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Ginkgo biloba Extract( GBE50) Dispersible Tablets is a new standardized prescription,which is widely used in the treatment of ischemic cardiovascular and cerebrovascular diseases. However,there are still many problems in its clinical application.Rational and safe use of GBE50 Dispersible Tablets is pivotal to the medication safety and clinical prognosis of patients. This consensus has been jointly formulated by clinical experts of traditional Chinese medicine and western medicine in cardiovascular and cerebrovascular diseases and followed the Manual for the Clinical Experts Consensus of Chinese Patent Medicine published by the China Association of Chinese Medicine. The present study identified clinical problems based on clinical investigation,searched the research papers according to PICO clinical problems,carried out evidence evaluation,classification,and recommendation by GRADE system,and reached the expert consensus with nominal group technique. The consensus combines evidence with expert experience. Sufficient evidence of clinical problems corresponds to " recommendations",while insufficient evidence to " suggestions". Safety issues of GBE50 Dispersible Tablets,such as indications,usage and dosage,and medication for special populations,are defined to improve clinical efficacy,promote rational medication,and reduce drug risks. This consensus needs to be revised based on emerging clinical issues and evidencebased updates in practical applications in the future.
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Humans , Cerebrovascular Disorders/drug therapy , Consensus , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , TabletsABSTRACT
OBJECTIVE：To evaluate the cost-effectiveness between Mycophenolate mofetil （MMF）dispersible tablets versus MMF capsules for the immunosuppressive therapy after renal transplantation ，and to provide reference for selecting more economical MMF preparations. METHODS ：Based on a systematic review about MMF dispersible tablets and MMF capsules for immunosuppressive therapy after renal transplantation （involving 6 clinical studies ），with simulation period of 6 months，Treeage 2010 software was used to establish decision tree model ，which included four states of graft normal ，acute rejection ，graft loss and death. Using QALYs as effect measurement index ，the cost-effectiveness analysis of two MMF preparations was carried out in combination with the cost data of West China Hospital of Sichuan University. Signal factor sensitivity analysis and probability sensitivity analysis were performed . RESULTS ：The incremental cost-effectiveness ratio of MMF capsules group to MMF dispersible tablets group was 623 111.614 0 yuan/QALY，which was higher than Chinese willing-to-pay value （212 676 yuan/QALY）；the results of sensitivity analysis supported the above results. CONCLUSIONS ：MMF dispersible tablets are better than MMF capsules in cost-effectiveness of immunosuppressive therapy after renal transplantation.
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Objective To compare the efficacy and adverse reactions of desloratadine citrate disodium tablets and loratadine dispersible tablets in treatment of patients with allergic rhinitis,and their influence on leukotriene B4(LTB4),interleukin-4 (IL-4),interleukin-10 (IL-10) and interferon gamma (INF-γ).Methods From June 2015 to June 2016,a total of 110 patients with allergic rhinitis in the Second People's Hospital of Cangnan County were selected and randomly divided into control group and observation group according to the digital table,with 55 cases in each group.The control group was given loratadine dispersible tablets,while the observation group was given desloratadine citrate disodium tablets.Both two groups were treated for 14 days.The clinical efficacy,adverse reactions and changes of LTB4,IL-4,IL-10,INF-γ levels before and after treatment were compared between the two groups.Results The total effective rate of the observation group was 94.5 ％,which was significantly higher than 80.0％ of the control group(x2 =6.310,P ＜ 0.05).The incidence rate of adverse reactions in the observation group was 16.4％,which was similar to 20.0％ in the control group.Before treatment,there were no statistically significant differences in LTB4,IL-4,IL-10,INF-γ levels between the two groups (all P ＞ 0.05).After 2 weeks of treatment,the levels of LTB4,IL-4,IL-10 and INF-γ in the observation group were (67.74 ±10.15) ng/L,(52.37 ± 5.12) μg/L,(81.26 ± 11.78) μg/L,(94.47 ± 7.87) μg/L,respectively,which in the control group were (80.32 ± 9.97) ng/L,(62.95 ± 5.45) μg/L,(96.32 ± 11.57) μg/L,(86.74 ± 7.63) μg/L,respectively,there were statistically significant differences between the two groups (t =7.124,5.262,4.654,3.718,all P ＜ 0.05).Conclusion Both desloratadine citrate disodium tablets and loratadine dispersible tablets can effectively treat patients with allergic rhinitis,improve the symptoms and physical signs,reduce the levels of LTB4,IL-4 and IL-10,increase the level of INF-γ,and the adverse reactions are less and slight,but the efficacy of desloratadine citrate disodium tablets is better than loratadine dispersible tablets.
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OBJECTIVE: To study preparation process and formula of Kang'aiping dispersible tablets. METHODS: Orthogonal designs were used to optimize water extraction process of traditional Chinese herbs from Kang'aiping pills, spray drying process of extracts and formulas of Kang'aiping dispersible tablets. RESULTS: The optimal water-extraction process is established by adding eight times water of raw materials, boiling for 60 min and extracting for two times. The optimal spray drying process parameters are that the density of the liquid extracts is 1.20 g•mL-1, inlet air temperature is 180 ℃ and outlet air temperature is 80 ℃. And the optimal formula consists of 37% microcrystalline cellulose, 5:1 of the ratio of croscarmellose sodium and PVPP, and 0.15% magnesium stearate. CONCLUSION: Formula and process optimized by using orthogonal experimental design is suitable for preparation of Kang'aiping dispersible tablets.
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Objective To study and analyze of entecavir dispersible tablets on the treatment of patients with decompensated hepatitis B cirrhosis. Methods From February 2014 to September 2016, 100 patients with decompensated hepatitis B cirrhosis were randomly divided into the control group and the experimental group, 50 patients in each group. The control group were received routine treatment, while the experimental group were received entecavir dispersible tablets treatment on the basis of conventional treatment. The therapeutic effects in the two groups were compared and analyzed. Results The effective rate in the experimental group was 92.0%, and 70.0% in the control group. The effective rate in the experimental group was significantly higher than that in the control group, the difference has statistically significant (P<0.05). The Child-pugh score in the experimental group was (6.12±1.43) points, and the score in the control group was (7.23±1.95) points. The score in the control group was significantly higher than that in the experimental group, with statistical difference (P<0.05). The negative rate of HBeAg in the experimental group was 22.0%, while 86% in the control group the difference has statistically significant (P<0.05). Conclusion The clinical effect is better which entecavir dispersible tablets is used in the treatment of the patients with decompensated hepatitis B cirrhosis, which can improve the treatment efficiency to a great extent, recover the liver function, has the further promotion and application significance.
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OBJECTIVE:To develop a method for simultaneous determination of geniposide,baicalin,aloe-emodin,rhein, emodin,chrysophanol and physcion in Zhizi jinhua dispersible tablets. METHODS:HPLC method was adopted. The determination was performed on Dimonsil C18 column with mobile phase consisted of methanol-0.05%phosphoric acid(gradient elution)at the flow rate of 0.8 mL/min. The detection wavelength was set at 254 nm,and the column temperature was 25℃. The sample size was 20 μL. RESULTS:The linear ranges of geniposide,baicalin,aloe-emodin,rhein,emodin,chrysophanol and physcion were 0.0323-0.323 μg (r=0.9998),0.1374-1.374μg(r=0.9999),0.00372-0.0372μg(r=0.9997),0.0069-0.069μg(r=0.9995),0.00332-0.0332μg (r=0.9997),0.00864-0.0864 μg(r=0.9997) and 0.00122-0.0122 μg(r=0.9995),respectively. The limits of quantitation were 0.0321,0.1374,0.00372,0.0067,0.00330,0.00864,0.00122 μg,respectively. The limits of detection were 0.0095, 0.0041,0.0012,0.0020,0.0010,0.0026,0.0003 μg,respectively. RSDs of precision,stability and reproducibility tests were all lower than 3%. The average recoveries were 96.54%-99.52%(RSD=1.17%,n=6),97.23%-101.23%(RSD=1.36%,n=6), 97.22%-101.25%(RSD=1.83%,n=6),97.32%-100.23%(RSD=1.09%,n=6),97.99%-102.71%(RSD=1.73%,n=6), 96.99%-100.23%(RSD=1.21%,n=6),96.99%-103.01%(RSD=2.31%,n=6),respectively. CONCLUSIONS:The methods is simple and reproducible. It can be used for the content determination of 7 components in Zhizi jinhua dispersible tablets.
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Objective: To optimize the extraction technology of Chinese medicinal materials in Yanyanling dispersible tablets.Methods: Orthogonal design was used to study the effects of three factors, including the ratio of liquid to materials, extraction time and extraction times on the extraction rate of Chinese medicinal materials and the comprehensive score of gallic acid content and total solid yield was used as the index.Results: The optimum extraction conditions were as follows: the ratio of materials to liquid was 1∶10 (g·ml-1), the extraction time was one hour, and the extraction times was three.Conclusion: Under the optimum conditions, the extraction rate of gallic acid in Chinese medicinal materials in Yanyanling dispersible tablets is 0.058%, and the total solid yield is 21.4%.The optimal process is stable and feasible, which can provide reference for the production of Yanyanling dispersible tablets.
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Objective To study curative efficacy of radix notoginseng saponin dispersible tablets combined with rivaroxaban in treatment of tibial fracture after operation and its effects on joint function and the leves of inflammatory factors .Methods 90 patients of tibial fracture who received therapy from March 2014 to March 2016 in our hospital were selected.According to random number table,all elective surgery,those patients were divided into the observation group (n=45) and the control group (n=45),the control group was treated with radix notoginseng saponin dispersible tablets,while the observation group was treated combined with rivaroxaban.After two weeks of treatment, the hemorheology, inflammatory factors, joint function were compared between two groups.Results The patient swelling time and bed time in the observation group were shorter than the control group (P<0.05);after treatment,the levels of red cell volume, whole blood viscosity,fibrinogen in the observation group were lower than the control group (P<0.05);the levels of tumor necrosis factor TNF-α, IL-1,IL-6 in the observation group were lower than the control group (P<0.05);after treatment three months and six months,the Baird-Jackson scores in the observation group were higher than the control group (P <0.05).Conclusion Radix notoginseng saponin dispersible tablets combined with rivaroxaban is well for tibial fracture after operation,which can improve hemorheology,reduce the level of inflammatory factors,promote joint functional recovery.
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Objective:To establish a quantitative analysis method for determining the dissolution of Yinxingye dispersible tablets by quantitative analysis of multi-components with single-marker ( QAMS) . Methods:A small glass method was adopted. Hydrochloric acid (0. 1 mol·L-1 ) was used as the dissolution medium, and the stirring speed was at 50 r·min-1 . HPLC-ELSD with gradient elu-tion combined with QAMS was used to simultaneously determine the dissolution of 3 total flavonoids ( artemisinin, quercetin and isorh-amnetin) and 4 total lactones (ginkgo esters and lactones a, b and c) in Yinxingye dispersible tablets. Results:Within a certain line-ar range, the relative correction factors (RCFs) of quercetin and isorhamnetin with the reference of artemisinin was 1. 873 and 0. 324, respectively, and the RCFs of lactones a, b and c with the reference of ginkgo esters was 2. 280, 1. 659 and 1. 429, respectively, and the repeatability was good under the different experimental conditions. There were no significant differences between the calculated val-ues by QAMS and those by the external standard method in 5 batches of Yinxingye dispersible tablets, and the results showed that the RCFs was authentic. The dissolution uniformity of Yinxingye dispersible tablets was good in 0. 1 mol·L-1 hydrochloric acid. Conclu-sion:The method is simple, accurate and reproducible in the dissolution determination of Yinxingye dispersible tablets.
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OBJECTIVE:To study the effect of Elemene emulsion combined with ganciclovir on invasive ability and TIMP-1 mRNA expression in C6 brain tumor stem cells. METHODS:Cells with 3 generations were isolated and cultured from rats'C6 ma-lignant glioma cell lines,and immunocytochemistry was adopted to detect the protein expressions of stem cell markers CD133,Nes-tin. 20 rats were randomly divided into blank control group(normal saline),ganciclovir group(intragastrically administrated,216 mg/kg),Elemene emulsion injection group (intravenously injected in tail,36 mg/kg) and combination group (intragastrically ad-ministrated 216 mg/kg of ganciclovir+intravenously injected 36 mg/kg of Elemene emulsion injection in tail),5 in each group, once every day,for 10 d. After 2 h of last administration,the blood of rats in each group was collected,serum was isolated and co-cultured 24 h with C6 BTSCs in in vitro culture medium. Boyden invasion test was used to detect the invasive ability of C6 BTSCs,and real-time quantitative polymerase chain reaction(RT-PCR)method was used to determine the TIMP-1 mRNA expres-sion of C6 BTSCs. RESULTS:Cells with 3 generations had obvious protein expressions in CD133 and Nestin,indicating they were BTSCs. Compared with blank control group,the cell invasion rates of C6 BTSCs in ganciclovir group,Elemene emulsion in-jection group and combination group were obviously decreased,TIMP-1 mRNA expression was obviously enhanced,with statisti-cal significances(P<0.05). Compared with ganciclovir group and Elemene emulsion injection group,the cell invasion rate of C6 BTSCs in combination group was obviously decreased,TIMP-1 mRNA expression was obviously enhanced,with statistical signifi-cances(P<0.05). CONCLUSIONS:Elemene emulsion injection combined with ganciclovir can obviously inhibit the cell invasion of C6 BTSCs,the mechanism may be associated with promoting the TIMP-1 generation,and combination use shows better effect than single use.
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Objective:To optimize the formula of Junduqing dispersible tablets .Methods:Using appearance , disintegration time and dispersing uniformity as the indices ,the types of filler, disintegrating agent and adhesive were optimized by single factor tests;the amount of filler and disintegrating agent was optimized by orthogonal experiments with the disintegration time as the index ; using ap-pearance and sticking as the indices , the single factor tests were also used to optimize the lubricant , and the adding method of disinte-grating agent was optimized using disintegration time as the index .Results: For 500 tablets, the amount of Junduqing extract was 61.25 g, microcrystalline cellulose (52.5 g) and dextrin (17.5 g) were used as the fillers, crospolyvinylpyrrolidone (8.75 g) and croscarmellose sodium (26.25 g) were applied as the disintegrating agents , 70% ethanol was the binder , magnesiumstearate (3 g) and talcum powder (2.25 g) were used as the lubricants , and stevioside (3.5 g) was the flavoring agent .Conclusion:The formula is reasonable and feasible ,which provides reference for the preparation of Junduqing dispersible tablets .
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Objective: The purpose of this paper is to verify the key role of water absorption in the process of disintegration of Chinese materia medica (CMM) dispersible tablets, so as to provide the solution idea for slow disintegration of CMM dispersible tablets. Methods: In this paper, the influence of water absorption of raw materials and auxiliary materials on disintegration process was verified using oily Jianghuang Qingzhi Tablets (JQT) as research object. The water absorption and disintegrating process of different drugs, JQT with different materials, and modified dispersible tablet were determined. Results: The water absorption of JQT was lower than that of lactose tablets, and the disintegrating process was slower. The water absorption of different materials prescription of JQT was: CMS-Na-PVPP (1∶1) > PVPP > CMS-Na, and disintegrating process is the same as the former order. The water absorption of JQT after modification enhanced, and disintegration time was significantly shortened. It indicated that the water absorption of raw materials and excipients was stronger, the disintegration was faster. Conclusion: The study proves that water absorption is a key role in the disintegration of CMM dispersible tablets. And co-grinding of silica powder and raw materials is important technology to solve the problem of slow disintegration of CMM dispersible tablets.
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OBJECTIVE:To prepare Xuangui zhitong dispersible tablets and optimize its formulation technology. METHODS:Using disintegration time as index,single factor test was conducted for filler,disintegrating agent,the types and amount of adhe-sives and compression pressure. The amount of mixed disintegrating agent,avicel and gum arabic were optimized by orthogonal test. The tablet quality by optimized formulation was detected,and disintegration time,the content and dissolution rate of tetrahy-dropalmatine were determined;the similarity of in vitro dissolution rate of dispersible tablets and dropping pills were evaluated by similarity factor test. RESULTS:The optimized formulation was composed of 25% MCC as fillers,9% PVPP and 9% L-HPC as mixed disintegrants,85% ethanol solution as adhesives,micro-silica gel 2%,compression pressure of 3.0 kg/cm2. The average dis-integration time was 1.22 min,and the content of tetrahydropalmatine was 1.097 mg/g. The accumulative dissolution rate was more than 80% at 10 min and more than 90% at 15 min. The similarity factor f2 of dissolution curve was 62,using dropping pills as ref-erence preparation. CONCLUSIONS:Xuangui zhitong dispersible tablet had a rapid disintegration and the behavior of dissolution is similar to Xuangui zhitong dropping pills.
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Objective:To explore the formula and preparation technology parameters of Shengmai dispersible tablets. Methods:With the granulation status, disintegration time, friability, taste and and so on as the testing indices, the formula and preparation tech-nology of Shengmai dispersion tablets were optimized by uniform design. Results:The optimized formula of Shengmai dispersible tab-lets was as follows:25% extract powder, 58% MCC, 8% CCMC-Na, 4% CMS-Na, 2% L-HPC, 2% magnesium stearate and 1%sweetener. L-HPC and magnesium stearate were added after the granulation, and the tablet hardness was controlled at 25N. The opti-mized dispersible tablets could disintegrate uniformly within 3 min. Conclusion: The optimization of the prescription and preparation process parameters of Shengmai dispersing tablets is stable and reliable, and has good repeatability, and the process is feasible.
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Objective:To prepare Pingwei dispersible tablets and establish a method for the determination of atractylodin. Meth-ods:HPLC was performed on a Kromasil C18 column(250 mm × 4. 6 mm,5 μm)using methanol-water(75:25)as the mobile phase at a flow rate of 1 ml·min-1 . The detection wavelength was at 340nm. The column temperature was 30℃ and the injection volume was 10 μl. Results:The optimized formula of the tablets was as follows:the proportion of inner disintegrant microcrystalline cellulose,out-side disintegrant carboxymethyl cellulose sodium and HPMC was 40%,9% and 2%,respectively. The adhesive was 2% HPMC in 70% ethanol,and 1. 5% magnesium stearate was used as the lubricant. The linear range of atractylodin was 0. 100 6-0. 503 0 μg(r=0. 999 9),and the average recovery was 99. 3%(RSD=0. 9%,n=6). Conclusion:The formula and the preparation process of the tablets are reasonable and the content determination method is simple,accurate and specific,which can be used in the quality control of Pingwei dispersible tablets.
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Objective:To explore the therapeutic effect on blood glucose, lipid, and renal function of Bailing capsules combined with calcium dobesilate dispersible tablets in the treatment of diabetic nephropathy. Methods: Totally 216 patients with diabetic ne-phropathy in phase Ⅳ were randomly divided into the control group (108 cases) and the treatment group (108 cases). The control group was given the conventional therapy, and the treatment group was treated with Bailing capsules combined with calcium dobesilate dispersible tablets additionally. The levels of serum creatine (Scr), urean ntrogen (BUN), endothelin (ET-1), β2-microglobulin (β2-MG) ,cystatin C ( CYC) and urinary albumin excretion rate ( UAER) were detected for all the patients before and after the treat-ment. The adverse drug reactions were observed as well. Results:After the treatment, all the indices in the two groups were all obvi-ously decreased (P0. 05). The adverse drug reactions showed no significant differences between the two groups (P>0. 05). Conclusion:The effect of Bailing capsules combined with calcium dobesilate dispersible tablets is better than that of calcium dobesilate dispersible tablets in the treatment of diabetic nephropathy in phase IV, which can improve the renal function indices with high safety and without notable influence on blood glucose and lipid.
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Objective:To prepare Jieheling dispersible tablets and establish the dissolution determination method. Methods:The dissolution of fischeriana B in the tablets was determined by HPLC. The column was Kromasil C18(250 mm ×4.6 mm,5μm)with ace-tonitrile-water (40∶60) as the mobile phase at a flow rate of 1. 0 ml·min-1 . The detection wavelength was at 290nm. The column temperature was 30℃ and the sample size was 100 μl. Results: The linear range of fischeriana B was 0. 005-0. 057 μg ( r =0. 999 6). The average recovery was between 95% and 105%. Phosphate solution with pH of 6. 8 was used as the dissolution medi-um. Conclusion:The method is simple, accurate and specific, and can be used in the quality control of Jieheling dispersible tablets.
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Objective To optimize the prescription of preparation technology of Xiaoer Qingfei Dispersible Tablets. Methods The filler, disintegrant, adhesive, lubricant, and drug loading were screened by single factor tests. The combined application proportion of three disintegrating agents, PVPP, CMS-Na, and L-HPC, were optimized by orthogonal test. Results The best prescription of preparation technology of dispersible tablets:microcrystalline cellulose as filler;silica gel powder as lubricant;75%alcohol as the adhesive;PVPP, L-HPC, and CMS-Na as combined disintegrants (L-HPC∶PVPP∶CMS-Na=4∶3∶6). The disintegration time of prepared dispersible tablets was less than 3 minutes, and all through the No.2 sieve. Dispersible uniformity was in accordance with the provisions. Conclusion Xiaoer Qingfei Dispersible Tablets prepared by the optimized preparation process are stable and feasible, and suitable for clinical application.