CN108114183A - 红曲米中药泡服饮片 - Google Patents
红曲米中药泡服饮片 Download PDFInfo
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- CN108114183A CN108114183A CN201810058924.5A CN201810058924A CN108114183A CN 108114183 A CN108114183 A CN 108114183A CN 201810058924 A CN201810058924 A CN 201810058924A CN 108114183 A CN108114183 A CN 108114183A
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Abstract
本发明提供了一种红曲米中药泡服饮片，其制备工艺如下：1）将红曲米除去杂质，净制后，干燥，得到中间体；2）检验中间体，包装后进行电子束辐照灭菌；3）进行标准检验，包装后得到成品；所述的步骤2）中，电子束辐照灭菌的照射剂量为3‑10 kGy；所述的步骤3）中，内包装在D级洁净区进行。本发明是通过现代天然药物分析手段和中药制药工艺，将传统中药饮片红曲米制成符合现行国家相关药品法规、《江苏省中药饮片炮制规范》2002年版、《中国药典》2015年版四部标准、无需煎煮、可用沸水冲泡服用的红曲米中药泡服饮片。
Description
技术领域
本发明涉及一种红曲米中药泡服饮片，属于医药技术领域。
背景技术
红曲米，中药名，民间称之为红米，以籼稻、粳稻、糯米等稻米为原料，用红曲霉菌发酵而成，为棕红色或紫红色米粒。其性味：甘，温，具有健脾消食、活血化淤的功效，主治用于产后恶露不净，瘀滞腹痛，食积饱胀，赤白下痢，跌打损伤。红曲米是列入《江苏省中药饮片炮制规范》2002年版的一味中药的降血脂和妇科用药的中药饮片。
红曲中的主要功能成分有红曲色素、洛伐他汀类(MonacolinK)、麦角甾醇、酶类活性物质和γ－氨基丁酸等化合物
中医认为红曲米功能主治：活血化瘀，健脾消食。主饮食积，脘腹胀满，赤白下痢；产后恶露不尽；跌打损伤.现代西方医学研究红曲米的临床作用是治疗和预防心脑血管疾病。众所周知，心脑血管疾病是当前威胁中老年人群生命的第一杀手，而患高血脂和高胆固醇症又是主要病因之一。人体内积累胆固醇主要通过两大途径，外源性，指来自饮食，占1/4；内源性指自身合成占3/4，比例最大. 代谢途径表明。人体自身合成胆固醇需经过一系列代谢过程，其中关键就是羟甲基戍二酰辅酶A(HMG-CoA)在其还原酶(HMG-CoA-R)的作用下生成甲羟戊酸，再进一步合成胆固醇，而红曲中有效成份正是HMG-CoA还原酶的竞争性抑制剂,从而就阻断了合成胆固醇的通路,起到治疗与预防心脑血管疾病的作用。
红曲米是迄今为止发现的同时具备降血脂、降血压和降血糖的三种功能的天然食品；红曲可同时降低TC、LDL-C和升高HDL-C,从而起到综合降脂作用，降酯效果和毒副作用皆优于对血脂异常疗效确切的他汀类西药洛伐他汀。还具有抗肿瘤、抗疲劳、预防骨质疏松、增强免疫力等广泛的药理作用；同时除降脂外，红曲对心血管的多种有益作用，保护心肌和内皮细胞、改善动脉硬化和心肌重构、改善心脏舒张功能，具有高效、低毒、安全的特点，已被证实在心血管疾病的一级、二级预防中均可获益；对于维护血管健康、减少心血管事件的发生、发展均具有重要意义，对冠心病的二级预防已具开创性的里程碑意义。
由于其传统饮片的服用方法是水煎服用，传统服用方法给患者带来不便；中药红曲米饮片往往在其生长和存储过程中易被霉菌污染，从而给其用药安全带来风险。
可以直接用热水冲泡服用的“泡服饮片”名称的出现是在《中国药典》2015 版四部对泡服饮片列有微生物限度标准上，至今没有国家统一的该类饮片的质量执行标准，红曲米产品也不例外。此外，由于每味中药所含有的化学成分非常复杂，加之产地不同，品质不一样，其含量质量要求往往是以其指标成分或有效成分的含量达到某一值以上(毒性成分除外)，加上有效成分大都储存其细胞中，有效成分不易溶出等，至今未有较全面的科学数据对其质量包括其稳定性(有效期)进行全面的评估。
发明内容
本发明的目的是克服现有技术的不足，提供一种红曲米中药泡服饮片。
将需要煎服的红曲米普通饮片制成符合饮片药品规范的无需煎煮、可热水冲泡服用的红曲米中药泡服饮片产品。申请人意外地发现，利用照射剂量为3-10 kGy的电子束辐照灭菌，可以使红曲米热水(80-90℃)浸泡浸出物中指标性成分洛伐他汀的溶出率较传统中药饮片红曲米水煎分别提高15％以上，从而提高其有效成分的吸收率而达到提高临床疗效的效果。同时，产品微生物限度检验结果能完全符合相关泡服饮片标准，并且稳定性研究表明其产品的有效期可达5年以上。
本发明的红曲米中药泡服饮片，其制备工艺如下：
1)将红曲米除去杂质，净制后，干燥，得到中间体；
2)检验中间体，包装后进行电子束辐照灭菌；
3)进行标准检验，包装后得到成品；
所述的步骤2)中，电子束辐照灭菌的照射剂量为3-10kGy；
所述的步骤3)中，内包装在D级洁净区进行。
优选地，
所述的步骤2)中，电子束辐照灭菌的照射剂量为5kGy。
使用时，可直接用沸水冲泡服用。
本发明是通过现代天然药物分析手段和中药制药工艺，将红曲米制成符合现行国家相关药品法规、《江苏省中药饮片炮制规范》2002年版、《中国药典》 2015年版四部标准、无需煎煮、可用沸水冲泡服用的红曲米中药泡服饮片。
本发明的『红曲米』中药泡服饮片GMP生产工艺及其泡服饮片质量执行标准，可使『红曲米』产品的热水(80-90℃)浸泡浸出物中指标性成分洛伐他汀的溶出率较传统中药饮片红曲米水煎分别提高15％以上，产品微生物限度检验结果显示能完全符合相关泡服饮片标准，并且稳定性研究表明其产品的有效期可达 5能以上，本发明产品适合具有相关药品GMP资质的生产企业生产。
附图说明
图1为红曲米(6克)热水(80～90℃)冲泡与水煎浸出物中洛伐他汀含量 (μg)比较；
图2为红曲米(6克)加速(40℃)稳定性研究；
图3为红曲米电子束辐照前后的HPLC特征图谱。
表1为经电子束辐照处理的红曲米(6克)热水(80～90℃)冲泡浸出物中洛伐他汀含量(μg)；
表2为未经电子束辐照处理的红曲米(6克)热水(80～90℃)冲泡浸出物中洛伐他汀含量(μg)；
表3为电子束照射剂量对炒红曲米的灭菌效果比较。
具体实施方式
本发明中，红曲米HongQuMi说明如下：
【【来源】本品为曲霉科真菌紫色红曲霉Monascus purpureus Went.寄生在粳米上而成的红曲米。
【炮制】本品按红曲米【炮制】项下红曲米经净制、干燥、包装、灭菌制成的小包装红曲米。
【装量差异】±7％[参照《中国药典》2015年版四部通则0115]。
【成品性状】本品完整者呈长椭圆形，一端较尖，另一端钝圆，长5-8mm，宽约2mm，部分碎裂呈不规则碎米状颗粒。表面紫红色或暗红色，质酥脆，断面粉红色。气微，味淡或微苦、微酸。本品包装封口完整，不得有内容物漏出。
【鉴别】(1)本品粉末为红色或紫红色。糊化淀粉粒多，多聚集成团；淀粉粒多为单粒，类圆形或长圆形，直径5-8μm。菌丝浅棕色，细长弯曲，有分枝，直径1-3μm子囊孢子少见，椭圆形，棕色，直径3-5μm。
(2)取洛伐他汀对照品，加乙醇制成每1ml各含1mg的溶液，作为对照品溶液。照薄层色谱法(通则0502)试验，吸取[含量测定]项下的供试品溶液10-15 μl及上述对照品溶液10μl，分别点于同一硅胶G薄层板上，以三氯甲烷-丙酮 (5:1)为展开剂，展开，取出，晾干，喷以5％香草醛硫酸溶液，在105℃加热至斑点显色清晰。供试品色谱中，在与对照品色谱相应的位置上，显相同颜色的斑点。
【检查】水分 红曲米 不得过12.0％(通则0832第二法)。
二氧化硫残留量 照二氧化硫残留量测定法(通则2331)测定，不得过150mg/kg。
【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-0. 1％磷酸溶液(55:5:40)为流动相；检测波长为238nm。理论板数按洛伐他汀峰计算应不低于3000。
对照品溶液的制备 取洛伐他汀对照品适量,精密称定,加75％丙酮溶液制成每1ml含0.04mg的溶液,作为洛伐他汀对照品溶液。
供试品溶液的制备 取本品，研细，取约0.78g，精密称定，置具塞锥形瓶中，精密加入75％丙酮溶液25ml，称定重量，用75％丙酮溶液补足减失的重量，摇匀，滤过，取续滤液，即得。
测定法 分别精密吸取上述洛伐他汀对照品溶液与供试品溶液各5-10μl，注入液相色谱仪，测定，即得。
品按干燥品计算,每1g含洛伐他汀(C24H36O5),不得少于0.30mg。
微生物限度检查 依据《中国药典》2015年版四部通则1107非无菌药品微生物限度标准，照《中国药典》2015年版四部通则1105及通则1106测定。
需氧菌总数可接受的最大菌数为103cfu；霉菌和酵母菌总数可接受的最大菌数为102cfu；不得检出沙门菌(10g)；耐胆盐革兰阴性菌应小于104cfu(1g)。
【性味与归经】甘,温。归肝、脾、大肠经。
【功能与主治】活血化瘀，健脾消食。用于产后恶露不尽，瘀滞腹痛，食积饱胀，赤白下痢，跌扑损伤。
【规格】6g/袋。
【用法与用量】6-12g。
【贮藏】置干燥容器中，防霉蛀。
【有效期】60个月
编制依据：企业内控标准，参照《浙江中药材炮制规范》(2005年版)、《江苏省中药饮片炮制规范》2002年版及《中国药典》2015年版四部
1.装量差异依据《中国药典》2015年版四部通则0115散剂项下标准，本品规格为每袋6克，根据散剂项下标示示装量：1.5g以上至6.0g，装量差异限度应为±7％。
2.微生物限度检查依据《中国药典》2015年版四部通则1107非无菌药品微生物限度标准，非无菌药品的需氧菌总数、霉菌和酵母菌总数照“非无菌产品微生物限度检查：微生物计数法(通则1105)”检査；非无菌药品的控制菌照“非无菌产品微生物限度检査：控制菌检查法(通则1106)”检查。
实施例1
红曲米160公斤，分3个实验批次(每批次60公斤)，按药品GMP规范，去杂质，干燥，包装(洁净区)，灭菌，制成的小包装红曲米成品。
(1)水煎(100℃)与热水(80-90℃)水浸比较实验：
本发明的产品是基于对红曲米进行水煎(100℃)与热水(80-90℃)水浸比较实验，以水浸出物中洛伐他汀总量为指标，比较红曲米经电子束辐照灭菌后其水煎与热水冲泡二者指标可能存在的差别。
通过上述实验研究(见表1-2，图1)，本发明的结果显示：经电子束辐照处理的『红曲米』产品热水(80-90℃)浸泡浸出物中洛伐他汀总量较未经电子束辐照的处理传统中药饮片红曲米水煎提高15％以上，即红曲米作为泡服饮片的水溶出物中洛伐他汀总量比其传统饮片的水煎大为提高。同时，红曲米电子束辐照前后其HPLC的特征图谱一致，表明电子束辐照未对其化学成分产生任何影响 (见图3)。
因此，本发明服用方便的红曲米泡服饮片完全能替代传统的水煎红曲米饮片。
(2)电子束辐照灭菌的照射剂量及灭菌效果:
电子束辐照灭菌技术已非常成熟，用电子加速器产生的高能电子束照射可使一些物质产生物理、化学和生物学效应，并能有效地杀灭病菌、病毒和害虫。这一技术已被广泛应用于工业生产中的材料改性、新材料制作、环境保护、加工生产、医疗卫生用品灭菌消毒和食品灭菌保鲜等。它同钴源辐照一样，具有常温、无损伤、无残毒、环保、低能耗、运行操作简便、自动化程度高、适宜于大规模工业化生产等特点。与钴源相比，其最大优点是辐照束流集中定向，能源利用充分，辐照效率高，不产生放射性废物。电子加速器辐照装置具有明显的价格和经济优势。为指导和规范辐照技术在中药灭菌中的正确应用，保证中药药品的安全、有效、质量稳定，国家食品药品监督管理总局于2015年11月制定了《中药辐照灭菌技术指导原则》，对中药辐照灭菌应进行中药个体的和针对性的辐照前后的对比研究，包括所含成分种类或含量的变化情况、指纹或特征图谱的对比研究等等。基于上述指导原则，本发明对红曲米电子束辐照灭菌的照射剂量、灭菌效果，以及灭菌前后指标成分溶出量的变化进行了详细的考察研究。
本发明分别使用3、5、10kGy的照射剂量对红曲米(6克/袋包装)进行照射，并进行照射前后灭菌效果考察(见表3)。结果表明，应用本发明5kGy的电子束照射剂量完全能达到《中国药典》2015版四部对泡服饮片的微生物限度标准。本发明确定红曲米的电子束辐照灭菌的最佳照射剂量为5kGy。
(3)稳定性(有效期)的研究：
本发明应用新药加速稳定性研究方法对红曲米产品进行有效期的研究，研究结果表明，红曲米产品的有效期可达5年以上(见图2)。
(4)红曲米中药泡服饮片质量标准：
本发明旨在建立高于《中国药典》2015版一部红曲米项下、《中国药典》2015 版四部相关泡服饮片标准、新置入有效期等的『红曲米』中药泡服饮片质量执行标准，以确保『红曲米)泡服饮片质量。
表1 经电子束辐照处理的红曲米(6克)热水(80～90℃)冲泡浸出物中洛伐他汀含量(μg))
表2 未经电子束辐照处理的红曲米(6克)热水(80～90℃)冲泡浸出物中洛伐他汀含量(μg))
。
Claims (2)
1.红曲米中药泡服饮片，其特征在于，其制备工艺如下：
1）将红曲米除去杂质，净制后，干燥，得到中间体；
2）检验中间体，包装后进行电子束辐照灭菌；
3）进行标准检验，包装后得到成品；
所述的步骤2）中，电子束辐照灭菌的照射剂量为3-10 kGy；
所述的步骤3）中，内包装在D级洁净区进行。
2.根据权利要求1所述的红曲米中药泡服饮片，其特征在于，所述的步骤2）中，电子束辐照灭菌的照射剂量为5 kGy。
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| KR20060134652A (ko) * | 2005-06-23 | 2006-12-28 | (주)두루원 | 홍국균의 배양에 의한 기능성 쌀 및 이의 제조 방법 |
| CN107184661A (zh) * | 2017-05-19 | 2017-09-22 | 江苏苏轩堂药业有限公司 | 醋延胡索粉直接口服中药饮片 |
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| KR20060134652A (ko) * | 2005-06-23 | 2006-12-28 | (주)두루원 | 홍국균의 배양에 의한 기능성 쌀 및 이의 제조 방법 |
| CN107184661A (zh) * | 2017-05-19 | 2017-09-22 | 江苏苏轩堂药业有限公司 | 醋延胡索粉直接口服中药饮片 |
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