CN105327295A - 一种治疗肝炎的胶囊及制备方法 - Google Patents
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Abstract
本发明治疗肝炎的胶囊由以下重量份数的原料药：太子参150～450份、旱莲草150～450份、女贞子150～450份、北沙参150～450份、陈皮150～450份、五味子150～450份、郁金150～450份、败酱草150～450份、枸杞子150～450份、栀子150～450份、柴胡150～450份、半枝莲150～450份、黄芩150～450份、牡丹皮150～450份、茵陈150～450份、茯苓150～450份、山药150～450份、泽泻150～450份、甘草120～180份制成。制备过程包括以下步骤：将太子参、旱莲草、女贞子、北沙参、陈皮、五味子、郁金、败酱草、枸杞、栀子、柴胡、半枝莲、黄芩、牡丹皮、茵陈、茯苓、山药、泽泻、甘草按照所述重量份数经流通蒸汽灭菌，在35℃-50℃下烘干后按照所述重量份数混合，粉碎成100目-120目的药粉装入胶囊即得。本发明用于疏肝利胆、解毒保肝、修复肝脏受损细胞再生功能，对肝炎有显著地治疗效果。
Description
技术领域
本发明属于复方中药胶囊领域，具体地说，是一种治疗肝炎的胶囊。本发明还提供了一种治疗肝炎胶囊的制备方法。
背景技术
肝炎，通常是指由多种致病因素--如病毒、细菌、寄生虫、化学毒物、胶囊和毒物、酒精等，侵害肝脏，使得肝脏的细胞受到破坏，肝脏的功能受到损害，它可以引起身体一系列不适症状，以及肝功能指标的异常。肝炎可以分为急性肝炎、慢性肝炎等。
中医认为肝炎患病的原因主要是正气不足。由于饮食不节、失节，损伤了脾胃而不能化湿，湿热内生，困脾伤肝，造成肝胆脾胃不和，从而加剧了对正气的损伤，导致了肝炎的发生。
中医治疗肝炎的主要治法有：1、疏肝理气法，是治疗肝炎的常用方法，尤常与其他治法配合，综合调整肝脏功能，促进气血畅通，脾胃健运，代表方剂为逍遥散、小柴胡汤。2、清热利湿法，湿热内蕴，阻滞肝胆是肝炎的常见病证特点，清热利湿消除致病因素，有助于肝功能的恢复，代表方剂有茵陈蒿汤、黄连解毒汤。3、益气健脾法，肝炎病人免疫功能低下时，健脾益气有助于提高免疫功能，并且有利于清除肝炎病毒和恢复肝功能，代表方剂有四君子汤、参苓白术散。4、活血化瘀法，肝炎日久不愈多见有瘀血表现，活血化瘀法能改善肝脏血液循环，抑制肝脏纤维组织的增生，尤其在慢性肝炎后期常用，代表方剂有大黄蜇虫丸、人参鳖甲煎。5、滋养肝肾法，慢性肝炎病久不愈，正气损伤，肝肾不足，滋养肝肾法，可提高机体的抗病能力，也有助于肝炎病毒的清除，代表方剂有一贯煎、六味地黄丸。目前针对肝炎的胶囊治疗效果比较差，且对人体的毒副作用大，治标不治本，效果不大理想。
发明内容
本发明解决了现有技术的不足，提供一种疗效确切、无副作用、疗程短、标本兼治的治疗肝炎的胶囊。本发明还提供了一种工艺科学的治疗肝炎的胶囊的制备方法。
本发明治疗肝炎的胶囊由以下重量份数的原料药制备获得的：
太子参150～450旱莲草150～450女贞子150～450
北沙参150～450陈皮150～450五味子150～450
郁金150～450败酱草150～450枸杞子150～450
栀子150～450柴胡150～450半枝莲150～450
黄芩150～450牡丹皮150～450茵陈150～450
茯苓150～450山药150～450泽泻150～450
甘草120～180。
所述各原料药的优选重量份数为：
太子参300旱莲草300女贞子300
北沙参300陈皮300五味子300
郁金300败酱草300枸杞子300
栀子300柴胡300半枝莲300
黄芩300牡丹皮300茵陈300
茯苓300山药300泽泻300
甘草150。
该胶囊的制备方法包括以下步骤：将太子参、旱莲草、女贞子、北沙参、陈皮、五味子、郁金、败酱草、枸杞子、栀子、柴胡、半枝莲、黄芩、牡丹皮、茵陈、茯苓、山药、泽泻、甘草按照所述重量份数经流通蒸汽灭菌，在35℃-50℃下烘干后按照所述重量份数混合，粉碎成100目-120目的药粉装入胶囊即得，优选地，胶囊采用2号胶囊。
本发明药物组方中，太子参主治脾胃虚弱，食欲不振，倦怠无力，气阴两伤，干咳痰少，自汗气短；旱莲草主治滋补肝肾、凉血止血，可治各种吐血，肠出血等症；女贞子补益肝肾，明目，清虚热，主治头晕目眩，须发早白，视物昏花，阴虚发热；北沙参养阴清肺，益胃生津，又能养肝，用于肺热燥咳，劳嗽痰血，热病津伤口渴；陈皮理气健脾，燥湿化痰，脘腹胀满，食少吐泻，咳嗽痰多；五味子收敛固涩，益气生津，补肾宁心，用于久嗽虚喘，梦遗滑精，遗尿尿频，久泻不止，自汗盗汗，津伤口渴，内热消渴，心悸失眠；郁金辛活血止痛，行气解郁，清心凉血，利胆退黄，用于胸胁刺痛，胸痹心痛，经闭痛经，乳房胀痛，热病神昏，癫痫发狂，血热吐衄，黄疸尿赤；败酱草有清热解毒、消痈排脓、祛瘀止痛之功；枸杞子滋补肝肾，益精明目，用于虚劳精亏、腰膝酸痛、眩晕耳鸣、内热消渴、血虚萎黄、目昏不明；栀子清热，泻火，凉血，治热病虚烦不眠，黄疸，淋病，消渴，目赤，咽痛，吐血，衄血，血痢，尿血，热毒疮疡，扭伤肿痛；柴胡和解表里，疏肝解郁，升阳举陷，退热截疟，用于感冒发热，寒热往来，胸胁胀痛，月经不调，子宫脱垂，脱肛；半枝莲清热解毒，化瘀利尿，用于疔疮肿毒，咽喉肿痛，跌扑伤痛，水肿，黄疸，蛇虫咬伤；黄芩清热燥湿，泻火解毒，止血，安胎，用于湿温、暑湿，胸闷呕恶，湿热痞满，泻痢，黄疸，肺热咳嗽，高热烦渴，血热吐衄，痈肿疮毒，胎动不安；牡丹皮清热凉血，活血化瘀，主治热入营血，温毒发斑，吐血衄血，夜热早凉，无汗骨蒸，经闭痛经，跌扑伤痛，痈肿疮毒；茵陈有清利湿热，利胆退黄的功效，用于黄疸尿少，湿温暑湿，湿疮瘙痒；茯苓利水渗湿，健脾，宁心，用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻，心神不安，惊悸失眠；山药补脾养胃，生津益肺，补肾涩精，清热解毒，主治脾虚食少、久泻不止、肺虚喘咳、肾虚遗精、带下、尿频、虚热消渴；泽泻利水渗湿，泄热，化浊降脂，用于小便不利，水肿胀满，泄泻尿少，痰饮眩晕，热淋涩痛，高脂血症；甘草补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。
本发明采用多种药材组合协同，主要用于疏肝利胆、解毒保肝、修复肝脏受损细胞再生功能，对肝炎有显著地治疗效果。本发明将上述胶囊制成复方中药胶囊既保护了胶囊药性不被破坏，也保护了消化器官和呼吸道等。
为进一步考察本发明胶囊治疗肝炎的临床疗效，选择150例肝炎患者进行了临床疗效观察。
选择门诊病人150例，男88例，女62例；年龄27～58岁，病程2～15年，病情分级均为重度，辨证均为湿热中阻证，随机分为三组。均排除心、脑、肾、造血系统等重要器官器质性疾病。三组一般临床资料经统计学处理无显著性差异(P＞0.05)。
诊断标准
西医诊断标准:参考中华医学会肝病学分会、中华医学会感染病学分会联合制定，2005年12月2日发布的《慢性乙型肝炎防治指南》和2000年《病毒性肝炎防治方案》。有明显或持续的肝炎症状，如乏力、纳差、腹胀、尿黄、便溏等，伴有肝病面容、肝掌、蜘蛛痣、脾大(排除其他原因)，且无门静脉高压征。实验室检查血清ALT和(或)AST反复或持续升高，白蛋白降低或A/G比值异常、丙种球蛋白明显升高，并且白蛋白小于等于32g/L、胆红素大于5倍正常值上限、凝血酶原活动度60%～40%、胆碱酯酶小于2500U/L，4项检测中有1项者即可确诊。
中医辨证标准:参照1991年中国中医药学会内科分会肝病专业委员会制定的《病毒性肝炎中医辨证标准(试行)》。为湿热中阻证。临床表现为胁胀脘闷，恶心厌油，纳呆，身目发黄而色泽鲜明，尿黄，口黏口苦，大便黏滞秽臭或先干后溏，或饮而不多，肢体困重，倦怠乏力，舌苔黄腻，脉象弦数或弦滑数。
治疗方法：三组各50例，分别接受实施例1、实施例2、实施例3服用治疗肝炎的胶囊临床治疗。用法用量：口服，一次5—6粒，一日2-----—3次。在服药期间忌辛辣食物。
疗效标准:参考中华中医药学会内科肝病专业委员会1992年发布的《病毒性肝炎中医疗效判定标准(试行)》。治愈:主要症状、体征消失，肝功能恢复正常，病毒复制指标阴性。好转:主要症状、体征减轻(中医症状定量记分下降50%)或消失，肝功能好转。无效:未达到“好转”标准。
三组病例治疗后疗效比较统计结果如下：
| 组别 | 实施例1 | 实施例2 | 实施例3 |
| 例数 | 50 | 50 | 50 |
| 治愈（n%） | 5（10%） | 4（8%） | 3（6%） |
| 好转（n%） | 40（80%） | 40（80%） | 39（78%） |
| 无效（n%） | 5（10%） | 6（12%） | 8（16%） |
| 总有效率（n%） | 90% | 88% | 84% |
本发明药效持续时间长，疗效显著，无副作用，有利于病患及时减轻病状。
具体实施方式
下面给出的实施例拟对本发明作进一步说明，但不能理解为是对本发明保护范围的限制，本领域技术人员根据本发明内容对本发明的一些非本质的改进和调整，仍属于本发明的保护范围。
实施例1
取除去杂质、清洗干净的太子参300g、旱莲草300g、女贞子300g、北沙参300g、陈皮300g、五味子300g、郁金300g、败酱草300g、枸杞子300g、栀子300g、柴胡300g、半枝莲300g、黄芩300g、牡丹皮300g、茵陈300g、茯苓300g、山药300g、泽泻300g、甘草150g，经流通蒸汽灭菌，在35℃下烘干后按照上述重量份数混合，粉碎加工成100目的药粉,装入2#胶囊。每粒装量0.25g。
实施例2
取除去杂质、清洗干净的太子参150g、旱莲草150g、女贞子150g、北沙参150g、陈皮150g、五味子150g、郁金150g、败酱草150g、枸杞子150g、栀子150g、柴胡150g、半枝莲150g、黄芩150g、牡丹皮150g、茵陈150g、茯苓150g、山药150g、泽泻150g、甘草120g，经流通蒸汽灭菌，在40℃下烘干后按照上述重量份数混合，粉碎加工成110目的药粉,装入2#胶囊。每粒装量0.26g。
实施例3
取除去杂质、清洗干净的太子参450g、旱莲草450g、女贞子450g、北沙参450g、陈皮450g、五味子450g、郁金450g、败酱草450g、枸杞子450g、栀子450g、柴胡450g、半枝莲450g、黄芩450g、牡丹皮450g、茵陈450g、茯苓450g、山药450g、泽泻450g、甘草180g，经流通蒸汽灭菌，在50℃下烘干后按照上述重量份数混合，粉碎加工成120目的药粉,装入2#胶囊。每粒装量0.27g。
Claims (4)
1.一种治疗肝炎的胶囊，是由以下重量份数的中药为原料药制备获得的：
太子参150～450旱莲草150～450女贞子150～450
北沙参150～450陈皮150～450五味子150～450
郁金150～450败酱草150～450枸杞子150～450
栀子150～450柴胡150～450半枝莲150～450
黄芩150～450牡丹皮150～450茵陈150～450
茯苓150～450山药150～450泽泻150～450
甘草120～180。
2.根据权利要求1所述的治疗肝炎的胶囊，其特征在于：所述原料药的重量份数为：
太子参300旱莲草300女贞子300
北沙参300陈皮300五味子300
郁金300败酱草300枸杞子300
栀子300柴胡300半枝莲300
黄芩300牡丹皮300茵陈300
茯苓300山药300泽泻300
甘草150。
3.一种制备权利要求1所述胶囊的方法，其特征在于，包括以下步骤：
将太子参、旱莲草、女贞子、北沙参、陈皮、五味子、郁金、败酱草、枸杞子、栀子、柴胡、半枝莲、黄芩、牡丹皮、茵陈、茯苓、山药、泽泻、甘草经流通蒸汽灭菌，在35℃-50℃下烘干后按照所述重量份数混合，粉碎成100目-120目的药粉装入胶囊即得。
4.根据权利要求3所述的胶囊的制备方法，其特征在于，所述胶囊为2号胶囊。
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