New Biochemical Capsule Preparation Process And Quality Standards

Xinshenghua capsule , which is made from Radix Angelica sinensis , Rhizoma chuanxiong , Senmen persicae, Radix et rhizoma glycyrrhizae, Rhizoma zingiberis, Herba leonuri, Flos carthami, is an effective prescription of combination of traditional Chinese medicine , for treating lochiostasis after childbirth or pain in the abdomen by activating blood , removing blood stasis , acesodyne, also treating colporrhagia and hypermenorrhea as result of, the production had national criterion ,the criterion can be seen in WS₃-B-1056-91,but the dose was too big in the old criterion ,the author has made some amelioration ,has made an experimental study on its preparation , quality standards and primary pharmacodynamics . 1 .Study of the preparationIn the point of preparation technology , we used extracting ratio of naphtha as evaluating indexes and investigated the optimum preparing time by the parallel test, used the content of ferulic acid and extracting ratio as evaluating indexes and investigated the optimum preparing by the parallel test . The optimum extracting condition was : extracting the seven herbs with water for 3 times and boiling 5 hours, the residue was extracted by water ,the amount of water used was 8 , 6 times of the drug mixture respectively and boiling 2,1.5 hours.On the basis of these studies ,we used the content of ferulic acid and extracting ratio as evaluating indexes and investigated differ methods of dryness by the parallel test. investigated the mosisture absorption and fluidity of powder after mixed with the differ excipients . result: we selected the powder was dried by 60 ℃ in vacuum and mixed with mircrocrystalline cellulose(MCC)( ≥10%) to reduce the hygroscopy and increase the fluidity of mixed powder.2.Study of quality standardFor controlling this prescription inside quality availably, insure a product safety, valid, stability, establish science, reasonable, viable quality standard as follows:The Herba leonuri, Radix Angelica sinensis(Rhizoma chuanxiong mixed) were identified by TLC. it was verified that , Provide to try an article color to compose to win, in checking against the position that the medicine material color table corresponds, the spot of all same color, and the feminine gender check against be corresponding position to then have no interference .Ferulic acid was the one of mostly availability element in Radix Angelica sinensis(Rhizoma chuanxiong mixed). For the sake of assays of ferulic acid, the new high performance liquid chromatography methods were developed. Adopt to two means of the medication with circumfluence and surge in ultrasonic, it was verified that, the assays of ferulic acid was same by two means., circumfluence the sample in 70% methanol for 30 or 60 min, surge in ultrasonic for 15 or 30 min. The average...