CN113350320A - 一种活血化瘀抗炎止痛的盘龙七复方巴布剂及其制备方法 - Google Patents
一种活血化瘀抗炎止痛的盘龙七复方巴布剂及其制备方法 Download PDFInfo
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Abstract
本发明公开一种活血化瘀抗炎止痛的盘龙七复方巴布剂及其制备方法。巴布剂的药物组合,由以下原料制备而成:盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、过山龙、秦艽、木香、络石藤、川乌、白毛七、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、竹根七、缬草、伸筋草、牛膝、丹参、羊角七、八罩麻、重楼、乳香。巴布剂辅料组成:增湿剂、粘合剂、透皮促渗剂和增稠剂。本发明所制的巴布剂,具有粘度适宜、皮肤追随性好、可反复粘贴,无刺激等特点,能够有效改善和治疗关节炎。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,且巴布剂可反复使用多次使用。
Description
技术领域
本发明涉及中药组合物和中药制剂技术领域,具体涉及一种活血化瘀抗炎止痛的盘龙七复方巴布剂及其制备方法。
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。
盘龙七片为普通糖衣片,通过口服给药,片剂的载药量小,胃肠道吸收后,经血液循环到达病灶,生物利用度低。
发明内容
针对现有技术中存在的问题,本发明提供一种活血化瘀抗炎止痛的盘龙七复方巴布剂及其制备方法,盘龙七复方巴布剂载药量大,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,且巴布剂可反复使用多次使用。
本发明是通过以下技术方案来实现:
一种活血化瘀抗炎止痛的盘龙七复方巴布剂,按照质量份数计,制备原料包括:
(1)中药组合物:
(2)辅料:
包括:增湿剂250-300份、粘合剂30-60份、透皮促渗剂5-10份和增稠剂10-40份。
优选的,增湿剂为甘油、丁二醇或聚乙二醇。
优选的,粘合剂为聚丙烯酸钠或高岭土。
优选的,透皮促渗剂为氮酮、油酸或氮酮和油酸的混合物。
优选的,透皮促渗剂为氮酮和油酸混合物,氮酮和油酸质量比为6:4。
优选的,增稠剂为海藻酸钠、羧甲基纤维素钠或羟乙基纤维素钠。
优选的,辅料还包括尼泊金甲酯3-10份,尼泊金乙酯3-10份。
所述的活血化瘀抗炎止痛的盘龙七复方巴布剂的制备方法,包括:
取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过筛,得细粉和粗粉;粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草和伸筋草八味药材,加水煎煮,煎液滤过,滤液浓缩,烘干,粉碎,过筛,与上述所得细粉混匀,得盘龙七中药组合物;
将盘龙七中药组合物和透皮促渗剂加入水中,搅拌,使其均匀分散,得到溶液1;
增湿剂和粘合剂加入水中,搅拌均匀,静置,溶液2;
增稠剂溶于水中,静置,得到溶液3;
将溶液1、溶液2和溶液3混合,涂布于无纺布上,烘干,得到巴布剂。
优选的,制备盘龙七中药组合物的过程中,过筛是过80-100目筛。
与现有技术相比,本发明具有以下有益的技术效果:
本发明将盘龙七片药物组合开发应用于盘龙七中药组合物巴布剂,盘龙七复方巴布剂可直接作用于患处,通过透皮吸收,增加了药物的生物利用度,且巴布剂可反复使用多次使用。本发明在保持盘龙七片原有功效的同时能提高产品的使用价值和性能,让患者能舒适、安全、有效、方便地使用该产品。
本发明通过选择合适的辅料,所制的巴布剂,具有粘度适宜、皮肤追随性好、可反复粘贴,无刺激等特点,能够有效改善和治疗关节炎。
附图说明
图1按实施例2方法制备的盘龙七片中药组合巴布剂HPLC色谱图;
图2对照品丹参酮ⅡAHPLC色谱图;
图3按实施例2方法制备的盘龙七片中药组合巴布剂HPLC色谱图;
图4对照品齐墩果酸HPLC色谱图;
图5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。
本发明活血化瘀抗炎止痛的盘龙七复方巴布剂,按照质量分数计,其药物及辅料组合如下:
(1)中药组合物:
盘龙七 | 10-30份 | 壮筋丹 | 2-8份 | 五加皮 | 10-30份 |
杜仲 | 10-30份 | 当归 | 25-90份 | 珠子参 | 1-4份 |
青蛙七 | 1-4份 | 过山龙 | 5-15份 | 秦艽 | 10-30份 |
木香 | 5-15份 | 祖司麻 | 1-4份 | 络石藤 | 5-15份 |
川乌 | 1-4份 | 白毛七 | 2-8份 | 铁棒锤 | 1-4份 |
草乌 | 1-4份 | 老鼠七 | 2-8份 | 支柱蓼 | 5-15份 |
红花 | 5-15份 | 没药 | 5-15份 | 竹根七 | 5-15份 |
缬草 | 10-30份 | 伸筋草 | 2-8份 | 牛膝 | 10-30份 |
丹参 | 15-40份 | 羊角七 | 5-15份 | 八里麻 | 5-15份 |
重楼 | 15-40份 | 乳香 | 5-15份 |
(2)辅料组合:
①增湿剂250-300份:甘油、丁二醇或聚乙二醇,优选甘油;
②粘合剂30-60份:聚丙烯酸钠或高岭土,优选聚丙烯酸钠作为粘合剂;
③透皮促渗剂5-10份:氮酮、油酸或氮酮-油酸,优选氮酮-油酸(6:4)作为透皮促渗剂;
④增稠剂10-40份:海藻酸钠、羧甲基纤维素钠或羟乙基纤维素钠,优选海藻酸钠作为增稠剂。
辅料还可以包括防腐剂,例如尼泊金甲酯和尼泊金乙酯。
本发明盘龙七复方巴布剂制备工艺,包括:
(1)取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80-100目筛,细粉比重为15%-30%,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2-3小时,合并煎液滤过,滤液浓缩,50-80℃烘干,粉碎,过80-100目筛,与上述细粉混匀,得盘龙七中药组合物,备用。
(2)将步骤(1)制备的中药组合物与透皮促渗剂5-15份,加100mL蒸馏水,搅拌,使其均匀分散;
(3)量取250-300份增湿剂,称取30-60粘合剂分散于增湿剂中,加入420-800mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(4)称取增稠剂30-60份,溶于150-210份水中,静置过夜,使其充分溶胀、溶解;
(5)称取尼泊金甲酯和尼泊金乙酯各6-20份,溶于70份90%乙醇中,配成防腐剂溶液;
(6)将溶解好的增稠剂溶液加入粘合剂溶液中搅拌均匀后,依次加入步骤(2)、(5)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱30-50℃烘干,切割,包装,即得70片含有盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
实施例1
1.1、盘龙七中药组合物的制备:
按表1所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物86.71g,备用。
表1实施例1各中药用量
盘龙七 | 10g | 壮筋丹 | 2g | 五加皮 | 10g |
杜仲 | 10g | 当归 | 25g | 珠子参 | 1g |
青蛙七 | 1g | 过山龙 | 5g | 秦艽 | 10g |
木香 | 5g | 祖司麻 | 1g | 络石藤 | 5g |
川乌 | 1g | 白毛七 | 2g | 铁棒锤 | 1g |
草乌 | 1g | 老鼠七 | 2g | 支柱蓼 | 5g |
红花 | 5g | 没药 | 5g | 竹根七 | 5g |
缬草 | 10g | 伸筋草 | 2g | 牛膝 | 10g |
丹参 | 15g | 羊角七 | 5g | 八里麻 | 5g |
重楼 | 15g | 乳香 | 5g | 总计 | 174g |
1.2巴布剂制备:
(1)将1.1制备的中药组合物、氮酮-油酸(6:4)5g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取250mL甘油,称取30g聚丙烯酸钠分散于甘油中,加入420mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠30g,溶于150mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各6g,溶于70mL90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于4块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有1.24g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
实施例2
2.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物143.84g,备用。
表2实施例2各中药用量
盘龙七 | 16.7g | 壮筋丹 | 3.3g | 五加皮 | 16.7g |
杜仲 | 16.7g | 当归 | 41.7g | 珠子参 | 1.7g |
青蛙七 | 1.7g | 过山龙 | 8.3g | 秦艽 | 16.7g |
木香 | 8.3g | 祖司麻 | 1.7g | 络石藤 | 8.3g |
川乌 | 1.7g | 白毛七 | 3.3g | 铁棒锤 | 1.7g |
草乌 | 1.7g | 老鼠七 | 3.3g | 支柱蓼 | 8.3g |
红花 | 8.3g | 没药 | 8.3g | 竹根七 | 8.3g |
缬草 | 16.7g | 伸筋草 | 3.3g | 牛膝 | 16.7g |
丹参 | 25g | 羊角七 | 8.3g | 八里麻 | 8.3g |
重楼 | 25g | 乳香 | 8.3g | 总计 | 298.3g |
2.2巴布剂制备:
(1)将2.1制备的中药组合物、氮酮-油酸(6:4)10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有2.05g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
实施例3
3.1、盘龙七中药组合物的制备:
按表3所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物279.13g,备用。
表3实施例3各中药用量
盘龙七 | 30g | 壮筋丹 | 8g | 五加皮 | 30g |
杜仲 | 30g | 当归 | 90g | 珠子参 | 4g |
青蛙七 | 4g | 过山龙 | 15g | 秦艽 | 30g |
木香 | 15g | 祖司麻 | 4g | 络石藤 | 15g |
川乌 | 4g | 白毛七 | 8g | 铁棒锤 | 4g |
草乌 | 4g | 老鼠七 | 8g | 支柱蓼 | 15g |
红花 | 15g | 没药 | 15g | 竹根七 | 15g |
缬草 | 30g | 伸筋草 | 8g | 牛膝 | 30g |
丹参 | 40g | 羊角七 | 15g | 八里麻 | 15g |
重楼 | 40g | 乳香 | 15g | 总计 | 556g |
3.2巴布剂制备:
(1)将3.1制备的中药组合物、氮酮-油酸(6:4)15g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取300mL甘油,称取60g聚丙烯酸钠分散于甘油中,加入800mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠60g,溶于210mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各20g,溶于70mL90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有3.99g盘龙七中药组合的能有效改善和治疗关节炎的巴布剂。
实施例4
盘龙七中药组合物的制备中增湿剂为丁二醇。
4.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物144.27g,备用。
4.2巴布剂制备:
(1)将4.1制备的中药组合物、氮酮-油酸(6:4)10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL丁二醇,称取40g聚丙烯酸钠分散于丁二醇中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有2.06g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
实施例5
与实施例2的区别在于:在盘龙七中药组合物的制备中增湿剂为乙二醇。
5.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物143.79g,备用。
5.2巴布剂制备:
(1)将5.1制备的中药组合物、氮酮-油酸(6:4)10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL乙二醇,称取40g聚丙烯酸钠分散于乙二醇中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有2.05g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
实施例6
与实施例2的区别在于:在盘龙七中药组合物的制备中粘合剂为高岭土。
6.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物143.84g,备用。
6.2巴布剂制备:
(1)将6.1制备的中药组合物、氮酮-油酸(6:4)10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g高岭土分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入高岭土溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有2.05g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
实施例7
与实施例2的区别在于:在盘龙七中药组合物的制备中透皮促渗剂为氮酮。
7.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物143.84g,备用。
7.2巴布剂制备:
(1)将7.1制备的中药组合物、氮酮10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有2.05g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
实施例8
与实施例2的区别在于:在盘龙七中药组合物的制备中透皮促渗剂为油酸。
8.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物143.84g,备用。
8.2巴布剂制备:
(1)将8.1制备的中药组合物、油酸10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有2.05g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
分析测试
1、对实施例2方法制备的盘龙七中药组合物巴布剂进行高效液相分析,可检测出丹参特征组分丹参酮ⅡA
(1)对照品溶液制备方法
取丹参酮ⅡA对照品,加乙醇制成每1mL含0.5mg的溶液,作为对照品溶液。
(2)供试品溶液制备方法
取本品除去裱背材料,剪碎,精密称取1g,精密加入甲醇50mL,密塞,称定重量,回流提取1h,放冷,加甲醇补足减失重量,过滤,精密吸取滤液20mL蒸干,残渣加水10mL使溶解,充分溶解后用微孔滤膜(0.45μm)滤过,取续滤液作为供试品溶液。
(3)色谱条件
色谱柱:Hypersil C18 ODS(4.6×250mm×5μm),以1%磷酸水溶液:甲醇为流动相进行梯度洗脱(洗脱条件见下表1);流速:1.0mL·min-1;检测波长为270nm;SPD-20AV紫外-可见光检测器检测;柱温:25℃;进样量:10μL。
表1梯度洗脱条件
(4)实验结果
分别取对照品溶液和供试品溶液各10μL,按上述色谱条件进样。结果如图1和图2所示:盘龙七片中药组合物巴布剂在与对照品丹参酮ⅡA在相同保留时间处有出峰,表明该色谱条件可检出丹参药材中丹参酮ⅡA。
2、对实施例2方法制备的盘龙七中药组合物进行高效液相分析,检测出八里麻特征组分齐墩果酸
(1)对照品溶液制备方法
取齐墩果酸对照品,加无水乙醇制成每1mL含1mg的溶液,作为对照品溶液。
(2)供试品溶液制备方法
取本品除去裱背材料,剪碎,精密称取3g,精密加入无水乙醇50mL,密塞,称定重量,回流提取1h,放冷,加无水乙醇补足减失重量,过滤,精密吸取滤液20mL蒸干,残渣加水10m L使溶解,充分溶解后用微孔滤膜(0.45μm)滤过,取续滤液作为供试品溶液。
(3)色谱条件
色谱柱:Hypersil C18 ODS(4.6×250mm×5μm),以1%磷酸水溶液:乙腈为流动相进行梯度洗脱(梯度洗脱条件见下表2);流速:1.0mL·min-1;检测波长为204nm;SPD-20AV紫外-可见光检测器检测;柱温:30℃;进样量:10μL。
表2梯度洗脱条件
(4)实验结果
分别取对照品溶液和供试品溶液各10μL,按上述色谱条件进样。结果如图3和图4所示:盘龙七片中药组合物巴布剂在与对照品齐墩果酸在相同保留时间处有出峰,表明该色谱条件可检出八里麻药材中齐墩果酸。
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。
1.1、盘龙七中药组合物的制备:
按表2所述中药质量称取壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物135.19g,备用。
1.2巴布剂制备:
(1)将1.1制备的中药组合物、氮酮10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有1.93g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
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重楼。
2.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物133.20g,备用。
2.2巴布剂制备:
(1)将2.1制备的中药组合物、氮酮10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有1.90g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
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。
3.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物137.52g,备用。
3.2巴布剂制备:
(1)将3.1制备的中药组合物、氮酮10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有1.96g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
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杜仲。
4.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物136.91g,备用。
5.2巴布剂制备:
(1)将4.1制备的中药组合物、氮酮10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有1.96g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
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、秦艽和缬草。
5.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、杜仲、当归、珠子参、青蛙七、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物122.20g,备用。
5.2巴布剂制备:
(1)将5.1制备的中药组合物、氮酮10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有1.74g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
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丹参和当归。
6.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物123.82g,备用。
6.2巴布剂制备:
(1)将6.1制备的中药组合物、氮酮10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有1.77g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
对照例7
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、草乌和铁棒槌。
7.1、盘龙七中药组合物的制备:
按表2所述中药质量称取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过80目筛,过筛后的粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草、伸筋草八味药材,加水煎煮二次,每次2小时,合并煎液滤过,滤液浓缩,60℃烘干,粉碎,过80目筛,与上述细粉混匀,得盘龙七中药组合物140.02g,备用。
7.2巴布剂制备:
(1)将7.1制备的中药组合物、氮酮10g,加100mL蒸馏水,搅拌,使其均匀分散;
(2)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入600mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(3)称取海藻酸钠40g,溶于180mL水中,静置过夜,使其充分溶胀、溶解;
(4)称取尼泊金甲酯和尼泊金乙酯各12g,溶于70mL 90%乙醇中,配成防腐剂溶液;
(5)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,依次加入步骤(1)、(4)配好的溶液,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得70片巴布剂,每片含有2.00g盘龙七中药组合物的能有效改善和治疗关节炎的巴布剂。
空白组
巴布剂制备:
(1)量取270mL甘油,称取40g聚丙烯酸钠分散于甘油中,加入280mL蒸馏水,搅拌均匀,静置4小时,待其自然溶胀、溶解完全即可;
(2)称取海藻酸钠20g,溶于400mL水中,静置过夜,使其充分溶胀、溶解;
(3)称取尼泊金甲酯和尼泊金乙酯各5g,溶于60mL90%乙醇中,配成防腐剂溶液;
(4)将溶解好的海藻酸钠溶液加入聚丙烯酸钠溶液中搅拌均匀后,再加入配好的防腐溶和氮酮-油酸(6:4)10g,充分搅拌均匀成粘稠的流体后,立即涂布于2块无纺布(55cm*49cm)上,放烘箱40℃烘干,切割,包装,即得空白对照。
性能实验
滚球法的试验方法
取供试品3片,在室温下,除去盖衬,置于长30cm,与水平面成15或30(按各该品种项下规定)的斜面滚球装置中央,膏面向上,斜面上部10cm及下部15cm用0.025m厚的涤纶薄膜覆盖,中间留出5cm膏面,将各该品种项下规定的钢球(见表4),自斜面顶端自由滚,3片供试品中应有2片或2片以上能在测试段上粘住钢球,如有1片不能粘住,再用较小号的钢球试验,应能粘住。如只有1片能粘住钢球,而另2片只能粘住较小1号的钢球,应另取3片复试。3片均应能粘住钢球为合格。钢球的规格是:
表4滚球法中的钢球规格
对实施例1-6所得的巴布剂基质性能测试,结果是:
表5巴布剂性能测试结果
从表5中可以看出,本发明提供的巴布剂基质均匀、粘性好,可以反复揭贴。实施例4、5中的巴布剂由于在制备过程中加入的是丁二醇、乙二醇而非甘油,导致了巴布剂保湿效果变差,均匀度也受到了影响,导致多次揭帖后,对皮肤的粘接性下降;实施例6中由于加入的高岭土而非聚丙烯酸钠,使巴布剂的粘附性发生了下降。
药效学实验
1、镇痛实验
本实验采用扭体法测定盘龙七中药组合物巴布剂的镇痛活性。选取70只小鼠,称重(22.8±2.1g),编号,随机分为14组,每组5只,分别用实施例1-3和对照例4-12所得的巴布剂、空白组和布洛芬乳膏组(阳性对照)进行试验。连续用药6天,于末次给药后40min,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6盘龙七中药组合物巴布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70只,实验中小鼠无死亡,本实验有效样本量为70只。由表6可知,实施例1-3组中的小鼠平均扭体次数小于7次,镇痛率均达到62%以上,扭体潜伏期超过6.2min;实施例7、8组的小鼠平均扭体次数在9次,镇痛率均达到47%以上,扭体潜伏期超过4.7min。对照例1-6组的小鼠平均扭体次数在8-12次,镇痛率均达到25%以上,扭体潜伏期超过5.3min。对照例7组的小鼠平均扭体次数在14次以上,镇痛效果18.00%。
由此可知,盘龙七中药组合物巴布剂对醋酸刺激所致疼痛具有一定的镇痛作用,实施例1-3的镇痛效果最好,但弱于阳性对照组。实施例7、8组中透皮促渗剂分别为氮酮、油酸,透皮吸收能力减弱,镇痛作用也相应减弱。对照例1-6缺少了盘龙七、重楼、牛膝、杜仲、秦艽、五加皮、缬草、丹参和当归等药材后,镇痛效果均下降,说明盘龙七、重楼、牛膝、杜仲、秦艽、五加皮、缬草、丹参和当归在盘龙七中药组合物巴布剂的镇痛作用中发挥重要作用。对照例7缺少川乌、草乌和铁棒锤镇痛率减小为实施例的三分之一,说明川乌、草乌和铁棒锤三味中药在盘龙七中药组合物巴布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巴布剂的抗炎活性。选取70只小鼠,称重(23.4±1.7g),编号,随机分为14组,每组5只,分别用实施例1-8和对照例1-7所得的巴布剂、空白组和布洛芬乳膏组(阳性对照)进行试验,连续用药8天,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6盘龙七中药组合物巴布剂对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70只,无小鼠死亡,有效样本共70只。由表6可知,阳性对照组(布洛芬乳膏)的小鼠的耳片重量为6.22±1.73mg,肿胀抑制率39.73%。实施例1-3组中的小鼠耳片平均重量≤6.91mg,肿胀抑制率≥33.04%。对照例4、5组中的小鼠耳片平均重量≤7.98mg,肿胀抑制率≥21.61%。对照例6-12处方中缺少盘龙七、重楼、牛膝、杜仲、秦艽、五加皮、缬草、丹参、当归、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8的耳片肿胀程度最大,耳片重量为8.81±2.72mg,肿胀抑制率为14.63%。
由此可知,盘龙七中药组合物巴布剂具有一定的抗炎作用。其中实施例1-3的抗炎作用最好。实施例7、8组中透皮促渗剂分别为氮酮、油酸,透皮吸收能力减弱,抗炎作用减弱。对照例1-7在缺少盘龙七、重楼、牛膝、杜仲、秦艽、五加皮、缬草、丹参、当归、川乌、草乌和铁棒锤等药材后,抗炎作用相比实施例1-3低,对照例2、3分别缺少重楼和牛膝,抗炎作用下降最多,说明重楼和牛膝在盘龙七中药组合物巴布剂处方中发挥主要的抗炎作用。
3、抗关节炎实验
选取42个自愿者,随机分为14组,每组3人,分别用实施例1-8和对照例1-7所得的巴布剂基质、空白样和布洛芬进行试验。受试部位前一周不能使用任何产品;用测试样品和空白组10.0±0.3g凝胶样品/cm2的用量分别覆盖在关节炎患处,每天晚间使用一次,白天揭下,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5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、IFN-γ四种促炎性细胞因子随用药时间的增加含量逐渐降低,在用药结束后,四种促炎性细胞因子的水平已全部降至正常水平;体内IL-4、IL-10两种抑炎性细胞因子随用药时间增加,两种抑炎性细胞因子的含量逐渐升高,随着治疗的好转,IL-4和IL-10的含量逐渐降低。从患者用药期间炎症因子变化情况可知,实施例1-3对关节炎的治疗作用最好。实施例1-3在用药10天后,炎症因子IL-1β降至正常水平,用药20天后IL-8、INF-γ降低至正常水平,IL-4和IL-10含量升高至峰值,后逐渐降低。
表8受试患者关节炎病情
由表8可知,在测试的30天内,使用实施例1-3方法制备的巴布剂的9人,用药后17天内红肿消失,用药21天内疼痛消失,与对照组的治疗效果相当。停药后30天内,使用实施例1-3方法制备的巴布剂的9人未见病情复发;使用实施例7、8及对照例1-4方法制备的巴布剂的18人,用药后28天内红肿消失,用药期间有一人疼痛未消失,停药后30天内有10人复发;使用对照例5-7方法制备的巴布剂的9人,用药后19天内红肿消失,用药24天内疼痛消失停药后30天内有1人复发。
由此可知,本发明设计的盘龙七中药组合物巴布剂对关节炎有一定治疗作用,其中按照实施例2和实施例3制备的巴布剂效果最好。实施例7、8组中透皮促渗剂分别为氮酮、油酸,透皮吸收能力减弱,抗炎作用弱于实施例2。对照例1-4中分别未添加盘龙七、重楼、牛膝和杜仲,治疗效果大幅降低,说明本发明的盘龙七中药组合物巴布剂中盘龙七、重楼、牛膝和杜仲四味药材对关节炎治疗具有重要作用。对照例5、6中分别未加入秦艽、五加皮、缬草和当归、丹参,红肿和疼痛基本同时消失,说明秦艽、五加皮、缬草、当归和丹参5味药材对关节炎红肿有治疗作用。对照例7中未加入川乌、草乌和铁棒槌,红肿消失的时间和实施例1-3患者消失的时间相当,疼痛消失的时间增加较多,说明本发明的盘龙七中药组合物巴布剂中川乌、草乌和铁棒槌发挥镇痛的重要作用。
盘龙七中药组合物巴布剂药效学实验研究。通过镇痛实验(扭体法)初步确定了盘龙七中药组合物巴布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2和实施例3制备的巴布剂镇痛活性最佳。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巴布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2和实施例3制备的巴布剂抗炎活性最佳。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1-3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2和实施例3制备出的巴布剂对关节炎的治疗作用最好,该巴布剂能在16天内缓解关节炎患者红肿,17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,盘龙七中药组合物巴布剂具有镇痛、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巴布剂,实施例2和实施例3在镇痛和抗炎方面的活性最强。
Claims (9)
1.一种活血化瘀抗炎止痛的盘龙七复方巴布剂,其特征在于,按照质量份数计,制备原料包括:
(1)中药组合物:
(2)辅料:
包括:增湿剂250-300份、粘合剂30-60份、透皮促渗剂5-10份和增稠剂10-40份。
2.根据权利要求1所述的活血化瘀抗炎止痛的盘龙七复方巴布剂,其特征在于,增湿剂为甘油、丁二醇或聚乙二醇。
3.根据权利要求1所述的活血化瘀抗炎止痛的盘龙七复方巴布剂,其特征在于,粘合剂为聚丙烯酸钠或高岭土。
4.根据权利要求1所述的活血化瘀抗炎止痛的盘龙七复方巴布剂,其特征在于,透皮促渗剂为氮酮、油酸或氮酮和油酸的混合物。
5.根据权利要求1所述的活血化瘀抗炎止痛的盘龙七复方巴布剂,其特征在于,透皮促渗剂为氮酮和油酸混合物,氮酮和油酸质量比为6∶4。
6.根据权利要求1所述的活血化瘀抗炎止痛的盘龙七复方巴布剂,其特征在于,增稠剂为海藻酸钠、羧甲基纤维素钠或羟乙基纤维素钠。
7.根据权利要求1所述的活血化瘀抗炎止痛的盘龙七复方巴布剂,其特征在于,辅料还包括尼泊金甲酯3-10份,尼泊金乙酯3-10份。
8.权利要求1-7任一项所述的活血化瘀抗炎止痛的盘龙七复方巴布剂的制备方法,其特征在于,包括:
取盘龙七、壮筋丹、五加皮、杜仲、当归、珠子参、青蛙七、秦艽、木香、川乌、铁棒锤、草乌、老鼠七、支柱蓼、红花、没药、牛膝、丹参、八罩麻、重楼、乳香,进行粉碎,过筛,得细粉和粗粉;粗粉与祖司麻、竹根七、白毛七、过山龙、羊角七、络石藤、缬草和伸筋草八味药材,加水煎煮,煎液滤过,滤液浓缩,烘干,粉碎,过筛,与上述所得细粉混匀,得盘龙七中药组合物;
将盘龙七中药组合物和透皮促渗剂加入水中,搅拌,使其均匀分散,得到溶液1;
增湿剂和粘合剂加入水中,搅拌均匀,静置,溶液2;
增稠剂溶于水中,静置,得到溶液3;
将溶液1、溶液2和溶液3混合,涂布于无纺布上,烘干,得到巴布剂。
9.权利要求8所述的活血化瘀抗炎止痛的盘龙七复方巴布剂的制备方法,其特征在于,制备盘龙七中药组合物的过程中,过筛是过80-100目筛。
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