CN113546127A - 一种治疗骨关节炎的盘龙七中药组合物酊剂及其制备方法 - Google Patents
一种治疗骨关节炎的盘龙七中药组合物酊剂及其制备方法 Download PDFInfo
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Abstract
本发明提供一种治疗骨关节炎的盘龙七中药组合物酊剂及其制备方法,其是将组合物采用乙醇提取得到;按照质量份数计,组合物包括:盘龙七10‑20份、秦艽10‑20份、牛膝5‑10份、丹参20‑30份、五加皮10‑20份、缬草5‑10份、八里麻5‑10份、过山龙5‑10份、当归30‑50份、重楼20‑30份、青蛙七1‑3份、川乌1‑3份、草乌1‑3份、铁棒锤1‑3份、珠子参1‑3份、络石藤5‑10份、羊角七5‑10份、木香5‑10份、乳香5‑10份、祖司麻1‑3份、白毛七1‑5份、老鼠七1‑5份、杜仲10‑20份、红花5‑10份、壮筋丹1‑5份、没药5‑10份、伸筋草1‑5份、支柱蓼5‑10份和竹根七5‑10份。盘龙七复方酊剂载药量大,可直接作用于患处,通过透皮吸收,增加了药物的生物利用度。
Description
技术领域
本发明涉及中药组合物和中药制剂技术领域,具体涉及一种治疗骨关节炎的盘龙七中药组合物酊剂及其制备方法。
背景技术
当人体肌表经络遭受风、寒、湿邪侵袭后,使气血运行不畅,引起筋骨、肌肉、关节的酸痛、麻木、肿胀、伸屈不利和全身关节呈现游走性红、肿、疼痛,均属“痹症”。治以祛风通络为主、佐以散寒祛湿。临床发现盘龙七片可使奏理疏通,气血通畅,达到活血化瘀、消肿止痛、通经活络、强筋壮骨的作用。盘龙七片是含有29味中药的大处方制剂,所含的当归、丹参既能活血,又可养血,更有祛瘀之功,还可改善局部血液濡养;重楼、牛膝具有活血祛瘀、消肿之效,使瘀血去新血生;红花、乳香、没药有活血祛瘀、行气止痛之功;秦艽、络石藤祛风湿,止痹痛;五加皮、缬草祛风湿、止痹痛且芳香通络,易于药物发挥作用;杜仲、壮筋丹强筋牡骨,祛风湿,佐以木香行气止痛;支柱蓼、八里麻、竹根七、羊角七、过山龙祛风湿、舒筋通络、消肿镇痛,配以伸筋草,祛风除湿,舒筋活络;老鼠七、白毛七、祖师麻理气活血,消肿止痛,增强祛风湿、散瘀之力。诸药配伍,切近病机,相得益彰。共奏活血化瘀、消肿止痛、通经活络、强筋壮骨之效。
盘龙七片作为普通的糖衣片,载药量较小,另外由于口服后的药物首过效应,生物利用度很低。
发明内容
针对现有技术中存在的问题,本发明提供一种治疗骨关节炎的盘龙七中药组合物酊剂及其制备方法,盘龙七复方酊剂载药量大,可直接作用于患处,通过透皮吸收,增加了药物的生物利用度。
本发明是通过以下技术方案来实现:
一种治疗骨关节炎的盘龙七中药组合物酊剂,其是将组合物采用乙醇提取得到;
按照质量份数计,组合物包括:盘龙七10-20份、秦艽10-20份、牛膝5-10份、丹参20-30份、五加皮10-20份、缬草5-10份、八里麻5-10份、过山龙5-10份、当归30-50份、重楼20-30份、青蛙七1-3份、川乌1-3份、草乌1-3份、铁棒锤1-3份、珠子参1-3份、络石藤5-10份、羊角七5-10份、木香5-10份、乳香5-10份、祖司麻1-3份、白毛七1-5份、老鼠七1-5份、杜仲10-20份、红花5-10份、壮筋丹1-5份、没药5-10份、伸筋草1-5份、支柱蓼5-10份和竹根七5-10份。
所述的治疗骨关节炎的盘龙七中药组合物酊剂的制备方法,取盘龙七、秦艽、牛膝、丹参、五加皮、缬草、八里麻和过山龙八味药材,粉碎,过筛,加乙醇溶液,回流搅拌提取,得提取液1;取当归、重楼、青蛙七、川乌、草乌、铁棒锤、珠子参、络石藤、羊角七、木香、乳香、祖司麻、白毛七、老鼠七、杜仲、红花、壮筋丹、没药、伸筋草、支柱蓼和竹根七二十一味药材,加乙醇溶液,回流搅拌提取,得提取液2;提取液1和提取液2混合,即得含有盘龙七中药组合物酊剂。
优选的,制备提取液1时采用的乙醇溶液浓度为70-90%。
优选的,制备提取液2时采用的乙醇溶液浓度为50-70%。
优选的,提取液1具体制备方法为:取盘龙七、秦艽、牛膝、丹参、五加皮、缬草、八里麻和过山龙八味药材,粉碎,过筛,加乙醇溶液,回流搅拌提取若干次,每次提取1-3小时,过滤,冷却,静置,过滤,合并滤液得提取液1。
优选的,提取液2具体制备方法为:取当归、重楼、青蛙七、川乌、草乌、铁棒锤、珠子参、络石藤、羊角七、木香、乳香、祖司麻、白毛七、老鼠七、杜仲、红花、壮筋丹、没药、伸筋草、支柱蓼、竹根七,总计二十一味药材,加乙醇,回流搅拌提取若干次,每次提取1-3小时,过滤,冷却,静置,过滤,合并滤液得提取液2。
优选的,制备提取液1时每次采用的乙醇溶液体积与制备提取液2时每次采用的乙醇溶液体积比例为2:3。
优选的,提取液1和提取液2按体积比2:3比例混合,得到含有盘龙七中药组合物酊剂。
与现有技术相比,本发明具有有益的技术效果:
本发明盘龙七中药组合物制成酊剂,酊剂具有载药量充足,可直接外敷透皮吸收的优势,可显著增加药物的生物利用度,较好的弥补现有剂型的缺陷。本发明所制的酊剂,具有含药量较高,用药剂量小,渗透性好,易于保存等特点,能够有效改善和治疗关节炎。
附图说明
图1为受试患者连续用药30天内体内炎症因子变化。
具体实施方式
下面结合具体的实施例对本发明做进一步的详细说明,所述是对本发明的解释而不是限定。
本发明治疗骨关节炎的盘龙七中药组合物酊剂,其是将组合物采用乙醇提取得到。
按照质量份数计,组合物1包括:盘龙七10-20份、秦艽10-20份、牛膝5-10份、丹参20-30份、五加皮10-20份、缬草5-10份、八里麻5-10份、过山龙5-10份、当归30-50份、重楼20-30份、青蛙七1-3份、川乌1-3份、草乌1-3份、铁棒锤1-3份、珠子参1-3份、络石藤5-10份、羊角七5-10份、木香5-10份、乳香5-10份、祖司麻1-3份、白毛七1-5份、老鼠七1-5份、杜仲10-20份、红花5-10份、壮筋丹1-5份、没药5-10份、伸筋草1-5份、支柱蓼5-10份和竹根七5-10份;
组合物通过以下方法制备:
按组合物所述药物质量称取盘龙七、秦艽、牛膝、丹参、五加皮、缬草、八里麻、过山龙八味药材,粉碎,过20目筛,加1200mL 70-90%乙醇,回流搅拌提取3次,每次提取1-3小时,过滤,自然冷却,静置24h,过滤,合并滤液得提取液1,备用。按组合物所述药物质量称取当归、重楼、青蛙七、川乌、草乌、铁棒锤、珠子参、络石藤、羊角七、木香、乳香、祖司麻、白毛七、老鼠七、杜仲、红花、壮筋丹、没药、伸筋草、支柱蓼、竹根七,总计二十一味药材,加1800mL 50-70%乙醇,回流搅拌提取3次,每次提取1-3小时,过滤,自然冷却,静置24h,过滤,合并滤液得提取液2。提取液1和提取液2按体积比2:3比例混合,即得含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
实施例1
按所述药物组合,称取盘龙七10g、秦艽10g、牛膝5g、丹参20g、五加皮10g、缬草5g、八里麻5g、过山龙5g八味药材,粉碎,过20目筛,加1200mL 70%乙醇,回流搅拌提取3次,每次提取1小时,过滤,自然冷却,静置24h,过滤,合并滤液得1118mL提取液1,备用。按所述药物组合,称取当归30g、重楼20g、青蛙七1g、川乌1g、草乌1g、铁棒锤1g、珠子参1g、络石藤5g、羊角七5g、木香5g、乳香5g、祖司麻1g、白毛七1g、老鼠七1g、杜仲10g、红花5g、壮筋丹1g、没药5g、伸筋草1g、支柱蓼5g和竹根七5g,总计二十一味药材,加1800mL 50%乙醇,回流搅拌提取3次,每次提取1小时,过滤,自然冷却,静置24h,过滤,合并滤液得1695mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2795mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
实施例2
按所述药物组合,称取盘龙七16.7g、秦艽16.7g、牛膝8.3g、丹参25g、五加皮16.7g、缬草8.3g、八里麻8.3g、过山龙8.3g八味药材,粉碎,过20目筛,加1200mL 70%乙醇,回流搅拌提取3次,每次提取1小时,过滤,自然冷却,静置24h,过滤,合并滤液得1124mL提取液1,备用。按所述药物组合,称取当归41.7g、重楼25g、青蛙七1.7g、川乌1.7g、草乌1.7g、铁棒锤1.7g、珠子参1.7g、络石藤8.3g、羊角七8.3g、木香8.3g、乳香8.3g、祖司麻8.3g、白毛七1.7g、老鼠七1.7g、杜仲16.7g、红花8.3g、壮筋丹3.3g、没药8.3g、伸筋草3.3g、支柱蓼8.3g和竹根七8.3g,总计二十一味药材,加1800mL 50%乙醇,回流搅拌提取3次,每次提取1小时,过滤,自然冷却,静置24h,过滤,合并滤液得1709mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2810mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
实施例3
按所述药物组合,称取盘龙七20g、秦艽20g、牛膝10g、丹参30g、五加皮20g、缬草10g、八里麻10g、过山龙10g八味药材,粉碎,过20目筛,加1200mL 70%乙醇,回流搅拌提取3次,每次提取1小时,过滤,自然冷却,静置24h,过滤,合并滤液得1128mL提取液1,备用。按所述药物组合,称取当归50g、重楼30g、青蛙七3g、川乌3g、草乌3g、铁棒锤3g、珠子参3g、络石藤10g、羊角七10g、木香10g、乳香10g、祖司麻3g、白毛七5g、老鼠七5g、杜仲20g、红花10g、壮筋丹5g、没药10g、伸筋草5g、支柱蓼10g和竹根七10g,总计二十一味药材,加1800mL 50%乙醇,回流搅拌提取3次,每次提取1小时,过滤,自然冷却,静置24h,过滤,合并滤液得1683mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2805mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
实施例4
按所述药物组合,称取盘龙七16.7g、秦艽16.7g、牛膝8.3g、丹参25g、五加皮16.7g、缬草8.3g、八里麻8.3g、过山龙8.3g八味药材,粉碎,过20目筛,加1200mL 80%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1096mL提取液1,备用。称取当归41.7g、重楼25g、青蛙七1.7g、川乌1.7g、草乌1.7g、铁棒锤1.7g、珠子参1.7g、络石藤8.3g、羊角七8.3g、木香8.3g、乳香8.3g、祖司麻8.3g、白毛七1.7g、老鼠七1.7g、杜仲16.7g、红花8.3g、壮筋丹3.3g、没药8.3g、伸筋草3.3g、支柱蓼8.3g和竹根七8.3g,总计二十一味药材,加1800mL 60%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1691mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2740mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
实施例5
按药物组合物1所述药物组合,称取盘龙七16.7g、秦艽16.7g、牛膝8.3g、丹参25g、五加皮16.7g、缬草8.3g、八里麻8.3g、过山龙8.3g八味药材,粉碎,过20目筛,加1200mL90%乙醇,回流搅拌提取3次,每次提取3小时,过滤,自然冷却,静置24h,过滤,合并滤液得1102mL提取液1,备用。称取当归41.7g、重楼25g、青蛙七1.7g、川乌1.7g、草乌1.7g、铁棒锤1.7g、珠子参1.7g、络石藤8.3g、羊角七8.3g、木香8.3g、乳香8.3g、祖司麻8.3g、白毛七1.7g、老鼠七1.7g、杜仲16.7g、红花8.3g、壮筋丹3.3g、没药8.3g、伸筋草3.3g、支柱蓼8.3g和竹根七8.3g,总计二十一味药材,加1800mL 70%乙醇,回流搅拌提取3次,每次提取3小时,过滤,自然冷却,静置24h,过滤,合并滤液得1721mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2755mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
对照例1
与实施例2的区别在于:在盘龙七中药组合物的制备中未加入盘龙七。
按所述药物组合,称取秦艽16.7g、牛膝8.3g、丹参25g、五加皮16.7g、缬草8.3g、八里麻8.3g、过山龙8.3g七味药材,粉碎,过20目筛,加1200mL 80%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1124mL提取液1,备用。称取当归41.7g、重楼25g、青蛙七1.7g、川乌1.7g、草乌1.7g、铁棒锤1.7g、珠子参1.7g、络石藤8.3g、羊角七8.3g、木香8.3g、乳香8.3g、祖司麻8.3g、白毛七1.7g、老鼠七1.7g、杜仲16.7g、红花8.3g、壮筋丹3.3g、没药8.3g、伸筋草3.3g、支柱蓼8.3g和竹根七8.3g,总计二十一味药材,加1800mL 60%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1713mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2810mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
对照例2
与实施例2的区别在于:在盘龙七中药组合物的制备中未加入丹参和当归。
按所述药物组合,称取盘龙七16.7g、秦艽16.7g、牛膝8.3g、五加皮16.7g、缬草8.3g、八里麻8.3g、过山龙8.3g七味药材,粉碎,过20目筛,加1200mL 80%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1093mL提取液1,备用。按权利要求1所述药物质量称取重楼25g、青蛙七1.7g、川乌1.7g、草乌1.7g、铁棒锤1.7g、珠子参1.7g、络石藤8.3g、羊角七8.3g、木香8.3g、乳香8.3g、祖司麻8.3g、白毛七1.7g、老鼠七1.7g、杜仲16.7g、红花8.3g、壮筋丹3.3g、没药8.3g、伸筋草3.3g、支柱蓼8.3g和竹根七8.3g,总计二十味药材,加1800mL 60%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1629mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2715mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
对照例3
与实施例2的区别在于:在盘龙七中药组合物的制备中未加入牛膝和重楼。
按所述药物组合,称取盘龙七16.7g、秦艽16.7g、丹参25g、五加皮16.7g、缬草8.3g、八里麻8.3g、过山龙8.3g七味药材,粉碎,过20目筛,加1200mL 80%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1121mL提取液1,备用。所述药物质量称取当归41.7g、青蛙七1.7g、川乌1.7g、草乌1.7g、铁棒锤1.7g、珠子参1.7g、络石藤8.3g、羊角七8.3g、木香8.3g、乳香8.3g、祖司麻8.3g、白毛七1.7g、老鼠七1.7g、杜仲16.7g、红花8.3g、壮筋丹3.3g、没药8.3g、伸筋草3.3g、支柱蓼8.3g和竹根七8.3g,总计二十味药材,加1800mL 60%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1681mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2800mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
对照例4
与实施例2的区别在于:在盘龙七中药组合物的制备中未加入秦艽和络石藤。
按所述药物组合,称取盘龙七16.7g、牛膝8.3g、丹参25g、五加皮16.7g、缬草8.3g、八里麻8.3g、过山龙8.3g七味药材,粉碎,过20目筛,加1200mL 80%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1134mL提取液1,备用。称取当归41.7g、重楼25g、青蛙七1.7g、川乌1.7g、草乌1.7g、铁棒锤1.7g、珠子参1.7g、羊角七8.3g、木香8.3g、乳香8.3g、祖司麻8.3g、白毛七1.7g、老鼠七1.7g、杜仲16.7g、红花8.3g、壮筋丹3.3g、没药8.3g、伸筋草3.3g、支柱蓼8.3g和竹根七8.3g,总计二十味药材,加1800mL60%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1678mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2795mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
对照例5
与实施例2的区别在于:在盘龙七中药组合物的制备中未加入五加皮和缬草。
按所述药物组合,称取盘龙七16.7g、秦艽16.7g、牛膝8.3g、丹参25g、八里麻8.3g、过山龙8.3g六味药材,粉碎,过20目筛,加1200mL 80%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1127mL提取液1,备用。称取当归41.7g、重楼25g、青蛙七1.7g、川乌1.7g、草乌1.7g、铁棒锤1.7g、珠子参1.7g、络石藤8.3g、羊角七8.3g、木香8.3g、乳香8.3g、祖司麻8.3g、白毛七1.7g、老鼠七1.7g、杜仲16.7g、红花8.3g、壮筋丹3.3g、没药8.3g、伸筋草3.3g、支柱蓼8.3g和竹根七8.3g,总计二十一味药材,加1800mL60%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1669mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2780mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
对照例6
与实施例2的区别在于:在盘龙七中药组合物的制备中未加入川乌、草乌和铁棒锤。
按所述药物组合,称取盘龙七16.7g、秦艽16.7g、牛膝8.3g、丹参25g、五加皮16.7g、缬草8.3g、八里麻8.3g、过山龙8.3g八味药材,粉碎,过20目筛,加1200mL 80%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1132mL提取液1,备用。称取当归41.7g、重楼25g、青蛙七1.7g、珠子参1.7g、络石藤8.3g、羊角七8.3g、木香8.3g、乳香8.3g、祖司麻8.3g、白毛七1.7g、老鼠七1.7g、杜仲16.7g、红花8.3g、壮筋丹3.3g、没药8.3g、伸筋草3.3g、支柱蓼8.3g和竹根七8.3g,总计十八味药材,加1800mL 60%乙醇,回流搅拌提取3次,每次提取2小时,过滤,自然冷却,静置24h,过滤,合并滤液得1703mL提取液2。提取液1和提取液2按体积比2:3比例混合,即得2830mL含有盘龙七中药组合物得能改善和治疗骨关节炎的酊剂。
药效实验
1、镇痛实验(扭体法)
本实验采用扭体法测定盘龙七中药组合物酊剂的镇痛活性。选取65只小鼠,称重(24.8±2g),编号,随机分为13组,每组5只,分别用实施例1-5和对照例1-6所得的酊剂、生理盐水和对照组(0.2%罗通定)进行试验,每组用药0.2ml/10g体重。给药后20min,腹腔注射0.6%冰醋酸0.2mL/只,然后观察记录15min内小鼠出现扭体反应(腹部收缩成“S”形、身体扭曲、后肢伸展及蠕行等)及扭体次数。
镇痛率=(空白组扭体次数-用药组扭体次数)/空白组扭体次数*100%
表1盘龙七中药组合物酊剂对醋酸刺激所致小鼠疼痛的影响
通过扭体法测量用药小鼠对醋酸刺激所致疼痛的改变来反映药物的镇痛作用是评价镇痛效果的经典方法,本实验使用小鼠65只,实验中小鼠无死亡,本实验有效样本量为65只。由表1可知,实施例1-2组中的小鼠平均扭体次数在7-8次,镇痛率均达到54.2%以上,实施例3-5组中的小鼠平均扭体次数在6-7次,镇痛率均达到60%以上,扭体潜伏期超过6min;对照例1-5组的小鼠平均扭体次数在8-10次,镇痛率均达到40%以上,扭体潜伏期超过4min。对照例6组的小鼠平均扭体次数在12次,镇痛效果30.7%。
由此可知,盘龙七中药组合物酊剂对醋酸刺激所致疼痛具有一定的镇痛作用,实施例3-5的镇痛效果最好,但弱于对照组。对照例1-5缺少了盘龙七、丹参、当归、牛膝、重楼、秦艽、络石藤、五加皮和缬草等药材后,镇痛效果均下降,说明盘龙七、丹参、当归、牛膝、重楼、秦艽、络石藤、五加皮、缬草在盘龙七中药组合物酊剂的镇痛作用中发挥重要作用。对照例6缺少川乌、草乌和铁棒锤镇痛率减小为原处方的一半,说明川乌、草乌和铁棒锤三味中药在盘龙七中药组合物酊剂中发挥主要的镇痛作用。
2、抗炎实验(小鼠耳廓肿胀法)
本实验采用小鼠耳廓肿胀法测定盘龙七中药组合物酊剂的抗炎活性。选取65只小鼠,称重(21.5±2.3g),编号,随机分为13组,每组5只,分别用实施例1-5和对照例1-6所得的酊剂和对照组(阿司匹林)进行试验,每组0.2mL/10g体重的剂量灌胃,空白组正常饲养。连续灌胃8天,每天1次。于末次给药后45min,在每只小鼠右耳两面均匀涂布TPA(佛波酯)2.5μg,4h后脱颈椎处死小鼠,剪下耳片,用0.8cm打孔器在小鼠两耳相同部位各取一耳片,称重,以两耳片重量差作为肿胀度,计算肿胀抑制率。
肿胀抑制率=(空白组耳片重量-用药组耳片重量)/空白组耳片重量*100%
表2盘龙七中药组合物酊剂对TPA(佛波酯)所致小鼠耳廓肿胀的影响
小鼠耳廓肿胀法具有价格便宜、操作简便、易于测量和模型稳定的特点,是研究药物抗炎活性常用的方法之一,本实验共使用小鼠65只,对照例1中一只小鼠于第6日死亡,有效样本共64只。由表2可知,对照组(阿司匹林)的小鼠的耳片重量为5.90±0.84mg,肿胀抑制率36.42%。实施例1-5组中的小鼠耳片平均重量≤6.53mg,肿胀抑制率≥25.2%。对照例1-6处方中缺少盘龙七、丹参和当归、牛膝、重楼、秦艽、络石藤、五加皮、缬草、川乌、草乌和铁棒锤等药材后小鼠耳片平均重量增加,肿胀抑制率逐渐减小。其中,对照例3的耳片肿胀程度最大,耳片重量为8.63±1.42mg,肿胀抑制率为7%。
由此可知,盘龙七中药组合物酊剂具有一定的抗炎作用。其中实施例4-5的抗炎作用接近与对照例阿司匹林的抗炎重用。对照例1、对照例2、对照例4-6在缺少部分盘龙七、丹参和当归、牛膝、重楼、秦艽、络石藤、五加皮、缬草、川乌、草乌和铁棒锤等药材后,抗炎作用相比实施例1-5降低,对照例3缺少牛膝、重楼,抗炎作用下降最多,说明牛膝、重楼在盘龙七中药组合物酊剂处方中发挥主要的抗炎作用。
3、抗关节炎实验
选取39个自愿者(男15人,女14人)随机分为13组,每组3人,分别用实施例1-5和对照例1-6所得的酊剂和空白样进行试验。受试部位前一周不能使用任何产品;取一定量的测试样品和空白组搽于关节炎患处,每天使用3次,对照组患者服用布洛芬,重复上述试验30天。用药期间,在0、5、10、15、20、25、30天分别给患者取血,采用ELISA检测法测定患者血液中IL-1β、IL-6、IL-8、IFN-γ、IL-4和IL-10的含量。同时,记录用药后红肿消失时间和疼痛消失时间。使用30天后停止用药,记录30天内病情复发情况。
由图1可知,使用实施例和对照例的患者在测试的30天内,体内IL-1β、IL-6、IL-8和IFN-γ四种促炎症因子的含量随用药时间的增加逐渐减小,IL-4和IL-10两种抑炎症因子随用药时间的增加逐渐增大。在用药结束后,四种促炎症因子的水平已全部降至正常水平,两种抑炎症因子随病情好转,含量开始降低。从患者用药期间炎症因子变化情况可知,使用实施例4-5方法制备的酊剂对关节炎的治疗作用最好。实施例4-5在用药10天后,炎症因子IL-1β降至正常水平,用药15天后IL-6、IL-8和INF-γ降低至正常水平,IL-4和IL-10含量分别在用药后15天和10天升高到峰值后,含量开始下降。说明在用药15天后使用实施例4-5方法制备的酊剂的患者病情炎症消退,病情获得好转。
表3受试患者关节炎病情
由表3可知,在测试的30天内,使用实施例4-5方法制备的酊剂的6人,用药后11天内红肿消失,用药14天内疼痛消失,停药后30天内未见复发,实施例1中有1人复发;使用对照例1-6方法制备的酊剂的18人,用药后26天内红肿和疼痛均消失,停药后30天内复发率22.2%。
由表3可知,本发明设计的盘龙七中药组合物酊剂对关节炎有一定治疗作用,其中按照实施例4-5制备的酊剂效果最好。对照例1、3和6中分别未添加盘龙七、重楼、牛膝和杜仲和壮筋丹,治疗效果大幅降低,并有患者在停止用药30天内,出现症状复发现象,说明本发明的盘龙七中药组合物酊剂中盘龙七、重楼、牛膝和杜仲和壮筋丹五味药材对关节炎治疗具有重要作用。对照例4、5中分别未加入秦艽、五加皮、缬草和络石藤,红肿消失的时间较早,疼痛在17-23天后消失,说明秦艽、五加皮、缬草和络石藤4味药材对关节炎红肿有治疗作用。
盘龙七中药组合物酊剂药效学实验研究。通过镇痛实验(扭体法)初步确定了盘龙七中药组合物酊剂具有一定镇痛活性,处方中川乌、草乌和铁棒锤在处方中发挥主要的镇痛作用,其中采用实施例5制备的酊剂镇痛活性最佳。通过抗炎实验(小鼠耳廓肿胀法)初步确定了盘龙七中药组合物酊剂具有一定抗炎活性,确定了牛膝和重楼在处方中发挥主要的抗炎活性,其中采用实施例4、5制备的酊剂抗炎活性最佳。抗关节炎实验中,通过对患者用药期间体内炎症因子的监测,确定了实施例4-5对关节炎的治疗效果最好。通过用药期间患者红肿面积和疼痛程度的比较,终确定使用实施例5制备出的酊剂对关节炎的治疗作用最好,该酊剂能在11天内缓解关节炎患者红肿,14天内使疼痛消失。并在停药30天内未见病情复发现象。
综上所述,盘龙七中药组合物酊剂具有镇痛、抗炎作用,并在人体实验中发挥较好的治疗关节炎的作用。对比不同的制备方法制备的酊剂,实施例5在镇痛和抗炎方面的活性最强。
Claims (8)
1.一种治疗骨关节炎的盘龙七中药组合物酊剂,其特征在于,其是将组合物采用乙醇提取得到;
按照质量份数计,组合物包括:盘龙七10-20份、秦艽10-20份、牛膝5-10份、丹参20-30份、五加皮10-20份、缬草5-10份、八里麻5-10份、过山龙5-10份、当归30-50份、重楼20-30份、青蛙七1-3份、川乌1-3份、草乌1-3份、铁棒锤1-3份、珠子参1-3份、络石藤5-10份、羊角七5-10份、木香5-10份、乳香5-10份、祖司麻1-3份、白毛七1-5份、老鼠七1-5份、杜仲10-20份、红花5-10份、壮筋丹1-5份、没药5-10份、伸筋草1-5份、支柱蓼5-10份和竹根七5-10份。
2.权利要求1所述的治疗骨关节炎的盘龙七中药组合物酊剂的制备方法,其特征在于,取盘龙七、秦艽、牛膝、丹参、五加皮、缬草、八里麻和过山龙八味药材,粉碎,过筛,加乙醇溶液,回流搅拌提取,得提取液1;取当归、重楼、青蛙七、川乌、草乌、铁棒锤、珠子参、络石藤、羊角七、木香、乳香、祖司麻、白毛七、老鼠七、杜仲、红花、壮筋丹、没药、伸筋草、支柱蓼和竹根七二十一味药材,加乙醇溶液,回流搅拌提取,得提取液2;提取液1和提取液2混合,即得含有盘龙七中药组合物酊剂。
3.根据权利要求2所述的治疗骨关节炎的盘龙七中药组合物酊剂的制备方法,其特征在于,制备提取液1时采用的乙醇溶液浓度为70-90%。
4.根据权利要求2所述的治疗骨关节炎的盘龙七中药组合物酊剂的制备方法,其特征在于,制备提取液2时采用的乙醇溶液浓度为50-70%。
5.根据权利要求2所述的治疗骨关节炎的盘龙七中药组合物酊剂的制备方法,其特征在于,提取液1具体制备方法为:取盘龙七、秦艽、牛膝、丹参、五加皮、缬草、八里麻和过山龙八味药材,粉碎,过筛,加乙醇溶液,回流搅拌提取若干次,每次提取1-3小时,过滤,冷却,静置,过滤,合并滤液得提取液1。
6.根据权利要求2所述的治疗骨关节炎的盘龙七中药组合物酊剂的制备方法,其特征在于,提取液2具体制备方法为:取当归、重楼、青蛙七、川乌、草乌、铁棒锤、珠子参、络石藤、羊角七、木香、乳香、祖司麻、白毛七、老鼠七、杜仲、红花、壮筋丹、没药、伸筋草、支柱蓼、竹根七,总计二十一味药材,加乙醇,回流搅拌提取若干次,每次提取1-3小时,过滤,冷却,静置,过滤,合并滤液得提取液2。
7.根据权利要求2所述的治疗骨关节炎的盘龙七中药组合物酊剂的制备方法,其特征在于,制备提取液1时每次采用的乙醇溶液体积与制备提取液2时每次采用的乙醇溶液体积比例为2:3。
8.根据权利要求7所述的治疗骨关节炎的盘龙七中药组合物酊剂的制备方法,其特征在于,提取液1和提取液2按体积比2:3比例混合,得到含有盘龙七中药组合物酊剂。
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