参瓜颗粒制备工艺及药效学研究
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摘要
目的优选参瓜颗粒制备工艺,并对其辅助降糖作用进行观察。方法采用正交试验法,考察润湿剂(乙醇)浓度、黏合剂(聚维酮)浓度以及辅料配比对制备工艺的影响,用多指标综合评分方法进行数据处理,确定本方的最佳制备工艺。将链脲佐菌素致化学损伤性糖尿病小鼠随机分为正常对照组、模型对照组、阳性药组、参瓜颗粒给药组,分别灌胃给药(模型对照组给予蒸馏水,阳性药组给予二甲双胍250 mg·kg~(-1),参瓜颗粒给药组给予参瓜颗粒3 g·kg~(-1)),记录血糖变化并进行统计学分析。结果实验确定参瓜颗粒最佳制备工艺:以70%乙醇作为润湿剂,1%聚维酮作为黏合剂,辅料选择淀粉-糊精质量比为1∶1。阳性药组和参瓜颗粒给药组血糖水平均低于模型对照组,且具有统计学意义(P<0.05)。结论实验确定的制备工艺设计合理,生产操作简单可行,产品质量稳定可靠,参瓜颗粒对链脲佐菌素所致化学损伤性糖尿病小鼠具有降低空腹血糖的功效,为相关中药制剂的研发提供了参考。
OBJECTIVE To optimize the preparation process of Shengua granules and observe its auxiliary hypoglycemic effect. METHODS The orthogonal experiment was adopted to investigate the effects of wetting agent(ethanol) concentration,binder(povidone) concentration and excipients radio on the preparation process. Date processing was carried out with the multi-index comprehensive scoring method, and the best preparation process was determined. The streptozotocin-induced diabetic mice were randomly divided into normal control group, model control group, positive drug group and Shengua granules treatment group, and administered by intragastric(the model control group was given the distilled water, the positive drug control group was given the metformin 250 mg·kg~(-1), the Shengua granules treatment group was given the Shengua granules 3 g·kg~(-1)).The blood glucose changes were recorded and the statistical analysis was carried out. RESULTS The optimal preparation process of Shengua granules was as following: 70% ethanol as the wetting agent, 1% povidone as the binder, and the excipients was the starch : extrin=1:1. The blood glucose levels of the positive drug group and the Shengua granules treatment group were lower than that of the model control group, and the difference was statistically significant(P<0.05). CONCLUSION The optimal preparation process is reasonable, simple and feasible, and the quality of the product is stable and reliable. Shengua granules has the effect of reducing fasting blood glucose in streptozotocin-induced diabetic mice, which provides inspiration for the research and development of related Chinese medicine preparations.
OBJECTIVE To optimize the preparation process of Shengua granules and observe its auxiliary hypoglycemic effect. METHODS The orthogonal experiment was adopted to investigate the effects of wetting agent(ethanol) concentration,binder(povidone) concentration and excipients radio on the preparation process. Date processing was carried out with the multi-index comprehensive scoring method, and the best preparation process was determined. The streptozotocin-induced diabetic mice were randomly divided into normal control group, model control group, positive drug group and Shengua granules treatment group, and administered by intragastric(the model control group was given the distilled water, the positive drug control group was given the metformin 250 mg·kg~(-1), the Shengua granules treatment group was given the Shengua granules 3 g·kg~(-1)).The blood glucose changes were recorded and the statistical analysis was carried out. RESULTS The optimal preparation process of Shengua granules was as following: 70% ethanol as the wetting agent, 1% povidone as the binder, and the excipients was the starch : extrin=1:1. The blood glucose levels of the positive drug group and the Shengua granules treatment group were lower than that of the model control group, and the difference was statistically significant(P<0.05). CONCLUSION The optimal preparation process is reasonable, simple and feasible, and the quality of the product is stable and reliable. Shengua granules has the effect of reducing fasting blood glucose in streptozotocin-induced diabetic mice, which provides inspiration for the research and development of related Chinese medicine preparations.
引文
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[2]TANG X,RUAN Y,YU Y R.Status and influencing factors of glycemic control in type 2 diabetes patients in communities of Shihezi city[J].Agric Reclam Med(农垦医学),2017,39(4):331-334.
[3]CHEN R,CHEN D J,ZHANG J X.Lowering blood glucose,blood lipids and antioxidant effects of Panax quinquefolius polysaccharide peptide on diabetic mice[J].Acta Agric Boreali-Occidentalis Sin(西北农业学报),2013,22(11):195-201.
[4]LIU Y S,LI X K,WANG J J.Effects of total saponins from balsam pear on insulin resistance,adiponectin and leptin in rat model of type 2 diabetes[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2010,16(9):177-179.
[5]包万员,丁超,刘有旺.苦瓜降血糖作用的研究进展[J].中国老年学杂志,2011,31(7):1269-1270.
[6]ZHU D J,YIN X G,LIU Z Y,et al.Effect of total saponins from bitter gourd to myocardial apoptosis in type 2 diabetic rats[J].Med J West China(西部医学),2016,28(10):1360-1364,1377.
[7]尹长江,杨坤宝,张学军,等.枸杞总多糖对2型糖尿病大鼠的降糖作用研究[J].中成药,2014,36(8):1750-1753.
[8]GAO C S,SHAN L,CUI G H,et al.Physical characterization of excipients used for rapid-release solid dosage forms[J].Chin J New Drugs(中国新药杂志),2005,14(3):313-315.
[9]张荣泉,田垚,吕方,等.制粒工艺对藿精片制备的影响[J].中药材,2012,35(4):651-653.