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Study on the Preparation and Quality Standards of Xiaobi Capsules

Author: ZhangHaiZhu
Tutor: LiYanBing
School: Heilongjiang University of Traditional Chinese Medicine
Course: Pharmaceutical Analysis
Keywords: XiaoBi capsule Cyclomastopathy Preparation technology Quality standard
CLC: TQ461
Type: Master's thesis
Year: 2008
Downloads: 104
Quote: 0
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Abstract


Cyclomastopathy is a Paraplasm disease of mammary glandular tissue, which is changed like cyst by distension of lobule of mammary gland,tubule of mammary gland and periphery vessel.The morbidity is take first place disease of breast.It has the severe impaction on the life quality of woman.We had changed decoction to capusule for taking medicine conveniently and enhancing stability of drugs.XiaoBi capsules is an effective prescription to cure cyclomastopathy, which is composed of eight traditional Chinese medicines,including radix paeoniae alba,radix bupleuri,rhizoma curcumae,radix curcumae.There are many effectiveness about this prescription such as calm the liver to alleviate pain,dispersing the depressed liver-energy and reliefing gloom,promoting blood flow and expelling stagnate,nourishing the blood and regualting menstruation,softening hard lumps and dispelling nodes and so on.The route and condtion of the technology was based on the prerequisite of the clinical efficacy and combined the qualities of the medicine of the prescription.The potential influence factors to the performance of extraction were fully considered.Studies on extraction of volatile oil,studies on inclusion of volatile oil and decocted with water,which were designed in scientific and reasonable way with orthogonal design,the reasonable extract equipments and technique conditions were optimized by taking those representative effective constituents as criterion.In order to guarantee the quality and curative effects of XiaoBi capsule, the researches of quality standard,with the help of modern science and technology,such as TLC and HPLC.After a series of experimental studies, radix paeoniae alba,radix bupleuri,rhizoma curcumae have been tested to exist by TCL,we adopted the convention quality examination in the capsules and the assay of the Peoniflorin has been constructed.In addition,primary stabilitywas tested in three lots of pilot study samples during the period of three months,and all the items covered the certification.The experimental result suggested that the technology of XiaoBi capsule is convenient and feasible,the physical properties and chemical properties are stable and the quality is controllable.

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