[Establishment of concentration process and physical property parameter model of Carthami Flos extract based on quality by design].

To explore the potential of "physical property model" based on the concept of quality by design(QbD),during the application of process analysis technology(PAT) in the concentration process. The Carthami Flos was used as a model drug. Firstly, the total flavonoid retention rate and the hydroxysafflor yellow A(HSYA) retention rate of the concentrated solution were used as indicators to determine the concentration temperature range of the Carthami Flos extract. Then different concentrations were prepared at the optimal concentration temperature, and the corresponding viscosity(η) and electrical conductivity(σ) at different concentrations and temperatures were measured. Data processing software such as Excel, 1 stOpt, SPSS, and MATLAB were used to establish Carthami Flos extract's mathematical model of physical parameters: ρ-C, η-C, η-T, η-C-T, σ-T, σ-C-T. The results showed that the best concentration temperature of the Carthami Flos extract should not exceed 60 ℃, and the R~2 of the exponential equation and Arrhenius equation established based on physical parameters was all greater than 0.9, indicating that such model had better predictive ability. The mathematical model:η=14.465 1 exp(-0.019 8T+ 0.771 1C-0.058 3C~2), σ=4.061 0 + 0.004 3T +(-1.104 1 +0.950 9T)C-0.556 9TC~2 can be used to reflect the comprehensive effect of concentration and temperature on viscosity or conductance, laying foundation for the establishment of an online monitoring system for the viscosity or conductivity of the extraction liquid in the concentration step, rapid prediction of the concentration status, and control of the concentration endpoint. This study has initially proved the feasibility of using the physical property model as the core of the research idea in application of PAT for intelligent quality control of traditional Chinese medicine concentration links, providing a reference for the online intelligent monitoring of concentration steps of traditional Chinese medicine extracts.

Study on preparation technology and physical fingerprint of Carthami Flos Granules based on quality by design / 中草药

Objective: To study the prescription and preparation technology of Carthami Flos Granules and evaluate its physical quality based on quality by design. Methods: Carthami Flos was used as a model drug. The evaluation indicators were retention rate of hydroxysafflor yellow A (HSYA) and total flavonoid, primary formation rate, bulk density, tap density, relative homogeneity index, Hausner ratio, angle of repose, loss on drying, and hygroscopicity. The single factor experiments and the Box-Behnken design response surface method were used to investigate the particle forming process parameters. The physical fingerprint of granules was constructed by seven indexes including bulk density, tap density, relative homogeneity index, Hausner ratio, angle of repose, loss on drying, and hygroscopicity. Results: The optimum conditions were as follows: the dosage ratio of drug to adjuvant was 10.8, the amount of wetting agent (95% ethanol) was 32%, and dried at 70 ℃ for 120 min. The similarity of the physical fingerprint of 10 batches of Carthami Flos Granules was higher than 0.99. Conclusion: The prescription and preparation technology of Carthami Flos Granules and the physical quality were scientific and reasonable, which can provide ideas and methods for the research and development of Chinese materia medica.

Establishment and preliminary evaluation of multiple drug delivery system of effective components of Angelica sinensis / 药学学报

The multiple drug delivery system of components of traditional Chinese medicine is a system composed of multiple components and multiple units. According to the characteristics of each component, different drug delivery units are designed and combined to achieve the purpose of improving bioavailability and enhancing drug efficacy. In this study, supercritical extracts, phenolic acids, and polysaccharides derived from Angelica sinensis were examined as research objects, and a pellet-based vehicle was applied to construct a multiple drug delivery system for the treatment and chemoprevention of colitis and colorectal cancer. The extrusion-spheronization method was used to prepare pellets of Angelica polysaccharides which should be released in the stomach. The yield in 18-24 mesh and plane critical angle served as the index. The Box-Behnken design and the orthogonal design were used to optimize the formulation and parameters of pellets. According to a previous study, the colon specific pellets loading supercritical extracts and phenolic acid extracts were prepared by the optimized process. These two units of pellets were combined into the multiple drug delivery system of effective components of Angelica sinensis, and the quality evaluation and in vitro release study were conducted. The dynamic observation of pellets in mice was evaluated using small animal in vivo imaging system. The prescription of the Angelica polysaccharides gastric releasing pellets was:microcrystalline cellulose 6.5 g, polysaccharide 3.3 g, silica 0.2 g and 7 mL of 60% ethanol as wetting agent. The process parameters were as follows:extrusion rate at 75 r·min-1, rounding rate at 1 800 r·min-1, and rounding time for 3 min. Both in vivo and in vitro studies indicate that the prepared multiple drug delivery system of effective components of Angelica sinensis produced good release properties. The polysaccharide pellets could be rapidly released in the artificial gastric fluid and in the stomach. The colon specific pellets showed good targeting. They released little in the artificial gastric fluid within 2 hours, released less than 20% in the artificial intestinal fluid for 4 hours, and released more than 90% in artificial colon fluid for 6 hours.

Observation of curative effect of hemorrhoids lotion on pain, edema and bleeding after anorectal surgery / 中国中药杂志

The purpose of this study was to evaluate the value of Chinese herbal fumigation in the postoperative anal disease. The authors randomly divided 348 patients into treatment group and control group with 174 cases in each group. The treatment group was given to the Chinese herbal medicine hemorrhoids lotion for fumigation based on conventional anti infective therapy, routine dressing change and relaxing bowel. The control group was given to 1 000 mL 1: 5 000 potassium permanganate solution for sitz bath, fumigation based on conventional anti infective therapy, routine dressing change and relaxing bowel. The pain score, edema score, bleeding score, granulation tissue growth score and wound healing time of two groups were compared after operation. The results showed that the postoperative 6 h pain scores were higher in the two groups, the postoperative 3,5,7 d pain scores gradually decreased, the difference was statistically significant (P < 0.05). The difference of postoperative 6 h pain scores was no significant difference between the two groups, while postoperative 3,5,7 d pain scores in the treatment group were significantly lower than those in the control group (P < 0.05). 7 days after operation, anal margin of edema score and blood in the stool score in the treatment group were lower than those in control group, meat medicine growth score was higher than that of the control group, the difference had statistical meaning (P < 0.05). The healing time of two groups was respectively (13.89 + 2.78), (18.45 + 1.65) d (P < 0.05). This study suggested that Chinese herbal fumigation and washing could reduce the pain degree of patients, the anal margin of edema, and the blood in the stool, also could promote granulation tissue growth and shorten the time of wound healing, deserve the clinical expansion.