CN114949098A - 一种治疗骨关节炎的中药缓释凝胶剂及其制备方法 - Google Patents
一种治疗骨关节炎的中药缓释凝胶剂及其制备方法 Download PDFInfo
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Abstract
本发明属于制药领域,涉及治疗骨关节炎的中药缓释凝胶剂及其制备方法,所述中药缓释凝胶剂包括以下质量份数的组分:牛膝6‑9份、骨碎补4‑5份;淫羊藿2‑3份;独活2‑3份;穿山龙1‑1.5份;卡波姆980 0.5‑1份;明胶1‑2份;蚕丝蛋白微球1‑2份;聚乙二醇400 1‑2份;氢氧化钠0.5‑1份;羟苯乙酯0.01‑0.02份;二氧化硅粉末0.5‑1份。本发明所述中药缓释凝胶剂用于治疗和减缓患者的骨关节炎疾病,具有使用方便,缓释效果好等优势。
Description
技术领域
本发明属于制药领域,涉及一种治疗骨关节炎的中药缓释凝胶剂及其制备方法。
背景技术
骨关节炎是目前一种常见的疾病,患者常年受到该疾病的困扰,治疗骨关节炎的方法有药物、理疗、贴药膏等,其中贴药膏是一种简单方便的手段,因此合理配方的药膏很受患者欢迎。
应用技术获得长作用的药物剂型的研究和实践已有多年历史,特别是口服缓释和控释固体剂型的研究和开发已成为当今医药工业发展的一个重要方向。缓释制剂通过延缓药物从该剂型中的释药速率,降低药物进入机体的吸收速率,从而起到更佳的治疗效果的制剂,与其相应的普通制剂比较,给药频率比普通制剂减少一半或者有所减少,且能显著增加患者的顺应性。但目前市场上并未出现专门治疗骨关节炎的中药缓释凝胶剂。
发明内容
为了解决上述技术问题,本发明提供了一种治疗骨关节炎的中药缓释凝胶剂,用于治疗和减缓患者的骨关节炎疾病,具有使用方便,缓释效果好等优势。
本发明提供的技术方案如下:
一种治疗骨关节炎的中药缓释凝胶剂,包括以下质量份数的组分:牛膝6-9份、骨碎补4-5份、淫羊藿2-3份、独活2-3份、穿山龙1-1.5份;卡波姆980 0.5-1份;明胶1-2份;蚕丝蛋白微球1-2份;聚乙二醇400 1-2份,氢氧化钠0.5-1份;羟苯乙酯0.01-0.02份;二氧化硅粉末0.5-1份。
进一步的,所述中药缓释凝胶剂包括以下质量份数的组分:牛膝8份、骨碎补5份、淫羊藿3份、独活3份、穿山龙1.5份、卡波姆980 1份、明胶2份、蚕丝蛋白微球2份、聚乙二醇400 2份、氢氧化钠0.5份、羟苯乙酯0.01份、二氧化硅粉末0.5份。
进一步的,中药纳米颗粒粒径4-6纳米。
本发明还提供了一种治疗骨关节炎的中药缓释凝胶剂的制备方法,包括以下步骤:
将卡波姆980和聚乙二醇400加入水中混合均匀,再加入明胶搅拌均匀并放置过夜后,在50~60℃条件下搅拌反应1小时,制成混合基质;把氢氧化钠加入羟苯乙酯水溶液,搅拌使氢氧化钠溶解,然后将上述溶液加入到混合基质中,搅拌均匀,再在混合基质中加入二氧化硅粉末、蚕丝蛋白微球,搅拌均匀,在40~50℃条件下继续搅拌反应2小时,制成空白基质;把牛膝、骨碎补、淫羊藿、独活和穿山龙在水中煎熬,将煎熬后的药液浓缩后加入空白基质中,然后对空白基质进行干燥,干燥后压制成凝胶药膏,得到治疗骨关节炎的中药缓释凝胶剂。
进一步的,包括以下步骤:
(1)将0.5-1份卡波姆980和1-2份聚乙二醇400加入80份的水中混合均匀,再在混合溶液中加入1-2份明胶搅拌均匀,放置过夜后,在50~60℃条件下搅拌反应1小时,制成混合基质;
(2)将0.01-0.02份的羟苯乙酯溶于1000mL水中,制成羟苯乙酯水溶液,把0.5-1份氢氧化钠加入羟苯乙酯水溶液中,搅拌使氢氧化钠溶解,然后将上述溶液加入到步骤(1)中的混合基质中,搅拌均匀,再在混合基质中加入0.5-1份二氧化硅粉末、1-2份蚕丝蛋白微球,搅拌均匀,在40~50℃条件下继续搅拌反应2小时,制成空白基质;
(3)把6-9份牛膝、4-5份骨碎补、2-3份淫羊藿、2-3份独活和1-1.5份穿山龙在水中煎熬,得到煎熬后的药液,药液浓缩后加入空白基质中,然后对空白基质进行干燥,干燥后压制成凝胶药膏,得到治疗骨关节炎的中药缓释凝胶剂。
优选的,把凝胶药膏分割成小片包装制成成品。
有益效果
本发明的治疗骨关节炎的中药缓释凝胶剂,用于治疗和减缓患者的骨关节炎疾病,具有使用方便,疗效确切的优点,经过临床观察对治疗骨关节炎的有效率超过85%。
具体实施方式
下面对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例,都属于本发明保护的范围。
一种治疗骨关节炎的中药缓释凝胶剂,包括以下质量份数的组分:牛膝6-9份、骨碎补4-5份、淫羊藿2-3份、独活2-3份、穿山龙1-1.5份;卡波姆980 0.5-1份;明胶1-2份;蚕丝蛋白微球1-2份;聚乙二醇400 1-2份,氢氧化钠0.5-1份、羟苯乙酯0.01-0.02份、二氧化硅粉末0.5-1份。
制备上述治疗骨关节炎的中药缓释凝胶剂时,包括以下步骤:
(1)将0.5-1份卡波姆980和1-2份聚乙二醇400加入80份的水中混合均匀,再在混合溶液中加入1-2份明胶搅拌均匀,放置过夜后,在50~60℃条件下搅拌反应1小时,制成混合基质,备用;
(2)将0.01-0.02份的羟苯乙酯溶于1000mL水中,制成羟苯乙酯水溶液,把0.5份-1份氢氧化钠加入羟苯乙酯水溶液中,搅拌使氢氧化钠溶解,然后将上述溶液加入到步骤(1)中的混合基质中,搅拌均匀,再在混合基质中加入0.5份-1份二氧化硅粉末、1-2份蚕丝蛋白微球,搅拌均匀,在40~50℃条件下继续搅拌反应2小时,制成空白基质,备用;
(3)把6-9份牛膝、4-5份骨碎补、2-3份淫羊藿、2-3份独活和1-1.5份穿山龙在水中煎熬,得到煎熬后的药液,药液浓缩后加入空白基质中,然后对空白基质进行干燥,干燥后压制成凝胶药膏,即得。
把凝胶药膏分割成小片包装制成成品即可供患者使用。
上述说明已经充分揭露了本发明的具体实施方式。需要指出的是,熟悉该领域的技术人员对本发明的具体实施方式所做的任何改动均不脱离本发明的权利要求书的范围。相应地,本发明的权利要求的范围也并不仅仅局限于前述具体实施方式。
下面结合实施例对本发明作进一步说明。
实施例1
一种治疗骨关节炎的中药缓释凝胶剂,包括以下质量份数的组分:牛膝8份、骨碎补5份、淫羊藿3份、独活3份、穿山龙1.5份;卡波姆980 1份;明胶2份;蚕丝蛋白微球2份;聚乙二醇400 2份,氢氧化钠0.5份、羟苯乙酯0.02份、二氧化硅粉末0.5份。中药纳米颗粒粒径4-6纳米(公司自主研发的高分子纳米粉碎机制备)。
本发明以实施例1所给出的一种治疗关节炎的中药缓释凝胶剂,做临床疗效总结如下:
二、诊断依据:参照1994年国家中医药管理局《中医病证诊断疗效标准》制定的骨性关节炎诊断标准:
1、多为中老年人;
2、反复发作的关节周围疼痛,关节负重时疼痛加重,时有肿胀;
3、屈伸关节时多有粗糙的关节摩擦音;
4、X线示关节边缘骨赘,关节间隙明显变窄;
5、除外类风湿性关节炎。
三、用法用量:临床应用时取适量每日早、中、晚3次均匀使用。四周为一疗程。用药期间忌酸辣、油腻等刺激性食物。
四、疗效标准:参照1994年国家中医药管理局《中医病证诊断疗效标准》制定的骨性关节炎疗效评定标准:
(1)治愈:疼痛消失,关节活动功能恢复正常;
(2)显效:疼痛明显减轻,关节活动功能改善;
(3)有效:疼痛有所减轻,关节活动有所改善;
(4)无效:关节疼痛及活动范围无改善。
五、治疗效果:该临床观察病例中,服药1-3个疗程,痊愈28例,随访未见复发;显效10例,有效9例,无效3例。治疗期间未发生毒副作用。
六、典型病例:
1肩关节周围炎
病案1:
患者,男,55岁,2019年11月8日初诊。以左肩疼痛怕冷,活动受限5个月,加重2周为主诉。3个月前因夜间吹空调后出现左肩关节凉痛,得热则舒,未予重视,近日天冷加重,夜间为甚,难以入眠,活动不利,抬举受限,生活诸多不便;舌质暗红,苔薄白,脉沉弦。西医诊断:肩关节周围炎。中医诊断:肩痹(寒凝经脉证)。治宜温经散寒,活血止痛。
2019年12月16日二诊,患者诉使用上方药膏2周时左肩疼痛明显减轻。继续治疗两周。
2019年12月23日三诊,患者诉左肩疼痛已不明显,夜寐安和,但活动时仍疼痛。嘱患者配合肩关节功能锻炼,守上方再治疗1个疗程,左肩疼痛基本消失,功能明显改善。
2类风湿关节炎
病案2:
患者,女,52岁,2020年7月18日初诊。以四肢多关节肿痛13年,加重2个月为主诉。患者13年前无明显诱因发病,双手指关节、足趾关节相继出现肿痛,曾在多家医院治疗,时轻时重,反复发作,双手逐渐变形。1个月前因劳累和接触冷水发作,双手掌指关节、近端指间关节及腕关节肿胀,疼痛加重,双膝肿痛,双足趾肿痛不适,全身怕风怕冷,得温则舒,双手晨僵,舌质淡红,苔白滑腻,脉弦缓。红细胞沉降率(ESR)82mm·h-1,类风湿因子(RF)阳性。西医诊断:类风湿关节炎。中医诊断:历节(寒湿痹阻证)。
患者诉使用上方药膏两周时四肢关节肿痛及晨僵有所减轻,仍怕风怕冷。患者诉使用上方药膏四周时肿痛明显减轻,双手如释重负,感觉身热、鼻孔有热气。查ESR 17mm·h-1,RF阳性。方中辛热之品起效,又守方调治2周,肿痛症状基本消失,复查ESR、RF正常。
Claims (6)
1.一种治疗骨关节炎的中药缓释凝胶剂,其特征在于,包括以下质量份数的组分:牛膝6-9份、骨碎补4-5份、淫羊藿2-3份、独活2-3份、穿山龙1-1.5份;卡波姆980 0.5-1份;明胶1-2份;蚕丝蛋白微球1-2份;聚乙二醇400 1-2份,氢氧化钠0.5-1份;羟苯乙酯0.01-0.02份;二氧化硅粉末0.5-1份。
2.根据权利要求1所述的治疗骨关节炎的中药缓释凝胶剂,其特征在于,包括以下质量份数的组分:牛膝8份、骨碎补5份、淫羊藿3份、独活3份、穿山龙.5份;卡波姆980 1份;明胶2份;蚕丝蛋白微球2份;聚乙二醇400 2份,氢氧化钠0.5份;羟苯乙酯0.01份;二氧化硅粉末0.5份。
3.根据权利要求1所述的治疗骨关节炎的中药缓释凝胶剂,其特征在于,中药纳米颗粒粒径4-6纳米。
4.根据权利要求1~3任一项所述的治疗骨关节炎的中药缓释凝胶剂的制备方法,其特征在于,包括以下步骤:
将卡波姆980和聚乙二醇400加入水中混合均匀,再加入明胶搅拌均匀并放置过夜后,在50~60℃条件下搅拌反应1小时,制成混合基质;把氢氧化钠加入羟苯乙酯水溶液,搅拌使氢氧化钠溶解,然后将上述溶液加入到混合基质中,搅拌均匀,再在混合基质中加入二氧化硅粉末、蚕丝蛋白微球,搅拌均匀,在40~50℃条件下继续搅拌反应2小时,制成空白基质;把牛膝、骨碎补、淫羊藿、独活和穿山龙在水中煎熬,将煎熬后的药液浓缩后加入空白基质中,然后对空白基质进行干燥,干燥后压制成凝胶药膏,得到治疗骨关节炎的中药缓释凝胶剂。
5.根据权利要求4所述的治疗骨关节炎的中药缓释凝胶剂的制备方法,其特征在于,
(1)将0.5-1份卡波姆980和1-2份聚乙二醇400加入80份的水中混合均匀,再在混合溶液中加入1-2份明胶、搅拌均匀,放置过夜后,在50~60℃条件下搅拌反应1小时,制成混合基质;
(2)将0.01-0.02份的羟苯乙酯溶于1000mL水中,制成羟苯乙酯水溶液,把0.5份-1份氢氧化钠加入羟苯乙酯水溶液中,搅拌使氢氧化钠溶解,然后将上述溶液加入到步骤(1)中的混合基质中,搅拌均匀,再在混合基质中加入0.5份-1份二氧化硅粉末、1-2份蚕丝蛋白微球,搅拌均匀,在40~50℃条件下继续搅拌反应2小时,制成空白基质;
(3)把6-9份牛膝、4-5份骨碎补、2-3份淫羊藿、2-3份独活和1-1.5份穿山龙在水中煎熬,得到煎熬后的药液,药液浓缩后加入空白基质中,然后对空白基质进行干燥,干燥后压制成凝胶药膏,得到治疗骨关节炎的中药缓释凝胶剂。
6.根据权利要求4所述的治疗骨关节炎的中药缓释凝胶剂的制备方法,把缓释凝胶药膏分割成小片包装制成成品。
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