甘草提取物儿童栓剂的研制与标准化

T. Yarnykh, O. Rukhmakova
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摘要

本工作的目的是开发具有免疫调节作用的儿童直肠栓剂的技术及其标准化。为了获得栓剂,使用了甘草根提取物、洋甘菊和茶树精油。考虑到以溶解形式引入成分是可取的,我们研究了使用乳液栓剂的可能性。为评价栓剂的组成,对所制栓剂的均匀性和胶体稳定性进行了研究。均质性、熔化温度、衰变时间、平均质量按国家药典进行估计。为证实其有效成分的真实性,采用了色谱法。采用分光光度法测定甘草酸的含量。采用灌注法制备栓剂。甘草根提取物溶解于碱的亲水性相后加入栓剂。在(42.0±2.0)℃的温度下,将a型固体脂肪溶解在熔体中,引入洋甘菊精油和茶树精油。在“均匀性”和“胶体稳定性”两项指标上,组份样品分别为纯净水、聚山梨酸酯-80、卵磷脂、a型固体脂肪。为了证明栓剂中甘草根提取物的真实性,以氯仿-甲醇-水体系为最佳(26:14:3)。在气相色谱仪上对精油的鉴定表明,在色谱图上,所研究溶液的峰和保留时间与参比溶液的峰和保留时间一致。对甘草酸的定量测定研究表明,甘草酸在一个栓剂中的含量以甘草酸为单位不小于0.035 g。
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THE ASPECTS OF DEVELOPMENT AND STANDARDIZATION OF CHILDREN’S SUPPOSITORIES WITH EXTRACT OF LICORICE ROOT
The aim of this work was the development of technology of rectal suppositories of immunomodulatory action for children and their standardization. To obtain suppositories, a licorice root extract, chamomile and tea tree essential oils were used. Given that the introduction of ingredients in a dissolved form is preferable, we studied the possibility of using emulsion suppository bases. To evaluate the compositions, the homogeneity and colloidal stability of the suppositories obtained were studied. Estimation of homogeneity, melting temperature, decay time, average mass was carried out according to the State Pharmacopoeia. To confirm the authenticity of the active ingredients, a chromatography method was used. The quantitative determination of glycyrrhizin acid was carried out by spectrophotometric method. Suppositories were prepared by the pouring method. The licorice root extract was added to the suppository when dissolved in the hydrophilic phase of the base. Essential oils of chamomile and tea tree were introduced when a solid fat of type A dissolved in a melt, at a temperature of (42.0±2.0) ºC. Optimum indices for the criteria of “homogeneity” and “colloidal stability” were noted for the samples of the composition: purified water, polysorbate-80, lecithin, solid fat type A. To prove the authenticity of the licorice root extract in suppositories, the chloroform-methanol-water system was optimal (26:14:3). Identification of essential oils on a gas chromatograph showed that on the chromatogram the peaks and retention times of the solution under study coincide with the peaks and retention times of the reference solutions. The conducted studies of quantitative determination of glycyrrhizin acid have shown that its content in one suppository is not less than 0.035 g in terms of glycyram.
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