The WHO regards diabetes as one of the three most difficult diseases.Diabetic nephropathy is the leading cause of death from diabetes and it has seriously jeopardized human health.For the disease,there is still no effective therapeutic drug.On the basis of previous work,this experiment mainly carried out SH capsule quality standard research,established the qualitative identification and content determination method of the main active ingredients of SH capsule,and conducted acute toxicity study of the capsule contents to evaluate the safety of SH capsules.It lays an experimental foundation for the further development of this product.Methods:(1)Verification and amplification process production:The preparation and molding process were selected under laboratory conditions.The best preparation and molding process for SH capsule amplification was verified by measuring powder extraction rate and drug product yield,and three batches of pilot product were prepared for testing.(2)Select the taste of drugs to identify:According to the relevant prescription design,the main characteristic active ingredients of each drug taste are selected for identification by thin layer chromatography;the original medicinal materials of rhein,puerarin,tanshinone IIA,berberine,and baicalin are tasted by thin-layer chromatography on SH capsules.And for the test product to identify,identify the main active ingredients of SH capsules.(3)Determination of content:The active ingredients of Rhein,Puerarin and Tanshinone IIA in SH capsules were determined by HPLC,and the determination of SH capsules was established by measuring specificity,regression line equation,precision,repeatability,stability,and recovery rate.method.(4)General quality standards:Through the SH capsule traits,the amount of the difference,the disintegration time limit,the determination of moisture,microbiological examination,the establishment of SH capsule general quality standard measurement method.(5)Acute toxicity test:On the basis of the pre-test,the mice were given the maximum concentration and maximum dose of gavage needles,and the acute toxicity of the drug was taken as indicators of feeding,fur,faeces,secretions,limb movement,and animal death.Results:(1)Pilot scale up:The extraction rate of rhein,puerarin,and tanshinone ⅡA in SH capsules were all above 25%,and the actual yield was above 95%of the theoretical yield,which provided an effective optimal preparation process for the production of SH capsules.(2)Identification:Thin-layer chromatography was used to qualitatively identify the main active ingredients of SH capsules.A total of five major active ingredients in SH capsules were identified:rhein,puerarin,tanshinone ⅡA,berberine and baicalin.Rhubarb raw material samples,SH capsules,and rhein control sample chromatograms all showed the same spots and color spots.Negative controls showed no interference;The raw materials of Pueraria lobata samples.SH capsules,and puerarin control samples all showed the same spots and color spots,and the negative controls showed no interference;The tanshinone IIA reference drug sample,SH capsule,and tanshinone IIA control sample chromatogram all showed the same position and color spots,and the negative control interfered;The chromatograms of SH capsules and berberine hydrochloride control samples all showed the same spots and color spots,and the negative controls interfered;The chromatograms of the SH capsule and the baicalin reference sample all showed the same spots and color spots,and the negative control interfered.(3)Determination of content:Determination of rhein,puerarin and tanshinone ⅡA in SH capsules by HPLC.The regression line equations are rhein y=41.216x-72.175,where R2 is:0.992;puerarin y=20349x-4827.6.The value of R2 is:0.9996;Tanshinone Ⅱ Ay=780799x+31307,wherein the value of R2 is:0.9997.(4)Quality inspection:Through the Chinese Pharmacopoeia,SH capsules were tested for general quality;traits,moisture,loading capacity,disintegration time,and microbes were examined.The results confirmed that the product was a hard capsule with uniform contents,all of which were dark brown powder and slightly bitter in taste.Water content<9.0%;disintegration time<30min;loading capacity difference<10%;no Escherichia coli in SH capsules,total number of aerobic bacteria in SH capsule capsules(bacterial number<10,mold and yeast<10(g/g)are in compliance with relevant formulation standards.(5)Acute toxicity:24 hour small partial tertiary irritant feeding SH Capsule,equivalent equivalent 0.3 ml/10 g(1 g/ml)adult clinical adult day dose 86 times,observation 14 heaven,mice ’s fur,eclipse,faeces,limbs activity Denaturation,no cases death.Conclusions:1.This topic validated the best SH capsule extraction process and molding process.2.Through the qualitative identification,content determination and general quality standard detection of SH capsule,a stable,feasible,simple and reliable method for identification and content determination was established.The acute toxicity of the pilot product indicates the safety of acute medication. |