CN111939212A - 一种治疗生殖器疱疹的药物组合物及其制备方法 - Google Patents
一种治疗生殖器疱疹的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗生殖器疱疹的药物组合物及其制备方法，它是由黄芪、紫花地丁、人工牛黄、皂角刺为主要原料制备而成的制剂。本发明具有益气解毒的功效，疗效确切，且价格便宜、无副作用，可有效减轻临床症状积分，显著抑制生殖器疱疹的复发率。本发明还公开了以上所述药物的制备方法，根据每味中药的不同特性，分别以粉碎或溶剂提取等预处理后，按比例配制而成。
Description
技术领域
本发明涉及一种治疗生殖器疱疹的药物组合物。具体的说是黄芪、紫花地丁、人工牛黄、皂角刺为主要原料制备而成的中成药。本发明还涉及上述药物的制备方法。
背景技术
生殖器疱疹主要是由单纯疱疹病毒感染生殖器部位皮肤粘膜所引起的炎症、水疱、2～4天后破溃形成糜烂或溃疡，自觉疼痛。是最常见的性传播疾病(STD)之一。2型单纯疱疹病毒(HSV-2)是生殖器疱疹的主要病原体(90％)，传染后引起初发生殖器疱疹。初发生殖器疱疹消退后，残存的病毒经周围神经沿神经轴转移至骶神经节而长期潜伏下来，当机体抵抗力降低或某些激发因素如发热、受凉、感染、月经、胃肠功能紊乱、创伤等作用下，可使潜伏的病毒激活，病毒下行至皮肤黏膜表面引起病损，导致复发。
据最新世界卫生组织报告，如今全球共有大概5亿人携带了此病毒，近年，生殖器疱疹发病率在中国呈逐年上升趋势，主要是经过性接触传达的，本病危害性严峻，复发率高。女性感染后可致使女性不孕，流产，且子宫颈癌和阴茎癌的发病与生殖器疱疹病毒感染关系密切，患过生殖器疱疹的妇人比未患过者患宫颈癌的危险性大5～10倍。生殖器疱疹可反复发作，难以治愈。
目前西医治疗本病的方法主要采用抗病毒治疗，治疗药物有阿昔洛韦、伐昔洛韦、泛昔洛韦等。如果是初发生殖器疱疹，疗程为7～10天，复发性生殖器疱疹疗程为5天。对频发复发者则采用较低的剂量阿昔洛韦长时间服用。
目前的治疗方法尚不能达到彻底清除病毒、消除复发的效果，且长期服用阿昔洛韦等抗病毒药物会出现关节疼痛、腹泻、头痛、恶心、呕吐以及肝肾损害等副作用。
鉴于目前对生殖器疱疹缺乏有效的根治方法，因此，开发治疗生殖器疱疹、减少患者复发率的药物具有良好的市场前景。
发明内容
本发明的目的在于提供一种生殖器疱疹疗效确切的中药及其相应制剂。其特点有：可有效减轻临床症状积分，显著抑制生殖器疱疹的复发率，且价格便宜、无副作用。
生殖器疱疹属于中医热疮、阴疮范畴，主要病机为气虚毒盛，外感湿热邪毒，互结于阴，壅滞肌肤，循经蛰伏，厥阴绕于阴器，久之淫毒聚于肝胆二经，湿热邪毒日久耗伤正气，导致正气亏损，易致反复发作，邪毒难祛则发为本病。故中医治疗复发性生殖器疱疹当以益气解毒为主，处方来源于临床经验方，可有效减轻临床症状体征，提高免疫力，显著降低远期复发风险。
本发明是一种治疗生殖器疱疹的药物组合物，其特征在于它是以黄芪、紫花地丁、人工牛黄、皂角刺为主要原料制备而成，方配伍精妙，疗效确切。
重量配比组成如下：
(1)黄芪10-70份、紫花地丁10-70份、皂角刺10-70份、人工牛黄0.5-40份。
优选重量配比是：
(2)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份。
本发明药物组成还可以含有蜈蚣、甘草、三七、蒲公英、黄柏、蜂房、紫草、虎杖等中药中的一种或一种以上。
本发明药物可以是任何一种药剂学上所说剂型的药物。
该药物的制备可以按多种药剂学上的常规方法制备，如：
将蜈蚣、三七粉碎成细粉，或用乙醇提取，得醇提取物；将黄芪、紫花地丁、皂角刺、甘草、蒲公英、黄柏、蜂房、紫草、漏芦、虎杖用水按常规方法提取，得水提取物，将各提取物混匀，干燥，加入人工牛黄，制粒，制成所需剂型的药物。
以上制备过程中，如有必要，可加入适量药剂学中常用的辅料，如淀粉、糊精、微晶纤维、可压性淀粉、硬脂酸镁、微粉硅胶、蔗糖、羧甲基淀粉钠等。
一、为进一步验证本发明治疗生殖器疱疹的功效，开展了以下药效学试验。
1抗豚鼠生殖疱疹的试验研究
1.1构建豚鼠HSV-2初发模型
先用生理盐水清洗雌性Harly豚鼠外阴，再用粗糙的细玻璃棒反复摩擦损伤阴道黏膜，吸取0.1ml HSV-2病毒液伸入阴道内3cm左右，将液体推入阴道穹窿处缓慢退出并用明胶海绵塞入阴道，防止病毒液流出。观察外阴局部变化，当肉眼可见外阴及阴道红肿、疱疹、破损、糜烂及分泌物增多等症状时视为初发感染成功。观察外阴皮损并评分，阴道拭子病毒滴度测定。
1.2构建豚鼠HSV-2复发模型
选取初发感染痊愈后20天的豚鼠给予环磷酰胺注射液腹腔注射诱导(浓度为50mg/mL)，按1ml/kg注射。观察2周后开始用40W紫外线消毒灯局部照射豚鼠外阴，5-8min/次。照射5次后开始出现典型水疱，正常对照组经紫外线照射未出现水疱。
将初发感染痊愈的豚鼠分为5组，每组10只，然后分别给予本发明者组中药高、中、低剂量或阿昔洛韦治疗，模型组灌胃生理盐水。连续给药30天，进行荧光定量PCR检测复发性生殖器疱疹HSV-2病毒的脊髓神经节潜伏相关转录体(Latency-associatedtranccrpts，LATs)LATs拷贝量。
2结果：各组间LATs拷贝量比较，见表1。
表1各组间LATs拷贝量比较
注：与模型组比较，*P＜0.05，**P＜0.01；与阿昔洛韦组比较，ΔP＜0.05，ΔΔP＜0.01
由表1可见，与模型组相比，本发明组各剂量及对照药阿昔洛韦均可降低LATs拷贝量(P＜0.05或P＜0.01)；本发明中、高剂量组明显优于阿昔洛韦组(P＜0.05或P＜0.01)，说明本发明组能明显降低脊髓神经节LATs拷贝量，从而减少生殖器疱疹的复发，且疗效优于阿昔洛韦。
二、为进一步观察其疗效及安全性，笔者进行了随机对照临床研究。
选取生殖器疱疹患者70例，均符合西医诊断标准和《中药新药临床研究指导原则》。
纳入标准：(1)符合中医气虚兼余毒未清证诊断标准；(2)符合复发性生殖器疱疹的西医诊断标准；(3)年龄18-60岁；(3)患者签署知情同意书。
排除标准：(1)入组前1月服用抗病毒及免疫增强剂者；(2)初发生殖器疱疹者；(3)合并其他性传播疾病者；(3)有内分泌代谢性疾病、精神系统疾病者、免疫系统疾病者，恶性肿瘤者。
本试验采用随机、对照临床研究方法。所有符合入选条件的患者随机分入试验组(本发明组)和对照组(阿昔洛韦组)，本发明者40例，对照组30例。疗程为12周。观察各组临床症状积分及随访6月、12月复发率。
临床症状积分：根据《中药新药临床研究指导原则》对疱疹反复发作、水疱发生不全、疼痛进行评分，分值越低提示症状体征越轻。
1.两组临床症状积分比较，见表2
表2 两组组治疗前后临床症状积分比较
注：与对照组比较，*P＜0.05；与治疗前比较，ΔP＜0.05，ΔΔP＜0.01
治疗后，两组均可显著降低临床症状积分，试验组疗效优于对照组，差异有统计学意义(P＜0.05)。
2、两组患者随访6月、12月复发率比较：
阿昔洛韦组随访6月、12月复发率分别为50％(15/30)和80％(24/30)，本发明组随访6月、12月复发率分别为10％(4/40)和20％(8/40)。本发明组随访6月、12月复发率均显著低于阿昔洛韦组(P＜0.01)。
3.安全性评价
药物不良反应：经临床观察本试验组有1例出现一过性胃部不适，未见其他明显不良反应。
本临床研究表明，本发明组能明显降低生殖器疱疹的复发率，优于阿昔洛韦，且安全无副作用。
具体实施方式
下面结合实施例对本发明作进一步的描述。
本发明按重量配比组成如下：
(1)黄芪10-70份、紫花地丁10-70份、皂角刺10-70份、人工牛黄0.5-40份。
优选重量配比是：
(2)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份。
本发明药物组成还可以含有蜈蚣、甘草、三七、蒲公英、黄柏、蜂房、虎杖等中药中的一种或一种以上，重量配比组成如下：
(3)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、蒲公英10-50份。
(4)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、黄柏10-50份。
(5)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、蜂房10-50份。
(6)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、虎杖10-50份。
(7)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20分、甘草10-40份。
(8)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20分、蜈蚣0.5-20份、甘草10-40份。
(9)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、漏芦10-50份。
(10)黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、三七10-50份。
1、本发明药物的制备方法，以黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份为例，可参照如下方法：
将黄芪、紫花地丁、皂角刺用水按常规方法提取，浓缩，得提取物，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
2、本发明药物的制备方法，以黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、蒲公英10-50份为例，可参照如下方法：
将黄芪、紫花地丁、皂角刺、蒲公英用水按常规方法提取，浓缩，得提取物，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
3、本发明药物的制备方法，以黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、黄柏10-50份为例，可参照如下方法：
将黄芪、紫花地丁、皂角刺、黄柏用水按常规方法提取，浓缩，得提取物，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
人工牛黄0.5-20份、蜂房10-50份的制剂，可参照如下方法：
将黄芪、紫花地丁、皂角刺、蜂房用水按常规方法提取，浓缩，得提取物，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
5、本发明药物的制备方法，组成为黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、虎杖10-50份的制剂，可参照如下方法：
将黄芪、紫花地丁、皂角刺、虎杖用水按常规方法提取，浓缩，得提取物，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
6、本发明药物的制备方法，组成为黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20分、甘草10-40份的制剂，可参照如下方法：
将黄芪、紫花地丁、皂角刺、甘草用水按常规方法提取，浓缩，得提取物，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
7、本发明药物的制备方法，组成为黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20分、蜈蚣0.5-20份、甘草10-40份的制剂，可参照如下方法：
(1)将黄芪、紫花地丁、皂角刺、甘草、蜈蚣用水按常规方法提取，浓缩，得提取物，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
(2)将蜈蚣用乙醇提取，回收乙醇，得提取物；将黄芪、紫花地丁、皂角刺、甘草用水按常规方法提取，浓缩，得提取物，将各提取物混匀，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
(3)将蜈蚣粉碎成细粉；将黄芪、紫花地丁、皂角刺、甘草用水按常规方法提取，浓缩，得提取物，将各提取物混匀，干燥，加入蜈蚣细粉、人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
8、本发明药物的制备方法，组成为黄芪10-50份、紫花地丁1050份、皂角刺10-50份、人工牛黄0.5-20份、漏芦10-50份的制剂，可参照如下方法：
将黄芪、紫花地丁、皂角刺、漏芦用水按常规方法提取，浓缩，得提取物，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
9、本发明药物的制备方法，组成为黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20分、三七10-50份的制剂，可参照如下方法：
(1)将三七用乙醇提取，回收乙醇，得提取物；将黄芪、紫花地丁、皂角刺用水按常规方法提取，浓缩，得提取物，将各提取物混匀，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
(3)将三七粉碎成细粉；将黄芪、紫花地丁、皂角刺用水按常规方法提取，浓缩，得提取物，将各提取物混匀，干燥，加入三七细粉、人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
Claims (10)
1.一种治疗生殖器疱疹的药物组合物，其特征在于它是由下述重量配比的原料药制成：黄芪10-70份、紫花地丁10-70份、皂角刺10-70份、人工牛黄0.5-40份。
2.根据权利要求1所述的药物组合物，其特征在于原料药中各药物重量配比范围是：黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份。
3.一种治疗生殖器疱疹的药物组合物，其特征在于它是由下述重量配比的原料药制成：黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20分、三七10-40份。
4.一种治疗生殖器疱疹的药物组合物，其特征在于它是由下述重量配比的原料药制成：黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20分、蜈蚣0.5-20份、甘草10-40份。
5.一种治疗生殖器疱疹的药物组合物，其特征在于它是由下述重量配比的原料药制成：黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、黄柏10-50份。
6.一种治疗生殖器疱疹的药物组合物，其特征在于它是由下述重量配比的原料药制成：黄芪10-50份、紫花地丁10-50份、皂角刺10-50份、人工牛黄0.5-20份、蜂房10-50份。
7.根据权利要求1至6中任一项所述的药物组合物，其特征在于所说的药物组合物的剂型选自胶囊剂或颗粒剂或片剂。
8.制备权利要求2中所述药物组合物的制备方法，其特征在于：将黄芪、紫花地丁、皂角刺用水按常规方法提取，浓缩，得提取物，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
9.制备权利要求3中所述药物组合物的制备方法，其特征在于：将三七用乙醇提取，回收乙醇，得提取物；将黄芪、紫花地丁、皂角刺用水按常规方法提取，浓缩，得提取物，各提取物混匀，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
10.制备权利要求4中所述药物组合物的制备方法，其特征在于：将蜈蚣用乙醇提取，回收乙醇，得提取物；将黄芪、紫花地丁、皂角刺、甘草用水按常规方法提取，浓缩，得提取物，将各提取物混匀，干燥，加入人工牛黄、辅料，制粒，制成片剂、胶囊剂或颗粒剂。
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| CN116509920A (zh) * | 2023-06-06 | 2023-08-01 | 成都前路通生物科技有限公司 | 一种减少生殖器疱疹复发的药物组合物及其制备方法 |
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