A Reaearch Of Hepatoprotective Effect Soft Capsule

Chemical liver injury is a kind of liver damage that caused by chemicalhepaoatotoxicant. These chemicals include some chemical toxins in environment,such as alcohol and some medicaments. As an important detoxification organ in ourbody, the liver has the blood supply of both hepatic vein and hepatic artery. Thechemical substances can pass through the body circulation into the liver and do sometransformation. So that the liver is easy to be hurted by the toxic substances in thechemical.The reason why the rate of the chemical liver injury is on rising is thechange of people’s diet, psychological and the influence of modern societyfactors.Based on the reasons above,this thesis focuses on the research ofhepatoprotective effect soft capsule. The soft capsule is a pure traditional Chinesemedicine preparation which is made up of pueraria, sea buckthorn and nutmegandgardenia,mainly used for alleviating chemical liver injury.The thesis is to study the technological conditions, quality standards andpharmacodynamics of the soft capsule. We choose the soft capsule as a formulation ofthis preparation to test its manufacturing, procedure, quality standard, stability andefficacy.The detailed results are as followings.A. The extraction process of four kind of traditional Chinese medicineAccording to the puerarin or the weight,we study on the the extractiontechnology of ethanol of pueraria, gardenia and nutmeg, we take the volume ofsolvent, ethanol concentration, extraction time and the times of extraction as mainlyfactors,taking orthogonal test together with the orthogonal table L9(34).We know thatthe best extraction process is the solvent’s volume5times more than the sample’svolume,the concentration of70%ethanol and extracting3times,maintaining this statefor3hours.We extract seabuckthorn by supercritical fluid extraction of CO2.We takeCO2volume, extraction time, extraction pressure and extraction temperature asmainly factors.With the orthogonal test, we know that the best extraction process isthe extraction time of3hours, extraction pressure of25MPa, temperature of40degrees and the flow of CO210times more than the volume of extraction kettle’svolume. B. Study on quality standardWe study on the quality standard of hepatoprotective effect soft capsuleaccording to the China Pharmacopeia2010.We use thin layer chromatography (TLC) for gardenia qualitativeidentification.The experimental results show that the spots of TLC were clear, goodrepeatability,strong characters and the specific test without theinterference.TLC method is adept to the qualitative identification of hepatoprotectiveeffect soft capsule.We take puerarin’s content as factors, investigating the content of puerarin in thepreparation by using high performance liquid chromatograph.At the same time,wemake the content limit.The results show that theprecision, linearity, stability, reproducibility and recovery were good in thisexperiment. We set the specified puerarin’s content of the hepatoprotective effect softcapsule not less than12.32mg.C. Study on the stabilityWe use the accelerated test and normal temperature test to examine the stabilityof the preparation, verifing the preparation character, identification, contentuniformity, determination of content, microbial limit and so on.Accelerated test and normal temperature test were respectively investigated for3months. Both of them were no significant changes, so it indicates that the stabilityof the soft capsule is good.D. Pharmacodynamics experimentPharmacodynamics experiment shows that three dose groups of thehepatoprotective effect soft capsule shown obvious protective effect on liver injurymodecaused by CCl4.It can also significantly reduce serum AST,ALT and the degreeof liver injury at the same time.All the results show that the hepatoprotective effectsoft capsule has auxiliary improvement of chemical liver injury effects.The research results show that the hepatoprotective effect soft capsule has thefollowing advantages: reasonable preparation process, controllable quality and goodstability, alleviating chemical liver injury.