chinese medicinal theory and practice, through carrying on the re-development to the ease pill with the modern technology experiment method, provides the reliable experiment datum for the traditional Chinese medicinal modernization, builds the solid foundation for developing new product which the dosage-form advanced, the quality controllable, the high technology content , has the international competitive power.