CN115068578B - 一种治疗胰岛素抵抗型多囊卵巢综合征的中药组合物及其应用 - Google Patents
一种治疗胰岛素抵抗型多囊卵巢综合征的中药组合物及其应用 Download PDFInfo
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- CN115068578B CN115068578B CN202210710459.5A CN202210710459A CN115068578B CN 115068578 B CN115068578 B CN 115068578B CN 202210710459 A CN202210710459 A CN 202210710459A CN 115068578 B CN115068578 B CN 115068578B
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Abstract
本发明公开了一种治疗胰岛素抵抗型多囊卵巢综合征的中药组合物及其应用。该中药组合物为包括以下重量份的原料药制成：黄芩3‑10份、黄连2‑5份、清半夏3‑9份、干姜3‑10份、麸炒苍术3‑9份、枳壳3‑10份、厚朴3‑10份、冬瓜仁10‑15份、瓜蒌仁9‑15份、丹参10‑15份、夏枯草9‑15份。本发明还公开了上述中药组合物的制备方法及在制备治疗胰岛素抵抗型多囊卵巢综合征药物中的应用。本发明中药组合物可有效恢复胰岛素抵抗型多囊卵巢综合征患者的自发排卵和自主月经。
Description
技术领域
本发明涉及中医药技术领域。更具体地，涉及一种治疗胰岛素抵抗型多囊卵巢综合征的中药组合物及其应用。
背景技术
多囊卵巢综合征(Polycystic ovary syndrome，PCOS)是育龄期女性最常见的生殖内分泌代谢紊乱性疾病，在我国患病率高达5.6％，以排卵障碍、高雄激素血症和卵巢多囊样变为主要特征，其中，排卵障碍在我国患者中尤为普遍，占PCOS患者的89.4％，由排卵障碍所导致的月经异常和生殖功能障碍是患者来妇科就诊的最主要原因。对于有生育需求但存在排卵障碍的PCOS患者，中华医学会《多囊卵巢综合征中国诊疗指南》中推荐的促排卵药为来曲唑、克罗米芬，二者均为对症治疗，缺乏长期疗效，且存在受孕率低、易合并卵巢过度刺激综合征、卵泡黄素化不破裂综合征等局限性。促排卵药若应用次数过多，有增加卵巢癌的风险，因此不能长期应用。对于青春期或没有生育需求的患者，不适合使用促排卵药来恢复月经，而是需要一种能帮助其恢复自主月经和自发排卵的药物。
PCOS的临床表现具有高度异质性，胰岛素抵抗是其常见类型之一。该类患者表现为月经稀发或闭经，不孕，肥胖。近期易合并代谢综合征，远期则子宫内膜癌、糖尿病、心脑血管疾病的患病率增加。目前治疗胰岛素抵抗型PCOS的一线药物是二甲双胍。该药是胰岛素增敏剂，可以增加胰岛素敏感性，改善糖脂代谢及排卵情况，降低雄激素水平，但恢复排卵率为32％左右，胃肠道不良反应较为严重。
因此，针对胰岛素抵抗型PCOS患者，有待开发一种可有效恢复其自发排卵和自主月经的中药制剂。
发明内容
针对上述技术问题，本发明的一个目的在于提供一种新的中药组合物，该中药组合物能有效治疗胰岛素抵抗型PCOS。
本发明的另一个目的在于提供上述中药组合物在制备治疗胰岛素抵抗型PCOS药物中的应用。
为达到上述目的，本发明采用下述技术方案：
第一方面，本发明提供一种治疗胰岛素抵抗型PCOS的中药组合物，包括以下重量份的原料药制成：黄芩3-10份、黄连2-5份、清半夏3-9份、干姜3-10份、麸炒苍术3-9份、枳壳3-10份、厚朴3-10份、冬瓜仁10-15份、瓜蒌仁9-15份、丹参10-15份、夏枯草9-15份。
上述药材的选择是发明人根据中医理论经过多年的临床经验摸索、总结所得，并经过了分析、研究和验证。该中药组合物处方精简，对于自发排卵的恢复疗效更佳，更有利于PCOS患者自主月经的恢复。
在本发明处方中，黄芩和黄连同为君药，性苦寒，清泻胃热。半夏和干姜为臣药，味辛，散结消痞。麸炒苍术：健脾燥湿，为佐使药。枳壳和厚朴：行气消痞，为佐使药。冬瓜仁和瓜蒌仁：化痰，为佐使药。丹参和夏枯草：活血行气，为佐使药。
优选的，所述治疗胰岛素抵抗型PCOS的中药组合物，包括以下重量份的原料药制成：黄芩5-10份、黄连3-5份、清半夏5-9份、干姜4-6份、麸炒苍术5-9份、枳壳5-10份、厚朴5-10份、冬瓜仁12-15份、瓜蒌仁10-15份、丹参12-15份、夏枯草10-15份。
更优选的，所述治疗胰岛素抵抗型PCOS的中药组合物，包括以下重量份的原料药制成：黄芩10份、黄连5份、清半夏9份、干姜5份、麸炒苍术9份、枳壳10份、厚朴10份、冬瓜仁15份、瓜蒌仁15份、丹参15份、夏枯草12份。
本发明上述中药组合物的各原料药组成基本方，在本发明具体的实施方式中，根据临床症状在上述中药组合物的基础上可以进行调整，以达到治疗胰岛素抵抗型PCOS及改善某些临床症状的目的，进一步增强本发明组合物的适应性，提高治疗效果。
第二方面，本发明提供了一种上述治疗胰岛素抵抗型PCOS的中药组合物的制备方法，该制备方法包括如下步骤：按配方量取黄芩、黄连、清半夏、干姜、麸炒苍术、枳壳、厚朴、冬瓜仁、瓜蒌仁、丹参和夏枯草，加水煎煮两次，合并煎液，滤过，即得。
进一步的，为了便于储存，上述制备方法还可以包括将滤液浓缩为清膏的步骤。
进一步的，在上述制备方法中，加水量为原料药总质量的10-15倍；所述煎煮的时间为1-1.5小时；所述清膏为60℃测定的相对密度为1.30-1.35的清膏。
第三方面，本发明提供了一种治疗胰岛素抵抗型PCOS的药物，该药物以上述中药组合物作为活性成分。
根据实际需要，所述药物还可以包括药学上可接受的辅料。按照常规制剂工艺，制成各种制剂，如煎剂、颗粒剂、丸剂、胶囊剂、片剂、散剂、口服液等剂型。
本发明还提供了上述中药组合物在制备治疗胰岛素抵抗型PCOS的药物中的应用。
另外，如无特殊说明，本发明中药组合物各原料药均可通过市售商购获得，本发明所记载的任何范围包括端值以及端值之间的任何数值以及端值或者端值之间的任意数值所构成的任意子范围的中药组合物均可以达到治疗胰岛素抵抗型PCOS的目的。
本发明的有益效果如下：
本发明中药组合物有较好的恢复胰岛素抵抗型PCOS自发排卵和自主月经的作用，填补了恢复胰岛素抵抗型PCOS自发排卵和自主月经药物的空白。
具体实施方式
为了更清楚地说明本发明，下面结合优选实施例对本发明做进一步的说明。本领域技术人员应当理解，下面所具体描述的内容是说明性的而非限制性的，不应以此限制本发明的保护范围。
实施例1一种治疗胰岛素抵抗型PCOS的中药组合物
原料药配方：黄芩10g、黄连5g、清半夏9g、干姜5g、麸炒苍术9g、枳壳10g、厚朴10g、冬瓜仁15g、瓜蒌仁15g、丹参15g、夏枯草12g。
取以上十三味原料药，加10倍水煎煮两次，分别煎煮1.5小时、1小时，合并煎液，滤过，滤液浓缩至适量(相对密度为1.30～1.35(60℃)的清膏)，即得。
实施例2一种治疗胰岛素抵抗型PCOS的药物(颗粒剂)
原料药配方：黄芩10g、黄连5g、清半夏9g、干姜5g、麸炒苍术9g、枳壳10g、厚朴10g、冬瓜仁15g、瓜蒌仁15g、丹参15g、夏枯草12g。
取以上十三味原料药，加10倍水煎煮两次，分别煎煮1.5小时、1小时，合并煎液，滤过，滤液浓缩至适量(相对密度为1.30～1.35(60℃)的清膏)，减压干燥，粉碎过80目筛，加入适量糊精混匀，制粒，干燥，即得。
实施例3一种治疗胰岛素抵抗型PCOS的药物(煎剂)
原料药配方：黄芩9g、黄连5g、清半夏7g、干姜6g、麸炒苍术9g、枳壳9g、厚朴9g、冬瓜仁12g、瓜蒌仁10g、丹参12g、夏枯草10g。
取以上十三味原料药，加10倍水煎煮两次，分别煎煮1.5小时、1小时，合并煎液，滤过，即得。
实施例4本发明中药组合物治疗胰岛素抵抗型PCOS的疗效试验
1资料与方法
1.1一般资料
选择2020年12月～2022年6月在中国中医科学院广安门医院妇科门诊就诊的PCOSIR患者28人，年龄29.04±2.92岁，已婚17例，未婚11例。空腹胰岛素水平128.07±44.77.Pmol/L，HOMA-IR指数为4.65±1.88。
1.2诊断标准
1.2.1PCOS诊断标准
参照2003年5月欧洲人类生殖和胚胎学会(ESHRE)和美国生殖医学会(ASRM)制定并由中华医学会妇产科分会推荐使用的PCOS诊断标准。
1.2.2病例纳入标准
1)符合PCOS诊断标准；2)年龄18-35岁；3)同意接受12周治疗并签署知情同意书。
1.2.3病例排除标准
1)合并糖尿病、甲状腺、肾上腺等其他内分泌疾病患者；2)合并有心脑血管、肝、肾及造血系统等严重疾病及血栓性疾病患者；3)精神病或癌症患者；
4)近3个月内服用过激素类(黄体酮除外)及其他影响生殖内分泌的药物者；5)曾有严重中药过敏史者；6)月经来潮不足2年者。
1.3治疗方法
以实施例2制备的药物(颗粒剂)进行治疗。温水冲服，日一剂，早、晚分2次服，连续治疗12周。
1.4观察指标
(1)基础体温(BBT)：每天测量，计算基础体温双相率。
(2)空腹胰岛素及胰岛素抵抗指数：分别于治疗0周、12周进行，禁食12h后，测定空腹血糖、胰岛素，并计算胰岛素抵抗指数(HOMA-IR)(计算公式：HOMA-IR＝FINS(Pmol/L)*FPG(mmol/L)/22.5)，比较治疗前后差异。
(3)月经周期评分(自拟)，月经周期的评分标准为：正常0分，轻度1分，中度及重度2分。
(4)卵泡刺激素(FSH)、LH、雌二醇(E2)、睾酮(T)、泌乳素(PRL):于治疗前月经2～4天及治疗4周后清晨空腹抽静脉血。
1.5统计学方法
采用spss25.0建立数据库，并进行数据分析。符合正态分布的计量资料用均数加减标准差表示，治疗前后比较用t检验；不符合正态分布的计量资料用中值(四分位距)描述，治疗前后比较用非参数检验；计数资料用N(％)表示，治疗前后比较用卡方检验；P＜0.05时差异有统计学意义，P＜0.01时统计学差异具有显著性，P＞0.05时无统计学意义。
2结果
2.1对排卵的影响
基础体温出现双相说明95％的可能出现了排卵。28例患者中，19例患者基础体温出现双相，双相率为70.37％。其中有妊娠需求者3人，1人妊娠。说明本发明药物有一定恢复胰岛素抵抗型PCOS患者自发排卵的作用。
2.2对空腹胰岛素及HOMA-IR(胰岛素素抵抗)指数的影响
与治疗前相比，治疗后患者空腹胰岛素水平、HOMA-IR指数、胰岛素曲线下面积均有下降趋势(P＞0.05)(见表1)。
表1:对空腹胰岛素及HOMA-IR指数的影响
注：*P＜0.05
2.3对月经周期评分的影响
与治疗前相比，治疗后月经周期评分明显降低，差异有统计学意义(P＜0.01)，说明本发明药物有恢复患者自主月经的作用(见表2)。
表2:对月经周期评分的影响
注：**P＜0.01
2.3对女性激素的影响
28例患者在治疗前、后的女性激素水平均在正常范围内。与治疗前相比，治疗后患者血清E2明显降低，差异有统计学意义(P＜0.05)，T、LH、PRL有下降趋势，FSH治疗前相比无明显差异(见表3)。
表3治疗前后血清性激素水平的比较
注：*P＜0.05
3结论
本发明中药组合物有恢复胰岛素抵抗型PCOS患者自发排卵和自主月经的作用。
显然，本发明的上述实施例仅仅是为清楚地说明本发明所作的举例，而并非是对本发明的实施方式的限定，对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动，这里无法对所有的实施方式予以穷举，凡是属于本发明的技术方案所引伸出的显而易见的变化或变动仍处于本发明的保护范围之列。
Claims (10)
1.一种治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，其特征在于，由以下重量份的原料药制成：黄芩3-10份、黄连2-5份、清半夏3-9份、干姜3-10份、麸炒苍术3-9份、枳壳3-10份、厚朴3-10份、冬瓜仁10-15份、瓜蒌仁9-15份、丹参10-15份、夏枯草9-15份。
2.根据权利要求1所述的中药组合物，其特征在于，由以下重量份的原料药制成：黄芩5-10份、黄连3-5份、清半夏5-9份、干姜4-6份、麸炒苍术5-9份、枳壳5-10份、厚朴5-10份、冬瓜仁12-15份、瓜蒌仁10-15份、丹参12-15份、夏枯草10-15份。
3.根据权利要求1所述的中药组合物，其特征在于，由以下重量份的原料药制成：黄芩10份、黄连5份、清半夏9份、干姜5份、麸炒苍术9份、枳壳10份、厚朴10份、冬瓜仁15份、瓜蒌仁15份、丹参15份、夏枯草12份。
4.权利要求1-3任一所述的治疗胰岛素抵抗型多囊卵巢综合征的中药组合物的制备方法，其特征在于，所述制备方法包括如下步骤：按配方量取黄芩、黄连、清半夏、干姜、麸炒苍术、枳壳、厚朴、冬瓜仁、瓜蒌仁、丹参和夏枯草，加水煎煮两次，合并煎液，滤过，即得。
5.根据权利要求4所述的制备方法，其特征在于，所述制备方法还包括将滤液浓缩为清膏的步骤。
6.根据权利要求5所述的制备方法，其特征在于，加水量为原料药总重量的10-15倍；
所述煎煮的时间为1-1.5小时；
所述清膏为60℃测定的相对密度为1.30-1.35的清膏。
7.一种治疗胰岛素抵抗型多囊卵巢综合征的药物，其特征在于，所述药物以权利要求1-3任一所述的中药组合物为活性成分。
8.根据权利要求7所述的药物，其特征在于，所述药物还包括药学上可接受的辅料。
9.根据权利要求7所述的药物，其特征在于，所述药物的剂型为煎剂、颗粒剂、丸剂、胶囊剂、片剂、散剂或口服液。
10.权利要求1-3任一所述的中药组合物在制备治疗胰岛素抵抗型多囊卵巢综合征药物中的应用。
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