散结止痛巴布剂的质量标准、稳定性和药效学研究
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摘要
散结止痛巴布剂主要由重楼,白花蛇舌草,夏枯草,生川乌,天南星,冰片等中药提取制备而成,具有软坚散结,消肿止痛的功效。针对乳腺增生的病机,处方中重楼、白花蛇舌草清热解毒、消肿止痛散瘀,且入肝胃二经,直达乳房病所;夏枯草可通经入里、散结止痛;冰片辛散走窜、消肿止痛。诸药合用,外敷病位,可使药物直达病所,具有解毒散结、活络祛瘀、通络止痛之功。
本文首先对巴布剂的性状进行了说明,且对重楼药材和夏枯草药材进行了薄层鉴别,对冰片进行了气相色谱法的鉴别。针对中国药典的关于检查的项目,主要做了关于乌头碱限量的检查、含膏量检查、赋型性和粘附性检查。最后针对重楼中的重楼皂苷I和重楼皂苷II进行了含量检查、冰片中的龙脑含量检查作为其质量指标。结果显示:散结止痛巴布剂中的重楼、夏枯草和冰片有效成分可以被提取;其中检查的项目符合药典规定;重楼皂苷含量每片不低于0.070mg,冰片含量每片不低于10mg。
对散结止痛巴布剂稳定性研究针对散结止痛巴布剂质量标准中的项目进行了影响因素稳定性试验(温度、湿度和光照对其的影响)、加速稳定性试验和长期稳定性试验。结果显示:散结止痛巴布剂对光照和高温反应变化比较大,采用铝箔包装基本能够保持稳定。
针对巴布剂的药效学进行了研究,用肌注外源性苯甲酸雌二醇及黄体酮的方法复制大鼠乳腺增生病模型,观察各组大鼠乳头形态学变化,用放射免疫方法测定各组实验性大鼠模型血浆内雌二醇(E2)、孕激素(P)的含量,实验结果为水提巴布膏低、中、高治疗组大鼠的乳头红肿、乳腺增大和显微小叶、腺泡、导管增生以及血浆雌二醇水平均显著低于模型组。与醇提巴布膏组比较,水提各组升高孕酮浓度和降低腺泡数量和面积更加显著,表现出更好的抑制乳腺增生的药效。
Sanjie ZhiTong Cataplasm mainly by the re-building, diffusa, Prunella, ChuanWu, Araceae, borneol and other traditional Chinese medicine prepared from extracted with Endometriosis, pain swelling effect. For the pathogenesis of breast hyperplasia, prescription weight floor, diffusa Qingrejiedu, swelling pain stasis, liver and stomach and into the second after, the direct breast disease; Prunella can pass the means, the Sanjie pain; ice film Xinsan go channeling, swelling and relieve pain. Combination of various drugs, topical disease location, make the drugs directly to patients, with detoxification Sanjie, active stasis, Tongluozhitong achievements.
This article first described cataplasm’s traits, and the rebuilding of herbs and medicinal herbs Prunella vulgaris were TLC, borneol were on the identification of gas chromatography. Chinese Pharmacopoeia for the items on the check, mainly done on a limited inspection of aconitine, containing paste volume inspection, excipient and adherence checks. Finally, re-building in polyphyllins I and II were polyphyllins content inspection, borneol borneol content in check as its quality indicators. The results showed that: Sanjie pain Cataplasma heavy floor, Prunella and borneol active ingredients can be extracted; check items which meet the pharmacopoeia requirements; polyphyllins content of each piece not less than 0.070mg, borneol content of each not less than 10mg.
On the stability of Cataplasm Sanjie pain pain for Sanjie quality standards Cataplasm project was carried out in the stability test factors (temperature, humidity and light on its effects), accelerated stability test and long-term stability test . The results showed that: Sanjie cataplasm pain response to light and relatively large changes in temperature, the use of aluminum foil packaging can basically stable.
Pharmacodynamics for cataplasm was studied, using intramuscular injection of exogenous estradiol benzoate and progesterone way rat model of mammary glands, nipples were observed morphological changes in rats, using RIA Determination of experimental rat model of each group plasma estradiol (E2), progesterone (P) content of the water Ti Babu paste result of low, medium and high treatment group, nipple swelling, breast enlargement and significant small leaves, acinar, ductal hyperplasia and plasma estradiol levels were significantly lower than model group. Compared with alcohol Ti Babu cream, water extraction increased progesterone concentrations in each group and reduce the number and area of acinar more significant, showing a better efficacy of inhibition of mammary gland hyperplasia.
本文首先对巴布剂的性状进行了说明,且对重楼药材和夏枯草药材进行了薄层鉴别,对冰片进行了气相色谱法的鉴别。针对中国药典的关于检查的项目,主要做了关于乌头碱限量的检查、含膏量检查、赋型性和粘附性检查。最后针对重楼中的重楼皂苷I和重楼皂苷II进行了含量检查、冰片中的龙脑含量检查作为其质量指标。结果显示:散结止痛巴布剂中的重楼、夏枯草和冰片有效成分可以被提取;其中检查的项目符合药典规定;重楼皂苷含量每片不低于0.070mg,冰片含量每片不低于10mg。
对散结止痛巴布剂稳定性研究针对散结止痛巴布剂质量标准中的项目进行了影响因素稳定性试验(温度、湿度和光照对其的影响)、加速稳定性试验和长期稳定性试验。结果显示:散结止痛巴布剂对光照和高温反应变化比较大,采用铝箔包装基本能够保持稳定。
针对巴布剂的药效学进行了研究,用肌注外源性苯甲酸雌二醇及黄体酮的方法复制大鼠乳腺增生病模型,观察各组大鼠乳头形态学变化,用放射免疫方法测定各组实验性大鼠模型血浆内雌二醇(E2)、孕激素(P)的含量,实验结果为水提巴布膏低、中、高治疗组大鼠的乳头红肿、乳腺增大和显微小叶、腺泡、导管增生以及血浆雌二醇水平均显著低于模型组。与醇提巴布膏组比较,水提各组升高孕酮浓度和降低腺泡数量和面积更加显著,表现出更好的抑制乳腺增生的药效。
Sanjie ZhiTong Cataplasm mainly by the re-building, diffusa, Prunella, ChuanWu, Araceae, borneol and other traditional Chinese medicine prepared from extracted with Endometriosis, pain swelling effect. For the pathogenesis of breast hyperplasia, prescription weight floor, diffusa Qingrejiedu, swelling pain stasis, liver and stomach and into the second after, the direct breast disease; Prunella can pass the means, the Sanjie pain; ice film Xinsan go channeling, swelling and relieve pain. Combination of various drugs, topical disease location, make the drugs directly to patients, with detoxification Sanjie, active stasis, Tongluozhitong achievements.
This article first described cataplasm’s traits, and the rebuilding of herbs and medicinal herbs Prunella vulgaris were TLC, borneol were on the identification of gas chromatography. Chinese Pharmacopoeia for the items on the check, mainly done on a limited inspection of aconitine, containing paste volume inspection, excipient and adherence checks. Finally, re-building in polyphyllins I and II were polyphyllins content inspection, borneol borneol content in check as its quality indicators. The results showed that: Sanjie pain Cataplasma heavy floor, Prunella and borneol active ingredients can be extracted; check items which meet the pharmacopoeia requirements; polyphyllins content of each piece not less than 0.070mg, borneol content of each not less than 10mg.
On the stability of Cataplasm Sanjie pain pain for Sanjie quality standards Cataplasm project was carried out in the stability test factors (temperature, humidity and light on its effects), accelerated stability test and long-term stability test . The results showed that: Sanjie cataplasm pain response to light and relatively large changes in temperature, the use of aluminum foil packaging can basically stable.
Pharmacodynamics for cataplasm was studied, using intramuscular injection of exogenous estradiol benzoate and progesterone way rat model of mammary glands, nipples were observed morphological changes in rats, using RIA Determination of experimental rat model of each group plasma estradiol (E2), progesterone (P) content of the water Ti Babu paste result of low, medium and high treatment group, nipple swelling, breast enlargement and significant small leaves, acinar, ductal hyperplasia and plasma estradiol levels were significantly lower than model group. Compared with alcohol Ti Babu cream, water extraction increased progesterone concentrations in each group and reduce the number and area of acinar more significant, showing a better efficacy of inhibition of mammary gland hyperplasia.
引文
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