Study On The Quality Control Of Xuduan Jiegu Capsule

Xuduan Jiegu capsule is a side agreement Tianchang Hospital of Traditional Chinese Medicine orthopedic hospital preparations, through modern technology to extract 、 preparation consisting of wine Radix dipsaci, astragalus root, Angelica sinensis,with continued reunion,the effect of nourishing liver and kidney,for the treatment of fractures in the later period,after clinical validation of the old Chinese medicine for more than ten years, curative effect reliable. Thesis of Xuduan Jiegu capsule preparation process, quality control and stability were studied, and provide a theoretical basis for the quality standard established Xuduan Jiegu capsule.We use the method of orthogonal test for verification and optimization of water extraction technology of Xuduan Jiegu capsule, respectively, decocting time, decocting times as influencing factors,investigation index content of dry paste rate,Dipsacaceae saponin for. Research shows that, the production process of index components using the actual extraction amount about the optimum process of 94%,has been basically complete extraction,dry extract were comparable,greatly saves time and raw materials, preparation process of Xuduan capsule is feasible.We used the thin layer chromatography of Xuduan Jiegu capsule Astragalus,angelica,medlar were identified,the results of the study indicate that TLC method for identification of Radix Astragali,Chinese angelica,wolfberry fruit is simple,feasible.This paper according to the law of Xuduan Jiegu capsule moisture, load difference,disintegration time, microbial limit,heavy metal and arsenic salt and other projectswere examined, each check all conform to the general rules of capsule.This paper adopts high performance liquid on the content of Xuduan Jiegu capsule Nakagawa teasel root saponin chromatography were determined, by the methodology study, this method has good specificity, sensitivity and accuracy betterrepeatability experiment,high quality,the linear concentration range of teasel rootsaponin is 0.01913 mg/m L ~ 0.6120 mg/m L(r=0.9999), average therate of recovery was 100.89%,RSD=1.10%,according to the samples and three batches of samples test results,determine the limit content of Xuduan Jiegu capsule Dipsacussaponin Nakagawa for 1.2mg/ particle.This method can be used for the qualitative and quantitative study of Xuduan Jiegu capsule Nakagawa teasel root saponin,provides the reference for the quality control of Xuduan Jiegu capsule.At the same time,we made stability study of Xuduan Jiegu capsule,the results show that Xuduan Jiegu capsule inspection before and after the character identification, and content determination of microbial limits of disintegration time limit,moisture,conform to the stipulation,the initial formulation of the period of validity of Xuduan Jiegu capsule for 18 months.