CN109395026B - 一种预防产后子宫复旧不良的凝胶制剂的制备方法 - Google Patents
一种预防产后子宫复旧不良的凝胶制剂的制备方法 Download PDFInfo
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Abstract
本发明涉及一种预防产后子宫复旧不良的凝胶制剂的制备方法，其制备步骤为：(1)称取重量配比为：党参8‑12g、黄芪7‑13g、山茱萸8‑12g、当归5‑15g、益母草15‑25g、红花18‑22g、莪术13‑18g、三棱10‑20g的中药原料，进行有效成分提取、纯化，形成中药浓缩液；(2)再将中药浓缩液与羟丙基纤维素和丙三醇混合静置后得到凝胶制剂。本发明凝胶制剂经现代制备工艺纯化提取其有效成分制成，能快速经皮透穴给药吸收预防产后子宫复旧不良，弥补产妇产后体虚、胃纳差，口服中药制剂影响产妇食欲而导致优质食物摄入减少的不足，中草药穴位贴敷给药吸收慢、易脱落等问题。
Description
技术领域
本发明涉及用现代工艺提取中药有效成分合成凝胶制剂，具体的说是一种中药凝胶通过穴位经皮渗透预防治疗产后子宫复旧不良的凝胶制剂的制备方法。
背景技术
产后子宫复旧不良是一种产褥期常见病，常表现为血性恶露持续时间长，血量增多并且多伴随有臭味,如果子宫复旧不良不能及时得到纠正,会逐渐引起慢性炎症,从而形成子宫纤维化,致使月经延长或者是月经量增多严重影响产妇健康，导致近期并发症(腹痛、恶露不绝、感染、晚期产后出血等)和远期并发症(子宫肥大、盆腔淤血综合征、子宫内膜异位症等。
西医治疗该病症常用的缩宫剂包括垂体后叶素类(如催产素)、生物碱类(如麦角新碱注射液)和前列腺素类(如卡前列素氨丁三醇)3类药物干预治疗。缩宫素是最常用的药物，但有一定的副作用，产后大剂量使用缩宫素会使子宫强直收缩，有些产妇出现难以忍受的宫缩痛，少数患者会发生头晕、血压下降等不良反应；前列腺素类(如卡前列素氨丁三醇)价格昂贵，麦角新碱因其严重副作用已在国内很少使用。内病外治是中医的传统理论，临床上常口服中草药方剂或将中草药研磨成粉末状混合调制成糊状，贴敷于穴位，在治疗和预防子宫复旧不良取得不错的疗效，但口服中药胃肠刺激大，影响产妇食欲而导致大量优质食物摄入减少的不足，穴位外敷有效成分很难计量、不能迅速、充分的透皮透穴，被经络吸收利用，药物易脱落、不易固定，限制药效的发挥。
发明内容
本发明的目的是提供一种预防产后子宫复旧不良的凝胶制剂，用于穴位外敷来有效预防产后子宫复旧不良，主要以补养气血、缩宫止血，抗炎消肿、活血化瘀、祛腐生新、促进恶露排空净尽，治疗效果好，无毒副作用，标本兼治。
为了达到上述目的，本发明提供一种预防产后子宫复旧不良的凝胶制剂的制备方法，其制备步骤为：
(1)称取重量配比为：党参8-12g、黄芪7-13g、山茱萸8-12g、当归5-15g、益母草15-25g、红花18-22g、莪术13-18g、三棱10-20g的中药原料，进行有效成分提取、纯化，形成中药浓缩液；
(2)再将中药浓缩液与羟丙基纤维素和丙三醇混合静置后得到凝胶制剂。
一些优选的实施方式中，步骤(3)中得到的中药浓缩液在60℃测得相对密度1.05为佳。
一些优选的实施方式中，步骤(1)中提取、纯化步骤包括：
a在中药原料中加原料重量十倍的水，煎煮2h，过滤得第一煎煮液和药渣；
b在药渣中加原料重量八倍的水，浸泡2h；
c煎煮1h，过滤，得第二煎煮液和药渣；
d在c中得到的药渣中加入原料重量四倍的水，再煎煮1h，过滤，得第三煎煮液和药渣；
e合并a，c，d步骤的第一煎煮液、第二煎煮液和第三煎煮液，减压浓缩；
f搅拌、静置、过滤后形成中药浓缩液。
一些优选的实施方式中，步骤(2)中中药浓缩液与羟丙基纤维素和丙三醇混合静置后得到凝胶制剂的步骤包括：
a取中药浓缩液，加入纯化水，搅拌均匀；其中，中药浓缩液与纯化水重量比为6:4；
b加入羟丙基纤维素，搅拌均匀；
c加入丙三醇，搅拌均匀；其中，中药浓缩液：纯化水：羟丙基纤维素：丙三醇的重量比为600:400:1.2:0.15；
d调PH值至中性后，静置12h，得到凝胶制剂。
一些优选的实施方式中，步骤(2)的d步骤中通过柠檬酸或氢氧化钠来调节PH值。
一些优选的实施方式中，步骤(1)中中药原料的组分配比为：党参10g、黄芪10g、山茱萸10g、当归10g、益母草20g、红花20g、莪术15g、三棱15g、红花20g。
相比较传统中药提取制剂(如膏剂、胶剂、茶剂、酒剂等)传统工艺多制作粗糙、稳定性及安全性差，质量可控性不佳，且不利于携带和储存的情况，本发明的凝胶制剂的制备方法来提取、凝缩、制胶，其工艺简单、性质稳定、质量可控，且获得的凝胶制剂具有较好的生物粘附性，皮肤渗透性好，使用方便。
另一方面，本发明还提供一种预防产后子宫复旧不良的凝胶制剂，其中，该凝胶制剂的组分由以下重量配比制成：党参8-12g、黄芪7-13g、山茱萸8-12g、当归5-15g、益母草15-25g、红花18-22g、莪术13-18g、三棱10-20g。
一些优选的实施方式中，凝胶制剂的组分由以下重量配比制成：党参10g、黄芪10g、山茱萸10g、当归10g、益母草20g、红花20g、莪术15g、三棱15g。
本发明采用上述中药药物，是由于：
党参：其性味甘平，具有补中益气、健脾益肺兼养血之功效，临床上常用于脾肺气虚、中气不足、脾胃虚弱、热病伤津等症；
黄芪：其味甘,微温,具有补气升阳、益卫固表、利水消肿、托毒生肌之效；黄芪与党参同用,能增强益气健脾,升举阳气,可用于病后气虚体弱；
山茱萸：味酸涩，微温，入肝、肾经，功效有补肝益肾，涩精固脱，是中医临床常用的抗衰老药；
当归：味甘、辛、温，有补血活血、润肠通便之功效，主治血虚头昏、面色不华，跌打损伤、瘀血肿痛，血脉瘀滞、风湿痹痛，疮疡痈肿，月经不调、痛经闭经、崩漏及产后瘀滞腹痛等病症；
益母草：味辛苦、凉，具有活血调经，利尿消肿，清热解毒之功效，治疗妇女月经不调，胎漏难产，胞衣不下，产后血晕，瘀血腹痛；
红花：辛，温，活血通经，散瘀止痛，有助于治经闭、痛经、恶露不行、瘀滞腹痛、胸胁刺痛、跌倒损伤、疮疡肿痛疗效；
莪术：温味辛苦,具有破血祛瘀、行气止痛功效：用于气滞血瘀之经闭、腹痛等；
三棱：性平味苦，通肝经积血，女人月水，产后恶血，用于症瘕痞块，痛经，瘀血经闭。
按照中药君臣佐使组方配伍的原则，本研究的制剂以黄芪和党参为君药，黄芪性味甘、微温、入脾，脾为气血生化之源，补气效果明显，将当归、山茱萸以及熟地黄作为臣药具有抗血栓和止血镇痛功能。
此外，本发明还提供一种凝胶制剂的使用方法，其中，该凝胶制剂包含重量配比为：党参8-12g、黄芪7-13g、山茱萸8-12g、当归5-15g、益母草15-25g、红花18-22g、莪术13-18g、三棱10-20g的组分；其具体步骤为：
1.将凝胶制剂敷涂抹在腹部中脘穴、神阙穴、子宫穴和归来穴；
2.分别按摩中脘穴、神阙穴、子宫穴和归来穴各5分钟；
3.每天涂抹并按摩中脘穴、神阙穴、子宫穴和归来穴一次；连续按摩3-7天。
一些优选的实施方式中，该凝胶制剂包含重量配比为：党参10g、黄芪10g、山茱萸10g、当归10g、益母草20g、红花20g、莪术15g、三棱15g、红花20g的组分。
有益效果
本发明凝胶制剂经现代制备工艺纯化提取其有效成分制成，能快速经皮透穴给药吸收预防产后子宫复旧不良，弥补产妇产后体虚、胃纳差，口服中药制剂影响产妇食欲而导致优质食物摄入减少的不足，中草药穴位贴敷给药吸收慢、易脱落等问题。
附图说明
图1为本发明的中药原料提取和纯化流程图；
图2为本发明凝胶制备流程图。
具体实施方式
以下通过具体实施方式的描述对本发明做进一步说明，但这并非是对本发明的限制，本领域技术人员根据本发明的基本思想，可以做出各种修改或改进，但是只要不脱离本发明的基本思想，均在本发明的范围之内。
实施例一：凝胶制剂的制备
称取党参10g、黄芪10g、山茱萸10g、当归10g、益母草20g、红花20g、莪术15g、三棱15g，混合后加入1100g的水，煎煮2h。过滤得第一煎煮液和药渣，在药渣中加入880g的水，浸泡2h后煎煮1h，过滤，得第二煎煮液和药渣。再在药渣中加入440g的水，再煎煮1h，过滤，得第三煎煮液和药渣。合并第一煎煮液、第二煎煮液和第三煎煮液，减压浓缩，测得60℃时相对密度1.05；搅拌、静置、过滤后形成中药浓缩液600g。
在600g中药浓缩液中加入400g纯化水，搅拌均匀。再加入1.2g羟丙基纤维素，搅拌均匀。最后加入0.15g丙三醇搅拌均匀。测试浓缩液的PH值，若PH值小于7，则用氢氧化钠来将浓缩液调节到中性(PH＝7)，若PH值大于7，则用柠檬酸调PH值至中性。然后静置12h，得到凝胶制剂1000g。
实施例二：凝胶制剂的制备
称取党参8g、黄芪7g、山茱萸8g、当归5g、益母草15g、红花18g、莪术18g、三棱10g，按照实施例一的方法和添加物的添加配比提取中药有效成分合成得到凝胶制剂。
实施例三：凝胶制剂的制备
称取党参12g、黄芪13g、山茱萸12g、当归15g、益母草25g、红花22g、莪术13g、三棱20g，按照实施例一的方法和添加物的添加配比提取中药有效成分合成得到凝胶制剂。
实例四：凝胶制剂的使用方法及效果
张某某，女，32岁，嘉兴市秀洲区王江泾镇南汇村。
初诊日期：2018年11月8日13时40分，顺产后2小时回母婴同室，面色萎黄，宫底脐上一指，质硬，有宫缩痛，疼痛评3分，膀胱略充盈，患者因疼痛拒绝小便。
使用本发明凝胶制剂涂抹腹部中脘、神阙、子宫、归来穴位并按摩5分钟，一天一次，共3天。2小时后自觉宫缩痛减轻，疼痛评1分，产后4小时小便自解，通畅，3天后效果明显，子宫脐下三指，无宫缩疼痛，血色素未下降，正常出院，1周后复查无血性恶露，子宫复原正常大小。
实例五：凝胶制剂的使用方法及效果
肖某某，女，25岁，浙江省嘉兴市南湖区新丰镇杨庄村。
初诊日期：2018年11月8日，私人产科医院阴道分娩产后7天，阴道大于月经量出血2小时入院，医院诊断为产后子宫复旧不良，病情主要以下腹坠胀感，血性恶露量增多，全身乏力，胸闷，对产妇的身体和生活带来的极大的痛苦，患者家属异常紧张，来院就诊时面色萎黄无华，人体无力，仍有月经量出血。
使用本发明凝胶制剂涂抹腹部中脘、神阙、子宫、归来穴位并按摩5分钟，一天一次，共7天。3天后效果明显，5天后出院，1周后随访，无血性恶露，子宫复原正常大小，血色素正常。
实例六：：凝胶制剂的使用方法及效果
赵某某，女，25岁，浙江省嘉兴市海宁周王庙镇联民村。
初诊日期：2018年11月11日10时10分，因二次剖宫产术后回母婴同室，面色萎黄，宫底脐平，质硬，切口疼痛评2分，宫缩疼痛评3分。
使用本发明凝胶制剂涂抹腹部中脘、神阙、子宫、归来穴位并按摩5分钟，一天一次，共5天。10小时尿管拔除，术后11小时小便自解通畅，3天后效果明显，4天后出院，1周后随访，无血性恶露，子宫复原正常大小，血色素正常。
实施例7临床对照实验
入选的92例产妇依据数字表随机分成对照组和治疗组，治疗组产后使用产后子宫复旧的中药组合物凝胶制剂敷腹部中脘、神阙、子宫、归来穴位并按摩，一天一次。连续3天，对照组产后常规口服本院中医师配置的新生化中成药饮品，每天2次口服，连续3天。新生化中成药饮品组合物：川穹9克，当归12克，桃仁6克，炮姜3克，炙甘草5克，益母草10克，丹参10克，黄芪15克。治疗组初产妇30例，经产妇16，平均年龄29.12±4.32，平均孕周38.42±1.84；对照组初产妇28例，经产妇18例，平均年龄29.80±4.71，平均孕周38.12±1.76。
观察方法：
1子宫收缩情况：分别于产后1天、2天、3天测量子宫的高度与宽度，并计算乘积，护士记录产后第1～3天宫缩痛评分。
2阴道出血量计算：用已知重量的消毒产垫给血称重，减去原产垫重，再除以平均比重1.05，即得出血量。
3产后恶露结束时间，分≤10天，11-20天，21-30天
4产后子宫复旧的参照《中医临床病症诊断疗效标准》，痊愈：子宫恢复正常大小，恶露停止，症状消失，为痊愈。好转：恶露减少，6周内子宫复原接近正常大小，质软，症状接近好转，无效：连续治疗10天，症状无改善者，产后子宫复旧不良发生率于产后2个月追踪观察。
结果：
运用SPSS19.0统计软件进行处理。计量资料采用均数±标准差表示，计数资料采用频数表示。计量资料组间比较采用独立样本t检验，有序等级资料组间比较采用非参数秩和检验。P＜0.05差异有统计学意义。
采用独立样本t检验比较治疗组与对照组间产后1天、产后2天、产后3天宫底高宽乘积的变化，结果显示治疗组与对照组间产后1天宫底高度差异无统计学意义，治疗组与对照组间产后2天、产后3天宫底高度差异有统计学意义，治疗组产后2天、产后3天的宫底高度低于对照组。见表1
表1治疗组与对照组间宫底高宽乘积比较
采用独立样本t检验比较治疗组与对照组间产后1天、产后2天、产后3天阴道出血的差异，结果显示治疗组与对照组间产后1天阴道出血差异无统计学意义，治疗组与对照组间产后2天、产后3天阴道出血差异有统计学意义，治疗组产后2天、产后3天的阴道出血少于对照组。见表2
表2治疗组与对照组间阴道出血比较
采用非参数秩和检验比较治疗组与对照组间产后1天、产后2天、产后3天宫缩痛的差异，结果显示治疗组与对照组间产后1天宫缩痛差异无统计学意义，治疗组与对照组间产后2天、产后3天宫缩痛差异有统计学意义，治疗组产后2天、产后3天的宫缩痛等级低于对照组。见表3
表3治疗组与对照组间宫缩痛比较
采用独立样本t检验比较治疗组与对照组间恶露停止时间的差异，结果显示治疗组与对照组间恶露停止时间差异有统计学意义，治疗组的恶露停止时间少于对照组。见表4
表4治疗组与对照组间恶露停止时间比较
两组子宫复旧不良比较，结果显示治疗组与对照组间子宫复旧的有效率差异有统计学意义见表5
表5治疗组与对照组间子宫复旧不良比较
讨论：
临床经验提示我们：产后子宫复旧不良是一种产褥期常见病，临床研究显示其发生率在22％～39％，常表现为产后子宫收缩欠佳，恶露排除不畅，血性恶露持续时间长，严重者引发宫腔感染、如果子宫复旧不良不能及时得到纠正,会逐渐引起慢性炎症,从而形成子宫纤维化,致使月经延长或者是月经量增多严重影响产妇健康。中医认为产后子宫复旧不良主要是因为产后瘀血内阻,冲任二脉失固,气血运行失常,多虚多瘀。在《金匮要略》中也记载：“新产血虚，多汗出，喜中风亡津液，胃躁，故大便难”。这些都是由于产妇在产后生理得到改变而极易发生的病症。所以，中医常以活血活瘀是治疗子宫复旧的关键,养血益气是治疗子宫复旧的基础。当归、黄芪、熟地，有利于补养气血、缩宫止血，抗炎消肿、活血化瘀、祛腐生新、防治晚期产后出血或缩短产后出血时间，促进恶露排空净尽。
本组方凝胶制剂吸收中医验方中党参黄芪联合养血化瘀改善产后子宫复旧不良的药理作用，黄芪补气、既能升补脾气，又能益肺固表。党参补气，只能健脾补气，无固表之力，但党参却能益气生津，黄芪则无生津之效。黄芪兼能利水，党参无利水作用。如黄芪和党参联合，能发挥两种药的互补协同作用治疗产科顽症-产后子宫复旧不良，促进恶露排尽。
任何一种促进子宫复旧、减少产褥感染，减少出血量，促进恶露干净的新药问世，都会给产妇带来福音，维护女性健康。本组方凝胶制剂经腹部穴位贴敷疗法一方面通过药物经皮渗透吸收作用，避免了消化道酶的破坏及肝脏的首过效应，直达病所且药力专一；另一方面，人与动物都存在循经低阻现象，低阻点皮肤药物传输效率高，穴位给药后药物的透过量和稳态透皮速率较高，且经络对药物具有放大效应，有助于发挥药物的归经作用，在病变组织器官起到较强的药理作用。组方剂型方便，疗效确切，安全有效，是一种有前途值得开发的中药剂型。
Claims (4)
1.一种预防产后子宫复旧不良的凝胶制剂的制备方法，其制备步骤为：
称取重量为：党参8-12g 、黄芪7-13g 、山茱萸8-12g 、当归5-15g 、益母草15-25g、红花18-22g、莪术13-18g 、三棱10-20g的中药原料，进行有效成分提取、纯化，形成中药浓缩液；
再将中药浓缩液与羟丙基纤维素和丙三醇混合静置后得到凝胶制剂。
2.根据权利要求1所述的凝胶制剂的制备方法，其特征在于，步骤（1）中提取、纯化步骤包括：
a 在中药原料中加原料重量十倍的水，煎煮2h，过滤得第一煎煮液和药渣；
b 在药渣中加原料重量八倍的水，浸泡2h；
c 煎煮1h，过滤，得第二煎煮液和药渣；
d 在c中得到的药渣中加入原料重量四倍的水，再煎煮1h，过滤，得第三煎煮液和药渣；
e 合并a，c，d步骤的第一煎煮液、第二煎煮液和第三煎煮液，减压浓缩；
f 搅拌、静置、过滤后形成中药浓缩液。
3.根据权利要求1所述的凝胶制剂的制备方法，其特征在于，步骤（2）中中药浓缩液与羟丙基纤维素和丙三醇混合静置后得到凝胶制剂的步骤包括：
a 取一定量的中药浓缩液，加入纯化水，搅拌均匀；其中，中药浓缩液与纯化水重量比为6:4；
b加入羟丙基纤维素，搅拌均匀；
c加入丙三醇，搅拌均匀；其中，中药浓缩液：纯化水：羟丙基纤维素：丙三醇的重量比为600:400:1.2:0.15；
d调pH 值至中性后，静置12h，得到凝胶制剂。
4.根据权利要求1-3之一所述的凝胶制剂的制备方法，其特征在于，步骤（1）中中药原料的组分为：党参10g 、黄芪10g 、山茱萸10g 、当归10g 、益母草20g、红花20g、莪术15g 、三棱15g。
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