CN114177266B - 一种预防及治疗hpv病毒感染的中药组合物 - Google Patents
一种预防及治疗hpv病毒感染的中药组合物 Download PDFInfo
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- CN114177266B CN114177266B CN202210019852.XA CN202210019852A CN114177266B CN 114177266 B CN114177266 B CN 114177266B CN 202210019852 A CN202210019852 A CN 202210019852A CN 114177266 B CN114177266 B CN 114177266B
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Abstract
本发明公开一种预防及治疗HPV病毒感染的中药组合物及其提取物和发酵物以及应用。将半枝莲、地肤子、鸡血藤、莪术、黄柏、土茯苓、板蓝根、甘草、苦参、白花蛇舌草、木贼按君臣佐使配伍组合在一起，得出其提取物和发酵物，可制成具有预防及治疗HPV病毒感染作用的凝胶剂、栓剂、洗剂、贴剂、乳膏等剂型，能抑制和杀灭病原微生物，用于抗人乳头瘤病毒。本组合物具有解毒化瘀消疣之功效，能防治人乳头瘤病毒感染引起的宫颈上皮内瘤变、宫颈炎症、尖锐湿疣、扁平疣、寻常疣等病症，其作用温和、安全性好、使用方便，患者依从性好，适于个人护理和临床广泛应用。
Description
技术领域
本发明涉及中药组合物配伍、提取与应用技术，特别涉及一种预防及治疗HPV病毒感染的中药组合物及其提取物和发酵物以及应用。
背景技术
人乳头瘤病毒(human papilloma virus，HPV)是一种DNA病毒，主要感染上皮细胞，人是其唯一的宿主，近年来由HPV引起的女性生殖道感染发病率正逐年上升。HPV的持续感染是发生以下疾病的重要诱因：1、宫颈上皮内瘤变和宫颈癌；2、尖锐湿疣，多发于男女生殖器、肛周等部位；3、扁平疣、寻常疣，多发于面、手、足等部位。现有防治HPV感染方法通常使用免疫疗法、干扰素药物、激光、冷冻、外用腐蚀剂及手术治疗，具有一定创伤感染风险，存在刺激性大过程痛苦、特殊部位处理难度大、患者心里负担重、潜伏病毒不易清除复发几率大等局限性。而且物理干预后常会产生色素沉淀、皮肤瘢痕等副作用，难以满足患者的治疗需求。因此，研发更理想的预防及治疗人乳头瘤病毒感染的药物，尤其是更安全温和、效果良好、使用简便的天然中药提取功效型产品成了当务之急。
发明内容
为了解决现有技术的问题，本发明提供了一种预防及治疗HPV病毒感染的中药组合物及其提取物和发酵物以及应用，采用的中药组合物选自天然植物，通过大量试验，得出君臣佐使配伍的优选组合，其提取物和发酵物可直接使用，也可根据不同产品类型，往前述提取物或发酵物中添加适量辅助成分制成相应的产品，能防治人乳头瘤病毒感染引起的宫颈上皮内瘤变、宫颈炎症、尖锐湿疣、扁平疣、寻常疣等病症，其作用温和、安全性好、使用方便，患者依从性好，适于个人护理和临床广泛应用。
本发明所采用的技术方案如下：
一种预防及治疗HPV病毒感染的中药组合物，其按照质量份数，由以下组分组成：半枝莲22～264份、地肤子22～264份、鸡血藤22～264份、莪术22～264份、黄柏22～264份、土茯苓22～264份、板蓝根22～264份、甘草22～264份、苦参22～264份、白花蛇舌草22～264份、木贼22～264份。
一种中药组合物的提取物，是由所述中药组合物按其投料质量份数加入15倍重量纯水，置于煎药机内浸泡2～4h后，微沸提取1～1.5h，静置1～4h后取其上清液过滤，在真空负压-0.07～-0.1MPa、50～65℃环境下，浓缩至质量份数约5倍中药投料量的溶液即可制得中药提取物。
一种中药组合物的发酵物，是由所述中药组合物和发酵菌混合而得的初始体系，加入5 倍重量的纯水，经发酵而得的发酵物，置于煎药机内，按中药组合物的重量加入15倍重量纯水，微沸提取1～1.5h，静置1～4h后取其上清液过滤，在真空负压-0.07～-0.1MPa、50～65 ℃环境下，浓缩至质量份数约5倍中药投料量的溶液即可制得中药发酵物。
一种中药组合物的提取物和发酵物的应用，是按照重量百分比为1％～50％的比例掺入药品、医疗器械、个人护理用品或化妆品中。
本发明选用半枝莲、地肤子、鸡血藤、莪术、黄柏、土茯苓、板蓝根、甘草、苦参、白花蛇舌草、木贼11味中药按君臣佐使组方配伍，从而有效起到预防及治疗HPV病毒感染功效。药材功效简介如下：
半枝莲，根据中国医药科技出版社2015年6月第1版的国家药典委员会编著的《中国药典》2015年版一部118页记载有如下功效：清热解毒，化瘀利尿。根据上海科学技术出版社 2014年6月第2版的南京中医药大学编著的《中药大辞典》935页记载，具有抗癌、免疫调节、抗菌作用。
地肤子，根据中国医药科技出版社2015年6月第1版的国家药典委员会编著的《中国药典》2015年版一部124页记载有如下功效：清热利湿，祛风止痒。用于阴痒带下，风瘆，湿瘆，皮肤瘙痒。根据上海科学技术出版社2014年6月第2版的南京中医药大学编著的《中药大辞典》985页记载，地肤子水提物对迟发型超敏反应有一定的抑制趋势。根据中国医药科技出版社2018年8月第1版的余传隆，黄正明，修成娟等总主编的《中国临床药物大辞典》 229页记载，地肤子具有抗菌、抗真菌、抗肿瘤等作用。
鸡血藤，根据中国医药科技出版社2015年6月第1版的国家药典委员会编著的《中国药典》2015年版一部194页记载有如下功效：清热凉血，养阴生津。根据上海科学技术出版社 2014年6月第2版的南京中医药大学编著的《中药大辞典》1463页记载，鸡血藤具有抗血小板聚集和刺激造血系统的作用。根据中国医药科技出版社2018年8月第1版的余传隆，黄正明，修成娟等总主编的《中国临床药物大辞典》511页记载，鸡血藤具有抗病毒、抗肿瘤、抗炎等作用。
莪术，根据中国医药科技出版社2015年6月第1版的国家药典委员会编著的《中国药典》 2015年版一部275页记载有如下功效：行气破血，消积止痛。用于癥瘕痞块，淤血经闭等。根据上海科学技术出版社2014年6月第2版的南京中医药大学编著的《中药大辞典》2174页记载，莪术具有抗肿瘤、抗菌、抗炎等作用。
黄柏，根据中国医药科技出版社2015年6月第1版的国家药典委员会编著的《中国药典》 2015年版一部306页记载有如下功效：清热燥湿，泻火除蒸，解毒疗疮。根据上海科学技术出版社2014年6月第2版的南京中医药大学编著的《中药大辞典》2446页记载，黄柏具有抗病原微生物、抗炎等作用。
土茯苓，根据上海科学技术出版社2014年6月第2版的南京中医药大学编著的《中药大辞典》108页记载，土茯苓清热除湿，泄浊解毒。具有抗肿瘤、镇痛等作用。
板蓝根，根据中国医药科技出版社2015年6月第1版的国家药典委员会编著的《中国药典》 2015年版一部206页记载有如下功效：清热凉血，凉血利咽。根据上海科学技术出版社2014 年6月第2版的南京中医药大学编著的《中药大辞典》1564页记载，板蓝根具有抗细菌、抗病毒、抗内毒素、抗癌和免疫调节作用。
甘草，根据中国医药科技出版社2015年6月第1版的国家药典委员会编著的《中国药典》 2015年版一部87页记载有如下功效：补脾益气，清热解毒，缓急止痛，调和诸药。根据上海科学技术出版社2014年6月第2版的南京中医药大学编著的《中药大辞典》685页记载，甘草具有抗微生物、肾上腺皮质激素样、抗炎、抗氧化、解毒等作用。
苦参，根据中国医药科技出版社2015年6月第1版的国家药典委员会编著的《中国药典》 2015年版一部203页记载有如下功效：清热燥湿，杀虫，利尿。根据上海科学技术出版社2014 年6月第2版的南京中医药大学编著的《中药大辞典》1523页记载，苦参具有抗肿瘤、抗过敏作用。
白花蛇舌草，根据上海科学技术出版社2014年6月第2版的南京中医药大学编著的《中药大辞典》901页记载，白花蛇舌草清热解毒，活血消肿，利湿退黄。具有抗肿瘤、抗氧化作用。
木贼，根据中国医药科技出版社2015年6月第1版的国家药典委员会编著的《中国药典》 2015年版一部63页记载有如下功效：疏散风热，明目退翳。根据上海科学技术出版社2014年6 月第2版的南京中医药大学编著的《中药大辞典》419页记载，木贼具有抑制血小板聚集作用。
本发明提供的技术方案带来的有益效果是：
本发明为了达到预防及治疗HPV病毒感染的目的，将半枝莲、地肤子、鸡血藤、莪术、黄柏、土茯苓、板蓝根、甘草、苦参、白花蛇舌草、木贼按君臣佐使配伍组合在一起，得出其提取物和发酵物，可制成具有预防及治疗HPV病毒感染作用的凝胶剂、栓剂、洗剂、贴剂、乳膏等剂型，能抑制和杀灭病原微生物，用于抗人乳头瘤病毒。本组合物具有解毒化瘀消疣之功效，能防治人乳头瘤病毒感染引起的宫颈上皮内瘤变、宫颈炎症、尖锐湿疣、扁平疣、寻常疣等病症，其作用温和、安全性好、使用方便，患者依从性好，适于个人护理和临床广泛应用。本组合物与大多数药品、医疗器械、日用品和化妆品原料配伍良好，添加工艺简单，适合工业化生产。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将结合具体实施方式作进一步地详细描述。
实施例1：中药提取物的制备
称量半枝莲22g、地肤子264g、鸡血藤264g、莪术264g、黄柏264g、土茯苓264g、板蓝根22g、甘草22g、苦参22g、白花蛇舌草22g、木贼22g，洗净后用煎药袋装好，置于煎药机中，按中药组合物的重量，加入15倍的纯水，浸泡4h后微沸提取1.5h，静置4h后，取其上清液用1微米板框过滤取其滤液，在真空负压-0.07～-0.1MPa、50～65℃环境下，浓缩至约7300g溶液即可制得中药提取物。
实施例2：中药提取物的制备
称量半枝莲264g、地肤子22g、鸡血藤22g、莪术22g、黄柏22g、土茯苓22g、板蓝根264g、甘草264g、苦参264g、白花蛇舌草66g、木贼66g，洗净后用煎药袋装好，置于煎药机中，按中药组合物的重量，加入15倍的纯水，浸泡3h后微沸提取1.5h，静置2h后，取其上清液用1微米板框过滤取其滤液，在真空负压-0.07～-0.1MPa、50～65℃环境下，浓缩至约 6500g溶液即可制得中药提取物。
实施例3：中药提取物的制备
称量半枝莲132g、地肤子44g、鸡血藤44g、莪术44g、黄柏132g、土茯苓132g、板蓝根68g、甘草60g、苦参48g、白花蛇舌草44g、木贼44g，洗净后用煎药袋装好，置于煎药机中，按中药组合物的重量，加入15倍的纯水，浸泡2h后微沸提取1h，静置1h后，取其上清液用1微米板框过滤取其滤液，在真空负压-0.07～-0.1MPa、50～65℃环境下，浓缩至约 4000g溶液即可制得中药提取物。
实施例4：中药发酵物的制备
称量半枝莲22g、地肤子264g、鸡血藤264g、莪术264g、黄柏264g、土茯苓264g、板蓝根22g、甘草22g、苦参22g、白花蛇舌草22g、木贼22g，洗净后加入300g啤酒酵母菌，混合后加入7300g纯水，25℃下发酵72h后将发酵物用煎药袋装好，置于煎药机中，按中药组合物的重量加入15倍的纯水，微沸提取1.5h，静置4h后，取其上清液用1微米板框过滤取其滤液，在真空负压-0.07～-0.1MPa、50～65℃环境下，浓缩至约7300g溶液即可制得中药发酵物。
实施例5：中药发酵物的制备
称量半枝莲264g、地肤子22g、鸡血藤22g、莪术22g、黄柏22g、土茯苓22g、板蓝根264g、甘草264g、苦参264g、白花蛇舌草66g、木贼66g，洗净后加入100g啤酒酵母菌，混合后加入6500g纯水，42℃下发酵24h后将发酵物用煎药袋装好，置于煎药机中，按中药组合物的重量加入15倍的纯水，微沸提取1.5h，静置2h后，取其上清液用1微米板框过滤取其滤液，在真空负压-0.07～-0.1MPa、50～65℃环境下，浓缩至约6500g溶液即可制得中药发酵物。
实施例6：中药发酵物的制备
称量半枝莲132g、地肤子44g、鸡血藤44g、莪术44g、黄柏132g、土茯苓132g、板蓝根68g、甘草60g、苦参48g、白花蛇舌草44g、木贼44g，洗净后加入150g啤酒酵母菌，混合后加入4000g纯水，38℃下发酵48h后将发酵物用煎药袋装好，置于煎药机中，按中药组合物的重量加入15倍的纯水，微沸提取1.5h，静置1h后，取其上清液用1微米板框过滤取其滤液，在真空负压-0.07～-0.1MPa、50～65℃环境下，浓缩至约4000g溶液即可制得中药发酵物。
实施例7：中药提取物在抗HPV凝胶剂中的应用。
含10wt％实施例3制得的中药提取物的抗HPV凝胶剂配方如表1所示：
表1
表1配方中各组分按以下工艺进行制备：
(1)按上述表格中的组分名称和重量称取各组分投入搅拌锅；
(2)将A相中6种组分混合后搅拌至完全溶解；
(3)往A相中加入预先混合溶解的B相，高速搅拌至各组分混合均匀，出料。
实施例8：中药发酵物在抗HPV乳膏中的应用。
含15wt％实施例6制得的中药发酵物的抗HPV乳膏配方如表2所示：
表2
表2配方中各组分按以下工艺进行制备：
(1)按上述表格中的组分名称和重量称取各组分；
(2)将A相各组分混合后加热至80～85℃，溶解后搅拌均匀；
(3)将B相各组分混合搅拌至全部溶解并加热至80～85℃；
(4)将B相加入A相，于真空乳化锅中2500rmp均质8min后真空脱泡，搅拌冷却至 45℃以下，出料。
实施例7治疗HPV感染效果评价
取本发明实施例7制备的抗HPV凝胶剂进行功效实验。将高危HPV(HPV 16/18)阳性患者分成3组，每组30人，年龄22～60岁。空白组采用空白基质做成的凝胶剂，对照组采用重组人干扰素α-2b凝胶，使用方法：每晚睡前，清洁外阴后，取凝胶剂一支，平躺身体，将臀部抬高，去除辅助器的保护帽，将装有凝胶的辅助器缓慢推入至阴道深处后，撤出辅助器，保持臀位抬高仰卧。连续使用90天后，根据患者自觉症状、妇科检查及HPV检验评价高危型HPV阳性患者的治疗效果，标准如下：
显效：HPV检验阴性；
有效：阳性病毒载量下降≥50％(HC2 HPV DNA检测)；
无效：阳性病毒载量下降＜50％(HC2 HPV DNA检测)。
| 组别 | 病例数 | 显效 | 有效 | 无效 | 显效+有效率(％) |
| 空白 | 30 | 0 | 0 | 30 | 0 |
| 对照 | 30 | 1 | 15 | 14 | 53.33 |
| 实施例8 | 30 | 20 | 6 | 4 | 86.67 |
表3
结论：从表3可知，本发明提供的一种预防及治疗HPV病毒的中药组合物用于治疗高危 HPV阳性显效+有效率为86.67％，对比空白组和对照组具有显著的效果。
实施例8治疗HPV感染效果评价
取本发明实施例8制备的抗HPV乳膏进行功效实验。将低危HPV感染尖锐湿疣(HPV6/11)和扁平疣(HPV3)患者各分成3组，每组40人，年龄20～65岁。空白组采用空白基质做成的乳膏，对照组采用咪喹莫特乳膏，使用方法：取乳膏涂于皮损部位，轻柔按摩至吸收，每日一次，连续使用6周。治疗效果评价标准如下：
显效：疣体完全脱落，并通过HPV分型检测病毒标志物，能够有效清除HPV；
有效：疣体有明显缩小，或患者自觉症状有好转；
无效：疣体无明显变化或增大。
| 组别 | 病例数 | 显效 | 有效 | 无效 | 显效+有效率(％) |
| 尖锐湿疣空白 | 40 | 0 | 0 | 40 | 0 |
| 尖锐湿疣对照 | 40 | 3 | 16 | 21 | 47.50 |
| 尖锐湿疣实施例8 | 40 | 19 | 17 | 4 | 90.00 |
| 扁平疣空白 | 40 | 0 | 0 | 40 | 0 |
| 扁平疣对照 | 40 | 1 | 12 | 27 | 32.50 |
| 扁平疣实施例8 | 40 | 20 | 14 | 6 | 85.00 |
表4
结论：从表4可知，本发明提供的一种预防及治疗HPV病毒的中药组合物用于治疗低危HPV感染尖锐湿疣(HPV 6/11)显效+有效率为90.00％，对比空白组和对照组具有显著的效果。用于治疗扁平疣(HPV3)显效+有效率为85.00％，对比空白组和对照组具有显著的效果。
以上实施例中，中药组合物为原生药材或中药饮片。一种预防及治疗HPV病毒感染的中药组合物及其提取物和发酵物以及应用，包括中药组合物的提取物和发酵物的组成及制备，以及中药组合物的提取物和发酵物在制备具有抗病毒、抗菌、抗真菌、抗肿瘤、抗炎、止痒、抗过敏功效的药物、医疗器械、化妆品和消毒产品中的应用。
以上所述仅为本发明的较佳实施例，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (5)
1.一种预防及治疗 HPV 病毒感染的中药组合物，其按照质量份数，由以下组分制成：半枝莲 132 份、地肤子 44 份、鸡血藤 44 份、莪术 44 份、黄柏 132 份、土茯苓 132 份、板蓝根 68 份、甘草 60 份、苦参 48 份、白花蛇舌草 44 份、木贼 44 份。
2.根据权利要求 1 所述的一种预防及治疗 HPV 病毒感染的中药组合物，其特征在于，所述中药组合物按其投料质量份数加入 15 倍重量纯水，置于煎药机内浸泡 2～4h后，微沸提取 1～1.5h，静置 1～4h 后取其上清液过滤，在真空负压-0.07～-0.1MPa、50～65℃环境下，浓缩至质量份数 5 倍中药投料量的溶液即可制得中药提取物。
3.根据权利要求 1 所述的一种预防及治疗 HPV 病毒感染的中药组合物，其特征在于，所述中药组合物和发酵菌混合而得初始体系，加入 5 倍重量的纯水，经发酵而得的发酵物，置于煎药机内，按中药组合物的重量加入 15 倍重量纯水，微沸提取 1～1.5h，静置1～4h 后取其上清液过滤，在真空负压-0.07～-0.1MPa、50～65℃环境下，浓缩至质量份数5 倍中药投料量的溶液即可制得中药发酵物。
4.根据权利要求 3 所述的一种预防及治疗 HPV 病毒感染的中药组合物，其特征在于，发酵菌为啤酒酵母菌，以高活性干酵母的形式按 100～300 质量份加入中药组合物。
5.根据权利要求 4 所述的一种预防及治疗 HPV 病毒感染的中药组合物，其特征在于，发酵步骤中，温度为 25～42℃，时间为 24～72h。
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