CN110227108A - 一种茯苓温肾益发颗粒及其制备方法 - Google Patents
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Abstract
本发明公开了一种茯苓温肾益发颗粒及其制备方法，原料的重量组分为：茯苓：5‑15份；何首乌：5‑15份；黑蚂蚁：5‑15份；绞股蓝：5‑15份；黑桑葚：5‑15份；黑芝麻：10‑20份；枸杞子：5‑15份；核桃仁：5‑15份；绿茶：10‑20份；该颗粒为是在中医药理论指导下组方，采用非传统工艺制成的现代中药复方制剂，具有妙治白发转黑发，有补肾、补血、补气等功效。茯苓具有强大的抗氧化、疏通人体微循环的奇效，能很好地将血液中的营养成分输送到血管末端的毛囊，8～10周左右，毛囊被充分激活。通过何首乌等物补肾能迅速控制白发生成，3～6个月，白发变黑效果明显，白发逐渐从根部长出黑发，而且脱发明显减少，毛囊紧固，人体免疫力提高，还能提神醒脑。
Description
技术领域
本发明涉及一种茯苓温肾益发颗粒及其制备方法，属于医药领域。
背景技术
生白头发的原因分先天和后天两种。后天中又有几个原因：营养缺乏，长期精神紧张和阳光不足。中医认为白头发是肾阴虚造成，肾功能衰弱导致身体代谢功能减慢，因此白头发的治疗应先补足肾阴，从根本上调治。另外，一些皮肤病如白癜风等也会造成白头发。正常人一般是35岁开始生白头发，如果提早出现的话，就最好前去治疗。先天遗传造成的白头发难以医治，但后天原因生成的白头发经过治疗，情况是可以改善的。白发指头发全部或部分变白，可分为先天性和后天性两种。先天性白发往往有家族史，以局限性白发较常见，多见于前头发际部。后天性白发有老年性白发和少年白发两种。有的年迈体弱而白发很少。少年白发发生于儿童及青少年，常有家族史，除白发增多外，不影响身体健康。青春时期骤然发生的白发，有的与营养障碍有关。精神因素可影响头发变白。白发可以是某些疾病的一个症状，如早老症，白癜风等。本病目前尚无有效疗法，应帮助患者正确对待疾病，避免精神紧张和抑郁。
茯苓温肾益发颗粒就是根据中医理论，按照古人治疗白头发的经验方，结合现代文献研究资料和自己积累的临床经验，组成的方剂，通过临床实践证实对患者确有一定的临床效果。
发明内容
本发明提供一种茯苓温肾益发颗粒及其制备方法，使用一段时间后头发变黑，利用天然中草药材配方，配制而成的颗粒；吃了面色变得红润有弹性，头发自然慢慢会变黑了。
为了解决上述技术问题，本发明提供了如下的技术方案：
本发明一种茯苓温肾益发颗粒，原料的重量组分为：茯苓：5-15份；何首乌：5-15份；黑蚂蚁：5-15份；绞股蓝：5-15份；黑桑葚：5-15份；黑芝麻：10-20份；枸杞子： 5-15份；核桃仁：5-15份；绿茶：10-20份。
作为本发明的一种优选方案：原料的重量组分为：茯苓：10份；何首乌：10份；黑蚂蚁：10份；绞股蓝：10份；黑桑葚：10份；黑芝麻：15份；枸杞子：10份；核桃仁： 10份；绿茶：15份。
本发明提供一种茯苓温肾益发颗粒的制备方法，包括配料S1、提取S2、浓缩S3、制粒S4、干燥S5、整粒S6、总混S7、检验S8和包装S9；该方法的步骤如下：
S1：首先根据需要的比例选取茯苓、何首乌、黑蚂蚁、绞股蓝、黑桑葚、黑芝麻、枸杞子、核桃仁和绿茶；并将其按配比的配料配置10份，称重复核后，备用；
S2：称取S1中的9味药材中的1份重量加入多功能提取罐内,加水煎煮两次：第一次加水5-10份量，煎煮1.5-2.5小时；第二次加水4-8份量，煎煮1-2小时；合并两次提取液，注入浓缩罐；
S3：将提取S2中提取液合并煎液,滤液浓缩至相对密度为1.28g/ml-1.32g/ml(50℃热测)的浸膏；
S4：取S3中制得的浸膏1份，加淀粉适量，分别加入槽式混合机内，充分混合均匀后，封闭，开启混合15-30分钟后，用10-15目筛制粒；
S5：将S4中制得的湿颗粒，置于卧式沸腾干燥机进行干燥，干燥温度控制在55℃ -65℃，颗粒含水量控制在6％以内。干燥后颗粒，置洁净容器内；
S6：取S5中干燥的颗粒，置整粒机整粒，分选10～60目间的颗粒，称重后用洁净的中转袋密封；产生的细粉和大颗粒称量后标示，按《尾料管理规程》处理；
S7：将同一批次或分次制得的S6中所有整好的颗粒，参照《二维运动混合机岗位操作规程》充分混合20-40分钟，转入中间站待验；
S8：对S7中混合的颗粒，其中将合格的颗粒，填写请检单，由QA取样，检验，待取得半成品检验合格后，方可转移至下道工序进行分装；
S9：分为内包装和外包装。
作为本发明制备方法的一种优选方案，提取S2的提取方法为：
A1：首先根据需要选取茯苓：2g；何首乌：2g；黑蚂蚁：2g；绞股蓝：2g；黑桑葚： 2g；黑芝麻：3g；枸杞子：2g；核桃仁：2g；绿茶：3g；
A2：并将A1配比的配料加入多功能提取罐内,加水煎煮两次；
A3：对于A2中第一次煎煮时加5倍量的水，煎煮为2小时；
A4：对于A3中经过一次煎煮的配料进行第二次煎煮，煎煮时加水4倍量，煎煮1.5小时；
A5：合并两次提取液，开始浓缩。
与现有技术相比，本发明的有益效果是：该颗粒为是在中医药理论指导下组方，采用非传统工艺制成的现代中药复方制剂，具有妙治白发转黑发，有补肾、补血、补气等功效。茯苓具有强大的抗氧化、疏通人体微循环的奇效，能很好地将血液中的营养成分输送到血管末端的毛囊，8～10周左右，毛囊被充分激活。通过何首乌等物补肾能迅速控制白发生成，3～6个月，白发变黑效果明显，白发逐渐从根部长出黑发，而且脱发明显减少，毛囊紧固，头发不再脱落发质变好，睡的香，面色红润，肌肤变白，人体免疫力提高，还能提神醒脑。且该工艺稳定性好，产品质量可靠。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例，基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明的理论依据为：
发为血之余，肝肾同源，故本方以滋养肝肾为主，使其精血旺盛，足以养发生新。何首乌：补肝肾，益精血，乌须发，主治肝肾不足，血虚精亏引起的须发早白，是方中的君药。黑桑葚、黑芝麻、枸杞子，补肝肾，益精血，黑蚂蚁，补肾强身、滋阴壮阳、填精固髓，核桃仁，补肾固精；几味药共为臣药，以增强何首乌之补肝肾，益精血，乌须发之功；绞股蓝，养心健脾，益气和血，清热解毒，茯苓，渗湿运脾，绿茶，消食化痰、清心除烦，生津止渴，去腻减肥；几味药共为佐药，使上述诸补药不碍气机，补而不腻。
全方有清有润，寓阳于阴，共奏滋养肝肾，益气养血，先天后天同补之效，多服此方，则精血充足，气足血旺，肝肾强壮，从而达到固发、生发及乌须发之功。根据中医理论推理，头发是肾脏开出的花朵，肾为先天之本，肾好头发必然好；肝主藏血，主疏泄(排毒)，肝不好，血液不好，头发自然会脱落，变白；何首乌能滋补肝肾，自然也能治疗脱发与白发，随着现代医学的发展，许多传统中药能通过化学分析乃至小白鼠的实验，验证传统“仙草”的作用，从而揭开何首乌的层层面纱，还中医经典的真实面目，并将这真实面目应用于现代临床医学，老树发新枝。根据云南中医学院中药学院，云南农业科学院药用植物研究所共同研究证实，何首乌含大黄酚、大黄素、大黄酸、淀粉、粗脂肪、卵磷脂，其它还有氨基酸、微量元素等物质成分，这些成分在现代生物学概念中，其大黄酚，大黄素主要有抑菌抗癌作用，与脱发白发关联较大的仅有卵磷脂，氨基酸，微量元素等成分，卵磷脂具备分解油脂的作用，使血液中胆固醇、甘油三酯含量降低，确保人体血液循环不受阻碍，有血管清道夫的美誉，成为降血脂，抗动脉硬化症，预防高血压、心肌梗塞、脑溢血的坚强卫士。氨基酸中的络氨酸酶、微量元素中的铜，都是黑素颗粒形成的关键，缺一不可。
汇总起来，如果因为胆固醇、甘油三酯堆积导致的血管壁增厚，血液循环受阻，头部微循环减弱乃至部分关闭，头发失去血液营养，失去合成黑素颗粒的条件，这样的脱发与白发，从理论上是可以辅佐李时珍《本草纲目》乌髭发的理论依据的。
现取茯苓温肾益发颗粒三批中试样品生产技术的数据，分别对试样品去编号为：20150401、20150402和20150403，试样品检测结果的相关技术数据如下：
表1：试样品检测结果
表2：试样品微生物限度检测结果
上述三批中试样品经检测，其水分、装量差异、微生物限度检查均符合中国药典2010 年版一部附录颗粒剂项下规定。
表3：中试验数据汇总表
上述3批茯苓温肾益发颗粒中试样品工艺稳定性好，产品质量可靠，根据以上结果，说明该生产工艺是稳定的、成熟的，达到了试验目的。
最后应说明的是：以上仅为本发明的优选实施例而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (4)
1.一种茯苓温肾益发颗粒，其特征在于，原料的重量组分为：茯苓：5-15份；何首乌：5-15份；黑蚂蚁：5-15份；绞股蓝：5-15份；黑桑葚：5-15份；黑芝麻：10-20份；枸杞子：5-15份；核桃仁：5-15份；绿茶：10-20份。
2.根据权利要求1所述的一种茯苓温肾益发颗粒，其特征在于，原料的重量组分为：茯苓：10份；何首乌：10份；黑蚂蚁：10份；绞股蓝：10份；黑桑葚：10份；黑芝麻：15份；枸杞子：10份；核桃仁：10份；绿茶：15份。
3.根据权利要求1所述的一种茯苓温肾益发颗粒的制备方法，其特征在于，包括配料S1、提取S2、浓缩S3、制粒S4、干燥S5、整粒S6、总混S7、检验S8和包装S9；该方法的步骤如下：
S1：首先根据需要的比例选取茯苓、何首乌、黑蚂蚁、绞股蓝、黑桑葚、黑芝麻、枸杞子、核桃仁和绿茶；并将其按配比的配料配置10份，称重复核后，备用；
S2：称取S1中的9味药材中的1份重量加入多功能提取罐内,加水煎煮两次：第一次加水5-10份量，煎煮1.5-2.5小时；第二次加水4-8份量，煎煮1-2小时；合并两次提取液，注入浓缩罐；
S3：将提取S2中提取液合并煎液,滤液浓缩至相对密度为1.28g/ml-1.32g/ml(50℃热测)的浸膏；
S4：取S3中制得的浸膏1份，加淀粉适量，分别加入槽式混合机内，充分混合均匀后，封闭，开启混合15-30分钟后，用10-15目筛制粒；
S5：将S4中制得的湿颗粒，置于卧式沸腾干燥机进行干燥，干燥温度控制在55℃-65℃，颗粒含水量控制在6％以内。干燥后颗粒，置洁净容器内；
S6：取S5中干燥的颗粒，置整粒机整粒，分选10～60目间的颗粒，称重后用洁净的中转袋密封；产生的细粉和大颗粒称量后标示，按《尾料管理规程》处理；
S7：将同一批次或分次制得的S6中所有整好的颗粒，参照《二维运动混合机岗位操作规程》充分混合20-40分钟，转入中间站待验；
S8：对S7中混合的颗粒，其中将合格的颗粒，填写请检单，由QA取样，检验，待取得半成品检验合格后，方可转移至下道工序进行分装；
S9：分为内包装和外包装。
4.根据权利要求3所述的一种茯苓温肾益发颗粒的制备方法，其特征在于，提取S2的提取方法为：
A1：首先根据需要选取茯苓：2g；何首乌：2g；黑蚂蚁：2g；绞股蓝：2g；黑桑葚：2g；黑芝麻：3g；枸杞子：2g；核桃仁：2g；绿茶：3g；
A2：并将A1配比的配料加入多功能提取罐内,加水煎煮两次；
A3：对于A2中第一次煎煮时加5倍量的水，煎煮为2小时；
A4：对于A3中经过一次煎煮的配料进行第二次煎煮，煎煮时加水4倍量，煎煮1.5小时；
A5：合并两次提取液，开始浓缩。
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