Studies On Preparation And Quality Standards Of Licorice Cream

Objective:Based on the TCM theory, adopting the modern pharmaceutical technology, to establish the preparation process and the quality standard of licorice cream, laid the foundation for the development of new drugs.Methods:(1) Study on the Preparation of the licorice extract:Using the high performance liquid chromatography, with extraction rate of glycyrrhizic acid and liquiritin of licorice as evaluation index, preliminary screening the method for extracting effective components of Licorice from decocting method, percolation method, reflux method and immersion method; Using orthogonal design method, with ethanol concentration, solvent dosage, extraction time, and extraction times as factors, to optimize the optimum process conditions of ethanol reflux extraction method.(2) Study on the Forming process of licorice cream:With glossiness, delicate degree, spread, centrifugal stability, thermal stability and cold stability as evaluation index, screen the suitable matrix formulation from5groups of common matrix formulation as a basis for the optimization; Using single factor test to sift out the better level range of matrix factors as the factors of the orthogonal design study, then using orthogonal design method to optimize the basic prescription, screening out the highest comprehensive weighted score group of matrix formula; Adding amount of the main medicine and preservatives determined by single factor method; Using orthogonal design method, with emulsification temperature, emulsification time, stirring speed as factors, to optimize the optimum preparation technological conditions of licorice cream.(3) Study on the Pilot test:Expand the prescription dosage, with the best technology condition, continuous produce3batches of samples.(4) Study on the quality standard of licorice cream:According to the relevant provisions of appendix IR ointment of the first part of the2010version "China Pharmacopoeia" and reference the ointment preparation quality standard of the2010version "China Pharmacopoeia", to study prescription, preparation, character, identification, examination, content determination, function and indications, usage and dosage, specification, storage of licorice cream, and formulate relevant standards. With glycyrrhizic acid and liquiritin as standard, to establish the determination of glycyrrhizic acid and liquiritin of licorice cream and conduct methodological research by high performance liquid chromatography.(5) Study on the stability of licorice cream:Through accelerated test and long-term test investigate the stability of licorice cream.Results:(1) Study on the Preparation of the licorice extract:6times amount of55%alcohol, refluxing and extracting for3times, each time1.5h, extraction rate of glycyrrhizic acid and liquiritin has reached more than70%.(2) Study on the Forming process of licorice cream:The cream prescription includes mineral oil20.0g, polydimethylsiloxane30.Og, white chihua seed oil20.Og, caprylic/capric triglyceride40.0g, cetearyl alcohol40.0g, glyceryl stearate (and) PEG-100stearate25.0g, glycerol stearic acid ester14.0g, glycerol40.0g, lauryl sodium sulfate2.0g, licorice extract20.0g, methyl paraben and propylparaben (3:1) mixed preservatives1.0g, and add distilled water to1000g. The method for preparing cream was weigh the prescribed amount of water and oil phase, respectively stirring to homogeneous, heated to95℃, insulated at about80℃, added the water slowly to the oil phase, along the same direction, stirring speed at20r/min, and keep whisking30min, cooling to50℃, adding20.0g of licorice extracts, adjust the speed at2800r/min,3min, cooling to40℃and stop stirring.(3) Study on the Pilot test:The formulation and process conditions of the preparation was stable and feasible, the three batch of samples conform to the relevant provisions of ointment, and meet the requirements of industrial production.(4) Study on the quality standard of licorice cream:The formulation of the quality standard system was perfect, and could guarantee the quality stable and controllable, clinical application safe and effective of licorice cream.(5) Study on the stability of licorice cream:The character, identification, determination of content, microbial limit examination of the cream showed no significant change with0month, equivalent to under ambient conditions stored for2years, tentatively the cream was valid for24months.Conclusion:The preparation process was reasonable and feasible, quality standard was stable and controllable, product quality was stable, and could be used as a guide to industrial production and the basis of clinical medication.