Study On The Preparation And Quality Standard For The Compound Ganoderma Jiangtang Capsule

Compound Ganoderma jiangtang capsules are made up of Ganoderma, Dwarf Lilyturf Tuber, Common Anemarrhena Rhizome, Lily Bulb. It can be used in all kinds of II type of diabetes caused by deficiency of both vital energy and yin because it has effects of supplementing Qi and nourishing yin, removing heat to promote salivation.Under the guidence of the Traditional Chinese Medicine theory and practice ,applying modern preparation technology and the study carries through the researching of craft and quality standard before clinic.According to the requirement of clinic , taking the prescription and the character of the herbs into account,the study makes the dosage form as capsule.On the basis of the fuction and indiction of the prescription, physico-chemical property of the effective ingredient in the herbs ,the study lays preparation craft line and adopts orthogonal experiment method.Through detecting polysaccharide,the study constitutes the best extraction craft of Ganoderma, Dwarf Lilyturf Tuber, Common Anemarrhena Rhizome, Lily Bulb.the procession is as follow: water dosage, 12 times as extraction dosage, decoction,3 hour extraction time,2 as frequency, blending the filtrate and condensing ,the relative density to 1.15(80℃), adding EtOH (85% as concentration),standing, centrifuging,drying precipitation;the other 3 herbs adding water,8 times as extraction dosage, decoction, 1.5 hour as extraction time,3 as frequency, blending the filtrate and condensing ,the relative density to 1.15(80X3), adding EtOH (85% as concentration),standing, centrifuging,drying precipitation;at last mixing the above extractive ,crashing,sieving with 80 mesh ,filling into capsules.In the research of quality standard,the experiment uses the thin-layer chromatography to carry on the qualitative distinction of three herbs in the prescription.Assaying adopts anthrone-sulphuric acid colorimetric method taking polysaccharide as index and carries out the study of systematic technology(detecting wave length,extracting condition,linear, precision,stability, reproducibility, recovery rate of spotting.The result satisfied with the requirement.The recovery rate is 102.94%.the contents is not low 499.97mg/g.The study inspects the stability of acceleration and long-term.The procession is as follow:detecting the sample which is produced ,then detecting the sample which is kept 1 month,2 month,3 month,6 month.As the result,the character, identification, inspection, assaying of the three batch of the sample consist with the regulation.Above all the experiment proves that the craft is reasonable and practive, the quality standard is controlled, the quality is fundamentally stable.