CN107158125A - 一种用于妇科炎症、湿痒的制剂及其制备方法 - Google Patents
一种用于妇科炎症、湿痒的制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于妇科炎症、湿痒的制剂及其制备方法。本发明制剂包括以下重量份的组分:千里光20‑60份、金银花10‑30份、苦参10‑30份、黄柏20‑40份、蛇床子10‑30份、五倍子5‑15份、苦楝皮10‑30份、冰片3‑7份、醋酸氯己定2‑4份、吐温‑80为10‑20份、司盘‑80 10‑20份。本发明制剂通过中西药结合,经过提取、浓缩、乳化、均质等步骤制备而成,可明显提高药物稳定性和有效性,使用方便、安全、无毒、无副作用,对妇科炎症、湿痒有良好的疗效。
Description
技术领域
本发明属于药品领域,涉及一种中药制剂及其制备方法,特别是涉及一种用于妇科炎症、湿痒的制剂及其制备方法。
背景技术
妇科炎症是女性的常见疾病,主要是指女性生殖器官的炎症,包括各种原因引起的女性盆腔炎、附件炎、宫颈炎、阴道炎、尿道炎等。主要表现症状有:一、白带增多,其形状多为稀薄浆液状,颜色为黄绿色或者是灰黄色,同时还经常混杂着血丝,内部含有泡沫。有血性白带时,说明不但有阴道炎的症状,还可能存在宫颈糜烂的炎症。外阴有瘙痒、灼热亦常见,感染累及尿道口时,可有尿痛、尿急,甚至血尿;二、常见并发症滴虫能消耗上皮内糖原,改变阴道内的pH值,妨碍乳酸杆菌生长,故易引起继发性细菌感染,此时白带呈草绿色,有腥臭味;三、阴道与宫颈粘膜充血水肿,常有散在的红色斑点,或草莓状突起,后穹隆有多量的白带;四、下腹有坠胀感、坠痛等。湿痒是一种自觉皮肤瘙痒而无原发性损害的皮肤病,常见症状有剧烈瘙痒,可见于全身或局限于肛门、阴囊或女阴部,为阵发性、痒感剧烈,常在夜间加重,影响睡眠。
目前治疗妇科炎症和湿痒,西医多以抗生素治疗为主,虽然见效快,但存在易产生耐药性、易复发、副反应较多、费用高昂等诸多不足,远不能满足临床治疗的需要。中医理论认为,妇科炎症的主要病机是湿邪伤及任、带二脉,使任脉不固,带脉失约。湿邪是导致妇科炎症的主要原因,但有内外之别。脾肾肝三脏是产生内湿之因:脾虚失运,水湿内生;肾阳虚衰,气化失常,水湿内停;肝郁侮脾,肝火挟脾湿下注。外湿多因久居湿地,或涉水淋雨,以致感受湿邪。湿邪入侵机体也会导致水湿不运、湿热互结、流注下焦,从而导致皮肤湿痒。因此,中医认为治疗妇科炎症和湿痒关键在于清热利湿、疏风解毒、凉血化瘀、养血燥湿。
中药是我国特有的中医药理论与实践的产物,资源丰富,历史悠久,是人类最早应用的纯天然有机物质,其在治疗疾病方面有着毒副作用小、疗效好且作用持久的优势,虽然纯中药治疗妇科炎症和湿痒等病症存在起效慢等缺点,却克服了西药治疗易产生耐药性、易复发、副反应较多、费用高昂等诸多不足。本发明特别针对中、西药治疗妇科炎症、湿痒存在的不足,研究出一种中西药结合的制剂,目前,尚未见相关报道。
(1)千里光,为菊科植物千里光Senecio scandens Buch,-Ham.的干燥地上部分。收载于《中国药典》2015年版:【性味与归经】苦,寒。归肺、肝经。【功能与主治】清热解毒,明目,利湿。用于痈肿疮毒,感冒发热,目赤肿痛,泄泻痢疾,皮肤湿疹。
(2)金银花,为忍冬科植物忍冬Lonicera japonica Thunb.的干燥花蕾或带初开的花。收载于《中国药典》2015年版:【性味与归经】甘,寒。归肺、心、胃经。【功能与主治】清热解毒,疏散风热。用于痈肿疔疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。
(3)苦参,为豆科植物苦参Sophora flavescens Ait.的干燥根。收载于《中国药典》2015年版:【性味与归经】苦,寒。归心、肝、胃、大肠、膀胱经。【功能与主治】清热燥湿,杀虫,利尿。用于热痢,便血,黄疸尿闭,赤白带下,阴肿阴痒,湿疹,湿疮,皮肤瘙痒,疥癖麻风;外治滴虫性阴道炎。
(4)黄柏,为芸香科植物黄皮树Phellodendron chinense Schneid的干燥树皮。收载于《中国药典》2015年版:【性味与归经】苦、寒,归肾,膀胱经。【功能与主治】清热燥湿,泻火除蒸,解毒疗疮。用于湿热泻痢,黄疽尿赤,带下阴痒,热淋涩痛,脚气痿躄,骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹湿疮。
(5)蛇床子,为伞形科植物蛇床Cnidium monnieri(L.)Cuss.的干燥成熟果实。收载于《中国药典》2015年版:【性味与归经】辛、苦,温;有小毒。归肾经。【功能与主治】燥湿祛风,杀虫止痒,温肾壮阳。用于阴痒带下,湿疹瘙痒,湿痹腰痛,肾虚阳痿,宫冷不孕。
(6)五倍子,为漆树科植物盐肤木Rhus chinensis Mill.、青麸杨Rhus potaniniiMaxim或红麸杨Rhus punjabensis Stew.var.sinica(Diels)Rehd.et Wils.叶上的虫瘿,主要由倍子蚜Melaphis chinensis(Bell)Baker寄生而形成。收载于《中国药典》2015年版:【性味与归经】酸,涩,寒。归肺、大肠、肾经。【功能与主治】敛肺降火,涩肠止泻,敛汗,止血,收湿敛疮。用于肺虚久咳,肺热痰嗽,久泻久痢,自汗盗汗,消渴,便血痔血,外伤出血,痈肿疮毒,皮肤湿烂。
(7)苦楝皮,为楝科植物川楝Melia toosendan Sieb.et Zucc和楝Meliaazedarach L.的干燥树皮和根皮。收载于《中国药典》2015年版:【性味与归经】苦,寒;有毒。归肝、脾、胃经。【功能与主治】杀虫,疗癣。用于蛔虫病,蛲虫病,虫积腹痛;外治疥癣瘙痒。
(8)冰片,为无色透明或白色半透明的片状松脆结晶;气清香,味辛、凉;具挥发性,点燃发生浓烟,并有带光的火焰。收载于《中国药典》2015年版:【性味与归经】辛、苦,微寒。归心、脾、肺经。【功能与主治】开窍醒神,清热止痛。用于热病神昏、惊厥,中风痰厥,气郁暴厥,中恶昏迷,胸痹心痛,目赤,口疮,咽喉肿痛,耳道流脓。
以上背景技术内容的公开仅用于辅助理解本发明的发明构思及技术方案,其并不必然属于本专利申请的现有技术,在没有明确的证据表明上述内容在本专利申请的申请日已经公开的情况下,上述背景技术不应当用于评价本申请的新颖性和创造性。
发明内容
本发明的目的是针对中、西药用于治疗妇科炎症、湿痒时的不足,提供一种用于妇科炎症、湿痒中西药结合的制剂及其制备方法。
本发明从中药中选择合适的原料,通过合理配制,制成一种中西药结合的制剂。此制剂具有吸收较快,疗效迅速,使用方便等优点,能迅速缓解及消除皮肤湿痒、妇科炎症的各种临床症状,用于治疗妇科炎症(阴道炎、宫颈炎)以及各型皮肤湿痒等。本发明制剂制备方法简单,采用均质乳化技术,大大提高中西药物的溶解性以及分散均匀性,避免药物成分混合不均匀而影响疗效、增加毒性。
本发明采用的技术方案如下:
一种用于妇科炎症、湿痒的制剂,包括以下重量份的组分:千里光20-60份、金银花10-30份、苦参10-30份、黄柏20-40份、蛇床子10-30份、五倍子5-15份、苦楝皮10-30份、冰片3-7份、醋酸氯己定2-4份、吐温-8010-20份、司盘-80为10-20份。
以上所述的用于妇科炎症、湿痒的制剂,优选包括以下重量份的组分:千里光30-50份、金银花15-25份、苦参15-25份、黄柏25-35份、蛇床子15-25份、五倍子7.5-12.5份、苦楝皮15-25份、冰片4-6份、醋酸氯己定2.5-3.5份、吐温-8012.5-17.5份、司盘-8012.5-17.5份。
以上所述的用于妇科炎症、湿痒的制剂,最佳优选包括以下重量份的组分:千里光40份、金银花20份、苦参20份、黄柏30份、蛇床子20份、五倍子10份、苦楝皮20份、冰片5份、醋酸氯己定3份、吐温-8015份、司盘-8015份。
以上所述的用于妇科炎症、湿痒的制剂,可制备成乳剂、栓剂、洗剂,最佳优选制备成乳剂。
以上所述的用于妇科炎症、湿痒的制剂,在制备用于皮肤湿痒、妇科炎症的药物中的用途。
一种以上所述的用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,包括以下步骤:
S1:按以下重量份称取组分:千里光20-60份、金银花10-30份、苦参10-30份、黄柏20-40份、蛇床子10-30份、五倍子5-15份、苦楝皮10-30份、冰片3-7份、醋酸氯己定2-4份、吐温-8010-20份、司盘-8010-20份;
S2:取步骤S1称量好的千里光等七味中药材加5-10倍量水,煎煮2-3次,每次1-3h,过滤,合并滤液;
S3:将步骤S2的滤液浓缩至相对密度在60-65℃为1.03-1.07的清膏,加入与清膏等量的95%乙醇,静置,滤取上清液回收乙醇并浓缩至相对密度在60-65℃为1.17-1.21的清膏;
S4:取醋酸氯己定、冰片加适量乙醇溶解后,加入司盘-80搅拌均匀,备用;另取吐温-80加热至40℃-60℃,保温情况下加入步骤S3制得的清膏,搅拌均匀后加入以上醋酸氯己定、冰片混合液,40℃-60℃下均质搅拌20-40min,最后加水至配制量,继续以均质搅拌速度搅拌20-30min,取出,用100目滤布过滤,灭菌,灌装,即得所述乳剂。
进一步地,步骤S3所述清膏醇沉静置时间为12-24h;步骤S4所述的乙醇的浓度为95%,所述的均质搅拌速度为10000-30000rpm。
本发明的有益效果是:
1.本发明用于妇科炎症、湿痒的制剂,运用现代科学理论配制而成。方中千里光,具有清热解毒,利湿之功效,为君药;金银花清热解毒,疏散风热;苦参清热燥湿,杀虫;黄柏清热燥湿,泻火除蒸,解毒疗疮;蛇床子燥湿祛风,杀虫止痒;四药合用助君药清热解毒、燥湿之功,为臣药。五倍子敛肺降火,涩肠止泻,敛汗,止血,收湿敛疮;苦楝皮杀虫,疗癣;二者合用为佐药。冰片开窍醒神,清热止痛,为使药。诸药合用共奏清热利湿、疏风解毒、燥湿止痒之功。
2.本发明所用中药均收载于《中国药典》2015年版,通过科学合理配方,组方严谨,药少力专,同时与具有广谱抗菌作用的醋酸氯己定结合,制成乳液,各药味协同作用,能有效止痒止痛,抑制黏液分泌,促进组织再生,对妇科炎症如阴道炎、宫颈炎以及各型皮肤湿痒等很好的疗效,治疗总有效率分别达90%和93%以上。
3.本发明采用现代乳化技术,通过中西药结合和中西药互补,同时具备西药迅速杀灭病原菌和中药燥湿抗炎作用的的特点,显著地提高了制剂的疗效,减少了不良反应。既避免了传统的西医治疗易产生耐药性、疗程长、易复发、剂型单一、副反应较多、费用高昂等缺点,也克服了纯中药治疗存在起效慢的不足。
4.本发明制剂的制备方法简单,采用均质乳化技术,大大提高中西药物的溶解性以及分散均匀性,避免药物成分混合不均匀而影响疗效、增加毒性,可明显提高药物稳定性和有效性,使用方便、安全、无毒、无副作用。
具体实施方式
下面结合具体实施例对本发明作进一步描述,但不限制本发明的保护范围和应用范围:
一、用于妇科炎症、湿痒的制剂制备成乳剂的制备方法
实施例1
一种用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,包括以下步骤:
S1:按以下重量称取原料:千里光20kg、金银花10kg、苦参10kg、黄柏20kg、蛇床子10kg、五倍子5kg、苦楝皮10kg、冰片3kg、醋酸氯己定2kg、吐温-8010kg、司盘-8010kg;
S2:取步骤S1称量好的千里光等七味中药材加水煎煮3次,每次加5倍量水,每次煎煮1h,过滤,合并滤液;
S3:将步骤S2的滤液浓缩至相对密度在60℃为1.03的清膏,加入与清膏等量的95%乙醇,静置12h,取上清液回收乙醇并浓缩至相对密度在60℃为1.17的清膏;
S4:取醋酸氯己定、冰片加适量95%乙醇溶解后,加入司盘-80搅拌均匀,备用;另取吐温-80加热至40℃,保温情况下加入步骤S3制得的清膏,搅拌均匀后加入以上醋酸氯己定、冰片混合液,40℃下以速度为10000rpm均质搅拌20min,最后加水至配制量,继续以10000rpm速度搅拌20min,取出,用100目滤布过滤,灭菌,灌装,即得所述乳剂。
实施例2
一种用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,包括以下步骤:
S1:按以下重量称取原料:千里光30kg、金银花15kg、苦参15kg、黄柏25kg、蛇床子15kg、五倍子7.5kg、苦楝皮15kg、冰片4kg、醋酸氯己定2.5kg、吐温-8012.5kg、司盘-8012.5kg;
S2:取步骤S1称量好的千里光等七味中药材加水煎煮2次,第一次加7倍量水煎煮1.5h,第二次加6倍量水煎煮1.5h,过滤,合并滤液;
S3:将步骤S2的滤液浓缩至相对密度在62℃为1.04的清膏,加入与清膏等量的95%乙醇,静置18h,取上清液回收乙醇并浓缩至相对密度在62℃为1.18的清膏;
S4:取醋酸氯己定、冰片加适量95%乙醇溶解后,加入司盘-80搅拌均匀,备用;另取吐温-80加热至45℃,保温情况下加入步骤S3制得的清膏,搅拌均匀后加入以上醋酸氯己定、冰片混合液,50℃下以速度为15000rpm均质搅拌25min,最后加水至配制量,继续以15000rpm速度搅拌25min,取出,用100目滤布过滤,灭菌,灌装,即得所述乳剂。
实施例3
一种用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,包括以下步骤:
S1:按以下重量称取原料:千里光40kg、金银花20kg、苦参20kg、黄柏30kg、蛇床子20kg、五倍子10kg、苦楝皮20kg、冰片5kg、醋酸氯己定3kg、吐温-8015kg、司盘-8015kg;
S2:取步骤S1称量好的千里光等七味中药材加水煎煮2次,第一次加8倍量水煎煮3h,第二次加7倍量水煎煮2h,过滤,合并滤液;
S3:将步骤S2的滤液浓缩至相对密度在65℃为1.05的清膏,加入与清膏等量的95%乙醇,静置24h,取上清液回收乙醇并浓缩至相对密度在65℃为1.19的清膏;
S4:取醋酸氯己定、冰片加适量95%乙醇溶解后,加入司盘-80搅拌均匀,备用;另取吐温-80加热至50℃,保温情况下加入步骤S3制得的清膏,搅拌均匀后加入以上醋酸氯己定、冰片混合液,45℃下以速度为20000rpm均质搅拌30min,最后加水至配制量,继续以20000rpm速度搅拌30min,取出,用100目滤布过滤,灭菌,灌装,即得所述乳剂。
实施例4
一种用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,包括以下步骤:
S1:按以下重量称取原料:千里光50kg、金银花25kg、苦参25kg、黄柏35kg、蛇床子25kg、五倍子12.5kg、苦楝皮25kg、冰片6kg、醋酸氯己定3.5kg、吐温-8017.5kg、司盘-8017.5kg;
S2:取步骤S1称量好的千里光等七味中药材加水煎煮2次,第一次加9倍量水煎煮3h,第二次加8倍量水煎煮2h,过滤,合并滤液;
S3:将步骤S2的滤液浓缩至相对密度在65℃为1.06的清膏,加入与清膏等量的95%乙醇,静置20h,取上清液回收乙醇并浓缩至相对密度在65℃为1.20的清膏;
S4:取醋酸氯己定、冰片加适量95%乙醇溶解后,加入司盘-80搅拌均匀,备用;另取吐温-80加热至55℃,保温情况下加入步骤S3制得的清膏,搅拌均匀后加入以上醋酸氯己定、冰片混合液,55℃下以速度为25000rpm均质搅拌35min,最后加水至配制量,继续以25000rpm速度搅拌30min,取出,用100目滤布过滤,灭菌,灌装,即得所述乳剂。
实施例5
一种用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,包括以下步骤:
S1:按以下重量称取原料:千里光60kg、金银花30kg、苦参30kg、黄柏40kg、蛇床子30kg、五倍子15kg、苦楝皮30kg、冰片7kg、醋酸氯己定4kg、吐温-8020kg、司盘-8020kg;
S2:取步骤S1称量好的千里光等七味中药材加水煎煮3次,第一次加10倍量水煎煮2h,第二次加8倍量水煎煮1h,第三次加6倍量水煎煮1h,过滤,合并滤液;
S3:将步骤S2的滤液浓缩至相对密度在65℃为1.07的清膏,加入与清膏等量的95%乙醇,静置24h,取上清液回收乙醇并浓缩至相对密度在65℃为1.21的清膏;
S4:取醋酸氯己定、冰片加适量95%乙醇溶解后,加入司盘-80搅拌均匀,备用;另取吐温-80加热至60℃,保温情况下加入步骤S3制得的清膏,搅拌均匀后加入以上醋酸氯己定、冰片混合液,60℃下以速度为30000rpm均质搅拌40min,最后加水至配制量,继续以30000rpm速度搅拌30min,取出,用100目滤布过滤,灭菌,灌装,即得所述乳剂。
二、制剂的稳定性试验
离心试验
将本发明实施例1-5样品分别倒入试管内(试样约占试管三分之二高度),每个实施例倒2支试管,用干净的软木塞塞好。一支试管置于室温中,另一支放入已调节至38±1℃的电热恒温培养箱内,保温1h后,立即移入离心机中,2000r/min离心30min,取出观察,结果见表1。
表1 离心试验结果表
试验结果表明:本发明实施例1-5制剂在38±1℃条件下放置1h,取出离心,无分层、变色现象,说明本发明制剂的乳剂配方稳定性好。
三、制剂的抑菌试验
1.材料
1.1试验菌种
白色念珠菌[CMCC(F)98001]、大肠埃希菌[CMCC(B)44102]、金黄色葡萄球菌[CMCC(B)26003]。
1.2试验样品
供试品:本发明实施例1-5的样品,实验时精确称取适量溶于无菌纯化水中(终浓度100mg/ml);
阳性对照:
(1)市售的复方岗松乳剂(纯中药制剂),实验时用无菌纯化水稀释至200mg/ml;
(2)市售双唑泰乳剂(西药制剂),实验时用无菌纯化水稀释至10μg/mL;
阴性对照:灭菌生理盐水。
1.3培养基
胰酪大豆胨琼脂平板培养基、胰酪大豆胨液体培养基;沙氏葡萄糖琼脂平板培养基、沙氏葡萄糖液体培养基。
2.方法
2.1菌液的制备
将金黄色葡萄球菌、大肠埃希菌菌种接种于胰酪大豆胨液体培养基中,30℃培养24h;白色念珠菌菌种接种于沙氏葡萄糖液体培养基中,25℃培养48h。将所得的菌液进行梯度稀释至浓度为2×108CFU/mL,备用。
2.2试验平板的制备
先往已灭菌的平板中倾注20mL左右平板培养基,水平静置凝固,接种0.1mL菌液,用无菌的L型玻棒涂布均匀后,送相应试验菌株要求培养温度下培养15min,备用。
2.3抑菌圈方法(K-B法)试验
圆滤纸片经灭菌后烘干,于1.2项下各浓度的样品溶液中浸泡1h,然后用无菌镊子夹取含药滤纸片贴在2.2项下制备好的含菌平板培养基表面,轻轻按压,使纸片与培养基密切接触,每个培养皿均匀放置5张滤纸片,4℃预扩散2h,然后分别置35℃恒温培养箱培养24h(细菌),25℃生化培养箱培养48h(真菌),以十字交叉法测定其抑菌直径(以mm为单位),结果取平均值,详见表2。
表2 抑菌试验结果表
由表2可以看出,本发明实施例1-5样品和阳性对照对金黄色葡萄球菌、白色念珠菌、大肠杆菌均有抑制作用,实施例1-5样品对三种菌的抑制作用与阳性对照(2)相当,比阳性对照(1)强,说明本发明具有很好的抑菌作用。
四、应用试验
1.治疗妇科炎症
1.1病例选择
选择患有妇科炎症(宫颈炎、阴道炎)的患者。
1.2疗效判定
(1)痊愈:无阴道、外阴痒痛症状,阴道分泌物检查无异常,停药3个月经周期没有复发;
(2)显效:阴道、外阴痒痛症状改善,阴道分泌物检查无异常;
(3)有效:阴道分泌物检查无异常,但其他症状存在,或其他症状减轻、消失,但阴道分泌物检查异常;
(4)无效:症状及检查结果均无变化。
1.3给药方法
将符合上述病例选择标准患者255例(平均年龄32岁)按就诊顺序随机分成5个组,每组51人。
实施例组:取本发明实施例1、3、5样品,外用晚上睡觉前灌于阴道,一日1次,疗程:用药3周。
对照组:(1)取市售复方岗松乳剂,外用晚上睡觉前灌于阴道,一日1次,疗程:用药3周;(2)取市售双唑泰乳剂,外用晚上睡觉前灌于阴道,一日1次,疗程:用药3周。
1.4试验结果
结果详见表3。
在以上试验过程中,本发明3个实施例以及对照组(1)无一例患者出现不良反应,而对照组(2)中有5例患者在治疗初期出现皮疹、阴道烧灼感等不良反应,其中2例患者在治疗后期出现恶心、腹泻、口腔金属味等不良反应。
以上结果表明,本发明实施例1、3、5对妇科炎症的治疗总有效率达90%以上,均高于对照组,而且在治疗过程中未出现任何不良反应,说明本发明的制剂可有效治疗妇科炎症,使用安全有效。以下为几个典型的例子:
典型例子1:曾某,女,29岁,白带多,其形状多为稀薄浆液状,外阴瘙痒并有灼痛感,反复发作,持续时间3个月,经医院诊断为阴道炎。使用本发明实施例1的产品21天后,白带正常,外阴瘙痒现象消失,灼痛感消失,停药3个月经周期没有复发。
典型例子2:赵某,女,37岁,白带多,有时脓样,偶可带血性,常伴有腰酸、下腹痛及坠胀不适等症状,经医院诊断为宫颈炎。使用本发明实施例3的产品21天后,白带正常,腰酸、下腹痛、坠胀等症状消失,停药3个月经周期没有复发。
典型例子3:何某,41岁,白带多且呈脓样,偶见带血性,伴有腰酸、下腹坠胀痛等不适等症状,反复发作,持续12个月,最近还感觉外阴瘙痒且伴有灼热感,经医院诊断为慢性宫颈炎、阴道炎。使用本发明实施例5的产品21天后,不适症状基本消失,阴道分泌物检查恢复正常,停药4个月经周期没有复发。
2.治疗湿痒
本发明用于治疗妇科炎症、湿痒的制剂,曾用于165例湿痒患者,同时以(1)市售皮肤康乳膏(纯中药)、(2)醋酸曲安奈德益康唑乳膏(西药)做对照。将本发明实施例1、3、5样品以及对照样品,分别用于湿痒患者(男76例,女89例,平均年龄36岁)。结果详见表4。
表4 治疗湿痒效果表
在以上试验过程中,本发明3个实施例以及对照组(1)无一例患者出现不良反应,而对照组(2)中有3例患者出现皮肤烧灼感、针刺感等不良反应。
以上结果表明,本发明实施例1、3、5对湿痒的治疗总有效率达93%以上,均高于对照组,而且在治疗过程中未出现任何不良反应,说明本发明的制剂可有效治疗湿痒,使用安全有效。
以上内容不能认定本发明的具体实施只局限于这些说明,对于本发明所属技术领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干简单推演或替换,都应当视为属于本发明由所提交的权利要求书确定的专利保护范围。
Claims (10)
1.一种用于妇科炎症、湿痒的制剂,其特征在于,包括以下重量份的组分:千里光20-60份、金银花10-30份、苦参10-30份、黄柏20-40份、蛇床子10-30份、五倍子5-15份、苦楝皮10-30份、冰片3-7份、醋酸氯己定2-4份、吐温-80 10-20份、司盘-80 10-20份。
2.根据权利要求1所述的用于妇科炎症、湿痒的制剂,其特征在于,包括以下重量份的组分:千里光30-50份、金银花15-25份、苦参15-25份、黄柏25-35份、蛇床子15-25份、五倍子7.5-12.5份、苦楝皮15-25份、冰片4-6份、醋酸氯己定2.5-3.5份、吐温-80 12.5-17.5份、司盘-80 12.5-17.5份。
3.根据权利要求2所述的用于妇科炎症、湿痒的制剂,其特征在于,包括以下重量份的组分:千里光40份、金银花20份、苦参20份、黄柏30份、蛇床子20份、五倍子10份、苦楝皮20份、冰片5份、醋酸氯己定3份、吐温-80 15份、司盘-80 15份。
4.根据权利要求1-3任一项所述的用于妇科炎症、湿痒的制剂,其特征在于,所述制剂制备成乳剂、栓剂、洗剂。
5.根据权利要求1-3任一项所述的用于妇科炎症、湿痒的制剂,其特征在于,所述制剂制备成乳剂。
6.一种根据权利要求5所述的用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,其特征在于,包括以下步骤:
S1:按以下重量份称取组分:千里光20-60份、金银花10-30份、苦参10-30份、黄柏20-40份、蛇床子10-30份、五倍子5-15份、苦楝皮10-30份、冰片3-7份、醋酸氯己定2-4份、吐温-8010-20份、司盘-80 10-20份;
S2:取步骤S1称量好的千里光等七味中药材加5-10倍量水,煎煮2-3次,每次1-3h,过滤,合并滤液;
S3:将步骤S2的滤液浓缩至相对密度在60-65℃为1.03-1.07的清膏,加入与清膏等量的95%乙醇,静置,滤取上清液回收乙醇并浓缩至相对密度在60-65℃为1.17-1.21的清膏;
S4:取醋酸氯己定、冰片加适量乙醇溶解后,加入司盘-80搅拌均匀,备用;另取吐温-80加热至40℃-60℃,保温情况下加入步骤S3制得的清膏,搅拌均匀后加入以上醋酸氯己定、冰片混合液,40℃-60℃下均质搅拌20-40min,最后加水至配制量,继续均质搅拌20-30min,取出,用100目滤布过滤,灭菌,灌装,即得所述乳剂。
7.根据权利要求6所述的用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,其特征在于:步骤S3所述清膏醇沉静置时间为12-24h。
8.根据权利要求6所述的用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,其特征在于:步骤S4所述的乙醇的浓度为95%。
9.根据权利要求6所述的用于妇科炎症、湿痒的制剂制备成乳剂的制备方法,其特征在于:步骤S4所述的均质搅拌速度为10000-30000rpm。
10.根据权利要求1-3任一项所述的用于妇科炎症、湿痒的制剂,其特征在于,在制备用于皮肤湿痒、妇科炎症的药物中的用途。
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CN108452151A (zh) * | 2018-03-15 | 2018-08-28 | 广州佳静健康产业有限公司 | 一种阴道护理凝胶 |
CN108815274A (zh) * | 2018-07-25 | 2018-11-16 | 博凯健康产业有限公司 | 妇洁养护抑菌凝胶及其制备方法和应用 |
CN112022947A (zh) * | 2020-09-25 | 2020-12-04 | 长沙市嘉丽美生物科技有限公司 | 基于传统中草药及小分子化合物的抑菌剂及其制备方法和应用 |
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CN108066672A (zh) * | 2017-12-29 | 2018-05-25 | 广西万德药业有限公司 | 用于妇科炎症的乳剂及其制备方法 |
CN108452151A (zh) * | 2018-03-15 | 2018-08-28 | 广州佳静健康产业有限公司 | 一种阴道护理凝胶 |
CN108815274A (zh) * | 2018-07-25 | 2018-11-16 | 博凯健康产业有限公司 | 妇洁养护抑菌凝胶及其制备方法和应用 |
CN112022947A (zh) * | 2020-09-25 | 2020-12-04 | 长沙市嘉丽美生物科技有限公司 | 基于传统中草药及小分子化合物的抑菌剂及其制备方法和应用 |
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