CN117482185A - 一种治疗前列腺增生的中药组合物及其制备方法 - Google Patents
一种治疗前列腺增生的中药组合物及其制备方法 Download PDFInfo
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- CN117482185A CN117482185A CN202311741544.9A CN202311741544A CN117482185A CN 117482185 A CN117482185 A CN 117482185A CN 202311741544 A CN202311741544 A CN 202311741544A CN 117482185 A CN117482185 A CN 117482185A
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Abstract
本发明涉及一种治疗前列腺增生的中药组合物及其制备方法,该中药组合物是由薏苡仁、浙贝母、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、丁香、没药、甘草、蜜炙黄芪共十二味中药制备而成;该药具有清热利湿,散结祛瘀的功效;主要用于证属湿热蕴结,痰瘀交阻,前列腺增生症,症见尿频,尿急或尿细,排尿困难等的治疗,用途是在治疗前列腺增生疾病药物中的应用;其临床药效学试验效果显著,生物利用度高,且无任何毒副作用。
Description
技术领域
本发明涉及一种治疗前列腺增生的中药组合物及其制备方法,属于制药技术领域。
技术背景
前列腺增生是中老年男性前列腺肥大、增生引起排尿障碍的良性疾病,可出现排尿困难和尿频、尿急,严重的还会出现尿急、尿痛、夜尿频繁及入睡困难等情形。前列腺增生的发生率随年龄的增长而增长,与男性性激素平衡失调可能有较大关系。严重影响了中老年男性的身体健康。中医对前列腺增生主要以清热利湿,散结祛瘀为主。现有技术:1、中国专利公报2008年2月27日公开了名称为“一种治疗前列腺增生症的药物及其制备方法”公开号为CN101129870A的专利申请,组成此发明原料药的配比为:薏苡仁180份、浙贝母120份、川木通108份、栀子108份、金银花120份、旋覆花108份、泽兰108份、大黄36份、铜绿6份、甘草48份、黄芪144份。2、中国专利公报2009年7月22日公开了名称为“一种治疗前列腺疾病的中药组合物及其制备方法”公开号为CN101485847A的专利申请,组成此发明原料药的配比为:薏苡仁188份、浙贝母112份、川木通108份、栀子(炒)108份、金银花120份、旋覆花98份、泽兰108份、大黄36份、铜绿16份、甘草48份、黄芪(蜜炙)144份。发明人经多年研究发现,以上现有技术1-2在治疗前列腺增生疾病方面取得了一定的疗效;但在临床的应用中我们发现其疗效还不够理想,我们在以上现有技术1-2组方的基础上,通过大量的实验摸索,发现将“铜绿”改为“丁香,没药”,并对处方药材用量进行调整后,新处方制成的药物疗效显著提高,且长期服用无任何毒副作用。我们按常规工艺制成颗粒剂、胶囊剂和片剂。
发明内容
本发明的目的在于:提供疗效更为显著一种治疗前列腺增生的中药组合物及其制备方法。其特点是,本发明中药组合物各原料药的组成为:
本发明中药组合物各原料药优选的组成为:
1、本发明中药组合物颗粒剂的制备方法如下:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量蔗糖和糊精,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
2、本发明中药组合物胶囊剂的制备方法如下:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,装胶囊,制成1000粒,即得胶囊剂。
3、本发明中药组合物片剂的制备方法如下:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,压片,制成1000片,即得片剂。
本发明有益效果:本发明是发明人通过大量的实验摸索,在现有技术1(CN101129870A)和现有技术2(CN101485847A)组方的基础上,将“铜绿”改为“丁香,没药”,并对处方药材用量进行调整后,按照常规工艺制备,发现本发明中药配方制成的中成药,其临床药效学实验效果显著提高,且无任何毒副作用;我们按常规工艺制成颗粒剂、胶囊剂和片剂。本发明具有清热利湿,散结祛瘀的功效,主要用于证属湿热蕴结,痰瘀交阻,前列腺增生症,症见尿频,尿急或尿细,排尿困难等的治疗。本发明中药组合物的用途是在治疗前列腺增生疾病药物中的应用。
药效学试验:
本发明中药组合物与最接近的现有技术相比,药效学试验效果显著提高。
最接近的现有技术2:中国专利公报2009年7月22日公开了名称为“一种治疗前列腺疾病的中药组合物及其制备方法”公开号为CN101485847A的专利申请。
主要药效学试验证明:
本发明翁沥通颗粒组各原料药重量配比“薏苡仁180g、浙贝母48g、川木通108g、炒栀子108g、金银花48g、旋覆花108g、泽兰108g、大黄36g、丁香120g、没药54g、甘草48g、蜜炙黄芪120g。”同现有技术2CN101485847A具体实施方方式处方的重量配比组:“薏苡仁188份、浙贝母112份、川木通108份、栀子(炒)108份、金银花120份、旋覆花98份、泽兰108份、大黄36份、铜绿16份、甘草48份、黄芪(蜜炙)144份。”及同处方筛选1组重量配比:“薏苡仁48g、浙贝母180g、川木通108g、炒栀子48g、金银花108g、旋覆花108g、泽兰108g、大黄36g、丁香54g、没药120g、甘草48g、蜜炙黄芪120g。”及同处方筛选2组重量配比:“薏苡仁120g、浙贝母108g、川木通54g、炒栀子48g、金银花108g、旋覆花48g、泽兰108g、大黄36g、丁香180g、没药108g、甘草120g、蜜炙黄芪48g。”及同处方筛选3组重量配比:“薏苡仁36g、浙贝母120g、川木通108g、炒栀子108g、金银花54g、旋覆花108g、泽兰108g、大黄180g、丁香48g、没药48g、甘草48g、蜜炙黄芪120g”相比,药效学试验结果有显著提高。主要药效学试验如下:
(一)实验药物的制备:
1、原料:
本发明翁沥通颗粒组:按照本发明说明书实施例1的方法制得,具体如下:
组方配比:
制备方法:以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量蔗糖和糊精,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
a组:按照现有技术2CN101485847A的专利申请实施例1的方法制备。
b组(处方筛选1组):按照本发明说明书实施例1的工艺制备,具体处方工艺如下:
组方配比:
制备方法:以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量蔗糖和糊精,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
c组(处方筛选2组):按照本发明说明书实施例1的工艺制备,具体处方工艺如下:
组方配比:
制备方法:以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量蔗糖和糊精,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
d组(处方筛选3组):按照本发明说明书实施例1的工艺制备,具体处方工艺如下:
组方配比:
制备方法:以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量蔗糖和糊精,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
药效学实验过程:
实验目的:通过对本发明翁沥通颗粒组、a组、b组、c组和d组的抗炎、镇痛、利尿、治疗前列腺炎和前列腺增生等作用的药理实验研究,将本发明翁沥通颗粒组、与a组、b组、c组、d组进行对比,观察其药理作用的强弱。
试验方法:本发明翁沥通颗粒组、a组、b组、c组和d组对大鼠棉球肉芽肿的影响;对小鼠辐射热致痛的影响;对大鼠的利尿作用;对大鼠细菌性前列腺炎的抑制作用;对实验性前列腺增生大鼠的影响。
一、对大鼠棉球肉芽肿的影响
实验材料
1、动物:SD种雄性大鼠,体重160~180g。
2、药物:本发明翁沥通颗粒组、a组、b组、c组和d组。药物在实验前用蒸馏水配制,灌胃给药。
实验方法
SD种雄性大鼠60只,体重160~180g,随机分成6组,每组10只。各组大鼠乙醚浅麻醉,剪除大鼠胸毛,碘酒消毒,切开胸部皮肤,从切口向两前肢腋下分别塞入25mg无菌棉球各一个,缝合皮肤,肌注青链酶素抗感染。术后1h灌胃给药,对照组灌胃同体积的生理盐水;本发明翁沥通颗粒组、a组、b组、c组和d组分别灌胃给药均为8.0g/kg。连续给药7d,每天1次,于末次给药次日,处死大鼠,剥离棉球肉芽肿,于80℃烘箱干燥3h,精密称重,减去原棉球重量,计算肉芽肿的重量。实验结果:见表1
表1对大鼠棉球肉芽肿的影响
与对照组相比*P<0.05,**P<0.01;与本发明翁沥通颗粒组比△P<0.05。
结果表明:本发明翁沥通颗粒组、a组、b组、c组和d组对棉球引起的肉芽肿有明显的抑制作用,本发明翁沥通颗粒组与对照组相比有极显著性差异(P<0.01);a组、b组、c组、d组与对照组相比有显著性差异(P<0.05);a组、b组、c组、d组与本发明翁沥通颗粒组相比有显著性差异(P<0.05)。可见,本发明翁沥通颗粒组比a组、b组、c组、d组的抗炎作用强。
二、对小鼠辐射热致痛的影响
实验材料
1、动物:昆明种雄性小鼠,体重18~22g。
2、药物:本发明翁沥通颗粒组、a组、b组、c组和d组。药物在实验前用蒸馏水配制,灌胃给药。
实验方法
将小鼠固定于鼠筒内,一光束经凸透镜聚焦后照射于鼠尾中、下1/3交界处,测定启动光源至鼠尾急速摆动的时间,即甩尾潜伏期,亦称痛阈。先测定小鼠给药前的基础痛阈值,基础痛阈值小于3s或大于10s的反应过敏或迟钝动物剔除。筛选后的雄小鼠60只,体重18~22g,随机分成6组,每组10只。对照组灌胃同体积的生理盐水;本发明翁沥通颗粒组、a组、b组、c组和d组分别灌胃给药均为16.0g/kg。连续给药7d,每天1次,末次给药1h后,将小鼠进行辐射热刺激。记录给药1h后出现甩尾反应的时间,即为用药后的痛阈值。实验结果:见表2
表2对小鼠辐射热致痛的影响
与对照组相比*P<0.05,**P<0.01;与本发明翁沥通颗粒组比△P<0.05。
结果表明:本发明翁沥通颗粒组、a组、b组、c组和d组可显著提高辐射热致痛小鼠的痛阈值,本发明翁沥通颗粒组与对照组相比有极显著性差异(P<0.01);a组、b组、c组、d组与对照组相比有显著性差异(P<0.05);a组、b组、c组、d组与本发明翁沥通颗粒组相比有显著性差异(P<0.05)。可见,本发明翁沥通颗粒组比a组、b组、c组、d组的镇痛作用强。
三、对大鼠的利尿作用
实验材料
1、动物:SD种雄性大鼠,体重180~220g。
2、药物:本发明翁沥通颗粒组、a组、b组、c组和d组。药物在实验前用蒸馏水配制,灌胃给药。
实验方法
SD雄性大鼠60只,体重180~220g,随机分成6组,每组10只。预先在代谢笼内适应2d,实验前禁食不禁水18h。实验开始时轻压下腹部使膀胱排空,各组大鼠按2ml/lOOg体重剂量腹腔注射生理盐水,然后灌胃给药,对照组灌胃同体积的生理盐水;本发明翁沥通颗粒组、a组、b组、c组和d组分别灌胃给药均为8.0g/kg。给药后立即将大鼠放人代谢笼中接尿5h,测总尿量。实验结果:见表3
表3对大鼠排尿量的影响
与对照组相比*P<0.05,**P<0.01;与本发明翁沥通颗粒组比△P<0.05。
结果表明:本发明翁沥通颗粒组、a组、b组、c组和d组对大鼠在给药后5h内尿量明显增加,对水负荷大鼠有显著的利尿作用,本发明翁沥通颗粒组与对照组相比有极显著性差异(P<0.01);a组、b组、c组、d组与对照组相比有显著性差异(P<0.05);a组、b组、c组、d组与本发明翁沥通颗粒组相比有显著性差异(P<0.05)。可见,本发明翁沥通颗粒组比a组、b组、c组、d组的利尿作用强。
四、对大鼠细菌性前列腺炎的抑制作用
实验材料
1、动物:SD种雄性大鼠,体重250~280g。
2、药物:本发明翁沥通颗粒组、a组、b组、c组和d组。药物在实验前用蒸馏水配制,灌胃给药。
实验方法
SD雄性大鼠60只,体重250~280g,随机分为6组,每组10只,对照组灌胃同体积的生理盐水;本发明翁沥通颗粒组、a组、b组、c组和d组分别灌胃给药均为8.0g/kg。连续给药7d,每天1次,于给药后第4d,各组大鼠腹腔注射异戊巴比妥钠100mg/kg麻醉后,在无菌条件下腹正中切口,于前列腺侧叶每侧注射1.0×107个/ml大肠杆菌生理盐水悬液0.1ml,缝合后放入笼中饲养,造模后大鼠继续给药,于第7d给药后处死,迅速剖腹,取前列腺液一滴涂片进行卵磷脂小体密度检查。实验结果:见表4
表4对前列腺炎大鼠卵磷脂小体密度的影响
与对照组相比*P<0.05,**P<0.01;与本发明翁沥通颗粒组比△P<0.05。
结果表明:本发明翁沥通颗粒组、a组、b组、c组和d组可明显升高前列腺中卵磷脂小体密度,对大鼠细菌性前列腺炎有明显的抑制作用,本发明翁沥通颗粒组与对照组相比有极显著性差异(P<0.01);a组、b组、c组、d组与对照组相比有显著性差异(P<0.05);a组、b组、c组、d组与本发明翁沥通颗粒组相比有显著性差异(P<0.05)。可见,本发明翁沥通颗粒组比a组、b组、c组、d组的对大鼠细菌性前列腺炎的抑制作用强。
五、对实验性前列腺增生大鼠的影响
实验材料
1、动物:SD种雄性大鼠,体重160~180g。
2、药物:本发明翁沥通颗粒组、a组、b组、c组和d组。药物在实验前用蒸馏水配制,灌胃给药。
实验方法
SD雄性大鼠60只,体重160~180g,在无菌操作下切除双侧睾丸,术后观察饲养7d后,随机分成6组,每组10只。对照组灌胃同体积的生理盐水;本发明翁沥通颗粒组、a组、b组、c组和d组分别灌胃给药均为8.0g/kg;同时每只大鼠每天皮下注射丙酸睾丸酮3mg/kg/d,连续给药21d,每日1次。于末次给药后次日处死大鼠,取血,测血清酸性磷酸酶的水平。实验结果:见表5
表5对前列腺增生大鼠血清酸性磷酸酶活性的影响
与对照组相比*P<0.05,**P<0.01;与本发明翁沥通颗粒组比△P<0.05。
结果表明:本发明翁沥通颗粒组、a组、b组、c组和d组均能明显抑制实验性前列腺增生大鼠血清中酸性磷酸酶的含量,具有抑制实验大鼠前列腺的增生作用,本发明翁沥通颗粒组与对照组相比有极显著性差异(P<0.01);a组、b组、c组、d组与对照组相比有显著性差异(P<0.05);a组、b组、c组、d组与本发明翁沥通颗粒组相比有显著性差异(P<0.05)。可见,本发明翁沥通颗粒组比a组、b组、c组、d组对抗前列腺增生的作用强。
实验结果:本发明翁沥通颗粒组、a组、b组、c组和d组对棉球引起的肉芽肿有明显的抑制作用;可显著提高辐射热致痛小鼠的痛阈值;对大鼠在给药后5h内尿量明显增加,对水负荷大鼠有显著的利尿作用;可明显升高前列腺中卵磷脂小体密度,对大鼠细菌性前列腺炎有明显的抑制作用;能明显抑制实验性前列增生大鼠血清中酸性磷酸酶的含量,具有抑制实验大鼠前列腺的增生作用。
结论:本发明翁沥通颗粒组比a组、b组、c组、d组的抗炎、镇痛、利尿、治疗前列腺炎和前列腺增生等药理作用强,因此,本发明翁沥通颗粒组比a组、b组、c组、d组临床用于证属湿热蕴结,痰瘀交阻,前列腺增生症,症见尿频,尿急或尿细,排尿困难等治疗效果好,确定翁沥通颗粒的处方为本发明的处方。
具体实施方式
实施例1:本发明翁沥通颗粒组的制备:
组方配比:
制备方法:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量蔗糖和糊精,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
实施例2:本发明胶囊剂组的制备:
组方配比:
制备方法:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,装胶囊,制成1000粒,即得胶囊剂。
实施例3:本发明胶囊剂组的制备:
组方配比:
制备方法:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,装胶囊,制成1000粒,即得胶囊剂。
实施例4:本发明胶囊剂组的制备:
组方配比:
制备方法:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,装胶囊,制成1000粒,即得胶囊剂。
实施例5:本发明片剂组的制备:
组方配比:
制备方法:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,压片,制成1000片,即得片剂。
实施例6:本发明片剂组的制备:
组方配比:
制备方法:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,压片,制成1000片,即得片剂。
实施例7:本发明片剂组的制备:
组方配比:
制备方法:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,压片,制成1000片,即得片剂。
Claims (6)
1.一种治疗前列腺增生的中药组合物,其特征在于所述中药组合物原料药的组成为:
2.根据权利要求1所述的中药组合物,其特征在于所述中药组合物原料药优选组成为:
3.根据权利要求1或2所述中药组合物的制备方法,其特征在于:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量蔗糖和糊精,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
4.根据权利要求1或2所述中药组合物的制备方法,其特征在于:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,装胶囊,制成1000粒,即得胶囊剂。
5.根据权利要求1或2所述中药组合物的制备方法,其特征在于:
以上十二味,浙贝母、没药分别粉碎成细粉,过100目筛,备用;丁香加水10倍量浸泡后进行水蒸气蒸馏4小时,收集挥发油,备用,药渣连同水液加薏苡仁、川木通、炒栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙黄芪共九味加水8倍量煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08MPa 80℃的条件下减压浓缩至55℃时测得相对密度为120~125的清膏,喷雾干燥,得药物细粉,加入上述细粉及适量淀粉,混匀,制粒,干燥,整粒,喷入挥发油,压片,制成1000片,即得片剂。
6.根据权利要求1-2任意一项中药组合物或权利要求3-5所述制备方法制备得到的中药组合物在制备治疗前列腺增生疾病药物中的应用。
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