CN103239672A - 一种益气养血,安神健脾,滋阴补肝的中药组合物及其制剂工艺 - Google Patents
一种益气养血,安神健脾,滋阴补肝的中药组合物及其制剂工艺 Download PDFInfo
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Abstract
本发明涉及一种益气养血，安神健脾，滋阴补肝的中药组合物及其制剂工艺，其原料组分的配比为：黄芪10-15份，炒党参10-13份，炒当归9-14份，丹参10-15份，益母草25-35份，焦神曲10-15份，陈皮4-8份，制香附8-15份，乌药4-8份，木香4-8份，生地黄8-15份，熟地黄8-15份，砂仁1-5份，炒杜仲8-15份，泽泻10-15份，炙甘草1-5份，炒白芍8-15份，焦山楂5-12份，炒谷芽10-15份，炒麦芽10-15份。本发明有益气养血，安神健脾，滋阴补肝的作用，对产后、流产后贫血，恶露不净，头晕目眩，心悸多汗，失眠神疲，食欲不振等有良好的治疗效果，具有疗效好，见效快，治愈率高，服用方便等优点。
Description
技术领域：
本发明属于一种中药组合物及其制剂工艺，特别涉及一种治疗产后、流产后贫血，恶露不净、头晕目眩，心悸汗多，失眠神疲、食欲不振的中药组合物及其制剂工艺。
背景技术：
由于社会，家庭，产妇本身对怀孕后生活方式的偏颇认识，惰性懒散及高营养的不良生活习惯，使得巨大儿增加，难产率及剖宫产率提高，产后的诸多病症增多，产后病的复发率增加。产后率是危害妇女身体健康之一。尽管我国医疗保健水平不断提高，但是，目前产妇死亡率仍然没有明显下降。据统计，全国育龄妇女每年大约有2500万人怀孕分娩，接受人流手术的妇女又有数千万人次，因此做好产后(包括引产和流产后)的保健康复工作，对于保障广大妇女儿童的身体健康，提高人体素质具有重要意义。产妇产后由于分娩时带来的创伤和出血以及临床用力等，使产妇元气受损，抵抗力减弱内分泌剧变，易导致产后病，如贫血，血性恶露排尽时间延长，产后缺乳，产后血晕，产后大小便困难，剖宫产后的胀气以及产妇免疫力降低等问题。上述诸多病症之病机，乃是阴阳平衡气血失调，尤以多虚多瘀者居多。现代医学实验研究和临床观察证明，产褥期机体免疫功能低下，抗病能力差，血液粘度高，凝固性强，易于集聚，所以在产褥期易患疾病，影响正常的生理功能恢复。但是，由于产妇需要哺乳新生儿，市面上药物不能随便服用；同时又缺乏妇女产后方面的药物，特别是促进妇女产后康复和治疗产后病的药物，更为数甚少。因此，有必要开发出一种具有益气养血，安神健脾，滋阴补肝作用的治疗产后贫血，恶露不净，头晕目眩的中药组合物及其制剂。
发明目的：
本发明的目的是提供一种治疗产后，流产后贫血，恶露不净，头晕目眩，失眠神疲的中药制剂。该药物具有益气养血，安神健脾和滋阴补肝的作用。
技术方案：
一种益气养血，安神健脾和滋阴补肝制剂及其制备工艺，其特征在于：其原料组分的质量配比为：
黄芪10-15份，炒党参10-13份，炒当归9-14份，丹参10-15份，益母草25-35份，焦神曲10-15份，陈皮4-8份，制香附8-15份，乌药4-8份，木香4-8份，生地黄8-15份，熟地黄8-15份，砂仁1-5份，炒杜仲8-15份，泽泻10-15份，炙甘草1-5份，炒白芍8-15份，焦山楂5-12份，炒谷芽10-15份，炒麦芽10-15份。
本发明提供的中药组方，是按照中医理论指导，结合中医临床辨证施治进行组方，疗效显著。方中各味中药饮片药理药效如下：
黄芪：拉丁名：Leguminosae，味甘，性微温，归肝，脾，肺，肾经。有益气固表，敛汗固脱，托疮生肌，利水消肿功效。黄芪中含有黄酮，皂苷，蛋白质，多糖及丰富的卵磷脂类成分，对气虚乏力，脾胃虚弱及食欲不振有较好的治疗作用。
炒党参：拉丁名：Root of Pilose Asiabell，性平，味甘，微酸，归脾，肺经。具有补中益气，健脾益肺功效。党参含有挥发油，甾体类，糖类，生物碱和有机酸类成分，对脾肺气虚，气血两虚证有较好的治疗作用。
炒当归：拉丁名：Angelica Sinensis，味甘，辛，苦，性温，归肝，心，脾经，具有补血，活血，调经止痛功效。当归含有挥发油和维生素类成分，对血虚，眩晕心悸，虚汗腹痛等有较好的治疗作用。
丹参：拉丁名：Salvlae Miltiorrhizae Radixet Rhizoma，味苦，微寒，入心，肝经，具有活血，凉血功效。丹参含有二萜类，酚酸类和丹参酮等成分，对产后瘀痛，气滞血瘀等有较好的治疗作用。
益母草：拉丁名：Herbaleonuri，味辛，苦，性微寒，入心，肝，膀胱经，具有活血，祛瘀，调经和消水功效。对月经不调，产后恶露不净，痛经等有较好治疗作用。
焦神曲：性温，归脾，胃经，具有消食化积，健脾和胃功效。对产后淤血腹痛，消化不良，食欲不振等有较好的治疗作用。
陈皮：拉丁名：Citri Reticulatae Pericarpium，味苦，辛，温，归肺，脾经。主要功效是理气健脾，燥湿化痰。陈皮含有川陈皮素、橙皮苷及挥发油等成分。挥发油中主要成分为柠檬苦素和柠檬醛等成分，挥发油对胃肠道有温和刺激作用，可促进消化液的分泌，排除肠管内积气，增加食欲。
制香附：拉丁名：Rhizoma Cyper，辛微苦甘，平，入肝，三焦经。具有理气解郁功效。对调经止痛，月经不调等有较好的作用。
乌药：拉丁名：Radix Linderae，辛，温，入胃，肾经。具有顺气，开郁，散寒，止痛功效。乌药含有挥发油，生物碱，倍半萜及内酯类成分。对产后逆气，血气不和，腹胀痛有较好的治疗作用。
木香：拉丁名：Radix Aucklandiae，味辛，苦，性温，归脾，大肠，三焦经。具有理气疏肝，燥湿化痰功效。木香含有内酯，氨基酸和甾醇类成分，对脾胃气滞所致的脘腹胀痛，食少呕吐，肝胆气滞引起的胁痛有较好的治疗作用。
地黄：拉丁名：Rehmannia，味甘，苦，性寒，入心，肝，肾经。具有养血补血，清热生津滋阴的功效。地黄含有维生素，氨基酸和甾醇类化合物，对产后小便出血，腹痛，血晕危困等有较好的治疗作用。
砂仁：拉丁名：Fructus Amomi，味辛，性温，归脾经，胃经，肾经，具有温脾止泻，化湿开胃的功效。砂仁中含有挥发油和黄酮类成分，挥发油对胃肠道有温和刺激作用，可促进消化液的分泌，排除肠管内积气，增加食欲。对产后食欲不振，消化不良有较好的治疗作用。
炒杜仲：拉丁名：Eucommia Ulmoides，甘，温，归肝，肾经。具有补肝肾，强筋骨，增强人体免疫力等功效。杜仲含有蛋白质，氨基酸，木脂素和黄酮类成分，对产后恶露不净有较好的治疗作用。
泽泻：拉丁名：Rhizoma Alismatis，味甘，淡，性寒，归肾，膀胱经。具有利水渗湿，泄热通淋功效。泽泻含有泽泻醇，糖，胆碱和微量元素成分。对产后小便不利，眩晕心悸有 较好的治疗作用。
炙甘草：拉丁名：Radix Glycyrrhizae，味甘，性平，无毒，入脾，胃，肺经。具有益气补中，缓急止痛，润肺止咳，泻火解毒，调和诸药等功效。甘草主要成分是黄酮类化合物，对于产后气虚，食欲不振等有较好的治疗作用。
炒白芍：拉丁名：White Paeony Root，味苦酸，微寒。具有疏肝理气，柔肝养血功效。白芍含有挥发油，皂苷，脂肪油，糖等成分，对肝胃不和所致的胸胁胀痛，脘腹疼痛，月经不调，经行腹痛，崩漏等有较好的治疗作用。
焦山楂：拉丁名：Fructus Crataegi，味甘，酸，性微温。山楂含糖类，蛋白质，脂肪，维生素C等成分，对产后腹痛，食欲不振，消化不良有较好的治疗作用。
炒谷芽：拉丁名：Fructus Setariae Germinatus，性甘，平，归脾，胃经。具有消食化积，健脾开胃功效。谷芽含有蛋白质，脂肪油，淀粉，淀粉酶等成分，对产后食积不消，脾胃虚弱有较好的治疗作用。
炒麦芽：拉丁名：Fructus Hordei Germinatus，性甘，平，归脾，胃，肝经，具有行气消食，健脾开胃等功效。麦芽含有淀粉酶，催化酶，氨基酸和维生素类等成分，对产后食欲不振，缺乳具有较好的治疗作用。
本发明的药物制备方法如下：
(1)按处方量称取当归，制香附，益母草，乌药，木香，陈皮加水温浸2-4小时，挥发油提取3-7小时，收集挥发油A；
(2)按处方量称取黄芪，炒党参，丹参，焦神曲，生地黄，熟地黄，炒杜仲，泽泻，炙甘草，炒白芍，焦山楂，炒谷芽，炒麦芽加水煎煮两次，每次2-5小时。第二次与蒸馏后药渣合并煎煮，滤过，减压浓缩至相对密度为1.1～1.4(50-80℃)的浸膏B。
(3)取适量红糖制成糖浆，加入清膏B(每100g清膏加糖浆相当于红糖250-400g)混匀，继续浓缩至相对密度为1.05-1.50(50-80℃)的清膏C；
(4)将步骤(1)和(2)中制得的挥发油A，清膏C与药学上可接受的辅料或载体制备成临床接受的剂型药物。
本发明提供的具有益气养血，安神健脾，滋阴补肝作用的中药组合物，适用于制备治疗产后，流产后贫血，恶露不净，头晕目眩，食欲不振的药物。
本发明提供的中药制剂各原料的提取物制成片剂时，把各原料和乳糖或玉米淀粉，需要时加入润滑剂硬脂酸镁，混合均匀，制粒，整粒，然后压片制成片剂。
本发明提供的中药制剂各原料的提取物制成丸剂时，将水提组分干燥，粉碎成粉，加入蜂蜜和挥发油组分及乙醇制成丸剂。
本发明提供的中药制剂各原料的提取物制成胶囊剂时，把各原料的提取物和载体乳糖或玉米淀粉混合均匀，制粒，整粒，喷入挥发油组分，干燥，然后装胶囊制成胶囊剂。
本发明的创新之处是：
1由于采用了多种中药饮片配置而成，含有多种药效成分，起效快，药物稳定性好，功能主治产后，流产后贫血，恶露不净，头晕目眩，食欲不振等，具有益气养血，安神健脾，滋阴补肝的功效。
2疗效显著，特别是产后贫血，恶露不净，无毒副作用，可广泛应用于临床。
3本发明药物制作工艺科学，合理，先进，质量稳定可控，成本低，服用本药物后无痛苦，不反弹，且治愈后无复发。
具体实施方式
根据下述实施例，可以更好地理解本发明。然而，本领域的技术人员容易理解，实施例所描述的具体的物料配比、工艺条件及其结果仅用于说明本发明，不应当也不会限制权利要求书中所详细描述的本发明。
实施例1
处方：黄芪100g，炒党参120g，炒当归120g，丹参120g，益母草300g，焦神曲120g，陈皮60g，制香附100g，乌药60g，木香60g，生地黄100g，熟地黄100g，砂仁30g，炒杜仲100g，泽泻120g，炙甘草30g，炒白芍100g，焦山楂100g，炒谷芽100g，炒麦芽100g。
制备工艺：
(1)称取当归，制香附，益母草，木香，陈皮加水温浸2小时，挥发油提取5小时，收集挥发油A；
(2)按处方量称取黄芪，炒党参，丹参，焦神曲，乌药，生地黄，熟地黄，炒杜仲，泽泻，炙甘草，炒白芍，焦山楂，炒谷芽，炒麦芽加水煎煮两次，每次4小时。第二次与蒸馏后药渣合并煎煮，滤过，减压浓缩至相对密度为1.2(70℃)的浸膏B。
(3)取适量红糖制成糖浆，加入清膏B(每100g清膏加糖浆相当于红糖350g)混匀，继续浓缩至相对密度为1.3(70℃)的清膏C；
(4)取1/2份清膏C用喷雾干燥塔喷雾干燥，进风温度160℃，出风温度100℃得浸膏粉；其余的1/2份浸膏做粘合剂，以浸膏粉为母核，用一步制粒机制粒，进风温度60℃，出风温度40℃，得颗粒。加入收集到的挥发油，焖润过夜，得颗粒剂。
实施例2
处方：黄芪140g，炒党参130g，炒当归140g，丹参120g，益母草330g，焦神曲110g，陈皮60g，制香附90g，乌药70g，木香50g，生地黄100g，熟地黄100g，砂仁20g，炒杜仲120g，泽泻100g，炙甘草30g，炒白芍90g，焦山楂80g，炒谷芽130g，炒麦芽140g。
制备工艺：
(1)称取当归，制香附，益母草，木香，陈皮加水温浸3小时，挥发油提取6小时，收集挥发油A；
(2)按处方量称取黄芪，炒党参，丹参，焦神曲，乌药，生地黄，熟地黄，炒杜仲，泽泻，炙甘草，炒白芍，焦山楂，炒谷芽，炒麦芽加水煎煮两次，每次3小时。第二次与蒸馏后药渣合并煎煮，滤过，减压浓缩至相对密度为1.1(60℃)的浸膏B。
(3)取适量红糖制成糖浆，加入清膏B(每100g清膏加糖浆相当于红糖300g)混匀，继续浓缩至相对密度为1.4(50℃)的清膏C；
(4)取2/3份浸膏用喷雾干燥塔喷雾干燥，进风温度180℃，出风温度80℃得浸膏粉； 其余的1/3份浸膏做粘合剂，以浸膏粉为母核，用一步制粒机制粒，进风温度70℃，出风温度50℃，得颗粒。加入收集到的挥发油，焖润过夜，用胶囊填充机填充为0.5g/粒，得胶囊剂。
实施例3
将实施例1中干燥颗粒中加入24g交联羧甲基纤维素钠和3.4g硬脂酸镁，混匀，压片，即为本发明的片剂。
实施例4
处方：黄芪120g，炒党参120g，炒当归100g，丹参110g，益母草2800g，焦神曲140g，陈皮100g，制香附80g，乌药80g，木香70g，生地黄120g，熟地黄140g，砂仁10g，炒杜仲150g，泽泻110g，炙甘草50g，炒白芍110g，焦山楂90g，炒谷芽130g，炒麦芽140g。
制备工艺：
(1)称取当归，制香附，益母草，木香，陈皮加水温浸4小时，挥发油提取7小时，收集挥发油A；
(2)按处方量称取黄芪，炒党参，丹参，焦神曲，乌药，生地黄，熟地黄，炒杜仲，泽泻，炙甘草，炒白芍，焦山楂，炒谷芽，炒麦芽加水煎煮两次，每次5小时。第二次与蒸馏后药渣合并煎煮，滤过，减压浓缩至相对密度为1.2(50℃)的浸膏B。
(3)取适量红糖制成糖浆，加入清膏B(每100g清膏加糖浆相当于红糖280g)混匀，继续浓缩至相对密度为1.35(60℃)的清膏C；
(4)将挥发油A喷洒到清膏C中，混合均匀，即得煎膏剂。
实施例5典型治疗病例
张某某，女，32岁，产后阴道流血不止，食欲不振，消化不良，失眠多梦，导致贫血，经诊治为产后子宫复旧不全。服用本发明实施例1制备得到的颗粒剂，一天三次，饭后服用，服用3个月后病症消失。建议继续服用3个月巩固病情，现在以彻底痊愈。
宋某某，女，28岁，流产后恶露不净，头晕目眩，排便困难，食欲不振等。服用本发明实施例4制备得到的煎膏剂，一天一次，饭后服用，服用2个月病症消失。继续服用3个月，现已痊愈。
赵某某，女，35岁，产后缺乳，恶露不净，大便难，小便困难，产后血晕，剖宫产术后胃肠胀气，贫血等。服用本发明实施例4制备得到的片剂，一天3次，饭后服用，服用1个月病症消失，继续服用3个月，现已痊愈，随访无复发。
以上病例标明本发明提供的中药制剂具有益气养血，安神健脾，滋阴补肝等功效，对于由于产后，流产后贫血，恶露不净，头晕目眩，心悸，食欲不振，消化不良等具有显著疗效，同时本发明提供的中药制剂临床未发现不良反应，用药安全可靠。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (7)
1.一种具有益气养血，安神健脾，滋阴补肝的中药组合物及其制剂工艺，其特征在于：其原料组分的质量配比为：黄芪10-15份，炒党参10-13份，炒当归9-14份，丹参10-15份，益母草25-35份，焦神曲10-15份，陈皮4-8份，制香附8-15份，乌药4-8份，木香4-8份，生地黄8-15份，熟地黄8-15份，砂仁1-5份，炒杜仲8-15份，泽泻10-15份，炙甘草1-5份，炒白芍8-15份，焦山楂5-12份，炒谷芽10-15份，炒麦芽10-15份。
2.根据权利要求1所述的具有益气养血，安神健脾，滋阴补肝的中药组合物及其制剂工艺，其特征在于：其原料组分的重量配比为：黄芪10份，炒党参12份，炒当归12份，丹参12份，益母草30份，焦神曲12份，陈皮6份，制香附10份，乌药6份，木香6份，生地黄10份，熟地黄10份，砂仁3份，炒杜仲10份，泽泻2份，炙甘草3份，炒白芍10份，焦山楂10份，炒谷芽10份，炒麦芽10份。
3.根据权利要求2所述的具有益气养血，安神健脾，滋阴补肝中药组合物及其制剂工艺，其特征在于：
(1)按处方量称取当归，制香附，益母草，乌药，木香，陈皮加水温浸2-4小时，挥发油提取3-7小时，收集挥发油A；
(2)按处方量称取黄芪，炒党参，丹参，焦神曲，生地黄，熟地黄，炒杜仲，泽泻，炙甘草，炒白芍，焦山楂，炒谷芽，炒麦芽加水煎煮两次，每次2-5小时。第二次与蒸馏后药渣合并煎煮，滤过，减压浓缩至相对密度为1.1-1.4(50-80℃)的清膏B；
(3)取适量红糖制成糖浆，加入清膏B(每100g清膏加糖浆相当于红糖250-400g)混匀，继续浓缩至相对密度为1.05-1.50(50-80℃)的清膏C；
(4)将步骤(1)和(2)中制得的挥发油A，清膏C与药学上可接受的辅料或载体制备成临床接受的剂型药物。
4.根据权利要求1和2所述的具有益气养血，安神健脾，滋阴补肝作用制剂，其特征在于：所述中药组合物制剂为药剂学上所接受的剂型，选用的剂型为片剂，丸剂，胶囊剂和煎膏剂。
5.根据权利要求4所述的具有益气养血，安神健脾，滋阴补肝作用制剂，颗粒剂辅料选择为麦芽糖糊精和蔗糖。
6.根据权利要求4所述的具有益气养血，安神健脾，滋阴补肝作用制剂，片剂辅料选择为乳糖或玉米淀粉，润滑剂硬脂酸镁。
7.根据权利要求4所述的具有益气养血，安神健脾，滋阴补肝作用制剂，胶囊剂辅料选择稀释剂为植物油，矿物油，聚乙二醇，丙二醇，液体石蜡的一种或几种；抗氧剂为乙二胺四乙酸，乙二胺四乙酸二钠盐，生育酚，醋酸生育酚的一种或几种；润湿剂为大豆磷脂，吐温；油蜡混合物为蜂蜡-棕榈油，蜂蜡-棕榈油数比为1∶1-4。
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