Rapid, sensitive and specific methods were developed for the determination of diclofenac in pharmaceutical preparations by linear sweep voltammetry （LSV） and gas chromatography （GC） with mass spectrometry （MS） d...Rapid, sensitive and specific methods were developed for the determination of diclofenac in pharmaceutical preparations by linear sweep voltammetry （LSV） and gas chromatography （GC） with mass spectrometry （MS） detection. The linearity was established over the concentration range of 5- 35 μg/mL for LSV and 0.25-5 μg/mL for GC-MS method. The intra- and inter-day relative standard deviation （RSD） was less than 4.39% and 4.62% for LSV and GC-MS, respectively. Limits of quantification （LOQ） were determined as 4.8 and 0.15 μg/mL for LSV and GC-MS, respectively. No interference was found from tablet excipients at the selected assay conditions. The methods were applied for the quality control of commercial diclofenac dosage forms to quantify the drug and to check the formulation content uniformity.展开更多
[Objectives] To survey the current using situation and price distribution of pharmaceutical preparations in medical institutions of Sichuan Province,to provide basis for pricing the pharmaceutical preparations in medi...[Objectives] To survey the current using situation and price distribution of pharmaceutical preparations in medical institutions of Sichuan Province,to provide basis for pricing the pharmaceutical preparations in medical institutions. [Methods] From June to September2016,15 sample hospitals were selected from Ⅱ-B class,Ⅱ-A class,Ⅲ-B class and Ⅲ-A class hospitals,and questionnaire survey was adopted to survey the current situation of pharmaceutical preparations in medical institutions,and 24 effective questionnaires were collected.SPASS17. 0 software was used to analyze the data of the questionnaires. [Results]The pharmaceutical preparations in medical institutions between 10 and 15 yuan accounted for 35%,which was the biggest percentage. The second was between 5 and 10 yuan,which accounted for 25%. [Conclusions] Most of the pharmaceutical preparations in medical institutions of Sichuan Province are in the low price,and floating rate price adjustment mechanism is suggested.展开更多
Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang ...Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang Qi,黄芪),Paeoniae Radix Alba(Bai Shao,白芍)and Moutan Cortex(Mu Dan Pi,牡丹皮),which have well-established histories of use for treatment of rheumatic and arthritic diseases.We intended to establish the optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT to develop it as a novel botanical drug product for treatment of rheumatoid arthritis(RA).Methods The combinative approaches of chemical assessment,toxicological and pharmacological evaluation were explored to define the pharmaceutical preparation of QFJBT.Results The optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT were established in terms of greatest chemical contents of bioactive constituents,potent anti-inflammatory and antinociceptive activities,and favorable safety profile.Quality analysis of the pilot product of QFJBT by high-performance liquid chromatography(HPLC)demonstrated that the chromatographic fingerprint profiles of three batches of QFJBT were basically identical and the contents of four characteristic and bioactive markers were relatively consistent.General toxicological studies showed a favorable safety profile of QFJBT.The maximum tolerated single dose of QFJBT was determined in both sexes of rats to be 33.63 g/kg body weight which is equivalent to 346 times of clinical dose.In the chronic oral toxicity study,the results of laboratory investigation showed that QFJBT at doses of 3.89,6.80 and 9.72 g/kg body weight(equivalent to 40,70 and 100-fold clinical doses,respectively)caused no changes in all hematological parameters and blood biochemical parameters of rats.No mortality or specific toxic responses were observed in animals after three months of repeated dosing with QFJBT.Conclusion The optimized and standardized pharmaceutical and manufacturing processes for the production of QFJBT have been successfully screened and identified through established rigorous in-process controls.展开更多
This research paper describes simple analytical method for determination of Camylofin dihydrochloride and Nimesulide in tablet formulation by Gas chromatography method. Benzoic acid was used as internal standard. Vali...This research paper describes simple analytical method for determination of Camylofin dihydrochloride and Nimesulide in tablet formulation by Gas chromatography method. Benzoic acid was used as internal standard. Validation was carried out in compliance with the International Conference on Harmonization guidelines. The method utilized GC (Agilent Technologies 6890 N Network GC system with FID detector), and RTX-5 capillary column (5% diphenyl-95% dimethyl polysiloxane), 30 m × 0.53 mm, 1.5 μm as stationary phase. Helium was used as the carrier gas at a flow rate of 1.5 mL?min–1. The proposed method was validated for linearity, LOD, LOQ, accuracy, precision, ruggedness and solution stability. It can be conveniently adopted for routine quality control analysis.展开更多
基金supported by a grant from Ataturk University Research Foundation(Project no.:2012/78)
文摘Rapid, sensitive and specific methods were developed for the determination of diclofenac in pharmaceutical preparations by linear sweep voltammetry （LSV） and gas chromatography （GC） with mass spectrometry （MS） detection. The linearity was established over the concentration range of 5- 35 μg/mL for LSV and 0.25-5 μg/mL for GC-MS method. The intra- and inter-day relative standard deviation （RSD） was less than 4.39% and 4.62% for LSV and GC-MS, respectively. Limits of quantification （LOQ） were determined as 4.8 and 0.15 μg/mL for LSV and GC-MS, respectively. No interference was found from tablet excipients at the selected assay conditions. The methods were applied for the quality control of commercial diclofenac dosage forms to quantify the drug and to check the formulation content uniformity.
基金Supported by Sichuan Science and Technology Support Plan Program(2014-SZ0141)
文摘[Objectives] To survey the current using situation and price distribution of pharmaceutical preparations in medical institutions of Sichuan Province,to provide basis for pricing the pharmaceutical preparations in medical institutions. [Methods] From June to September2016,15 sample hospitals were selected from Ⅱ-B class,Ⅱ-A class,Ⅲ-B class and Ⅲ-A class hospitals,and questionnaire survey was adopted to survey the current situation of pharmaceutical preparations in medical institutions,and 24 effective questionnaires were collected.SPASS17. 0 software was used to analyze the data of the questionnaires. [Results]The pharmaceutical preparations in medical institutions between 10 and 15 yuan accounted for 35%,which was the biggest percentage. The second was between 5 and 10 yuan,which accounted for 25%. [Conclusions] Most of the pharmaceutical preparations in medical institutions of Sichuan Province are in the low price,and floating rate price adjustment mechanism is suggested.
基金support from the National Natural Science Foundation of China(No.81704065)China Postdoctoral Science Foundation(No.2016M600632 and No.2017T100604)+3 种基金Hunan Provincial Natural Science Foundation(No.2017JJ3239 and No.2018JJ2293)Hunan Education Department’s Science&Research Project(No.17K069)Hunan Provincial Science&Research Project of Chinese Medicine(No.201790)National First-class Disciple Construction Project of Chinese Medicine of Hunan University of Chinese Medicine
文摘Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang Qi,黄芪),Paeoniae Radix Alba(Bai Shao,白芍)and Moutan Cortex(Mu Dan Pi,牡丹皮),which have well-established histories of use for treatment of rheumatic and arthritic diseases.We intended to establish the optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT to develop it as a novel botanical drug product for treatment of rheumatoid arthritis(RA).Methods The combinative approaches of chemical assessment,toxicological and pharmacological evaluation were explored to define the pharmaceutical preparation of QFJBT.Results The optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT were established in terms of greatest chemical contents of bioactive constituents,potent anti-inflammatory and antinociceptive activities,and favorable safety profile.Quality analysis of the pilot product of QFJBT by high-performance liquid chromatography(HPLC)demonstrated that the chromatographic fingerprint profiles of three batches of QFJBT were basically identical and the contents of four characteristic and bioactive markers were relatively consistent.General toxicological studies showed a favorable safety profile of QFJBT.The maximum tolerated single dose of QFJBT was determined in both sexes of rats to be 33.63 g/kg body weight which is equivalent to 346 times of clinical dose.In the chronic oral toxicity study,the results of laboratory investigation showed that QFJBT at doses of 3.89,6.80 and 9.72 g/kg body weight(equivalent to 40,70 and 100-fold clinical doses,respectively)caused no changes in all hematological parameters and blood biochemical parameters of rats.No mortality or specific toxic responses were observed in animals after three months of repeated dosing with QFJBT.Conclusion The optimized and standardized pharmaceutical and manufacturing processes for the production of QFJBT have been successfully screened and identified through established rigorous in-process controls.
文摘This research paper describes simple analytical method for determination of Camylofin dihydrochloride and Nimesulide in tablet formulation by Gas chromatography method. Benzoic acid was used as internal standard. Validation was carried out in compliance with the International Conference on Harmonization guidelines. The method utilized GC (Agilent Technologies 6890 N Network GC system with FID detector), and RTX-5 capillary column (5% diphenyl-95% dimethyl polysiloxane), 30 m × 0.53 mm, 1.5 μm as stationary phase. Helium was used as the carrier gas at a flow rate of 1.5 mL?min–1. The proposed method was validated for linearity, LOD, LOQ, accuracy, precision, ruggedness and solution stability. It can be conveniently adopted for routine quality control analysis.
