Angelica Recipe Standardization Of The Granular Quality Standards

Baizhi Dispensing Granules(BZDG) which is made from the dried root of Angelica dahurica(Fisch.ex Hoffm.) Benth.et Hook.f.var.formosana(Boiss.) Shan et Yuan are produced following the steps:extracted by alcohol,concentrated,spray drying and forming. It has the functions of inducing diaphoresis to disperse cold,expelling wind to relieve pain, subduing swelling,promoting pus discharge.In order to work for the National Key Project, this article has made a comprehensive and systematic study on standardization of quality standard for BZDG according to "Technology Introduce of the Research on Material Medica Dispensing Granules" on the basis of pre-effort of the project group.In the quality research of the raw materials,the method of writhing induced by acetic acid was firstly used to compare the effect of ethanol extract of sulfured samples of Baizhi with the unsulfered ones.The results showed that the sulfured samples have no producing analgestia,but the unsulfured samples have certain analgestic effects in the same condition; The content of imperatorin in six samples of Radix Angelicae Dahuricae were determined by two HPLC methods established separately by Chinese Pharmacopoeia(2005 edition) and Chuan Baizhi GAP project group.The preparation of the former method is more available,simple and efficient,while by the latter method the three main coumarins in Chuan Baizhi can be determined simultaneously;The extraction method and solvent were optimized.The work above provided the scientific basis for the raw material screening of BZDG..The quality control factors were studied systematically,including the description and identification(TLC with standand of imperatorin),tests(granularity,moisture content, dissolution,weight variation,determination of heavy metals,lead,cadmium,arsenic, mercury and copper,pesticide residue and microbial limit),assay(ethanol-soluble extractives are not less than 50%;imperatorin is not less than 1.5mg/g;the total coumarins are not less than 9.5mg/g).The fingerprints of BZDG were studied by HPLC,the similarities of the products were both above 0.9 and the main chromatographic peaks in the granules were in correspondence to the raw material which shows the ethanol-percolating extract craftwork path is reasonable and feasible.Stability studies of three batches of semi-work productions were done for six months and all checks met the standards.The result showed the products were stable.So the quality guarantee period could be settled as two years temporarily.In pharmacodynamical confirmation and the secure appraisal aspect,the two indexes of anti-inflammatory and analgesia were selected to compare the equivalent pharmacodynamics of the dispensing granules and standard decoction of Baizhi;The experiments in rats of acute toxicity test and death rate were done to evaluate the safety of BZDG.The research result shows:the effects of anti-inflammatory and analgesia of the prescription granule are superior to standard decoction obviously.Though the toxicity of the former is much more obvious,it is still used in security(The value of LD₅₀ is 348 times of the dosage in clinic).Toxic reaction should not be ignored during use.The qualities of BZDG that produced in different pharmaceutical factories were firstly studied comparatively.They products in the market had distinct differences in quality and were of poor quality in the mass.