Studies On The Preparation Technology And Quality Standard Of Anxue Capsules

Anxue capsule is a chinese medicine preparation,which is made of 7 traditional chinese medicines including Radix Astragall,Herba Leonuri,Radix Codonopsis,Radix Angellcae Sinensis,Rhizoma Chuanxiong,Radix yathulae,Pollen Typhae.There are many effects about this prescription such as regulating qi and circulating blood.Using in Woman of qi deficieney and blood stasis.To treat the disease of prolonged uterine bleeding,more bloodshed,having the blood clot or the abdominal pain asthenia after drug abortion,the induced abortion or the natural childbirth.This topic to anxue capsule preparation technology,the quality standards and the preliminary stability test has conducted the system research.This topic research is in reliable clinical efficacy,combines the nature of prescription medicines ingredients,then screens the best technology route and conditions.The research mainly include:the smashing of the raw medicine,the steam distillation of volatile oil extraction,the water extraction technology and the ethanol extraction technology.The research of the best extraction technology of water and ethanol has been studied by using the orthogonal test,taking astragaloside and oleanolic acid as the inspection target.The quality standards research has established the TLC method of Herba Leonuri,Radix Angellcae Sinensis,Rhizoma Chuanxiong,which is feasible,has better reproducible and specificity by testing repeatedly.Simultaneously we has carried on the general quality inspection to anxue capsule according to the capsule relevant provisions of an appendix IL of the "Chinese Pharmacopoeia" 2005 version,finally the results conform to the requirements. We has prepared by astragaloside to control this preparation quality because Radix Astragall is larger in this prescription and its active ingredient is astragaloside.This method initially set HPLC to detect the content of astragaloside,with ELSD to Detect and with external standard two-point method to calculate.In the study of the preparation stability,three medium-scale experimental products have been examined for 0～3 months and the results showed that all indexes were consistent with the regulation.The findings suggested that the preparation technology is reasonable and feasible,the preparation quality is stable and controllable and meet the needs of the disease.