Study On Preparation Technology And Quality Control Of Shenqi Xiaoyan Granule

Lung cancer is one of the most harmful in the malignant tumor,of which 80%are Non-small cell lung cancer,its pathological mechanism is very complicated and can't be explained clearly.It studied and optimized the parameters of preparation technology of Shenqi Xiaoyan granules using uniform design.Adjuvant was intended: mannitol and sucrose were chose as fillers,microcrystalline cellulose as excipient,aspartame as flavoring agents.The ratio of dry powder,mannitol and sucrose,microcrystalline cellulose,aspartame is 3: 4: 2: 1: 0.1 and 90% ethyl alcohol was used as binder.The preparation technology is confirmed to be reasonable and feasible by verifying tests.Thin layer chromatography(TLC)was used for the qualitative identification of Shenqi Xiaoyan granules.Operation parameter was determined by studying the preparation method of samples,developing solvent,color reagent.The results showed that TLC of the granual sample showed same colour spot at the same position as compared with the original herb sample,and negative materials were not found.TLC of Curcumae radix,Curcumae longa,Astragalus,Prunella vulgaris,Hedyotis diffusa can be used as the quality control standard for Shenqi Xiaoyan granule.It carried out quantitative determination of Shenqi Xiaoyan granules by using Reverse Phase High Performance Liquid Chromatographic(RP-HPLC)method.Chromatography condition including detection wavelength,mobile phase,elution gradient and system suitability including the preparation for samples,precision,repeatability,stability were studied.The method for the simultaneous determination of curcumin,rosmarinic acid,calycosin-7-glucoside in Shenqi Xiaoyan granules was intended.The results indicated it is a simple,fast,reliable method.HPLC was also used to study the fingerprints of Shenqi Xiaoyan granule.On the basis of researching precision,repeatability and stability of the system,the standard HPLC fingerprint of Shenqi Xiaoyan granule was established and carried out by statistic analysis with similarities and principal component analysis(PCA).The results showed that similarities for 10 batches of samples are above 0.9 and the quality is steady.A total of 17 common peaks were identified by comparing HPLC fingerprint of Shenqi Xiaoyan granule with that of herbs and corresponding negative samples.The 17 common peaks were ascribed to the origins herb.The results showedthat six components are from Curcumae longa,two components are from Curcumae radix,three components are from Astragalus,two components are from Prunella vulgaris,one component is from Hedyotis diffusa,one is from Pseudostellaria heterophylla and one is from Nidus vespae.To sum up,the paper studied the preparation technology and the method for quality control of Shenqi Xiaoyan granule.The optimum parameter and quality control index of Shenqi Xiaoyan granule were intended.The results provided scientific control method and experimental basis for the quality uniformity,safety and effectiveness of Shenqi Xiaoyan granule.