CN110075242B - 一种妇科泡沫剂及其制备方法 - Google Patents
一种妇科泡沫剂及其制备方法 Download PDFInfo
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- CN110075242B CN110075242B CN201910371078.7A CN201910371078A CN110075242B CN 110075242 B CN110075242 B CN 110075242B CN 201910371078 A CN201910371078 A CN 201910371078A CN 110075242 B CN110075242 B CN 110075242B
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Abstract
本发明属于妇科制药技术领域,具体涉及一种妇科泡沫剂及其制备方法,通过莪术油提取物、洗必泰、丙二醇、氢化蓖麻油、月桂烯酰肌氨酸钠、羟乙基纤维素钠、纯化水等制备而成,所述莪术油提取物通过超临界二氧化碳萃取与水蒸气蒸馏联用的方法,并控制提取过程中溶剂及温度、压力等重要参数的变化,将莪术中的莪术醇高效地提取出去,去除莪术醇后的莪术油提取物用于制备妇科泡沫剂,能够较好地抑制妇科疾病,增强妇女机体免疫功能,改善女性内分泌且提高了安全性。
Description
技术领域
本领域属于妇科制药技术领域,具体涉及一种妇科泡沫剂及其制备方法。
背景技术
妇科疾病比如阴道炎通常是一些常见的多发病,通常久治不愈,给正常的生活、工作带来极大的不便。阴道炎临床上以白带的性状发生改变以及外阴瘙痒灼痛为主要临床特点,性交痛也常见,感染累及尿道时,可有尿痛、尿急等症状,阴道炎具有发病慢,反复性强,治疗难彻底的特点。目前临床对阴道炎的治疗多采用局部和或全身应用抗生素和或唑类抗真菌药,疗效肯定,但阴道炎极易复发,复发后的阴道炎患者需长期口服抗真菌药物,易损害肝脏,同时其他副作用也很明显如胃肠道不适,头痛和面色潮红,妊娠妇女是阴道炎的好发人群之一,应用抗真菌药物尚不能排除增加畸胎及死胎发生率的可能,故抗真菌药物多不被妊娠期阴道炎患者所接受,同时单纯用中药或西药抗菌、杀菌、消炎,毒副作用大、远期效果不好,极易在抗炎杀菌的同时杀灭了阴道内的有益菌群,破坏了阴道内的正常菌群平衡,导致其他阴道疾病的产生,或导致炎症的反复发作,治疗和康复的时间会比较长。中医药治疗萎缩性阴道炎有其独特的优势,近年来有不少治疗阴道炎的药物均以清热解毒、利湿散结、杀虫止痒、行气破瘀为法,采用清热解毒药为主,主要治疗其标证,目前市场上治疗阴道炎的药品,多以直接杀菌、抗炎的形式居多,其防治阴道炎的效果并不理想。
妇科疾病中宫颈癌也是日常生活中的一种常见病、癌症疾病,也是女性发生恶性肿瘤最常见的疾病,对女性的健康和生命造成了很大的损害。宫颈癌的发病率仅次于乳腺癌,是女性应该重视的恶性肿瘤之一。宫颈癌的原位癌高发年龄为30-35岁,浸润癌为45-55岁,近年来其发病有年轻化的趋势。早期宫颈癌常无明显症状和体征,宫颈可光滑或难与宫颈柱状上皮异位区别。颈管型患者因宫颈外观正常易漏诊或误诊。随病变发展,可出现以下表现:(1)阴道流血早期多为接触性出血;中晚期为不规则阴道流血。出血量根据病灶大小、侵及间质内血管情况而不同,若侵袭大血管可引起大出血。年轻患者也可表现为经期延长、经量增多;老年患者常为绝经后不规则阴道流血。一般外生型较早出现阴道出血症状,出血量多;内生型较晚出现该症状。(2)阴道排液多数患者有阴道排液,液体为白色或血性,可稀薄如水样或米泔状,或有腥臭。晚期患者因癌组织坏死伴感染,可有大量米汤样或脓性恶臭白带。(3)晚期症状根据癌灶累及范围出现不同的继发性症状。如尿频、尿急、便秘、下肢肿痛等;癌肿压迫或累及输尿管时,可引起输尿管梗阻、肾盂积水及尿毒症;晚期可有贫血、恶病质等全身衰竭症状。目前宫颈癌的治疗方案以手术和放射治疗为主,手术和放、化疗只能解决局部问题,放、化疗后病情反复的不在少数。中医中药治疗癌症可减轻病人的症状和痛苦,且毒副作用小,疗效稳定,但目前的中药治疗效果不佳,仍然需要进一步研究。
近年来有不少治疗妇科病的药物均以清热解毒、利湿散结、杀虫止痒、行气破瘀为法,采用清热解毒药为主,主要治疗其标证,目前市场上治疗阴道炎的药品,多以直接杀菌、抗炎的形式居多,其防治妇科病的效果并不理想。
莪术油提取物是一种从莪术中提取的挥发油,具有抗肿瘤、抗病原微生物(细菌、病毒、支原体、衣原体等)等作用,有报道称莪术油可抑制人乳头瘤病毒(HPV),降低宫颈癌的发生率;莪术油包含薄荷油、丁香油、肉桂油、薄荷脑、麝香草酚、熏衣草油、桉油、松节油等多种精油,具有广泛的用途,莪术油中含有多种治疗癌症的有效成分,如莪术二酮、莪术醇、榄香烯等,但由于文献报道莪术醇具有抗小鼠生育的作用,常被用于制作抗鼠害的饵剂,这使得其在制备治疗妇科炎症药物方面有一定的安全隐患。因此,去除莪术油中的莪术醇并保留其它有效成份具有重要的意义。中国专利CN 102363019A公开了一种温莪术油提取物及其制备方法和用途,其制备的莪术油可用于制备多种药物,但是其对莪术醇的分离去除效率并不高,这使得该提取物可能存在一定的抗生育效果,在制备治疗育龄妇女相关疾病的药物方面受到一定限制,不能很好的利用其药效价值。
发明内容
为克服以上技术问题,本申请提供一种莪术油的提取方法,提取工艺简单,制得的莪术油提取物不含有莪术醇,该莪术油提取物制成的药物对妇科疾病具有较好的预防及治疗作用,且安全性好。
为实现以上目的,本发明提供以下技术方案:
一种妇科泡沫剂,包括以下组分:
莪术油提取物、洗必泰、丙二醇、氢化蓖麻油、月桂烯酰肌氨酸钠、羟乙基纤维素钠、纯化水;其中,所述莪术油提取物中不含有莪术醇。
优选地,按重量份数计,所述妇科泡沫剂,包含以下组分:
莪术油提取物10-20份、洗必泰0.5-3份、丙二醇10-30份、氢化蓖麻油1-10份、月桂烯酰肌氨酸钠1-5份、羟乙基纤维素钠0.5-1份、纯化水100-500份。
更优选地,按重量份数计,所述妇科泡沫剂,包含以下组分:
莪术油提取物12-16份、洗必泰0.5-1.5份、丙二醇15-25份、氢化蓖麻油5-7份、月桂烯酰肌氨酸钠2-4份、羟乙基纤维素钠0.8-1份、纯化水250-400份。
优选地,所述莪术油提取物通过以下方法制备而成:
(a)取莪术,粉碎后过筛;
(b)加入改性剂,超临界二氧化碳萃取20-30min,用有机溶剂收集萃取液,过滤得残渣;
(c)残渣中加入纯化水,用水蒸气蒸馏2-3h;得水蒸气蒸馏提取物,将萃取液和水蒸气蒸馏提取物混合,得莪术油;
(d)将莪术油精馏,分离,收集3-5kpa的压力下,温度为170-180℃时的固液混合馏分;
(e)将固液混合馏分过滤去除固体成分,得滤液,将滤液与其余馏分混合,即制得不含莪术醇的莪术油提取物。
优选地,步骤(a)中,所述过筛的目数为30-50目。
优选地,步骤(b)中,所述改性剂为乙醇与丙二醇的混合溶剂。
优选地,所述乙醇与丙二醇的混合溶剂的总质量占莪术质量的10-25%;其中,乙醇与丙二醇的体积比为3-5:1。
优选地,步骤(b)中,所述超临界二氧化碳萃取的条件为:温度60-65℃,压力10-15mpa。
优选地,步骤(b)中,所述有机溶剂为乙醇或丙二醇中的任一种。
优选地,步骤(c)中,所述纯化水的加入量为残渣质量的3-6倍。
优选地,步骤(c)中,所述水蒸气蒸馏在120-130℃下进行。
本发明的另一目的在于,提供一种妇科泡沫剂的制备方法,包含以下制备步骤:
(1)将莪术油提取物、洗必泰、氢化蓖麻油加入丙二醇中,加热,得混合物1;
(2)向纯化水中加入月桂烯酰肌氨酸钠,加热,得混合物2;
(3)用冷水将羟乙基纤维素钠冲开,加入到混合物2中,加热、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温;装罐,得泡沫剂。
优选地,步骤(1)中,所述加热为将温度加热至65-70℃;
优选地,步骤(2)中,所述加热为将温度加热至60-80℃;
优选地,步骤(3)中,所述加热为将温度加热至80-95℃;
优选地,步骤(3)中,所述冷水温度不高于30℃;
优选地,步骤(4)中,所述降温为将温度降至20-30℃。
本发明的目的还在于,提供上述妇科泡沫剂或制备方法所制备的妇科泡沫剂在妇科药物中的应用。
与现有技术相比,本发明的优势在于:
(1)本申请采用超临界二氧化碳与水蒸气蒸馏混合的方法对莪术油进行提取,一方面保护了莪术油中有效成分不变性,另一方面,降低了莪术油的挥发损失量,并有效地将精馏后固体成分莪术醇过滤去除。
(2)加入乙醇和丙二醇的混合溶液作为改性剂,可以更好地促进提取莪术中莪术醇的分离效率,并通过调整两种试剂的使用比例,在尽量节约资源的前提下,提高其改性效果。
(3)本发明采用不含有莪术醇的莪术油提取物与洗必泰为主要有效成份,二者联合使用,更能充分发挥两者的协同作用,一方面对治病细菌有杀灭作用,制备治疗或预防由细菌、真菌、衣原体、支原体、病毒等引起的阴道炎等妇科疾病;另一方面加强了抗肿瘤及抗病原微生物的作用,并同时可以抑制人乳头瘤病毒(HPV),降低宫颈癌的发生率,并且安全性高,对机体无抗生育作用。
(4)本发明泡沫剂能够深度给药,其喷出物不流动,泡沫稳定、持续时间长,大大延长了药物在病灶部位的作用时间,它直接作用于病灶,可以充满穹隆和皱襞,可以任何体位给药,药液通过粘膜吸收进入下腔静脉,不经过肝脏,避免肝肾的毒性。
(5)本发明制备的中药剂具有杀菌、抗炎、抗病毒,对细菌、霉菌、真菌、滴虫引起的妇科炎症,瘙痒,异味等均具有较为理想的功效,能够增强妇女机体免疫功能,改善内分泌,提高性功能。
具体实施方式
实施例1
莪术油提取物的制备,包括以下步骤:
(a)取莪术,粉碎,过40目筛;
(b)按照莪术质量的20%加入体积比为4:1的乙醇与丙二醇的作改性剂,温度60℃,压力12mpa下,进行超临界二氧化碳萃取25min,用乙醇或丙二醇收集萃取液,过滤得残渣;
(c)向残渣中加入5倍的纯化水,在125℃下,用水蒸气蒸馏2.5h;得水蒸气蒸馏提取物,将萃取液和水蒸气蒸馏提取物混合,得莪术油;
(d)将莪术油精馏,分离,收集3-5kpa的压力下,温度为170-180℃时的固液混合馏分;
(e)将固液混合馏分过滤去除固体成分,得滤液,将滤液与其余馏分混合,即制得不含莪术醇的莪术油提取物。
妇科泡沫剂的制备:
(1)将15份莪术油提取物、1份洗必泰、6份氢化蓖麻油加入20份丙二醇中,加热至68℃,得混合物1;
(2)向300份纯化水中加入3份月桂烯酰肌氨酸钠,加热至70℃,得混合物2;
(3)用20℃冷水将0.9份羟乙基纤维素钠冲开,加入到混合物2中,加热至90℃、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温至25℃;装罐,得泡沫剂。
实施例2
莪术油提取物的制备,包括以下步骤:
(a)取莪术,粉碎,过30目筛;
(b)按照莪术质量的10%加入乙醇与丙二醇的体积比为3:1作改性剂,温度60℃,压力10mpa下,进行超临界二氧化碳萃取20min,用乙醇或丙二醇收集萃取液,过滤得残渣;
(c)向残渣中加入3倍的纯化水,在120℃下,用水蒸气蒸馏2h;得水蒸气蒸馏提取物,将萃取液和水蒸气蒸馏提取物混合,得莪术油;
(d)将莪术油精馏,分离,收集3-5kpa的压力下,温度为170-180℃时的固液混合馏分;
(e)将固液混合馏分过滤去除固体成分,得滤液,将滤液与其余馏分混合,即制得不含莪术醇的莪术油提取物。
妇科泡沫剂的制备:
(1)将10份莪术油提取物、0.5份洗必泰、1份氢化蓖麻油加入10份丙二醇中,加热至65℃,得混合物1;
(2)向100份纯化水中加入1份月桂烯酰肌氨酸钠,加热至60℃,得混合物2;
(3)用30℃冷水将0.5份羟乙基纤维素钠冲开,加入到混合物2中,加热至80℃、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温至20℃;装罐,得泡沫剂。
实施例3
莪术油提取物的制备,包括以下步骤:
(a)取莪术,粉碎,过50目筛;
(b)按照莪术质量的25%加入乙醇与丙二醇的体积比为5:1作改性剂,温度65℃,压力15mpa下,进行超临界二氧化碳萃取30min,用乙醇或丙二醇收集萃取液,过滤得残渣;
(c)向残渣中加入6倍的纯化水,在130℃下,用水蒸气蒸馏3h;得水蒸气蒸馏提取物,将萃取液和水蒸气蒸馏提取物混合,得莪术油;
(d)将莪术油精馏,分离,收集3-5kpa的压力下,温度为170-180℃时的固液混合馏分;
(e)将固液混合馏分过滤去除固体成分,得滤液,将滤液与其余馏分混合,即制得不含莪术醇的莪术油提取物。
妇科泡沫剂的制备:
(1)将10莪术油提取物、3份洗必泰、10份氢化蓖麻油加入30份丙二醇中,加热至70℃,得混合物1;
(2)向500份纯化水中加入5份月桂烯酰肌氨酸钠,加热至80℃,得混合物2;
(3)用20℃冷水将1份羟乙基纤维素钠冲开,加入到混合物2中,加热至95℃、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温至30℃;装罐,得泡沫剂。
实施例4
莪术油提取物的制备,包括以下步骤:
(a)取莪术,粉碎,过30目筛;
(b)按照莪术质量的25%加入乙醇与丙二醇的体积比为5:1作改性剂,温度65℃,压力15mpa下,进行超临界二氧化碳萃取20min,用乙醇或丙二醇收集萃取液,过滤得残渣;
(c)向残渣中加入6倍的纯化水,在120℃下,用水蒸气蒸馏3h;得水蒸气蒸馏提取物,将萃取液和水蒸气蒸馏提取物混合,得莪术油;
(d)将莪术油精馏,分离,收集3-5kpa的压力下,温度为170-180℃时的固液混合馏分;
(e)将固液混合馏分过滤去除固体成分,得滤液,将滤液与其余馏分混合,即制得不含莪术醇的莪术油提取物。
妇科泡沫剂的制备:
(1)将12份莪术油提取物、0.5份洗必泰、5份氢化蓖麻油加入15份丙二醇中,加热至65℃,得混合物1;
(2)向250份纯化水中加入2份月桂烯酰肌氨酸钠,加热至60℃,得混合物2;
(3)用20℃冷水将0.8份羟乙基纤维素钠冲开,加入到混合物2中,加热至80℃、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温至20℃;装罐,得泡沫剂。
实施例5
莪术油提取物的制备,包括以下步骤:
(a)取莪术,粉碎,过50目筛;
(b)按照莪术质量的10%加入乙醇与丙二醇的体积比为4:1作改性剂,温度65℃,压力14mpa下,进行超临界二氧化碳萃取25min,用乙醇或丙二醇收集萃取液,过滤得残渣;
(c)向残渣中加入5倍的纯化水,在120℃下,用水蒸气蒸馏2h;得水蒸气蒸馏提取物,将萃取液和水蒸气蒸馏提取物混合,得莪术油;
(d)将莪术油精馏,分离,收集3-5kpa的压力下,温度为170-180℃时的固液混合馏分;
(e)将固液混合馏分过滤去除固体成分,得滤液,将滤液与其余馏分混合,即制得不含莪术醇的莪术油提取物。
妇科泡沫剂的制备:
(1)将16份莪术油提取物、1.5份洗必泰、7份氢化蓖麻油加入25份丙二醇中,加热至70℃,得混合物1;
(2)向400份纯化水中加入4份月桂烯酰肌氨酸钠,加热至80℃,得混合物2;
(3)用不高于30℃冷水将1份羟乙基纤维素钠冲开,加入到混合物2中,加热至95℃、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温至30℃;装罐,得泡沫剂。
对比例1(与实施例1比,莪术油的提取方法不同)
莪术油提取物的制备,包括以下步骤:
(a)取莪术,粉碎,过40目筛;
(b)在温度60℃,压力12mpa下,进行超临界二氧化碳萃取25min,用乙醇或丙二醇收集萃取液,过滤得残渣;
(c)向残渣中加入5倍的纯化水,在125℃下,用水蒸气蒸馏2.5h;得水蒸气蒸馏提取物,将萃取液和水蒸气蒸馏提取物混合,得莪术油;
(d)将莪术油精馏,分离,收集3-5kpa的压力下,温度为170-180℃时的固液混合馏分;
(e)将固液混合馏分过滤去除固体成分,得滤液,将滤液与其余馏分混合,即制得不含莪术醇的莪术油提取物。
妇科泡沫剂的制备:
(1)将15份莪术油、1份洗必泰、6份氢化蓖麻油加入20份丙二醇中,加热至68℃,得混合物1;
(2)向300份纯化水中加入3份月桂烯酰肌氨酸钠,加热至70℃,得混合物2;
(3)用20℃冷水将0.9份羟乙基纤维素钠冲开,加入到混合物2中,加热至90℃、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温至25℃;装罐,得泡沫剂。
对比例2(与实施例1比,妇科泡沫剂的组分不同)
莪术油提取物的制备:同实施例1中的方法。
妇科泡沫剂的制备:
(1)将16份莪术油、6份氢化蓖麻油加入20份丙二醇中,加热至68℃,得混合物1;
(2)向300份纯化水中加入3份月桂烯酰肌氨酸钠,加热至70℃,得混合物2;
(3)用20℃冷水将0.9份羟乙基纤维素钠冲开,加入到混合物2中,加热至90℃、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温至25℃;装罐,得泡沫剂。
对比例3(与实施例1比,妇科泡沫剂的组分不同)
莪术油提取物的制备:同实施例1中的方法。
妇科泡沫剂的制备:
(1)将16份洗必泰、6份氢化蓖麻油加入20份丙二醇中,加热至68℃,得混合物1;
(2)向300份纯化水中加入3份月桂烯酰肌氨酸钠,加热至70℃,得混合物2;
(3)用20℃冷水将0.9份羟乙基纤维素钠冲开,加入到混合物2中,加热至90℃、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温至25℃;装罐,得泡沫剂。
对比例4(与实施例1比,妇科泡沫剂的制备工艺不同)
莪术油提取物的制备:同实施例1中的方法。
妇科泡沫剂的制备:
(1)将15份莪术油、1份洗必泰、6份氢化蓖麻油加入20份丙二醇中,加热至68℃,得混合物1;
(2)向300份纯化水中加入3份月桂烯酰肌氨酸钠和0.9份羟乙基纤维素钠,加热至90℃,搅拌,得混合物2’;
(3)将所述混合物1和混合物2’混合、搅拌、降温至25℃;装罐,得泡沫剂。
对比例5(与实施例1相比,未除去莪术醇)
莪术油提取物的制备,包括以下步骤:
(a)取莪术,粉碎,过40目筛;
(b)按照莪术质量的20%加入体积比为4:1的乙醇与丙二醇的作改性剂,温度60℃,压力12mpa下,进行超临界二氧化碳萃取25min,用乙醇或丙二醇收集萃取液,过滤得残渣;
(c)向残渣中加入5倍的纯化水,在125℃下,用水蒸气蒸馏2.5h;得水蒸气蒸馏提取物,将萃取液和水蒸气蒸馏提取物混合,得莪术油提取物;
妇科泡沫剂的制备:
(1)将15份莪术油提取物、1份洗必泰、6份氢化蓖麻油加入20份丙二醇中,加热至68℃,得混合物1;
(2)向300份纯化水中加入3份月桂烯酰肌氨酸钠,加热至70℃,得混合物2;
(3)用20℃冷水将0.9份羟乙基纤维素钠冲开,加入到混合物2中,加热至90℃、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温至25℃;装罐,得泡沫剂。
效果例
1.抑菌效果评价
参照QBT 2738-2012《日化产品抗菌抑菌效果的评价方法》对实施例1、3、5及对比例1-3所述的方法制备的药物进行抑菌效果试验;结果如下表1。
表1抑菌效果评价
试验组 | 试验菌种 | 作用时间(min) | 抑菌率(%) |
实施例1 | 白色念珠菌、大肠杆菌、金黄色葡萄糖球菌 | 1 | 99.1 |
实施例3 | 白色念珠菌、大肠杆菌、金黄色葡萄糖球菌 | 1 | 98.9 |
实施例5 | 白色念珠菌、大肠杆菌、金黄色葡萄糖球菌 | 1 | 98.7 |
对比例1 | 白色念珠菌、大肠杆菌、金黄色葡萄糖球菌 | 1 | 70.3 |
对比例2 | 白色念珠菌、大肠杆菌、金黄色葡萄糖球菌 | 1 | 75.5 |
对比例3 | 白色念珠菌、大肠杆菌、金黄色葡萄糖球菌 | 1 | 65.3 |
对比例4 | 白色念珠菌、大肠杆菌、金黄色葡萄糖球菌 | 1 | 69.8 |
由此可知,本发明具有较好的抑菌效果,同时,莪术油提取物和洗必泰具有较好的协同作用,二者共同使用可以增强泡沫剂的抑菌效果。
2.大鼠阴道炎的抑制效果实验
实验方法:取苯酚5ml,西黄蓍胶1g,甘油4ml,加蒸馏水至20ml,配成含25%苯酚胶浆。
取大鼠,雌性,200±20g,用带有灌胃针头的1ml的注射器在每只大鼠阴道内约1cm处按0.2ml/只注射苯酚胶浆,每天1次,连续4天,观察并记录外阴的变化。造模4天后,大鼠阴道口会出现白色甚至白色分泌物,阴道口红肿,溃烂,阴道充血,说明造模成功。
取造模成功的大鼠80只,按照空白组、实施例1、3、5,对比例1-3,阳性对照组随机分组,每组10只。按照100mg/kg BW阴道给药,实施例1、3、5及对比例1-3用注射器注入大鼠阴道内,阳性对照组为市售消糜阴道泡腾片,切成条捏成圆柱状,塞入大鼠阴道内。治疗10天后,放血处死后,立即取大鼠阴道至子宫分角处组织,处理后,用光学显微镜观察大鼠的炎性细胞数量。实验结果如表2。
表2消炎效果数据
试验组 | 炎性细胞总数(个) |
空白组 | 328.3±88.2<sup>c</sup> |
实施例1 | 161.4±78.1<sup>a</sup> |
实施例3 | 173.9±60.5<sup>a</sup> |
实施例5 | 180.5±81.2<sup>a</sup> |
对比例1 | 246.7±101.3<sup>b</sup> |
对比例2 | 233.8±74.4<sup>b</sup> |
对比例3 | 259.1±98.6<sup>b</sup> |
对比例4 | 261.4±66.5<sup>b</sup> |
阳性对照组 | 152.6±59.7<sup>a</sup> |
注:不同字母间具有显著性差异。
由此可知,本发明制备的妇科喷雾剂对阴道炎具有较好的抑制效果,且效果同现有阴道炎消炎药效果相近。
3.抗生育效果
实验动物:成年健康Wistar大鼠,雌性大鼠24只,体重250±10g,雄性大鼠24只,体重300±10g。按完全随机分组法将雌鼠随机分为3组:(1)空白基质组(0.7%的生理盐水);(2)实施例1组;(3)对比例5组。阴道内给予药0.5ml,15天后,与雄鼠合笼,次晨8点取阴道分泌物镜检,发现有阴栓或精子者,立即分笼饲养。在用药后第10天,用0.8%戊巴比妥钠麻醉后常规解剖子宫,肉眼观察记数每鼠左右子宫角内活胎数、死胎数、着床点等,凡有一个着床点即算为妊娠鼠,计算生育率。
表3抗生育效果实验
试验组 | 大鼠个数 | 着床数(个) |
空白组 | 8 | 14.2±1.3<sup>p</sup> |
实施例1 | 8 | 13.9±1.6<sup>p</sup> |
对比例5 | 8 | 9.3±2.1<sup>q</sup> |
注:不同字母间具有显著性差异。
由此可知,去除莪术醇之后的莪术油提取物所制备的妇科喷雾剂能够有效避免抗生育作用,使妇科喷雾剂使用者不会因为药物的使用而影响生育功能。
上述详细说明是针对本发明其中之一可行实施例的具体说明,该实施例并非用以限制本发明的专利范围,凡未脱离本发明所为的等效实施或变更,均应包含于本发明技术方案的范围内。
Claims (7)
1.一种治疗阴道炎的妇科泡沫剂,其特征在于,按重量份数计,包含以下组分:莪术油提取物10-20份、洗必泰0.5-3份、丙二醇10-30份、氢化蓖麻油1-10份、月桂烯酰肌氨酸钠1-5份、羟乙基纤维素钠0.5-1份、纯化水100-500份;
所述莪术油提取物通过以下方法制备而成:
(a)取莪术,粉碎后过筛;
(b)加入改性剂,超临界二氧化碳萃取,用有机溶剂收集萃取液,过滤得残渣;
(c)残渣中加入纯化水,用水蒸气蒸馏;得水蒸气蒸馏提取物,将萃取液和水蒸气蒸馏提取物混合,得莪术油;
(d)将莪术油精馏,分离,收集3-5kPa的压力下,温度为170-180℃时的固液混合馏分;
(e)将固液混合馏分过滤去除固体成分,得滤液,将滤液与其余馏分混合,即制得不含莪术醇的莪术油提取物;
所述改性剂为乙醇与丙二醇的混合溶剂;所述乙醇与丙二醇的混合溶剂的总质量占莪术质量的10-25%;其中,乙醇与丙二醇的体积比为3-5:1。
2.如权利要求1所述的妇科泡沫剂,其特征在于,按重量份数计,包含以下组分:莪术油提取物12-16份、洗必泰0.5-1.5份、丙二醇15-25份、氢化蓖麻油5-7份、月桂烯酰肌氨酸钠2-4份、羟乙基纤维素钠0.8-1份、纯化水250-400份。
3.如权利要求1所述的妇科泡沫剂,其特征在于,步骤(b)中,所述超临界二氧化碳萃取的条件为:温度60-65℃,压力10-15MPa。
4.如权利要求1所述的妇科泡沫剂,其特征在于,步骤(c)中,所述纯化水的加入量为残渣质量的3-6倍,所述水蒸气蒸馏的温度为120-130℃。
5.如权利要求1-2任一所述妇科泡沫剂的制备方法,其特征在于,包含以下制备步骤:
(1)将莪术油提取物、洗必泰、氢化蓖麻油加入丙二醇中,加热,得混合物1;
(2)向纯化水中加入月桂烯酰肌氨酸钠,加热,得混合物2;
(3)用冷水将羟乙基纤维素钠冲开,加入到混合物2中,加热、搅拌,得混合物3;
(4)将所述混合物1和混合物3混合、搅拌、降温;装罐,得泡沫剂。
6.如权利要求5所述妇科泡沫剂的制备方法,其特征在于,
步骤(1)中,所述加热为将温度加热至65-70℃;
步骤(2)中,所述加热为将温度加热至60-80℃;
步骤(3)中,所述加热为将温度加热至80-95℃;所述冷水温度不高于30℃;
步骤(4)中,所述降温为将温度降至20-30℃。
7.如权利要求1-4任一所述的妇科泡沫剂或权利要求5或权利要求6所述妇科泡沫剂的制备方法制备的妇科泡沫剂在制备治疗阴道炎药物中的应用。
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CN1238947A (zh) * | 1998-06-15 | 1999-12-22 | 贵州宏宇药业有限公司 | 一种治疗妇科疾病的泡沫剂及其制备方法 |
CN1687071A (zh) * | 2005-03-30 | 2005-10-26 | 延边天保生物制剂有限公司 | 一种莪朮醇的提取方法、以其作为主要活性成分的鼠用抗生育药物 |
CN103122005A (zh) * | 2011-11-21 | 2013-05-29 | 成都市湔江制药厂 | 一种提取莪术醇的方法 |
CN103768497A (zh) * | 2012-10-24 | 2014-05-07 | 海南碧凯药业有限公司 | 一种药物组合物及其制剂和用途 |
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CN1238947A (zh) * | 1998-06-15 | 1999-12-22 | 贵州宏宇药业有限公司 | 一种治疗妇科疾病的泡沫剂及其制备方法 |
CN1687071A (zh) * | 2005-03-30 | 2005-10-26 | 延边天保生物制剂有限公司 | 一种莪朮醇的提取方法、以其作为主要活性成分的鼠用抗生育药物 |
CN103122005A (zh) * | 2011-11-21 | 2013-05-29 | 成都市湔江制药厂 | 一种提取莪术醇的方法 |
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