Preparation And Pharmacodynamics Of Shenai Lotion

Shenai Lotion is a female product for genital itching,redness and pain caused by bacterial vaginitis.It is prepared according to the clinical prescriptions of a hospital in Wuhan.The prescription is a traditional gynecological topical lotion,which is composed of Phellodendron chinense Schneid.,Sophora flavescens Ait.,Cnidium monnieri(L.)Cuss.,Artemisia argyi levl.et Vant.,Kochia scoparia(L.)Schrad.and Stemona tuberosa lour.with definite curative effect.Due to the deep color,strong smell,inconvenience of self-decocting during use,and difficulty in controlling the concentration of the drug,the topical lotion of traditional Chinese medicine is difficult to adapt to the fast-paced lifestyle and clinical application needs of modern society.This topic is guided by the theory of traditional Chinese medicine,using modern preparation technology to extract the active ingredients in the prescription,and prepare it into a gynecological topical lotion that is convenient for clinical use.The development of this preparation has enriched the types of gynecological external preparations related to mugwort leaves,plays a leading role in the deep processing of wormwood resources and the extension of the industrial chain.Its application will contribute to the development of local agricultural economy and care for women’s health.The research work of this subject will provide a theoretical and experimental basis for the industrial development of Shenai Lotion in the future.In order to investigate the influence of the main ingredients in the extraction prescription,the star-point design-response surface method was used to evaluate the main active ingredients of the prescription Chlorogenic acid,Oxymatrine,Osthole and Berberine hydrochloride as the evaluation index.Factors and levels of active ingredients.Finally,the best extraction process was selected: 70% ethanol was used as the solvent,the liquid-to-material ratio was 10:1,soak for 1 hour,and the extraction was refluxed for 2 hours,extracting the dregs again with the same method.The preferred extraction process has simple operation,is stable and feasible,has high resource utilization rate,and is suitable for industrialized production.In the research of the molding process,the preparation method of Shenai Lotion and the adding ratio of the solubilizer were systematically investigated.When the ratio of polysorbate 80 to the prescription amount extract is 1:1,the transparency and stability of the prepared sample is the best.Therefore,the best formula and preparation method are determined.In this subject,the qualitative identification and content determination of the main active ingredients in the preparation were carried out.Thin layer chromatography(TLC)was used to qualitatively identify Phellodendron chinense Schneid.Sophora flavescens Ait.,and Cnidium monnieri(L.)Cuss.in preparations,and high performance liquid chromatography(HPLC)to determine Chlorogenic acid,Oxymatrine,Osthole and Berberine hydrochloride in preparations.The quality standard of Shenai Lotion was established to provide a scientific basis for the quality control of this preparation.In accordance with the relevant requirements in the guidelines for the stability test of raw materials and preparations in the 2020 edition of the “Chinese Pharmacopoeia”(General Principles 9001),combined with the draft quality standard of this preparation,the preliminary stability of the obtained preparation was investigated.Using high temperature,strong light irradiation and accelerated stability tests,the appearance properties,p H value and content of Shenai Lotion were investigated.The test results show that the inspection indicators are basically stable and meet the quality standard requirements.Taking SPF-grade BALB/c mice as the research object,using 4-aminopyridine-induced mouse pruritus and xylene-induced mouse ear swelling acute inflammation as the pathological model,to test the effect of Shenai Lotion and the original decoction commonly used in clinic anti-itch and anti-inflammatory effects.The results show that Shenai Lotion can significantly reduce the swelling of mice ears caused by xylene and the number of itching in mice caused by 4-aminopyridine.The water decoction has the similiar curative effect to Shenai Lotion when it was diluted one time.Thus,the effect of this preparation was verified.This subject has conducted a systematic study on the extraction,molding process and quality standards of Shenai Lotion,drafted the draft quality standard of it.We conducted initial stability and preliminary pharmacodynamic research,which laid a foundation for the development of Shenai Lotion.At the same time,the research and development of this preparation not only enriches the types of wormwood related products,and further extends the wormwood industry chain.The development of the industry chain will surely drive the income of wormwood growers and local agricultural economic development.The application of the results of this research will provide a contribution to the health problems of key populations such as women,which was emphasized in the "Healthy China 2030" Plan.