ABSTRACT
In this paper,the case reports on rug-induced liver injury( ADR cases) related to Gukang Capsules containing Psoralea corylifolia( Buguzhi,BGZ) were collected from the adverse reaction monitoring database from January 1,2012 to December 31,2016,and the in-patients cases with drug-induced liver injury admitted to a tertiary Class A liver disease hospital from January 1,2010 to December 31,2016 were also collected. These collected cases were re-evaluated and analyzed. 110 cases with liver injury related to this preparation were collected from adverse reaction monitoring database,and 55 cases of them received the preparation alone,mainly for fracture treatment( 52. 74%). Ninty one cases( 82. 72%) met the standard of the biochemical diagnostic criteria for drug-induced liver injury. 89. 01% of patients were over the age of 41 and women accounted for 60. 9%. The time from administration to liver injury was 1-208 days,with the median of 29 d. The dose of the preparation was 2. 4-4. 8 g per day,with a cumulative dose ranging from 3. 6-699. 6 g. The recovery and improvement rate reached 96. 70% after positive treatment. Seven inpatient cases related to the preparation were collected in a tertiary Class A liver disease hospital,6 females and 1 male. All of them were over 40 years old. Two cases reached the " suspicious diagnosis" standard and 5 cases reached the " clinical diagnosis" standard in Guidelines for the diagnosis and treatment of herb-induced liver injury. Six patients had a good prognosis effect,but another one had liver failure. This preparation is commonly used in fracture,osteoarthritis and other diseases,with remarkable curative effect. However,ADR cases and hospital cases all indicated the risk of liver injury. There was no significant correlation between the time and dose of drug use and the occurrence of liver injury.The induced-liver injury may have immunological heterogeneity,thus regular monitoring of liver function should be taken during clinical use.
Subject(s)
Adult , Female , Humans , Male , Chemical and Drug Induced Liver Injury , Databases, Factual , Drugs, Chinese HerbalABSTRACT
Objective: To investigate the effects of Buguzhi Pills and three kinds of simulative Buguzhi Pills on diarrhea rats with spleen-kidney yang deficiency, and to confirm the rationality of the salt-processed composition of Buguzhi Pills. Methods: SD rats were randomly divided into nine groups: normal group, model group, positive drug group, salt-processed Psoraleae ructus group, raw Psoraleae Fructus group, Buguzhi Pills (salt-processed Psoraleae Fructus + salt-processed Foeniculi Fructus) group and three kinds of simulative Buguzhi Pills groups (salt-processed Psoraleae Fructus + raw Foeniculi Fructus; raw Psoraleae Fructus + salt-processed Foeniculi Fructus; raw Psoraleae Fructus + raw Foeniculi Fructus). A complex method of hydrocortisone and sennae folium was adopted to establish the diarrhea model due to spleen-kidney yang deficiency. After administration, the organ indexes of thymus, spleen, kidney, adrenal gland, and testis were measured; The pathological changes of corresponding organs were observed; The serum levels of motilin and testosterone were detected by ELISA. Results: Compared with the normal group, the food intake and body weight reduced; The organ indexes decreased in varying degrees; The above organs showed obvious pathological changes under the microscope; the level of motilin showed an upward trend, and the level of testosterone decreased significantly in model group. The above symptoms and indicators were improved in varying degrees after administration, and the effect of Buguzhi Pills was better than that of Psoraleae Fructus alone and three kinds of simulative Buguzhi Pills on the whole. Conclusion :The efficacy of Buguzhi Pills on warming kidney-spleen yang and relieving diarrhea was superior to that of Psoraleae Fructus alone, and the antidiarrheal effect can be enhanced by salt-processing.
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OBJECTIVE: To investigate the effects of nine flavonoids in Buguzhi on the proliferation, differentiation of on Postmenopausal women's osteoblasts and their structure-activity relationship analysis. METHODS: Osteogenic cells were obtained from the femur in postmenopausal women. The effects of flavonoids on the proliferation, differentiation and osteoblasts were determined by MTT method, measuring the activity of alkaline phosphatase. RESULTS: Among the nine flavonoids, bavachin exhibited the highest proliferation, differentiation activity. The final result showed that their proliferation, differentiation activity may be related to the parent structure, the position of hydroxyl group and prenyl group. The results demonstrate that flavonone parent, 7-OH, 6-prenyl may improve the proliferation, differentiation effect. CONCLUSION: The results demonstrated that the effects of nine flavonoids in Buguzhi on proliferation, differentiation activity had connection with their structures.
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OBJECTIVE: To establish the GC method for content determination of psoralen and isopsoralen in Buguzhi tincture.METHODS: The determination was performed on HP-1(30 m?0.53 mm,1 ?m) column with nitrogen as carrier gas and FID as detector,the inlet temperature was 260 ℃.The injector temperature was kept at 280 ℃ with diphenhydramine as internal standard.RESULTS:The linear range of psoralen were 4.82～48.22 mg?L-1(r=0.999 9) with an average recovery 103.11% (RSD=2.20%,n=6).The linear range of isopsoralen were 5.09～50.9 mg?L-1(r=0.999 9) with an average recovery of 100.98% (RSD=3.70%,n=6).CONCLUSION: This method is simple,rapid,accurate and reliable for the quality control of Buguzhi tincture.
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AIM: To determine coumarin and flavonoid in Compound Buguzhi Sustained-Release Tablet(Fructus Psoraleae,etc). METHODS: HPLC method was developed.The separation was performed on an ODS column with the mobile phase of CH_3OH-H_2O.The flow rate was 1 mL/min and the detection wavelength was 320 nm. RESULTS: The result showed that there was good linear relation between the area and the concentration of psoralen、isopsoralen、isobavachin、bavachin、corylin、corylifolinin、bvachinin、psoraidin and bavachalcone within 0.4-152.0,26.4-132.0,13.6-66.0,27.2-136.0,31.2-156.0,48.8-244.0,50.4-252.0,36.0-180.0,(8.8)-44.0 ?g/mL.The average recovery of psoralen and bavachin is 98.7% and 97.6%. CONCLUSION: This method is convenient,reliable,and can be used to control the quality of Compound Buguzhi Sustained-Release Tablet.