CN110013470B - 肾宝片在制备治疗盆腔炎性疾病后遗症药物中的应用 - Google Patents
肾宝片在制备治疗盆腔炎性疾病后遗症药物中的应用 Download PDFInfo
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Abstract
本发明涉及肾宝片及其治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)的用途,本发明所述肾宝片,批准文号为国药准字Z20080627,成份:淫羊藿、葫芦巴、金樱子、熟地黄、补骨脂、蛇床子、制何首乌、肉苁蓉、枸杞子、菟丝子、五味子、覆盆子、黄芪、红参、白术、山药、茯苓、当归、川芎、小茴香、车前子、炙甘草,本发明在于提供肾宝片制剂在制备治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)的药物中的应用,本发明的应用,包括对盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)患者施用肾宝片,服用方法是口服,一次3片,一日3次,本发明是经过临床试验结果获得的,组间比较差异有统计学意义(P<0.05)。
Description
技术领域:
本发明涉及中药制剂,制备及其应用,特别涉及肾宝片治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)。
背景技术:
肾宝片是一种已经上市的中成药,国药准字Z20080627,成份:淫羊藿、葫芦巴、金樱子、熟地黄、补骨脂、蛇床子、制何首乌、肉苁蓉、枸杞子、菟丝子、五味子、覆盆子、黄芪、红参、白术、山药、茯苓、当归、川芎、小茴香、车前子、炙甘草。辅料为羟丙基纤维素、糊精、硬脂酸镁、微粉硅胶。肾宝片的功能主治:调和阴阳,温阳补肾,扶正固本。用于腰腿酸痛,精神不振,夜尿频多,畏寒怕冷,妇女白带清稀。
中国专利CN03109434公开了该制剂的组成、制法及用于腰腿酸痛,精神不振,夜尿频多,畏寒怕冷;妇女白带清稀治疗用途,但该药在治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)方面未见报道。
已经发现,肾宝片还具有抗疲劳作用,可防止肾阳虚动物胸腺,精囊腺和包皮腺萎缩的作用。可使去势大鼠血中睾酮水平增高,促进性行为,增加性兴奋,有一定壮阳作用。具有促进幼鼠性器官生长的作用。
妇人腹痛乃妇科常见杂病之一,指非因月经、妊娠、产后疾病所引起之小腹部疼痛,临床表现为下腹疼痛、坠胀,腰骶酸痛,常见劳累、性交后及月经前后加重,伴带下增多,月经不调,不孕或异位妊娠等,可伴低热起伏、全身疲乏无力等症状。现代医学的盆腔炎、盆腔瘀血综合征等均属妇人腹痛的范畴,而当中又以慢性盆腔炎占大多数,故一般提及妇人腹痛时主要指为西医之慢性盆腔炎。美国疾病控制和预防中心于近年将慢性盆腔炎更名为盆腔炎性疾病后遗症。西医对盆腔炎性疾病后遗症目前尚无特殊有效的治疗方法。中医多采用清热利湿、活血化淤类中药对其治疗。目前常见疗法为在抗菌药物治疗的基础上,辅以康妇消炎栓等清热利湿类中成药、桂枝茯苓胶囊、红花如意丸等活血化瘀类中成药治疗。
肾宝片是在宋·《和剂局方》收载的“四君子汤”,元·《丹溪心法》收载的“五子衍宗丸”、以及明·《景岳全书》收载的“五福饮”基础上加入温肾益精之品而得。方中用淫羊藿、胡芦巴温肾壮阳、益精起萎、强筋骨;熟地滋补肾精;金樱子酸涩收敛,具固精、缩尿、止带作用,四味共为本方之君药。补骨脂、蛇床子、肉苁蓉温阳祛寒,助君药温暖下元;枸杞子、菟丝子、制何首乌填精补髓、滋阴补肾,取“阴中求阳”之义,于是可以“阴平阳秘”,调和阴阳;五味子、覆盆子固肾止遗、涩精止带,以上八味药均能增强君药之作用,共为本方之臣药。黄芪、红参、白术、山药、茯苓补脾益气,补后天之本,使药引津气四迄,则周身之机运流通,水谷精微敷布;当归、川芎补血和血;小茴香温肾暖肝、散寒止痛;茯苓、五味子又可宁心安神;妙在车前一味,泻而通之,泻有形之邪浊,涩中兼通,补而不滞,上九味共为佐药。使以炙甘草调和阴阳,调和脾肾,调和补泻,调和诸药。诸药合用,共奏调和阴阳,温阳补肾,扶正固本之效。
本发明在现有肾宝片的基础上,对其制备、用途等进行了新的研究,发现了一些新用途和新制法,有关内容形成了本发明,具体见本发明内容部分。
发明内容:
本发明提供一种治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)的肾宝片制剂及其新用途。
本发明的肾宝片制剂,其配方如下:
优选的,本发明的肾宝片制剂,其配方如下:
本发明的肾宝片制剂,其制备方法如下:
制备方法1:以上22味,取淫羊藿、红参粗粉用10倍量50%乙醇浸泡1小时,回流提取2次,每次2小时,合并提取液,回收乙醇,浓缩成相对密度为1.05 (50℃)的清膏,待用;取蛇床子、五味子、白术、当归、川芎、小茴香粗粉,加12倍量水,浸泡40分钟,提取挥发油,蒸馏后的水煎液另器收集;取金樱子等其余十四味药材,加12倍量水,浸泡40分钟,水煎二次,每次1小时。水煎液与提取油后的水煎液合并。合并浓缩成相对密度为1.10(50℃)的清膏,加入乙醇至含醇量达65%,静置12小时以上,滤过,滤液回收乙醇,浓缩至相对密度为1.12(50℃)的清膏,加入淫羊藿、红参醇提液,搅匀,加入乙醇至含醇量达85%,静置12小时以上,取上清液,回收乙醇,浓缩至相对密度为1.05 (50℃)的清膏,离心,药液浓缩至相对密度为1.35(50℃)的浸膏,加糊精、微粉硅胶适量、5%羟丙基纤维素,混匀,制粒,干燥,放冷,混入用微粉硅胶吸附的挥发油、5%羟丙基纤维素、1.0%硬脂酸镁,压制成片,包薄膜衣,即得。制备方法2:以上22味,取淫羊藿、红参粗粉用10倍量50%乙醇浸泡1小时,回流提取2次,每次2小时,合并提取液,回收乙醇,浓缩成相对密度为1.05 (50℃)的清膏,待用;取蛇床子、五味子、白术、当归、川芎、小茴香粗粉,加12倍量水,浸泡40分钟,提取挥发油,蒸馏后的水煎液另器收集;取金樱子等其余十四味药材,加12倍量水,浸泡40分钟,水煎2次,每次1小时。水煎液与提取油后的水煎液合并。合并液浓缩成相对密度为1.10(50℃)的清膏,加入乙醇至含醇量达65%,静置12小时以上,滤过,滤液回收乙醇,浓缩至相对密度为1.12(50℃)的清膏,加入淫羊藿、红参醇提液,搅匀,加入乙醇至含醇量达85%,沉淀12小时以上,回收乙醇,浓缩至相对密度为1.05(50℃) 的清膏,离心,滤液中加入5%的可溶性糊精,喷雾干燥,制成干浸膏粉,取干浸膏粉,加入微粉硅胶适量、5%羟丙基纤维素,混合,过筛,制颗粒,干燥,放冷,混入用微粉硅胶吸附的挥发油、5%羟丙基纤维素、1.0%硬脂酸镁,压制成1000片,包薄膜衣,即得。
以下为经过改进的制备方法,称为制备方法3
以上22味,取淫羊藿、红参粗粉用10倍量50%乙醇浸泡1小时,回流提取2次,每次2小时,合并提取液,待用;取蛇床子、五味子、白术、当归、川芎、小茴香粗粉,加12倍量水,浸泡40分钟,提取挥发油,蒸馏后的水煎液另器收集;取金樱子等其余十四味药材,加12倍量水,浸泡40分钟,水煎二次,每次1 小时,得到十四味药的水煎液,将其与提取挥发油后的水煎液合并,浓缩成相对密度50℃为1.10的清膏,加入乙醇至含醇量达65%,静置12小时,滤过;合并含醇溶液,回收乙醇,药液浓缩至相对密度50℃为1.35的浸膏;浸膏中加糊精、微粉硅胶适量、5%羟丙基纤维素,混匀,制粒,干燥,放冷,混入用微粉硅胶 5g吸附的步骤2得到的挥发油、5%硫酸钙、1.0%硬脂酸镁,压制成片,包薄膜衣,即得。
本发明进一步提供肾宝片制剂在制备治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)的药物中的应用,本发明的应用,包括对盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)患者施用肾宝片,服用方法是口服,一次3片,一日3次,每片肾宝片,片重约0.7g,30天为一个疗程。本发明的应用,是根据以下实验结果确定的。
一、试验药物名称与规格
试验组72例:肾宝(本发明实施例2方法制备)片,口服,一次3片,一日3 次。
右归丸模拟剂,口服,一次1袋(9克),一日3次。
对照组24例:右归丸,口服,一次1袋(9克),一日3次。
肾宝片模拟剂,口服,一次3片,一日3次。
疗程:84天。
二、临床试验单位
天津中医药大学第一附属医院、山东中医药大学第二附属医院、涿州市医院、漯河市中医院
三、疗效
疗效评价标准:
中医证候疗效
临床痊愈:中医临床症状、舌脉消失或基本消失,证候积分减少≥95%;
显效:中医临床症状、舌脉明显改善,证候积分减少<95%而≥70%;
进步:中医临床症状、舌脉均有好转,证候积分减少<70%而≥30%;
无效:中医临床症状、舌脉无明显改善,甚或加重,证候积分减少不足30%。
注:计算公式:[(疗前总积分-疗后总积分)/疗前总积分]×100%。
(1)中医证候综合疗效
表1中医证候疗效比较(FAS)
FAS分析结果显示,试验组:临床控制:6例(8.33%)、显效:28例(38.89%)、进步27例(37.5%)、无效11例(15.28%);对照组:临床控制:2例(8.33%)、显效: 9例(37.5%)、进步:9例(37.5%)、无效4例(16.67%),两组中医证候综合疗效相比差异无统计学意义(P=0.762)。统计分析数据表明,两组等效。PPS结果与FAS 一致。
(2)中医证候总评分
表2两组中医证候总评分比较(FAS)
FAS分析结果显示,两组中医证候总评分组间相比差异无统计学意义(P=0.720)。
统计分析数据表明,两组等效。PPS结果与FAS结果一致。
四、结论
肾宝片治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)的试验结果表明,试验组与对照组治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)安全有效,两组疗效无差异。
本发明发现肾宝片具有治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)的作用,且与传统方剂右归丸相比无疗效优势。
本发明针对上述问题,在现有工艺的基础上对肾宝片的制备工艺进行了改进,改进后的肾宝片在疗效上有显著提升,可以长期服用,以下为本发明改进后的肾宝片的配方和制备方法:
本发明的肾宝片制剂,其配方和制备方法如下:
以上22味,取淫羊藿、红参粗粉用10倍量50%乙醇浸泡1小时,回流提取2次,每次2小时,合并提取液,待用;取蛇床子、五味子、白术、当归、川芎、小茴香粗粉,加12倍量水,浸泡40分钟,提取挥发油,蒸馏后的水煎液另器收集;取金樱子等其余十四味药材,加12倍量水,浸泡40分钟,水煎二次,每次1 小时,得到十四味药的水煎液,将其与提取挥发油后的水煎液合并,浓缩成相对密度50℃为1.10的清膏,加入乙醇至含醇量达65%,静置12小时,滤过;合并含醇溶液,回收乙醇,药液浓缩至相对密度50℃为1.35的浸膏;浸膏中加糊精、微粉硅胶适量、5%羟丙基纤维素,混匀,制粒,干燥,放冷,混入用微粉硅胶 5g吸附的步骤2得到的挥发油、5%硫酸钙、1.0%硬脂酸镁,压制成片,包薄膜衣,即得。
为提高肾宝片的疗效,降低副作用,避免长期服用效果不明显而放弃治疗,本发明在现有工艺的基础上对肾宝片的制备工艺进行了改进,以增加有效成分的含量,改进后的肾宝片在疗效上有显著提升,可以长期服用。
本发明的其改进之处在于:对于由原工艺的两次醇沉改为一次醇沉,即对于水煎液与提取挥发油后的水煎液合并后,加入乙醇至含醇量达65%,滤过,滤液加入淫羊藿、红参醇提液,回收乙醇一步完成。
本发明新的制备方法,减少了操作步骤,经过检测发现,淫羊藿苷和金樱子多糖的含量提高了10%左右,同时上火、胃肠道副作用有所下降。
本处方由22味药材组成,其中淫羊藿和金樱子均为君药,其中淫羊藿苷经过改进后含量提高有利于药效的提高,如本发明经过以下检测发现本发明的淫羊藿苷含量提高近10%,本发明淫羊藿苷含量采用以下方法进行测定:
【含量测定】照高效液相色谱法(通则0512)测定。
色谱条件与系统适用性试验以十八烷基硅烷键合硅胶为填充剂;以乙腈-水 (29:71)为流动相;检测波长为270nm,理论板数按淫羊藿苷峰计算应不低于 2500。
对照品溶液的制备取淫羊藿苷对照品适量,精密称定,加甲醇制成每1ml含淫羊藿苷30μg的溶液,即得。
供试品溶液的制备取本品10片,除去薄膜衣,研细,取1g,精密称定,精密加入乙醇25ml,称定重量,超声处理30分钟,放冷,用70%乙醇补足减失的重量,摇匀,滤过,取续滤液,即得。
测定法分别精密吸取对照品溶液和供试品溶液各20μl,注入液相色谱仪,测定,即得。
结果:
本发明实施例1的方法制备的肾宝片,淫羊藿苷含量为:2.11mg/片
本发明实施例2的方法制备的肾宝片,淫羊藿苷含量为:2.10mg/片
本发明实施例3方法制备的肾宝片,淫羊藿苷含量为:2.33mg/片
本发明减少现有技术中第二步醇沉步骤,意外的发现,改进后的肾宝片在疗效上有显著提升。以下通过实验数据说明本发明的有益效果:
一、试验药物名称与规格
试验组72例:肾宝片(本发明实施例3方法制备),口服,一次3片,一日3 次。
右归丸模拟剂,口服,一次1袋(9克),一日3次。
对照组24例:右归丸,口服,一次1袋(9克),一日3次。
肾宝片模拟剂,口服,一次3片,一日3次。
疗程:84天。
二、临床试验单位
天津中医药大学第一附属医院、山东中医药大学第二附属医院、涿州市医院、漯河市中医院
三、疗效
疗效评价标准:
中医证候疗效
临床痊愈:中医临床症状、舌脉消失或基本消失,证候积分减少≥95%;
显效:中医临床症状、舌脉明显改善,证候积分减少<95%而≥70%;
进步:中医临床症状、舌脉均有好转,证候积分减少<70%而≥30%;
无效:中医临床症状、舌脉无明显改善,甚或加重,证候积分减少不足30%。
注:计算公式:[(疗前总积分-疗后总积分)/疗前总积分]×100%。
(1)中医证候综合疗效
表3中医证候疗效比较(FAS)
表4中医证候疗效比较(PPS)
FAS分析结果显示,试验组:临床控制:2例(2.78%)、显效:50例(69.44%)、进步18例(25%)、无效2例(2.784%);对照组:临床控制:2例(8.33%)、显效:10 例(41.67%)、进步:8例(33.33%)、无效4例(16.67%),两组中医证候综合疗效相比差异有统计学意义(P=0.024)。统计分析数据表明,试验组优于对照组。
PPS分析结果显示,试验组:临床控制:2例(2.94%)、显效:49例(72.06%)、进步17例(25%)、无效0例(0%);对照组:临床控制:2例(8.33%)、显效:10例 (41.67%)、进步:8例(33.33%)、无效4例(16.67%),两组中医证候综合疗效相比差异有统计学意义(P=0.002)。统计分析数据表明,试验组优于对照组。
(2)中医证候总评分
表5两组中医证候总评分比较(FAS)
表6两组中医证候总评分比较(PPS)
FAS分析结果显示,两组中医证候总评分组间相比差异有统计学意义 (P=0.0034)。统计分析数据表明,试验组优于对照组。
PPS分析结果显示,两组中医证候总评分组间相比差异有统计学意义 (P=0.004)。统计分析数据表明,试验组优于对照组。
(3)腹部疼痛VAS评分
表7 VAS评分差值汇总(FAS)
表8 VAS评分差值汇总(PPS)
FAS分析结果显示,腹部疼痛VAS评分两组组间相比差异有统计学意义 (P=0.017)。统计分析数据表明,试验组优于对照组。
PPS分析结果显示,腹部疼痛VAS评分两组组间相比差异有统计学意义(P=0.005)。统计分析数据表明,试验组优于对照组。
四、副作用
本次临床试验,试验组和对照组均无副作用。
五、结论
肾宝片治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)的试验结果表明,试验组与对照组治疗盆腔炎性疾病后遗症(中医妇人腹痛肾阳虚证)安全有效,且试验组疗效优于对照组。
具体实施方式:
以下通过实施例进一步说明本发明,但不作为对本发明的限制。
实施例1
以上22味,取淫羊藿、红参粗粉用10倍量50%乙醇浸泡1小时,回流提取2次,每次2小时,合并提取液,回收乙醇,浓缩成相对密度为1.05(50℃)的清膏,待用;取蛇床子、五味子、白术、当归、川芎、小茴香粗粉,加12倍量水,浸泡40分钟,提取挥发油,蒸馏后的水煎液另器收集;取金樱子等其余十四味药材,加12倍量水,浸泡40分钟,水煎2次,每次1小时。水煎液与提取油后的水煎液合并。合并液浓缩成相对密度为1.10(50℃)的清膏,加入乙醇至含醇量达65%,静置12小时以上,滤过,滤液回收乙醇,浓缩至相对密度为1.12(50℃) 的清膏,加入淫羊藿、红参醇提液,搅匀,加入乙醇至含醇量达85%,沉淀12 小时以上,回收乙醇,浓缩至相对密度为1.05(50℃)的清膏,离心,滤液中加入5%的可溶性糊精,喷雾干燥,制成干浸膏粉,取干浸膏粉,加入微粉硅胶适量、5%羟丙基纤维素,混合,过筛,制颗粒,干燥,放冷,混入用微粉硅胶吸附的挥发油、5%羟丙基纤维素、1.0%硬脂酸镁,压制成1000片,包薄膜衣,即得。
实施例2
以上22味,取淫羊藿、红参粗粉用10倍量50%乙醇浸泡1小时,回流提取2次,每次2小时,合并提取液,回收乙醇,浓缩成相对密度为1.05(50℃)的清膏,待用;取蛇床子、五味子、白术、当归、川芎、小茴香粗粉,加12倍量水,浸泡40分钟,提取挥发油,蒸馏后的水煎液另器收集;取金樱子等其余十四味药材,加12倍量水,浸泡40分钟,水煎二次,每次1小时。水煎液与提取油后的水煎液合并。合并浓缩成相对密度为1.10(50℃)的清膏,加入乙醇至含醇量达65%,静置12小时以上,滤过,滤液回收乙醇,浓缩至相对密度为1.12(50℃) 的清膏,加入淫羊藿、红参醇提液,搅匀,加入乙醇至含醇量达85%,静置12 小时以上,取上清液,回收乙醇,浓缩至相对密度为1.05(50℃)的清膏,离心,药液浓缩至相对密度为1.35(50℃)的浸膏,加糊精、微粉硅胶适量、5%羟丙基纤维素,混匀,制粒,干燥,放冷,混入用微粉硅胶吸附的挥发油、5%羟丙基纤维素、1.0%硬脂酸镁,压制成1000片,包薄膜衣,即得。
实施例3
以上22味,取淫羊藿、红参粗粉用10倍量50%乙醇浸泡1小时,回流提取2次,每次2小时,合并提取液,待用;取蛇床子、五味子、白术、当归、川芎、小茴香粗粉,加12倍量水,浸泡40分钟,提取挥发油,蒸馏后的水煎液另器收集;取金樱子等其余十四味药材,加12倍量水,浸泡40分钟,水煎二次,每次1 小时,得到十四味药的水煎液,将其与提取挥发油后的水煎液合并,浓缩成相对密度为1.10(50℃)的清膏,加入乙醇至含醇量达65%,静置12小时,滤过;合并含醇溶液,回收乙醇,药液浓缩至相对密度为1.35(50℃)的浸膏;浸膏中加糊精100g、羟丙基纤维素35g,混匀,制粒,干燥,放冷,混入用微粉硅胶吸附的步骤2得到的挥发油、硫酸钙35g、硬脂酸镁7g,混匀后,压制成片,包薄膜衣,得到肾宝片制剂1000片,每片重量0.7g。
Claims (3)
1.一种治疗盆腔炎性疾病后遗症的肾宝片制剂,由以下重量份的中药原料药经下述工艺制备而成:
以上22味,取淫羊藿、红参粗粉用10倍量50%乙醇浸泡1小时,回流提取2次,每次2小时,合并提取液,待用;取蛇床子、五味子、白术、当归、川芎、小茴香粗粉,加12倍量水,浸泡40分钟,提取挥发油,蒸馏后的水煎液另器收集;取金樱子等其余十四味药材,加12倍量水,浸泡40分钟,水煎二次,每次1小时,得到十四味药的水煎液,将其与提取挥发油后的水煎液合并,浓缩成相对密度50℃为1.10的清膏,加入乙醇至含醇量达65%,静置12小时,滤过;合并含醇溶液,回收乙醇,药液浓缩至相对密度50℃为1.35的浸膏;浸膏中加糊精、微粉硅胶适量、5%羟丙基纤维素,混匀,制粒,干燥,放冷,混入用微粉硅胶5g吸附的步骤2得到的挥发油、5%硫酸钙、1.0%硬脂酸镁,压制成片,包薄膜衣,即得。
2.权利要求1所述的肾宝片制剂在制备治疗盆腔炎性疾病后遗症,即中医妇人腹痛肾阳虚证的药物中的应用。
3.根据权利要求2所述的应用,包括对盆腔炎性疾病后遗症患者施用肾宝片,服用方法是口服,一次3片,一日3次。
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