CN116036174B - 一种治疗肺结节的药物及其制备方法 - Google Patents
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Abstract
本发明属于中药药物制剂技术领域，公开了一种治疗肺结节的药物及其制备方法。成分包括：僵蚕、五味子、金沸草、皂角刺，制备方法为在僵蚕、五味子、金沸草、皂角刺中加入上述总重八倍的蒸馏水浸泡30分钟，然后控制温度在60℃‑100℃之间进行煎煮，煎煮1‑3次，每次煎煮时间1‑3小时，然后滤取煎煮后的药液进行浓缩干燥，所得干膏即为所述治疗肺结节的药物。本发明提供的用于治疗肺结节的中药组合物所用中药的药味少，成本低，毒副作用小。提供的制备工艺操作简单，生产过程中易于进行质量控制，制得的中药组合物化学成分稳定。
Description
技术领域
本发明属于中药药物制剂技术领域，具体涉及一种治疗肺结节的药物及其制备方法。
背景技术
现代医学研究表明肺结节病是一种原因未明的以非干酪性上皮细胞肉芽肿性炎症为病理特征的***性疾病，其发生的关键机制在于未知抗原引起的机体细胞免疫和体液免疫反应。随着科技水平与生物技术的不断提升，最新研究已经表明代谢性功能***紊乱是导致肺结节的重要诱因。人体肺部是重要的呼吸与免疫器官，当人体代谢功能受到破坏时，会阻碍各种免疫细胞的产生、分化、迁移、聚集等过程，造成人体微循环功能的代谢性异常，导致炎症反应及肺部肉芽肿形成或纤维化，治疗不当会诱发癌变甚至死亡。
随着城市的快速发展，许多生活在大城市的人们生活及工作压力不断加大，伴随着环境问题矛盾的日趋突显，诱发肺部方面相关的疾病，特别是肺结节，发病率逐年升高对于家庭稳定和社会安宁起到了严重的威胁；现代医学临床对于肺结节早期患者的治疗多为糖皮质激素类药物(甲氨蝶呤等)，虽然起到一定的治疗作用，但是长期服用易引起严重的脑血管疾病及内分泌代谢的异常反应，甚至危及到生命。中医药在治疗疾病方面具有价格低廉、毒副作用小、疗效长期有效的特点，尤其在治疗肺癌病变早期结节症状也有着独特的优势。
发明内容
为了克服现有技术的不足，本发明提供一种治疗肺结节的药物及其制备方法，由僵蚕、金沸草、五味子、皂角刺配伍组合而成，从化痰散结、祛风通络、益气养阴的角度入手，可长期服用，且副作用小，药效稳定。
本发明的上述目的是通过以下技术方案实现的：一种治疗肺结节的药物，成分包括：僵蚕、五味子、金沸草、皂角刺。
进一步的，所述治疗肺结节药物成分包括僵蚕5-10g、五味子2-6g、皂角刺3-10g、金沸草5-10g。
本发明的进一步优选，所述治疗肺结节药物成分比例为僵蚕:金沸草:五味子:皂角刺＝3:2:1:2。
一种治疗肺结节的药物的制备方法，包括如下步骤：在僵蚕、五味子、金沸草、皂角刺中加入上述总重八倍的蒸馏水浸泡30分钟，然后控制温度在60℃-100℃之间进行煎煮，煎煮1-3次，每次煎煮时间1-3小时，然后滤取煎煮后的药液进行浓缩干燥，所得干膏即为所述治疗肺结节的药物。
进一步的，所述治疗肺结节的药物为颗粒剂、片剂、丸剂、胶囊剂。
本发明的进一步优选，所述治疗肺结节的药物的制备方法中煎煮温度80℃，提取3次，每次提取3小时。
僵蚕是传统的平肝息风药，能化痰散结、息风止痉、祛风止痛。本品味辛行散且咸，既能祛风、化痰、通络，又可软坚散结、兼可化痰。现代研究发现，僵蚕主要含有蛋白质与脂肪，其体表的白粉中含有草酸铵等物质，具有较强的降血糖、降血压的作用。现代药理学研究表明，僵蚕具有较强的抗凝血作用，对金黄葡萄球菌、绿脓杆菌等细菌感染具有良好的抑菌作用。近年来研究显示，僵蚕在抑制肝癌细胞与肺癌细胞方面也有较好的作用。
金沸草是旋覆花的地上部分，其功效性味与旋覆花较为相似，但金沸草偏于疏散化痰。现代临床主要应用于慢性支气管炎、上呼吸道感染、风湿性关节炎、泌尿道感染等疾病的治疗。药理研究发现，金沸草对于疱疹病毒有较强的抑制作用。
皂角刺为皂荚树的棘刺，与中药皂荚有相似的功效。性味辛温，入肝肾经，具有消肿排脓、行气理气、温经通络、活血祛瘀之功。中医临床常用于疮疡肿痛、乳汁不畅、胞衣不下等病症的治疗。现代药理学研究表明皂角刺能促进呼吸道黏膜分泌，具有良好的化痰作用。
五味子为木兰科植物五味子的成熟果实，味酸收敛，甘温而润，上敛肺气，下滋肾阴，为治疗久咳虚喘的要药。现代科学研究表明，五味子对神经***及中枢***均有兴奋的作用，对呼吸***也具有兴奋作用。还能降低血压、降血脂，降低血清转氨酶的水平，对肝脏细胞起到保护作用；增强细胞免疫功能，促进机体各脏器SOD水平的提升，具有提高免疫力、抗氧化、抗衰老的作用。
本发明与现有技术相比的有益效果是：本发明提供的用于治疗肺结节的中药组合物的组分僵蚕为君药，皂角刺与金沸草为臣药，五味子为佐药。其中以僵蚕化痰散结、通络；以皂角刺行气理气、消肿排脓、活血祛瘀；以金沸草降气化痰、疏散行水；辅以五味子上敛肺气，下滋肾阴、益气生津、宁心安神。各组分共同作用，达到治疗肺结节的效果。本发明提供的用于治疗肺结节的中药组合物所用中药的药味少，成本低，毒副作用小。提供的制备工艺操作简单，生产过程中易于进行质量控制，制得的中药组合物化学成分稳定。药理研究实验结果表明，本发明提供的提取工艺制得的中药组合物能够显著降低血清TNF-α、IL-10、IL-6、IL-1β的表达水平，改善肺结节肿胀程度，具有提高免疫功能，缓解肺结节病变的作用。说明本发明提供的中药组合物疗效确定可靠，可以用来制备治疗肺结节的药物。
附图说明
下面结合附图与具体实施方式对本发明作进一步说明
图1是本发明药物成分与肺结节肿胀抑制率的关系示意图，其中A为金沸草、五味子与肺结节肿胀抑制率的关系；B为僵蚕、金沸草与肺结节肿胀抑制率的关系；C为僵蚕、皂角刺与肺结节肿胀抑制率的关系；D为僵蚕、五味子与肺结节肿胀抑制率的关系；E为金沸草、皂角刺与肺结节肿胀抑制率的关系；F为五味子、皂角刺与肺结节肿胀抑制率的关系。
具体实施方式
下面通过具体实施例详述本发明，但不限制本发明的保护范围。如无特殊说明，本发明所采用的实验方法均为常规方法，所用实验器材、材料、试剂等均可从商业途径获得。
实施例1
下述临床常用量份数比的中药原料僵蚕:金沸草:五味子:皂角刺＝3:2:1:2；通过单因素实验以出膏率为考察指标确定制备工艺范围，在中药原料中加入8倍量的蒸馏水，浸泡0.5h，煎煮1-3次，每次煎煮1-3小时，温度控制在60℃-100℃，利用正交实验L9(34)确定组方最佳制备工艺。
表1制备工艺因素水平表
表2组方制备工艺试验结果
表3组方制备工艺直观分析结果：
表4组方制备工艺出膏率方差分析结果：
试验结果可直观分析得到，以出膏率(％)为观察指标时，B因素对制备工艺过程有显著影响，通过对比考察的各因素影响主次分布为：C＞B＞A＞D，即煎煮次数＞煎煮时间＞煎煮温度。综合考虑各因素对提取的贡献率以及能源损耗与工艺等因素，最佳制备工艺组合为A2B3C3，即控制80℃的煎煮温度，提取3次，每次提取3小时。
实施例2
1.实验动物：
SD雄性大鼠186只
2.实验周期：
60天
3.仪器与试剂：
天平、二氧化硅悬浊液
4.实验药物：
中药原料加入8倍量的蒸馏水，浸泡0.5h，煎煮3次，每次煎煮3小时，温度控制在80℃，合并煎液，趁热过滤，除去滤渣，将滤渣浓缩为内含药1g/mL，制成灌胃体积的药物溶液。
5.造模方法：
各组大鼠腹腔内注射质量分数为3.0％戊巴比妥钠溶液(剂量为45mg/kg体质量)，麻醉后将其固定。以体积分数为75.0％的乙醇消毒大鼠颈部皮肤，沿着颈正中线切开，钝性分离肌肉，暴露其气管。采用非暴露式气管插管术染毒，一次性向气管内注入质量浓度为250g/L的二氧化硅混悬液200μL。
6.检测指标：
肺肿胀系数＝肺湿重(g)/体重(g)×100％
肺结节肿胀抑制率＝(给药组肺肿胀***－空白组肺肿胀系数)/(模型组肺肿胀系数－空白组肺肿胀系数)×100％
7.星点设计实验：
在上述制备工艺实验的基础上，以僵蚕、金沸草、五味子和皂角刺用量为考察因素(用A、B、C、D表示)，以肺结节肿胀抑制率为效应进行4因素、3水平的星点设计，因素水平设计见表。
表5星点设计因素水平表
8.实验方法：
186只SD大鼠以每组6只分为空白组、模型组，空白组正常饲养，模型组按照上述方法进行造模，造模后将大鼠随机分为模型组与星点设计1-29给药组，给药组每天给予不同配伍组合的药物溶液，空白和模型组每天给予等量的生理盐水，共计60天。给药结束后，将各组大鼠大鼠麻醉后处死，称取大鼠肺部组织重量，计算肺肿胀系数与肺结节肿胀抑制率。
表6空白组与模型组大鼠肺肿胀系数(n＝6)
表7实验设计与指标测定：
表8方差分析及回归模型系数显著性检验：
运用Design-Expert 13.0软件对上述数据进行统计分析，以肺结节肿胀抑制率为指标进行多元非线性回归拟合，采用软件推荐的多项式模型，模型项P＜0.05，可得到回归方程：Y＝78.92+5.84A+5.50B+4.78C+7.65D－3.85AB－3.53AC－0.45AD－0.325BC+8.47BD－6.33CD+2.44A2－7.34B2－6.41C2－1.87D2(R2＝0.8097)，说明该回归模型的拟合情况比较良好。各因素相互关系及肺结节肿胀抑制率的响应面和等高线图见附说明(图1)。软件推荐组方配伍组合为僵蚕:金沸草:五味子:皂角刺＝3:2:1:3。
对比例1
现查有治疗肺结节的中药组合物配方(清肺散结丸)，本对比实验以现有的中药组方与本发明进行对比，具体如下：
1.实验动物：
SD雄性大鼠40只
2.实验周期：
60天
3.仪器与试剂：
酶标仪、TNF-α(肿瘤坏死因子α)、IL-10(白介素10)、IL-6(白介素6)、IL-1β(白介素1β)试剂盒
4.实验药物：
中药组方按照僵蚕:金沸草:五味子:皂角刺＝3:2:1:3，加入8倍量的蒸馏水，浸泡0.5h，煎煮温度80℃，煎煮3次，每次煎煮3小时，合并煎液，趁热过滤，除去滤渣，将滤渣浓缩为内含药1g/mL，制成灌胃体积的药物溶液。
清肺散结丸(海南龙圣堂制药，3g×6/盒)，根据传统制剂的配置方法，将药物配置成1g/mL的药物混悬液。
5.造模方法：
各组大鼠腹腔内注射质量分数为3.0％戊巴比妥钠溶液(剂量为45mg/kg体质量)，麻醉后将其固定。以体积分数为75.0％的乙醇消毒大鼠颈部皮肤，沿着颈正中线切开，钝性分离肌肉，暴露其气管。采用非暴露式气管插管术染毒，一次性向气管内注入质量浓度为250g/L的二氧化硅混悬液200μL。
6.检测指标：
血清TNF-α、IL-10、IL-6、IL-1β
7.实验方法：
40只SD大鼠以每组10只分为空白组、模型组、比对组(清肺散结丸)和优选组(本发明)，空白组正常饲养，其余3组按照上述方法进行造模；造模后，比对组与优选组每天给予剂量1mL/100g的对应药物溶液，空白和模型组每天给予等量的生理盐水，共计60天。给药结束后，将大鼠麻醉，腹主动脉取血后处死。全血室温条件静置30min后，4℃下，3500r/min离心10min，取上清液，ELISA法检测血清中TNF-α、IL-10、IL-6、IL-1β的含量。
表9大鼠血清TNF-α、IL-10、IL-6、IL-1β含量测定结果
与空白组比较，*P＜0.01，**P＜0.01；与模型组比较，#P＜0.05，##P＜0.01
从表9可以看出，与空白组相比，模型组血清TNF-α、IL-10、IL-6、IL-1β的含量显著升高(P＜0.01)；与模型组相比，比对组与优选组大鼠血清TNF-α、IL-10、IL-6、IL-1β的含量显著降低(P＜0.01)，且优选组血清免疫因子水平更接近空白组，效果略优于比对组。
以上所述实施方式仅为本发明的优选实施例，而并非本发明可行实施的全部实施例。对于本领域一般技术人员而言，在不背离本发明原理和精神的前提下对其所作出的任何显而易见的改动，都应当被认为包含在本发明的权利要求保护范围之内。
Claims (4)
1.一种治疗肺结节的药物，其特征在于，成分为：僵蚕5-10g、五味子2-6g、皂角刺3-10g、金沸草5-10g；成分比例为僵蚕:金沸草:五味子:皂角刺＝3:2:1:2。
2.根据权利要求1所述的治疗肺结节的药物，其特征在于，所述治疗肺结节的药物为颗粒剂、片剂、丸剂、胶囊剂。
3.如权利要求1或2所述的治疗肺结节的药物的制备方法，其特征在于，包括如下步骤：在僵蚕、五味子、金沸草、皂角刺中加入上述总重八倍的蒸馏水浸泡30分钟，然后控制温度在60℃-100℃之间进行煎煮，煎煮1-3次，每次煎煮时间1-3小时，然后滤取煎煮后的药液进行浓缩干燥，所得干膏即为所述治疗肺结节的药物。
4.根据权利要求3所述的治疗肺结节的药物的制备方法，其特征在于，所述治疗肺结节的药物的制备方法中煎煮温度80℃,提取3次，每次提取3小时。
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