Study On Tibetan Medicine Siwei Jianghuang Capsules Preparation Techniques And Quality Standards

Objective:Under the guidance of Traditional Tibetan Medicine theory,carried out the experimental studies for preparation technology and quality standards research by using the modern pharmaceutical techniques on Tibetan medicine Siwei Jianghuang capsules.Methods:This paper carried out the experimental studies for the active pharmaceutical ingredients?medicine?inspection,compound experimental studies on extraction techniques,prescription molding process,and,prescription quality standard research of the capsules,using quality analysis technique and experimental design methods,such as TLC and HPLC,the single factor experiment and the uniform design method.Results:?1?According to the early studies of the team for Siwei Jianghuang soup powder,this product had obviously improved diabetic nephropathy related indicators,related research had applied for national invention patent?patent No.:201710135750.3,patent name:a kind of drug combination and its preparation methods for prevention and treatment of diabetic nephropathy?.?2?Curcumae Longae Rhizoma,Phyllanthi Fructus and Tribuli Fructus,accord with“Chinese pharmacopoeia”2015 edition,curcumin(C₂₁H₂₀O₆)of Curcumae Longae Rhizoma was 1.7%,gallic acid?C₇H₆O₅?of Phyllanthi Fructus was 2.6%.Using toluene-ethyl acetate-methanol-isopropyl alcohol-water?6:3:3:2:1?as developing solvent,examined under the UV lamp?365 nm?,chromatographic corresponding to the position were showed the same fluorescent spots in the chromatogram of testing products;content of magnoflorine,Jatrorrhizine hydrochloride,palmatine hydrochloride and berberine hydrochloride respectively were 6.28%,0.51%,0.32%and 2.45%in Berberidis Cortex.?3?Established a simultaneous determination on seven ingredients content of the Siwei Jianghuang soup powder by HPLC.Gallic acid,magnoflorine,ellagic acid,Jatrorrhizine hydrochloride,palmatine hydrochloride and berberine hydrochloride and curcumin respectively were in the range of 0.2496¹.4976?g?0.2840¹.7040?g?0.0361⁰.2165?g?0.0756⁰.4536?g?0.0236⁰.1416?g?0.0159⁰.0959?g and0.0604⁰.3624?g?n=6?,and between concentrations and peak area obtained.The contents of seven ingredients respectively were 7.6482 mg·g^-1?13.8024 mg·g^-1?3.7290 mg·g^-1?0.9316 mg·g^-1?0.6789 mg·g^-1?4.6780 mg·g^-1and 3.7890 mg·g^-1.?4?Siwei Jianghuang capsules optimized preparation process were:Curcumae Longae Rhizoma crushed to crude powder,adding 10 folds of 70%ethanol,macerated 12 hours,collected diacolation liquid,vacuum concentration and recycled ethanol to the thick paste,then adding pregelatinized starch powder,vacuum drying,and smashed to fine powder;Berberidis Cortex crushed to crude powder,the first and second times respectively were adding 14 folds 75%ethanol for 2 hours using reflux extraction method,and the third time was 12 folds 75%ethanol for 1 hour,then filtration,collecting filtrate;Phyllanthi Fructus and Tribuli Fructus crushed to crude powder,the first time was adding 14 folds 90%ethanol for 2 hours using reflux extraction method,and the second time was adding 12 folds 70%ethanol for 1 hour,then filtration,collecting filtrate,and mixed the above two filtrates,vacuum concentration and recycled ethanol to the thick paste,vacuum drying,and smashed to fine powder.Mixing above two powders,mixed with proportion?extract powders:microcrystalline cellulose=13:2?,made granules by adding 80%ethanol,drying under 60?,filled capsules.?5?Gallic acid,Ellagic acid and Berberine hydrochloride and Curcumin in Siwei Jianghuang capsules?1 g?respectively were 35.4180 mg,14.1220 mg,17.4433 mg and 7.8630 mg.Conclusion:Siwei Jianghuang capsules preparation techniques were feasible and quality standards were controllable,providing Tibetan drug selection for DN in clinical treatment,and helpfully for Tibetan medicine development.