1.Effects of Standardization of Clinical Research on Results of Evidence-based Medicine Analysis for Yao-tongning Capsules
Lijun NI ; Xiaoxiao DONG ; Liguo ZHANG
China Pharmacy 2017;28(18):2520-2523
OBJECTIVE:To investigate influential factors of standardization of clinical research on therapeutic efficacy of Yao-tongning capsules,and to provide direction for reasonable and standard development of clinical research. METHODS:Retrieved from CJFD,VIP and Wanfang database,RCTs about Yaotongning capsules in the treatment of related disease were collected. After data extraction and quality evaluation,Meta-analysis was conducted by using Rev Man 5.3 statistical software. The effects of the di-alectical situation,treatment course and route of administration on the evaluation of therapeutic efficacy of Yaotongning capsules were compared;based on this,the concepts of index evidence-based value which reflected clinical standardization were put for-ward,and its effects on Yaotongning capsules were investigated. RESULTS:A total of 71 RCTs were included,involving 11009 patients. Results of Meta-analysis showed therapeutic efficacy of Yaotongning capsules was better than that of other drugs in dialecti-cal case(P=0.02),while therapeutic efficacy of Yaotongning capsules was inferior to that of other drugs in non-dialectical case(P<0.01);therapeutic efficacy of Yaotongning capsules was inferior to that of other drugs when treatment course was shorter than 30 days(P<0.05),while treatment course was longer than 30 days,there was no difference in therapeutic efficacy between Yaotongn-ing capsules and other drugs(P=0.99). When did not take medicine according to the instruction,therapeutic efficacy of Yaotongn-ing capsule was inferior to that of other drugs(P<0.05);when taking medicine according to the instruction,there was no differ-ence in therapeutic efficacy between Yaotongning capsules and other drugs(P=0.94). When evidence-based value was ≥5,thera-peutic efficacy of Yaotongning capsules was better than that of other drugs(P=0.03);when evidence-based value was equal to 4, there was no difference in therapeutic efficacy between Yaotongning capsules and other drugs(P=0.56);when evidence-based val-ue was ≤3,therapeutic efficacy of Yaotongning capsules was inferior to that of other drugs(P<0.05),with statistical significance. CONCLUSIONS:It is an important guarantee of playing therapeutic efficacy of Yaotongning capsules to regularly use drugs strictly according to the principle of dialectical treatment,and take drugs according to treatment course and instructions. Clinical trials should be standardized strictly in accordance with the instructions,so as to provide objective and fair clinical findings.
2.Influence of Heating Method on the Quality of Extracts from Radix Salviae Miltiorrhizae
Lijun NI ; Kefang WU ; Liguo ZHANG
Traditional Chinese Drug Research & Clinical Pharmacology 1993;0(01):-
Objective To observe the influence of heating method (or temperature control strategy) on the concentration of main active components in extracts from Radix Salviae Miltiorrhizae. Methods Common chromatographic peak area and the contents of Salvianolic acid B in three kinds of extracts obtained by 3 kinds of heating methods were compared. Results With the content of extracts extracted by the first heating method as the baseline, content of salvianolic acid B in extracts extracted by the second heating method was decreased 21.73 percent and that by the third method decreased 55.44 percent. Conclusion Quality of Salvianolic acid extracts can be affected greatly by temperature range and temperature control strategy. It is important to strictly control the heating method for the exaction of heat- sensitive active compounds from Chinese herbs.
3.Study on Two Chelating Resins Removing Heavy Metal from Extracts of Radix Isatidis
Jixin WEI ; Liguo ZHANG ; Lijun NI
Traditional Chinese Drug Research & Clinical Pharmacology 1993;0(02):-
Objective To study the feasibility of chelating resins A and B removing heavy metals from the extracts of Radix Isatidis.Methods Heavy-metal Removal experiment was performed on automatic control platform in industry mode.With dry ointment yield,comparability of HPLC and removal rate of heavy metals as the indexes,the effects of two kinds of Chelating resins in removing heavy metal were compared.Results After finishing heavy metal removal step,the loss rate of the dry-extract was lower than 7 %,and the heavy metal contents in dry-extract were lower than national limits.HPLC similarity of the extracts before and after removing heavy metals by resin A was higher than 0.97,but that by resin B was very low.Conclusion Chelating resin A is suitable for removing heavy metals from extracts of Radix Isatidis.
4.Pharmacological Evaluation on Different Active Fractions ofYao-Tong-Ning Capsule Based on Cell Models
Lijun NI ; Tingting ZHU ; Nannan WANG ; Liguo ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2015;(5):963-970
This study was aimed to evaluate the effects ofYao-Tong-Ning Capsule (YTNC) whole formula, dissembled YTNC formulas, and their active fractions on cell proliferation, immunity, anti-inflammation and osteocytes repair. According to the formulating principle of YTNC and combinatorial chemistry concepts, six samples were prepared by combining different active fractions. Half-maximal effective concentrations (EC50) or half-maximal inhibitory concentrations (IC50) were applied to evaluate the effects of samples on promoting the secretion of IL-1β, IL-6 and TNF-α in macrophage (Ana-1) cells, on inhibiting the production of lipopolysaccharide (LPS)-induced PGE2 in Ana-1 cells, on promoting the cell proliferation induced by IL-1β and glycosaminoglycan (GAG) synthesis, on influencing synoviocytes proliferation induced by IL-1β, and on promoting the secretion of IL-6, respectively. The interactions among the active fractions in these samples were investigated by comparing the additive EC50 (or IC50) values with their experimental EC50 (or IC50). The results showed that pharmacological activities of the six samples were different in the same cell model. Some pharmacological activities of a few dissembled YTNC formulas were superior or significantly superior to the YTNC whole formula. However, the YTNC whole formula was good at promoting cell immunity, anti-inflammation and osteocytes repair. The YTNC’s vehicle Chinese rice wine played an important role on strengthening the activity of YTNC. It was concluded that the synergistic effects between active fractions in YTNC were the material foundation that YTNC had comprehensive efficacy of strengthening immunity, anti-inflammation and promoting osteocytes repair.
5.Study on the Application of Chelating Resins for Removal of Heavy Mental from Extracts of Folium Ginkgo
Xiaoliang CHENG ; Yani YANG ; Lijun NI ; Liguo ZHANG
Traditional Chinese Drug Research & Clinical Pharmacology 2000;0(06):-
Objective To study the feasibility of using chelating resins D751 and D403 to remove the heavy metals from the extracts of Folium Ginkgo (FG). Methods Heavy metal removal experiments were performed on automatic control platform in industry mode. With dry ointment yield,total content of flavones,comparability of HPLC and removal rate of heavy metal as the indexes,the effects of two kinds of chelating resins on removing heavy metal were compared. Result After removing heavy metal by resins D751 and D403,the loss rate of the dry extract were less than 6%,and the heavy metal contents were lower than national limits;HPLC similaritites were higher than 0.98,and the loss rates of total flavones were less than 5%. Conclusion Chelating resins D751 and D403 can be used to remove heavy metal from extracts of Folium Ginkgo.
6.Decomposition kinetics of salvianolic acid B's aqueous solution
Jing ZHU ; Huiqing CHEN ; Peng BAI ; Lijun NI ; Liguo ZHANG
Chinese Traditional Patent Medicine 1992;0(04):-
AIM: To study the decomposition reaction kinetics of aqueous salvianolic acid B(Sal B). METHODS: HPLC was applied to determine Sal B's content of samples.Relationship between Sal B's content and heating time was regressed. RESULTS: Decomposition reaction of Sal B's aqueous solution was first order reaction.The effect of temperature on reaction rate of Sal B's decomposition was higher than pH value.At lower temperature(50℃),reaction rate constant K of Sal B's decomposition was very low and it changed very little with pH values. CONCLUSION: Water extraction process of Salvia Militiorrhiza should avoid applying high temperature,alkaline condition and long heating time in order to reduce loss and decomposition of Sal B,and then also increase Sal(B's) content in the extract.
7.Simulation and experimentation of separation condition of Ginkgolic Acids
Yinghua LI ; Lijun NI ; Rong ZHENG ; Liguo ZHANG ;
Chinese Traditional Patent Medicine 1992;0(07):-
Objective: To optimize extraction conditions to completely separate ginkgolic acids off ginkgolic flavonone glycosides and terpene lactones. Methods: A liquid liquid equilibrium model was used to simulate extracting process of active components in ginkgo biloba leaves. Results of calculation and experiment were compared to value the extraction system, and the best extracting condition was established. Results: when pH=2.5, extractant consists of 20% ethanol water solution and cyclo hexane, the best extraction efficient can be obtained. Conclusion: There is a great difference between theoretical simulating distribution ratio and experiment value in order of magnitude. However, their relative relationship is consistent.
8.Study of effect of extracting time and solvent on the quality of extract of Salvia Miltiorrhiza Bunge
Lijun NI ; Xiaohao SHI ; Xiujiao GAO ; Ning WANG ;
Chinese Traditional Patent Medicine 1992;0(10):-
Objective:To study the effect of the extracting time and solvent on the concentration of main active components in Salvia Miltiorrhiza Bunge, and to provide basic data and theoretical guide to GEP(general extraction practice). Methods: Salvianolic acid B and Tanshinone ⅡA were extracted by 90% alcohol and water respectively from Salvia Miltiorrhiza Bunge and their contents were etermined by means of HPLC at regular intervals. Results: Extracting time and solvent were significant factors in the prcess of concentrating Salvianolic acid B and Tanshinone ⅡA from extract of Salvia Miltiorrhiza Bunge. Conclusion: Water is suitable for extracting Salvianolic acids, the extracting time is 40~50 minutes; alcohol is suitable for extracting Tanshinones, the extracting time is 20~30 minutes.
9.Distribution of cardiocerebral vascular disease death and its life expectancy eliminating causes of death in Shandong Province in 2012
Ni WANG ; Bingyi WU ; Jilei WU ; Lijun PEI ; Xinchao ZHAO
Chinese Journal of Disease Control & Prevention 2017;21(9):917-920
Objective To explore the impact of cardio cerebral vascular diseases (CVD) on life expectancy among residents in Shandong Province,develop effective preventive measures for the high-risk population and provide guidance for the health care resource allocation.Methods Based on the death monitoring data of the disease in Shandong Province in 2012,we calculated the crude mortality and standardized the mortality rate of the disease.We designed life tables with all causes of death and with eliminating causes of CVD death and analysed life expectancy with and without them examined.Results In 2012,crude mortality rate of CVD was 320.16/100 000 (SMR 252.85/100 000) in Shandong Province.The death rate of CVD was of 46.30% of all deaths reported by monitoring system.The mortality rate of CVD in male and female were 332.99/100 000 and 307.02/100 000,respectively.The mortality rate of CVD in rural and urban areas were 341.84/100 000 and 267.28/100 000,respectively.The mortality of CVD increased with age and growed rapidly after the age of 60.Life expectancy of urban and rural areas was 79.20 years and 78.14 years,respectively.After eliminating causes of CVD death,life expectancy for eliminating causes of CVD death in urban and rural areas increased 8.51 years and 10.02 years,respectively.Life expectancy for eliminating causes of CVD death in male and female increased 8.02 years and 11.10 years,respectively.Conclusions Life expectancy of urban and rural areas,the male and female for eliminating causes of CVD death than that of all causes of death were greatly extended.Reducing the death caused by CVD to increase health life expectancy have important public health significance.
10.Method Evaluation of HPLC Fingerprints for Quality Control of Chinese Herbal Medicine
Lijun NI ; Jia GUO ; Xiaohong ZENG ; Liguo ZHANG
Traditional Chinese Drug Research & Clinical Pharmacology 1993;0(02):-
Objective To investigate the effects of different chromatogram fingerprints analysis methods on the quality evaluation of Chinese herbal medicine. Methods With the chromatogram fingerprints of a Chinese patent medicine in different batches as the analytic object, the quality evaluation of three methods such as peak area ratio,peak area quantification and similarity coefficient were investigated. Results The method of peak area ratio has the highest accuracy rate and the precise rate for quality evaluation, and similarity coefficient and peak area quantification came next. The result of peak area quantification was similar to that by current evaluation method. Conclusion Different chromatogram fingerprints analysis methods would result in a great difference in the quality evaluation of Chinese herbal medicine.