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Objective:To improve the determination method of vitamin U in vitamin U preparations. Methods: A potentiometric titration method was established for the determination of vitamin U and the results were compared with those of the manual titration method described in the current quality standard. Results:The determination results of vitamin U by the potentiometric titration method were affected by neither the excipients and the other components contained in the preparations,nor the precipitation produced in the ti-tration process. The recoveries for two types of vitamin U ( methylmethinine sulfonium chloride and s-methy-L-methionine iodide) were 99. 47%(RSD=1. 0%,n=9) and 100. 22%(RSD=1. 4%,n=9), respectively. The determination results of 6 samples from 3 dif-ferent companies detected by the method were basically consistent to those detected by the manual titration method described in the cur-rent quality standards with the relative deviation less than or equal to 0. 5%. Conclusion:The method is simple,accurate and reliable, and can be used for the quantitative determination of vitamin U in various vitamin U preparations.
ABSTRACT
Objective:To improve the determination method of vitamin U in vitamin U preparations. Methods: A potentiometric titration method was established for the determination of vitamin U and the results were compared with those of the manual titration method described in the current quality standard. Results:The determination results of vitamin U by the potentiometric titration method were affected by neither the excipients and the other components contained in the preparations,nor the precipitation produced in the ti-tration process. The recoveries for two types of vitamin U ( methylmethinine sulfonium chloride and s-methy-L-methionine iodide) were 99. 47%(RSD=1. 0%,n=9) and 100. 22%(RSD=1. 4%,n=9), respectively. The determination results of 6 samples from 3 dif-ferent companies detected by the method were basically consistent to those detected by the manual titration method described in the cur-rent quality standards with the relative deviation less than or equal to 0. 5%. Conclusion:The method is simple,accurate and reliable, and can be used for the quantitative determination of vitamin U in various vitamin U preparations.
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Objective To analyze and compare two potency assay methods of protamine sulfate.Methods Heparin titration method was according to foreign pharmacopoeia,while biological assay method was according to China pharmacopoeia(2015).Results The absorbance at the end-point was stable at 0.10 mg/mL and 0.15 mg/mL test solutions.The relative standard deviations(RSDs)of potency results were all less than 5%.Three test solutions and volumes of the titrant had a good linear relationship(R2 =1.000).The results of titration method were significantly related to those of biological assay(P=0.013),with similar RSD(P>0.05).However,the potency of titration method were significantly lower than those of biological assay (P=0.045).Conclusion Heparin titration method is good-using,convenient,and need to be applied widely at home.
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Objective: To synthesize butyryl galactose ester (But-Gal) and prepare butyryl galactose ester-modified coix component microemulsions (But-Gal-CMEs) and to evaluate its physicochemical properties and anticancer activity in vitro. Methods: But-Gal was synthesized by enzyme-catalyzed reaction and the structure of the product was confirmed by 1H-NMR and FT-IR. The CMEs and But-Gal-CMEs were prepared by aqueous titration method using coix seed oil, Cremophor RH40, PEG400, But-Gal, and coixan solution as oil phase, surfactant, cosurfactant, target ligand, and aqueous phase, respectively. The average particle size, polydispersity index (PDI), and Zeta potential were detected by dynamic light scattering (DLS). The cytotoxicity of CMEs and But-Gal-CMEs aganist HepG2 cells was determined by MTT assay. The cellular uptake of CMEs and But-Gal-CMEs was detected by fluorescence microscopy. Results: The structure of But-Gal was confirmed by 1H-NMR and FT-IR. The But-Gal-CMEs displayed the spherical surface with mean droplet size of (57.68 ± 6.65) nm, PDI of 0.070 ± 0.006, and Zeta potential of (-2.95 ± 0.23) mV, respectively. MTT experiments showed that the half of HepG2 cell proliferation inhibition concentration (IC50) of But-Gal-CMEs and CMEs was 62.55 and 71.23 μg/mL. The HepG2 cell uptake results suggested that the fluorescence intensity of But-Gal-CMEs group was higher than that of CMEs group. Conclusion: The But-Gal-CMEs presents small particle size, good roundness, and good stability. In addition, But-Gal could increase the uptake rate of CMEs in HepG2 cells and enhance the inhibition of HepG2 cell proliferation.
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Objective To establish a method for the determination of the dissolution rate of CaSO4 ·2H2 O in Gypsum Fibrosum. Methods The dissolution rate was determined by EDTA-2Na titration method,with a paddle,800 mL of purified water as dissolution medium,at rotation speed of 75 r·min-1,and temperature of(37. 0±0. 5 ) ℃,at 5,10,20,30,60,90, 120 min for the sampling. Results There was a linear regression relationship between dissolution time and dissolution of CaSO4 ·2H2 O,when the particle size of Gypsum Fibrosum were 2. 000, 0. 150 mm. There was a logarithmic regression relationship between dissolution time and dissolution of CaSO4 ·2H2 O,when the particle size of Gypsum Fibrosum was 0. 075 mm. Conclusion The method is simple and accurate,which can be used for determination of the dissolution rate of CaSO4 · 2H2 O in Gypsum Fibrosum.
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Objective To establish a method for the determination of alum residual amount in Rhizoma Pinelliae Preparata from different companies,and to provide a scientific evidence for quality evaluation of Rhizoma Pinelliae Preparata.Methods Na2EDTA titration method was applied for the quantitative analysis.Results There were obvious differences in residual quantity of alum in Rhizoma Pinelliae Preparata from different companies.Conclusion The method is simple,reproducible and accurate,it can be used for the determination of alum residual amount in Rhizoma Pinelliae Preparata.