Study On Preparation Technology And Quality Standard Of Shehuang Gel

The prescription of Shehuang Gel was derived from the preparation of Shehuang Ointment in the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,which was composed of two drugs: Phellodendri Chinrnsis Cortex and Cnidii Fructus.The original preparation(ointment)is composed of fine powder and substrate(petroleum jelly,glycerin).It has the effect of clearing away heat and detoxification,removing wind and dampness,and relieving itching.It is mainly used for pruritus,scaling off,bacterial infection and other symptoms in subacute eczema stage.The original formula powder is used as medicine with low drug load,slow release of pharmacodynamic ingredients,high clinical dosage,oily matrix is easy to clog pores,pollute clothes and is not easy to clean,and poor patient compliance.In view of the above problems,the research group improved the gel,developed it as a gel,and studied its extraction process,molding process and quality standard to form a draft quality standard,so as to ensure the safety,effectiveness and stability of Shehuang Gel.In the extraction process part,six index components related to clinical efficacy were selected,including pyrazine hydrochloride,berberine hydrochloride,magnolitin,prickly ash toxin,imperatorin and osthole,and the optimal extraction process was selected by single factor combined with orthogonal experiment.In the molding process,appearance properties,viscosity,coating malleability and in vitro release were selected as evaluation indexes.The prescription of Shehuang gel was optimized by the combination of single factor and Box-Behnken response surface method.Finally,the process prescription was determined as 4% HPMC,2% CMC-Na,10%glycerol,5% drug loading,and azone dosage 5%,ethyl hydroxybenzoate dosage 0.1%,p H value set to 6～7.In the study of quality standards,a TLC method was established for the qualitative identification of Phellodendron Chinese Schneid and Cnidii fructus.The method was stable and feasible with no negative interference.HPLC method was established for the quantitative determination of Phellodendrine hydrochloride,Berberine hydrochloride,Impermetin,and Osthole in the finished products,and the content limits of gel per gram were determined: Phellodendrine hydrochloride should be no less than 0.40 mg,Berberine hydrochloride should be no less than 3.80 mg,Osthole should be no less than 0.60 mg,and Imperatoxin should be no less than 0.35 mg.In the fingerprint research part,15 batches of samples were established,16 common peaks were demarcated in total,6 peaks were identified by the mixed reference,and each peak was assigned.Through similarity evaluation,it was determined that the preparation process had good stability and good overall consistency.The stability of the gel was mainly studied in terms of cold-resistant stability,heat-resistant stability,centrifugal stability and accelerated stability.