| Wuzi Yanzong Recipe is an ancient recipe used to treat kidney deficiency.The Lycium barbarum L.and Cuscuta chinensis Lam.are king medicines.Among them,Lycium barbarum L.is good at filling essence and nourishing blood.Rubus chingii Hu and Schisandra chinensis(Turcz.)Baill.are the principal medicine.Among them,Rubus chingii Hu can not only collects astringent solid essence and shrink urine,but also benefits liver and kidney;Schisandra chinensis(Turcz.)Baill.is equipped with five flavors,and the sour taste is the strongest,can nourish kidney and arrest seminal emission;The whole prescription only uses the Plantago asiatica L.as adjuvant,with the property of slight cold to restrict the luck-warm effects of other drugs.At the same time,it can also have the effect on clearing heat and diuresis;The whole prescription is mainly for tonifying the kidney,which is not only tonifying the kidney-Yin but also kidney-Yang,nourishing the bone marrow.And this prescription is mild,neither dry nor severe,and no adverse effect for long-term use.This paper combines theory with practice to change the dosage form of the original formula,uses the method of alcohol extraction followed by water extraction to fully extract the effective parts,combines the two extraction parts.The granules were made by the wet granulation technique.And quality standard was established,pharmaceutical effects of the granules is investigated.The specific research contents are as follows:Preparation technology research: In this paper,star point design-responsesurface method was used to extract the active components of wuzi yanzong recipe.Alcohol extraction is evaluated by content composite scores of total flavonoids and total lignans,the water extraction is evaluated by the content of total polysaccharide.The factors and levels influencing the content of main active ingredients in the prescription were investigated,to optimize the best extraction process.By studying the molding process and examining the the density extract,the type of auxiliary materials,the amount and the proportion,the optimal preparation process parameters are optimized.Finally,the stability and feasibility of the molding process were verified through verification experiments,which had certain reference value.Study on quality standard: Lycium barbarum L.,Cuscuta chinensis Lam.and Schisandra chinensis(Turcz.)Baill.in wuzi yanzong granules were identified by thin layer chromatography(TLC).The contents of the active ingredients in wuzi yanzong granules,including hypericin and schisandrae alcohol,were determined by High performance liquid chromatography(HPLC).In addition,methodological investigation was carried out to ensure the controllability of preparation quality.Preliminary stability study: The accelerated tests of Wuzi Yanzong granules have been carried out,inspecting appearance,particle size,content,melting and other physical and chemical indicators of Wuzi Yanzong granules respectively in the 0 to 6 months.The test results showed that all inspection items meet quality standards and the relevant requirements of general rules for granules in《Chinese pharmacopoeia》,the stability is good.Pharmacodynamic study: the safety of wuzi yanzong granules was studied by measuring the level of biochemical indexes.The effect of wuzi yanzong granules on relieving physical fatigue was studied by swimming test with heavy load and liver sugar element test.The anoxia tolerance of wuzi yanzong granules was studied by atmospheric pressure anoxia tolerance test.The immunological enhancement of wuzi yanzong granules was studied by the determination of viscera/body weight ratio.According to the results of the experiment,wuzi yanzong granules developed in this study have the functions of anti-fatigue and anti-hypoxia,and can enhance immunity to some extent.In this project,the extraction technology and forming technology of wuzi yanzong granules were studied in depth,and the quality standards of wuzi yanzong granules was established.The stability and pharmaceutical effect of wuzi yanzong granules were preliminarily investigated,which provided the experimental basis for the extensive application of wuzi yanzong granules in the future. |
