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OBJECTIVE:To evaluate the stability of 12 kinds of submicro emulsion in market,and screen the test method for the stability. METHODS:12 kinds of submicro emulsion in market were selected,high pressure sterilization (121 ℃,30 min), high speed centrifugation(4000 r/min,15 min),accelerated test [placing 6 months under temperature of(40±2)℃,relative hu-midity of (75 ± 5)%] were conducted to investigate the pH,particle size and other indexes,and SPSS 22.0 was used to analyze the distribution variance and chi-square test,and investigate the correlation of 3 evaluation methods. RESULTS:In terms of stabili-ty investigation,the pH value of 12 kinds of submicro emulsion decreased to some extent after accelerated test,average particle size of 6 kinds of submicro emulsion samples were greater than 300 nm,the variance of the particle size distribution of 9 kinds ap-peared in 0.05-0.15,the chi-square test results of 8 kinds distributed below 1. The average particle size of 4 kinds of submicro emul-sions changed more than 10 nm after accelerated test. In terms of stability test method,Pearson chi-square progressive significance of high pressure sterilization and accelerated test was 0.665,which was higher than 0.05,indicating there was no correlation (no significance),the stability results of high pressure sterilization can not represent the results of accelerated test;that of high speed centrifugation and accelerated test was 0.004,which was lower than 0.05,indicating stability results between high speed centrifuga-tion and accelerated test results were significantly correlated. CONCLUSIONS:The submicro emulsion in market can meet the re-quirements of stability. To a certain extent,high speed centrifugation can replace the acceleration test.
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Objective To investigate the stability of jinyin qingre oral liquid. Methods According to the stability test guidelines for pharmaceutical preparations,the appearance,pH and relative density of jinyin qingre oral liquid were detected, the contents of geniposide,chlorogenic acid and salvia acid B were determined by HPLC. The chromatographic conditions were as follows:AtlantisT3 column(150 mm×4. 6 mm,3 μm),mobile phase A:0. 05% phosphoric acid,mobile phase B:acetonitrle, gradient elution at the flow rate of 0. 8 mL · min-1 ,and column temperature at 35 ℃. The detection wavelength was set at 254 nm. Results The appearance,pH,and relative density of jinyin qingre oral liquid did not change significantly with the acceleration test,but the contents of geniposide,chlorogenic acid and salvia acid B decreased time dependently. Conclusion Light and high temperature could decrease the stability of the jinyin qingre oral liquid.
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OBJECTIVE: To investigate the stability of 0.5% glutaraldehyde solution. METHODS: Classic constant temperature accelerated test method and sample observation method were applied with the content of glutaraldehyde as index. The content of glutaraldehyde was determined by titration which was determined by titration. RESULTS: The content change of 0.5% glutaraldehyde solution was in line with the first order kinetics, and the results of both methods were similar. The validity duration of 0.5% glutaraldehyde solution was 85.7 days at room temperature (25 ℃). CONCLUSION: 0.5% glutaraldehyde solution should be used up as soon as possible and the perfect time is less than 2 week.
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OBJECTIVE:To study the stability of ethylenediamine diaceturate(EDD)for injection and compatible stability of 3 kinds of clinically common infusions.METHODS:The experiement of influencing factors(including light,high temperature,10 days)was carried out meanwhile the accelerated test(6 months)was performed for the preparation under the condition of being packaged;the stability of EDD in 5% glucose injection,10% glucose injection or in 0.9% sodium chloride injection within 8.0 h were observed.The major outcome measures were appearance,visible foreign substances,pH value,contents of principal agent(area of the chief peak),the relative substances and 5-hydroxymethyl furfural,etc.RESULTS:No marked change was noted for all the outcome measures except a slight increase of the content of the related substances in the light exposure test.CONCLUSION:EDD for injection stored away from light at room temperature shows good stability,and it is stable within 8.0 h after mixing with 3 kinds of common infusions.
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OBJECTIVE:To investigate the stability of Yanhouyan mixture(for pharyngolaryngitis).METHODS: The st-ability of Yanhouyan mixture was investigated by classic constant temperature accelerated test method and sample observation method taking the content of Baicalin as index which was determined by HPLC.RESULTS:The content change of Bacilin in Yanghouyan mixture was in line with the first order kinetics,and the test results for both methods were similar.Under room temperature(25 ℃),the validity duration of Yanhouyan mixture was 1.06 years.CONCLUSION:In establishing the quality standard for Yanhouyan mixture,the advisable storage life of 1 year for which should be considered.
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OBJECTIVE:To prepare gatifloxacin chitosan eye drops and to establish its quality control.METHODS:The eye drops was prepared with chitosan as the base.The content of gatifloxacin was determined by UV spectrophotometry and the stability of the preparation was detected by initial average accelerated method.RESULTS:The linear range for gati?floxacin was5.0～15.0?g/ml(r=0.9990,n=5),the average recovery rate was98.91%(RSD=1.43%).The activation energy for pyrolytic reaction of gatifloxacin chitosan eye drops was25.91kcal/mol,its shelflife at25℃and10℃were93.8days and950days,respectively.CONCLUSION:The preparation technology is feasible and the quality control method is reliable.
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AIM:To predetermine the period of efficacy of Diedahuoxue film former METHODS:The chemical stability of Diedahuoxue film former was studied by the constant temperature accelerated test according to the principle of chemical kinetics Using the emodin in Diedahuoxue film former as an index,its content was determined by spectrophotometry The period of efficacy of Diedahuoxue film former was determined RESULTS:The results showed that the decomposition of emodin in Diedahuoxue film former accorded with the primary reaction CONCLUSION:At room temperature(25℃),it is predetermined that the period of efficacy of Diedahuoxue film former is 1 10 years
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OBJECTIVE:To study the stability of Baicalin in Biyuanling granules and predicate its validity duration. METHODS:The content of Baicalin in Biyuanling granules was determined by RP HPLC on Diamonsil ODS C_(18) chromatographic column(200 mm?4.6 mm,5?m) with methanol -water- phosphoric acid(53:47:0.2) used as mobile phase.The detective wavelength was set at 274 nm.The stability of Baicalin in Biyuanling granules was determined by classical accelerated test process in constant temperature and its validity duration was computed.RESULTS:The disintegration constant of Baicalin at 25℃was K = 4.592?10 ~6 h~1,and the validity duration was t_(0.9)=2.62 years.CONCLUSION:The method developed in this study was proved to be scientific,reasonable and suitable for the study of the stability of Biyuanling granules.
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The chemical stability of aqueous solution of ferulic acid was studied by the constant temperature accelerated test according to the princiPle of chemical dynamics. The ferulic acid in sample was determined by HPLC. The result showed that the decomposition of ferulic acid in aqueous solution accords with the primary reaction. At room temperature (25℃),the time of decomposition of 10℃ ferulic acid in aqueous solution (the expiry date of drug) was calculated robe 19. 36mo and 17.41 too-20. 69mo,calculated by classical and simple calculation methods, respectively.
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Study on stability of Caitong Tablets with the constant temperature accelerated test has been carried out. Using the flavone component in Caitong Tablets as an index,their content was determined. It was predetermined that the shelf life was 4. 11 years.
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AIM: To determine the thermo-stability of quercetin in Compound Flavone Capsules in order to predicate the capsules's shelf life. METHODS: The quercetin content in Compound Flavone Capsules was determined by HPLC and its stability was determined by the accelerate test with constant temperature method. RESULTS: The shelf-life of Compound Flavone Capsules was 2.5 years. CONCLUSION: The methods adopted in the study are simple and convenient and Compound Flavone Capsules have good stability.