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Objective To evaluate the release characteristics in vitro, pharmacokinetics in rabbits and in vivo-in vitro correlation of silymarin phospholipid complex microporous osmotic pump controlled release tablets（SM-PC MPOP）. Methods The release characteristics of SM-PC MPOP in vitro were detected by HPLC in the artificial gastric fluid. Six beagle dogs were subjected to double cycle cross control, which were given SM-PC MPOP and Legalon（30 mg/kg）. The concentration of silybin in plasma was determined by HPLC and the data were processed by software. Results The cumulative release rate of SM-PC MPOP in vitro was over 85% in 12 h. The pharmacokinetics in beagle dogs showed that SM-PC MPOP and legalon conformed to double compartment first-order absorption model and the pharmacokinetic parameters were obtained: tmax:（3.2±0.4）and（0.9±0.1）h, Cmax:（0.298 6±0.068 9）and（0.629 9±0.076 5）μg/ml, AUC0→24:（2.996 8±0.583 3）and（2.268 9±0.432 8）h·μg /ml. The relative bioavailability of SM-PC MPOP was（162.21 ± 30.82）%. Conclusion SM-PC MPOP could release slowly, which could increase the relative bioavailability significantly. The correlation between the absorption in vivo and release in vitro was fine（r = 0.839 0）.
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Objective To screen the macroporous adsorption resin suitable for the separation and purification of total polyphenols from purple tea and establish the purification process parameters to prepare high-purity total polyphenols from purple tea. Methods The static adsorption-elution test was used to screen macroporous adsorption resin for the purification of total polyphenols from purple tea. Based on the single factor test, the comprehensive score of adsorption rate was used as the index to investigate the effects of different factors on the purification process and identify the optimal parameters for the purification process. Those factors included sample concentration, the pH value of the sample solution, the ratio of column diameter to height, sample size, ethanol percentage in the eluent, eluent volume and elution flow rate. Results The best process parameters for purification of total polyphenols from purple tea by AB-8 macroporous adsorption resin were as following. The sample concentration was 375 μg/ml with flow rate 2 ml/min. The sample volume was 3 BV. The sample solution pH was 2. The ratio of colume diameter to height was 1∶6. The impurities were removed first by water 3 BV. 50% ethanol 4 BV was used for elution with flow rate 2 ml/min. Conclusion AB-8 macroporous resin was selected for the purification of polyphenols from purple tea under the optimized technological conditions. The mass fraction of total polyphenols increased from 40.2% to an average of 69.8%. The solid content decreased from 56.0 mg to 29.9 mg. The established purification process has good stability and feasibility. It can be used as a purification process for total polyphenols from purple tea.
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Objective To establish a method for analyzing total polysaccharide content and its monosaccharide composition in the caulis polygoni multiflori mixture. Methods The polysaccharides of the caulis polygoni multiflori mixture were extracted by water-extraction and alcohol-precipitation. After the treatment with phenol-sulfuric acid, the content of total polysaccharides in the preparation was determined by ultraviolet spectrophotometry. In addition, after the polysaccharide was hydrolyzed into monosaccharides wtih trifluoroacetic acid, the hyrolysate was derivatized with PMP, and then the PMP derivates of monosaccharides were analyzed by HPLC method. Yilite krosmasil C18(4.6 mm×250 mm, 5 μm) was used at 30 ℃. Acetonitrile-0.1% NaH2PO4 (pH=6.8) (16:84) was the moblie phase with a flow rate of 1.0 ml/min. The detecting wavelength was at 250 nm. The injection volume was 20 μl. Results concentration of D-anhydrous glucose in the range of 21 ~ 105 μg/ml had a good linear relationship with the absorbance. The linear regression equation was A= 0.007x+0.0105, r=0.9982. The average recovery rate was (100.45±1.57)% (n=6). The average contents of total polysaccharides in four batches of samples were 14.24, 21.09, 17.85 and 18.17 mg/ml. The polysaccharide of the caulis polygoni multiflori mixture mainly consisted of D-mannose, D-glucosamine D-hydrochloride, D-Galacturonic acid, D-glucose, galactose, L-arabinose. The monosaccharides peak area ratios were about 9.10:0.26:1.00:3.02:4.14:2.12. Conclusion The method is accurate and reliable, and can be used for the determination of total content of polysaccharides and the analysis of monosaccharide composition in the preparation.
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Objective: To optimize the extraction process of total flavonoids from Oxytropis falcata bunge.Methods: With the content of total flavonoids as the index,and based on the results of single factor tests, central composite design-response surface methodology was adopted to optimize the extraction technology with the solvent amount, ethanol concentration and extraction time as the factors.Results: The optimal extraction conditions were as follows: extracted twice with 20-fold amount of 66% ethanol, and 84 minute per time.Under the above conditions, the extraction rate of total flavonoids was up to 23.21 mg·g-1.Conclusion: The central composite design-response surface methodology is convenient and highly predictive for the extraction optimization of total flavonoids from oxytropis falcata bunge.
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Objective:To optimize the ultrasonic extraction process of total alkaloids from Oxytropis falcata bunge. Methods:The independent variables were solvents ratio, extracting time and ethanol concentration, and the dependent variable was content of total al-kaloids. Based on single factor tests, central composite design and response surface methodology was adopted to optimize the extraction technology. Results:The optimal extraction conditions were as follows: extracted twice with 36-fold amount of 72% ethanol ( contai-ning 1% acetic acid) at 60 ℃, and extracted 77 minutes each time. Under the above conditions, the content of total alkaloids was 2. 793 mg·g-1 with the bias ratio less than 2% when compared with the model predictions. Conclusion:Ultrasonic extraction process of total alkaloids from Oxytropis falcata Bunge optimized by central composite design and response surface method is simple, highly pre-cise, reliable and predictable.
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Objective To establish the quality control standards for Compound caulis Polygoni multiflori mixture .Meth-ods Caulis polygoni multiflori ,cortex alibiziae and schisand chinensis were identified by TLC ,total flavonoids were deter-mined by UV .Results Caulis polygoni multiflori ,cortex alibiziae and schisand chinensis could be detected by TLC .A better linear relationship between concentration and absorbance in the range of 9 .12~27 .36 μg/ml .The linear regression equation was A=0 .034 55 C-0 .110 34 (r=0 .999 2) ,The average recovery of emodin was 101 .0% (RSD=1 .58% ) .Conclusion The method is simple ,quick ,accurate and sensitive ,which could be used as a quantitative analysis method for this preparation .
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Objective This article reviewed the moisture‐proof strategies of Chinese meteria medica preparation to pro‐vide a basis for quality control of traditional Chinese medicine .Methods Review ,analyze and summarize through referring to relevant literatures in recent years .Results The hygroscopicity of Chinese meteria medica preparation can be influnced by ex‐tractive techniques ,auxiliary material and application of film coating .Conclution Study on techniques of Chinese meteria med‐ica preparation needs further in‐depth investigation .
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Objective To optimize the prescription and preparation technology of finasteride dispersible tablets .Methods Wet granulation technique was applied to optimize the formulation and technology of finasteride tablets .Results The formulation of fi-nasteride tablets was that microcrystalline cellulose and lactose acts as diluent , 5% of low-substituted hydroxypropyl cellulose acts as disintegrant , 5%of povidone in alcohol water mixture acts as adhesive and 15%of opadry 85 G type acts as coating solution .The per-centage of dissolution was more than 90%in 45 miniutes.Conclusion The self-made finasteride tablets had stable quality , reliable process and were suitable for industrialized mass production .
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Objective To prepare insulin thiolated hyaluronic acid nanoparticles (Ins-HA-Cys-NPs)and study its physicochemical properties. Methods The Ins-HA-Cys-NPs was prepared by ultrasonic emulsifying method,and the properties of nanoparticles including morphology,mean diameter,Zeta potential,entrapment efficiency and drug loading efficiency were studied,as well as the cryoprotectant selection.Results The prepared nanoparticles was round in appearance and the mean diameter was(178.5 ±0.8)nm,the polydispersity index was (0.214 ±0.013)and the Zeta potential was -(38.47 ±0.46 )mV,while the entrapment efficiency was (48.85 ±0.66 )%,drug loading efficiency was (4.79 ±0.13 )%;10%mannitol as cryoprotectant provided uniform and well dispersed suspension of nanoparticles with blue opalescence after redispersion.Conclusion The thiolated hyaluronic acid nanoparticles may be used as the carrier for oral drug delivery system of insulin,and it provides a basis for studies on rats in vivo.