| Wuwei hepatic protecting oral liquid was scientifically formulated by health experts of Nanjing University of Chinese medicine according to Chinese medicine theory,in accordance with the requirements of health food recipes.It is used for the prevention of liver damage caused by alcohol.Alcohol liver damage(ALD)is a liver diseasecaused by long-term heavy drinking.In major clinical,ALD manifestations of fatty liver,alcoholic hepatitis,alcoholic liver fibrosis,and thus become irreversible cirrhosis.This paper aims to follow the SFDA "Health Food Registration(Trial)" health food registration reporting requirements,to study the preparation process,quality standards and preliminary stability of Wuwei hepatic protecting oral liquid.According to SFDA "auxiliary protection evaluation method(revised)on chemical liver injury" requirement,this paper will research the function of Wuwei hepatic protecting oral liquid,to explore its secondary protection against alcoholic liver injury.This paper analyzed the prescrption to determine its active ingredients according to the physical of chemical properties,design the production process route.And the impact of various factors of production and technical conditions were optimized.1.The alcohol extraction process of Puerariae Lobatae Radix,Schisandra chinensis and Panax ginseng was optimized using L9(34)orthogonal experiment by taking the content ofpuerarin and schizanurin and the yield of extract as index.The optimum alcohol extraction process:Pieces was extracted three times by 12 times 70%ethanol of the Pieces’ total amount,each time 1.5h.2.The water extraction process of Glycyrrhiza and Lycii Fructus was optimized using L9(34)orthogonal experiment by taking the content of Glycyrrhizin,licorice ammonium and polysaccharides and the yield of extract as index.The optimum water extraction process:Pieces was extracted twice by 15 times water of the Pieces’ total amount.each time 1.5h and soak 0.5h before etract.3.This paper used water extraction and alcohol precipitation to research the refining and purification process.The water extract was concentrated to the relative density of 1.12-1.15(60℃),then add ethanol to the alcohol content of 50%.You can get good refined purification effect after standing 48h.4.The enrichment process was optimized by taking the content of puerarin,schizandrin and polysaccharide as index.The optimum enrichment process was the water extract was concentrated after alcohol precipitation,combined with the alcohol extract concentrate,evaporated to the relative density of 1.05～1.08(60℃)through 0.095Mpa,60 ℃.5.Centrifugation process,pH,flavoring agents,and preservatives was considered in the molding processes of the preparation The optimum molding processes was pH 6.0～7.0,6%sucrose was added as a flavoring agent,0.5‰ Ethylparaben added as a preservative.6.The results of three batches of Standard Test certificates:transfer rates of Puerarin and Schisandra were greater than 55%,the process is stable and feasible.This paper researched the quality standards of the product in accordance with the relevant requirements of the "health food accepting administrative licensing examination point" health food quality standards.1.In accordance with the relevant provisions of mixture items under the 2010 version of "Chinese Pharmacopoeia" in Appendix I J,this paper checked the relative density,pH value,the amount of difference,microbial limit of the test sample.The results came out to be that they are all in line with the requirements.2.This paper simultaneous determined puerarin and schisandrin in preparation by HPLC and studied the methodology.Puerarin and Schizandrin showed good linear relationships within the range of 0.1058～0.5289 and 0.0075～0.0376 mg/ml respectively.Their average recoveries were 100.06%、101.11%.RSD:2.64%and 0.64%.This paper formulated content limits of puerarin and Schizandrin according to the content results measured in three batches of test sample.This product is tentatively scheduled that each mixture containing puerarin not less than 45.5mg,Schizandrin not less than 1.9mg.The developed determination method of puerarin and schisandrin in the product was included in the establishment of oral quality standards.3.According to GB/T 1.1-2009"standardization guidelines" related requirement to write the quality standards of Wuwei hepatic protecting oral liquid(Draft).According to the relevant requirements of SFDA "health food stability test guidelines",by stability test,this paper study the sensory,chemical,physical and biological changes of Wuwei hepatic protecting oral liquid under different environmental conditions(such as temperature,relative humidity,etc.)in the extent and patterns of increase over time,in order to determine the sample packaging,storage conditions and shelf life stability.We checked the character,identification,inspection,content of puerarin and schisandrin in 3 batches of test samples,to observe the stability of retained samples at room temperature for 12 months and three months of accelerated test study.The results showed that the quality of the preparations were stabe in the study period.Stability study is continuing to determine their actual expiration date.This paper researched functions performed of Wuwei hepatic protecting oral liquid in accordance with the " auxiliary protection evaluation method(revised)on chemical liver injury" requirement.The results showed that each dose group of Wuwei hepatic protecting oral liquid could significantly lower the serum total cho lesterol(CHOL),serum bilirubin(TBIL),low-density lipoprotein(LDL)levels of sub-acute alcoholic liver injury in mice.There was a significant difference in the dose group and model group,which indicated that Wuwei hepatic protecting oral liquid have a good secondary protection from alcoholic liver injury.Under the guidance of the theory of Traditional Chinese medicine,this paper preferred the scientific formula and the raw materials in formulation,According to requirements of "The Ministry of Health to further standardize health food ingredients notice" combined with the effectiveness ingredients commonly used in Health functions to be declared.In addition,this paper completed the development of Wuwei hepatic protecting oral liquid,depending on the selected materials physicochemical properties of the main active ingredient,combined with actual production and the use of modern preparations technology and quality control measures.Finally this paper provided a scientific basis to declare health food formulations. |
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