CN107412713A - 治疗自体免疫性与免疫相关性疾病的中成药、医疗食品及制备方法 - Google Patents
治疗自体免疫性与免疫相关性疾病的中成药、医疗食品及制备方法 Download PDFInfo
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Abstract
本发明公开了治疗自体免疫性与免疫相关性疾病的中成药，包括冬虫夏草或虫草菌粉0.5‑50份，金银花20－50份，胎盘10‑30份，甘草10－50份，姜0.5‑50份，以上重量份原料部分经粉碎、部分经提取有效物质混合后，制成任何适宜的应用形式；加入营养组件制成医疗食品；以及中成药与医疗食品的制备方法。本发明组方简单，无副作用，服用方便，无禁忌，临床测试对自体免疫性与免疫相关性疾病具有显著的疗效，对比传统治疗方法，总有效率大幅提升，是对人类健康的重大贡献，具有特别意义。
Description
技术领域
本发明涉及医疗中成药或特殊食品领域，具体涉及治疗自体免疫性与免疫相关性疾病的中成药、特殊医疗用食品及制备方法。
背景技术
目前，肺纤维化（阻塞性肺病），系统性红斑狼疮，强直性脊柱炎，硬皮病，恶病质，消化道（如溃疡性结肠炎、口腔溃疡等），类风湿性关节炎，再生不良性贫血，易患感冒及其他感染性疾病，易疲劳或易过敏等自体免疫与免疫机能（状态）相关性疾病；ＥＢ病毒等病毒感染等自体免疫与免疫相关性疾病：以及癌肿（如肺癌、肝癌、消化道恶性肿瘤（包括食道、胃、肠、肠粘膜系统））在我国发病率有成逐年增加的趋势，而且自体免疫性与免疫相关性疾病目前国内外尚无明确理想有效的治疗方法，大多用中药（亦或中成药）、西药及中西结合。而此类中药（或中成药）大多数存在着处方组成复杂，从而导致产品对人体有多重复杂的作用甚至诸多副作用的缺点，为患者所不能忍受；或价格太高，为患者所不能接受；或毒副作用太大为患者所不能承受；或在服药期间对患者限制性要求太多，影响患者的正常工作与生活等等。西药又多以激素或免疫抑制剂为基础，对人体损伤（副作用）较大。
发明内容
本发明要解决的技术问题是提供一种治疗自体免疫性及免疫相关性疾病的中成药、医疗食品，组方简单、疗效好，在“治本”的基础上实现对这类疾病的彻底疗愈，在服药期间对患者无限制性要求，不影响患者的正常工作与生活。
本发明通过以下技术方案实现：
治疗自体免疫性与免疫相关性疾病的中成药，冬虫夏草或虫草菌粉0.5-50份，金银花20－50份，胎盘10-30份，甘草10－50份，姜0.5-50份，以上重量份原料部分经粉碎、部分经提取有效物质混合后，制成胶囊、或粉剂、或片剂、或颗粒剂、或粉（散）剂、或混悬剂，或其他适宜的应用形式。
本发明进一步优选是，冬虫夏草或虫草菌粉0.9-5份，金银花10－25份，胎盘19-30份，甘草20－25份，姜5-15份。
治疗自体免疫性与免疫相关性疾病的特殊医疗用食品，冬虫夏草或虫草菌粉0.5-50份，金银花20－50份，胎盘10-30份，甘草10－50份，姜0.5-50份，营养组件即麦芽糊精0.9-60份，膳食纤维0.5-30份，中链甘油三酯0.1-45份，微量元素0.1-19份，水溶性维生素0.1-27份，脂溶性维生素0.1-5份，奶味调味剂0.9-15份，以上重量份原料部分经粉碎、部分经提取有效物质混合后，制成胶囊、或粉剂、或片剂、或颗粒剂、或粉（散）剂、或混悬剂，或其他适宜的应用形式。
本发明进一步优选是，冬虫夏草或虫草菌粉0.9-5份，金银花10－25份，胎盘19-30份，甘草20－25份、姜5-15份，营养组件即麦芽糊精9-20份，膳食纤维1-15份，中链甘油三酯0.1-9份，微量元素0.1-9份，水溶性维生素0.2-17份，脂溶性维生素0.1-5份，奶味调味剂0.9-10份。
本发明要解决的另一个技术问题是提供这种中成药或特殊医疗用食品的制备方法。
（1）取金银花、姜放入蒸馏容器内，加水6倍重量，浸泡40－70分钟，水蒸气蒸馏2.5-3.5h，得到油水混合物，再对油水混合物进行蒸馏得到挥发油，然后以10倍重量β-环糊精包合挥发油，在60±5℃包合2小时，得到包合物；对蒸馏后的剩余物料进行液固分离，得到药渣和药液；
（2）将步骤（1）所得药渣，用乙醇回流提取2次，第一次加10倍重量浓度为60%－85%乙醇，回流提取1.5-2.5小时，过滤后的药渣再加8倍重量浓度为60%－85%乙醇，回流提取1.5-2.5小时，合并两次提取液，并在负压状态下回收乙醇，直至提取液无醇味得到含脂溶性物质的液体；对回流后的剩余物料进行液固分离，得到药渣；
（3）将步骤（2）所得药渣与甘草混合，加入胎盘煎煮二次，每次40-70分钟，第一次加9.5倍重量水，第二次加6倍重量水，分离煎煮液，取出胎盘，合并两次煎煮过滤后的药液，以及步骤（1）得到的药液，负压浓缩至相对密度为1.10-1.15后得提取浓缩液，备用；
（4）将步骤（3）煎煮后的胎盘于80-85℃烘干1.5-2.5小时，烘干后粉碎，过70目药筛备用；或将步骤（3）煎煮后的胎盘于绞浆机中灭菌状态下绞浆，用酶切技术将其酶解成300-400Da≥85%备用；
（5）取步骤（3）制得的提取浓缩液加入步骤（1）的包合物、步骤（2）的含脂溶性物质的液体，以及步骤（4）制成的药粉或酶切物，混合均匀后，喷雾干燥成粉状，然后加入粉碎好的冬虫夏草粉或虫草菌粉混合均匀，采用负压干燥至含水量≤5％后，将其制成中成药胶囊，或片剂、颗粒剂、粉（散）剂、片剂、混悬剂，或其他适宜的应用形式；或加入粉碎好的冬虫夏草粉或虫草菌粉、营养组件混合均匀，采用负压干燥至含水量≤5％后，将其制成特殊医疗用食品。
本发明更进一步改进方案是，步骤（3）所述的负压浓缩是容器内的液体温度在75-80℃之间的浓缩；步骤（5）所述的喷雾干燥，干燥塔内的烘干压力为100—150Pa，干燥塔的进口温度为180±5℃，出口温度为80±5℃；所述的负压干燥是容器内的固体处于75-80℃之间的干燥，或于-40±2℃冷冻后减压干燥。
本发明与现有技术相比，具有以下明显优点：
本发明组方简单，无副作用，服用方便，无禁忌，临床测试对自体免疫性与免疫相关性疾病具有显著的疗效，对比传统治疗方法，总有效率大幅提升，是对人类健康的重大贡献，贡献在于培植并提升机体的免疫能力和机体自身修复能力，具有特别意义。
具体实施方式
以下临床试验本发明的中成药或医疗食品治疗自体免疫性与免疫相关性疾病，与传统的治疗方法的疗效对比分析：
一、对肺纤维化的疗愈作用
对肺纤维化传统的治疗方法为给予吸氧、激素，抗生素，对自体免疫性与免疫相关性疾病具有一定的缓解作用，是临床上常用于肺纤维化处置的方法之一，因此，选用其作为对照组。在“双盲”的条件下对临床主要症状、肺功能、肺纤维化等血清、CT影像学等指标进行观察对比、分析。
1.对象与方法
1.1对象。观察对象150例，均为肝纤维化患者，其中男80例，女70例；年龄45—79岁，平均年龄为55岁。
1.2分组：150例随机分成治疗组75例，其中男40例，女35例，年龄45-78岁。对照组75例，其中男40例，女35例，年龄46-79岁。两组性别、年龄分布及病情基本一致，两组均接受基础治疗，包括⑴控制性氧气治疗（控制性吸氧）；⑵盐酸氨溴索注射液静滴⑶口服乙酰半胱氨酸⑷必要时使用抗生素⑸对症基础治疗；治疗组在对照组基础治疗的基础上，增加服用本发明的中成药制剂（每粒胶囊装药粉0.5克），每天3次，每次3-6粒（或医疗用特殊食品营养制剂粉末5-15克）；对照组。对症治疗一致，疗程3个月，随访半年。
1.3观察项目。（1）症状：咳嗽、喘息（气喘）、胸闷、肺部Velcro啰音、面色气短、痰多（2）肺功能；（3）动脉血气分析：（4）血清免疫指标:血清前白蛋白（PA）、白蛋白（ALB）含量、白蛋白球蛋白比值（A/G）；（5）胸部HRCT等
2. 疗效比较：
2.1治疗前后症状变化：两组患者治疗后主要症状（咳嗽、咳痰、气喘、胸闷、肺Velcro啰音 徒步气喘、口渴、纳差）均获得明显改善，结果见（表1）。
表1 治疗前后症状变化（例数）
结果表明，在综合主要症状（咳嗽、咳痰、气喘、胸闷、肺Velcro啰音 徒步气喘、口渴、纳差）等方面两组治疗前后均获得改善，且治疗组显著地优于对照组（P＜0.05）。
2．2治疗前后肺功能变化：
表2 治疗前后肺功能变化情况比较表
治疗前两组患者肺总量 （TLC）、肺活量（VC）占预计值百分比（%）、一氧化碳弥散量（DLCO）占预计值百分比（%）无显著差异（P＞0.05），具可比性。两组肺功能相关指标治疗后均有不同程度改善，治疗组治疗前后有显著性差异（P＜0.05），对照组治疗前后差异无显著性（P＞0.05）。在肺功能改善方面治疗组显著地优于对照组（P＜0.05）。
2.3两组患者治疗前后动脉血氧、二氧化碳分压变化情况
表3.两组治疗前后动脉血氧、二氧化碳分压比较（mmHg)比较表
治疗前后两组患者动脉血氧、二氧化碳分压均获不同程度的改善，治疗组治疗前后变化具显著性差异，治疗组显著地优于对照组，具统计学意义（P＜0.05）；
2.4治疗前后血清前白蛋白（PA）、白蛋白（ALB）含量、白球比（A/G）情况
表4.治疗组与对照组治疗前后血清前白蛋白（PA）、白蛋白（ALB）含量、白球比（A/G）情况对比表
两组治疗前，两组患者血清前白蛋白（PA）、白蛋白(ALB)、白蛋白球蛋白比值（A/G）对比差异无统计学意义，治疗后，上述指标值均明显改善，且治疗组明显优于对照组，组间对比，差异均有统计学意义（P＜0.05）。尤其值得提示的是，A/G的改善，提示该发明的制剂对改机体免疫机能，提高机体自身修复能力具有特别重要的意义。
2.5治疗前后两组患者胸部HRCT变化情况
2.5.1.HRCT显示肺间质纤维化：病变以胸膜下，基底部分分布为主的网格影、蜂窝、伴或不伴牵张性支气管扩张。
2.5.2.肺纤维化病变范围评分
采用4分法对肺纤维化病变范围评分(x±s，分），根据网格和蜂窝病变占整个肺脏的范围：⑴0分：未受累；⑵1分：病变范围≤25%；⑶2分：病变范围≥26%，≤50%（26%~50%）；⑷3分：病变范围51%~75%（≥51%病变范围≤75%）；⑸4分：病变范围76%~100%（76%≥病变范围≤100%）；
HRCT影像学显示，治疗前两组患者治疗前在牵张性支扩（例）、网格影（例）、蜂窝（例）、纵隔淋巴结肿大（例）和肺纤维化评分(x±s，分）等方面均无统计学显著性差异（P＞0.05），具可比性；治疗后两组患者上述考核指标方面具统计学显著性差异（P＜0.05）
表5.两组患者治疗前后胸部HRCT影像学相关指标对比表
2.5.3.治疗前后两组患者胸部HRCT情况比较
表6.治疗前后两组患者疗效比较表
肺间质纤维化在影像学上不同的病程、不同时期有不同的表现：肺泡炎期表现为病理变化尚可逆的磨玻璃影；肺纤维化期表现为网织结构；而肺纤维化后期影像学表现为蜂窝状可伴有少量磨玻璃影、网织结构。胸部HRCT可发现初期病变，如出现在胸膜下，较早发现肺内出现不规则的线条状网格样改变，常伴有囊性小气腔形成，其相互连接可形成胸膜下线，是诊断早期肺间质纤维化的重要手段之一。研究结果示：治疗组治疗后有15例患者胸部HRCT病灶影大部吸收或消失；27例患者胸部HRCT好转，32例处于稳定状态，1例较治疗前疑似有进展，有效率98.7%；对照组治疗后有0例患者胸部HRCT病灶影大部吸收或消失；10例患者胸部HRCT好转，32例稳定，33例加重，总有效率56.0%；治疗组显著地优于对照组（P＜0.05）。
二、对系统性红斑狼疮的疗愈作用
1.对象与方法
1.1对象。观察对象150例，均为狼疮性肾炎患者，其中男6例，女144例；年龄18—69岁，平均年龄为39.1岁。
1.2分组：150例随机分成治疗组75例，其中男3例，女72例，年龄18-68岁，平均病程7.3年。对照组75例，其中男3例，女2例，年龄19-69岁平均病程7.2年。两组性别、年龄分布及病情基本一致，具有可比性（P值均＞0.05）
1.3.病例收集标准：⑴入选标准：所选病例均符合1982年美国风湿病学会修订的系统性红斑狼疮（SLE）诊断标准，同时均有不同程度肾脏损害的表现（蛋白尿、管型尿、轻度肾功能减退等）⑵排除标准：有严重心、脑、肺并发症及肾萎缩患者。
1.4.给药方式及疗程：治疗组：给予本发明制剂中成药每次2-5克（或医疗用特殊食品营养制剂粉末5-15克），每日2次；同时根据病情予口服泼尼松20～30 mg/d,或羟氯奎等系统性红斑狼疮基础性治疗药物，获效后递减；对照组：根据病情予口服泼尼松20～30mg/d,或羟氯奎等系统性红斑狼疮基础性治疗药物，获效后递减;疗程均6个月。
1.5.观察指标及方法:①临床活动性症状及体征:发热、皮疹、浆膜炎、水肿、肌痛、非侵蚀性关节炎等。②主观观察指标(中医症候):面色晦暗、腰膝酸软、神疲乏力、下肢浮肿、舌胖质淡、脉细无力。③生化指标:红细胞沉降率(ESR)、肌酐清除率、24h尿蛋白定量。
1.6.免疫指标:采用免疫定量法测定补体C3，C4；间接免疫荧光法检测T细胞亚群，包括CD3 、CD4 、CD8和自然杀伤(NK)细胞。
1.7.疗效标准:⑴显效:临床活动性症状积分≤1，24h尿蛋白下降≥70%,活动性实验室指标(ESR、C3、sIL-2R)至少有1项转为正常，其余指标均有改善。⑵有效:临床活动性症状积分≤3，24h尿蛋白下降20-69%,活动性实验指标((ESR、C3、sIL-2R)均有下降，其余指标均有所改善。⑶无效:达不到有效标准者。
1.8.统计学处理:数据用x士s表示，采用t检验。
安全性指标:
(1)一般检查项目:血常规，尿常规，大便常规+OB，肝功能、肾功能，心
电图，胸片。
(2)根据相关症状行相应检查。如病程中出现胸闷、气急者行胸部CT、心脏
彩超等检查;有咳嗽、咳痰者予痰培养、痰抗酸染色等。
(3)观察可能出现的不良反应，主要观察感染情况。
2．疗效比较
2.1临床活动症状积分变化：治疗组：治疗前积分为3.56士1.28，治疗后为2.01士0.23。对照组：治疗前积分为3.82士1.34，治疗后为2.97士0. 61。治疗前两组间差异无统计学意义；治疗后两组较治疗前及组间比较差异均有显著性(P值均＜0.05 )。
2.2主观观察指标改善情况：治疗组和对照组均显著改善(P值均＜0.05 )。见表7.
表7.治疗组和对照组主观症候改善情况
表7.显示，治疗组各项指标治疗后均较治疗前获得显著性改善(P均＜0.01)；除面色晦暗外，其余主观观察指标治疗组较对照组均具极显著性差异(P均＜0.01)
2.3.临床疗效:治疗组显效29例，有效40例，无效6例，总有效率为92.0%。对照组显效5例，有效49例，无效21例，总有效率为72.0%。两组显效率、总有效率的差异均有显著性(P＜0.01)。
2.4临床生化指标 见表8.
表8.临床生化指标的变化((x士s)
与治疗前比较:aP＜0.05 bP＜0.01
表8.结果显示，治疗前两组患者生化指标:红细胞沉降率(ESR)、肌酐清除率、24h尿蛋白定量等差异均无统计学意义，具可比性；治疗后治疗组上述指标均较治疗前，及两组均具显著或极显著性差异（P＜0.05，或＜0.01），对照组肌酐清除率治疗后较治疗前差异差异无统计学意义（P＞0.05），红细胞沉降率(ESR)、24hn尿蛋白有显著性差异（P＜0.05）
2.5免疫学指标
2.5.1补体的变化:治疗组：治疗后C3.C4明显增高，差异具极显著性(P＜0.01，或P＜0.05)而对照组治疗前后的差异无显著性(P＞0.05)。见表9.
表9. 治疗前后补体的变化((x士s，n=75，pg/ml)
与治疗前比较:aP＜0.O5, bP＜0.O1
2.5.2 NK细胞的变化:治疗组治疗前NK细胞为10.63士4.32，治疗后为13.01士4.62。对照组治疗前：NK细胞为10.13士4.90，治疗后为9.08士4.74。两组治疗前后的差异均有显著性(P值分为＜0.O1和＜0.05)。
2.5.3 T细胞亚群的变化:治疗组治疗后CD4明显上升(P＜0.05)。见表10.
表10.治疗前后T细胞亚群的变化(x士s)
与治疗前比较:bP＜0.01
3.结果讨论
狼疮性肾炎导致肾功能衰竭是SLE主要死亡原因之一，确诊SLE4年后，肾炎的发病率高达92.3%。目前主要应用糖皮质激素、免疫抑制剂等治疗。本研究治疗组总有效率为92%，显著高于对照组72%。本发明营养制剂能明显降低狼疮性肾炎患者的临床活动症状积分、24h尿蛋白量和ESR，并能改善主观观察指标(中医症候）、提高肌酐清除率，对狼疮性肾炎患者失调的兔疫功能有较好的调节、恢复作用。
三.本发明设计依据及对自体免疫性与免疫相关性等疾病的治疗机制。
肺纤维化、系统性红斑狼疮等自体免疫及免疫相关性疾病致病因素、病情复杂，一旦形成后，国内外均无明确有效的治疗措施。我们认为血瘀和虚损（主要表现为免疫功能缺损（或低下）、机体自身修复能力、疗愈能力低下）在疾病的演变过程中起着重要作用。故治疗上主张以活血化瘀，扶正固本为主。
本发明由虫草、金银花、姜、甘草、胎盘等扶正化瘀药物组成。
冬虫夏草乃名贵药材，在传统意义上冬虫夏草入肺、肾二经。补虚损，益精气，止咳化痰。主治痰饮喘嗽，虚喘，痨嗽，咯血，自汗盗汗，阳痿遗精，腰膝酸痛，病后久虚，不复。保肺益肾，止血化痰，已劳嗽。主要用于补肺，壮肾阳，治痰饮喘嗽（现代临床医学上也多用于肺纤维化的治疗）。本发明通过深入挖掘传统医药和现代医药学对冬虫夏草的研究成果，经过研究，我们发现冬虫夏草对人体具有：活血通络，调节并增强人的免疫功能；增强人体对外环境的适应能力和应激能力；提高人对各种刺激的抵抗能力、耐受力和适应性，而很少有副作用；虫菌酸，虫草菌素为一种特殊的多糖甙，具有增强人体的修复功能的特殊功效；冬虫夏草的膳食纤维，一方面能较好地调节并增强人的胃肠道功能，减少糖份、脂类和胆固醇的不合理吸收，另一方面，部分特殊的膳食纤维，在行使一般的膳食纤维对胃肠道功能的维护作用的同时，通过吸附人体摄入的过多的糖类、油脂和胆固醇从而起到调节并降低血糖、血脂和胆固醇的功效；有的又可被肠道益生菌分解为对人体有奇特功能的特殊成分。本发明的组方牢牢抓住并充分挖掘这一名贵药材对人体的特殊而奇特的药理作用，结合传统中医药组方”君、臣、佐、使“的有关理论，科学合理组方而成。
冬虫夏草性味甘温，具有补亏损、益精气、益肾保肺之功能，对慢性肾炎及各种功能衰弱等症均有良好疗效。现代科学研究表明，冬虫夏草的主要成分为蛋白质、氨基酸、甾醇、甘露醇、生物碱、多糖及钾、钙、铬、镍、锰、铁、铜、锌等人体必需微量元素，且含量较为丰富。其中虫草多糖是一种高度分枝的半乳甘露聚糖，能促进淋巴细胞转化，调节机体的免疫功能，增强机体自身抗癌、抑癌的能力。由于天然虫草产量稀少，不能满足临床需求，故以人工虫草制剂替代势在必行。本方采用了源于青藏高原的纯正菌种以及获得国家专利的独特加工工艺，其理化性质、药理功效均与天然虫草无异。本研究提示，人工虫草制剂可调节狼疮性肾炎患者的免疫功能，加强其免疫自稳胜，从而使病情活动性指标恢复或接近正常。如补体C3 、C4经治疗后明显上升;sIL-2R治疗后明显下降;能增强NK细胞的活性;降低ds-DNA。抗DNA抗体可增加免疫复合物的PI值，加重肾脏损害，产生大量蛋白尿，所以ds-DNA的减少可能是该药治疗狼疮性肾炎蛋白尿的主要原因之一。
紫河车，即健康产妇的新鲜胎盘，除去羊膜、脐带，洗净，蒸或置沸水中淖过，干燥而得。味甘、咸，性温。能补肾益精，补气益血。研究表明紫河车，含多种抗体及干扰素，多种激素样物质，酶类，红细胞生成素，磷脂，多糖类以及β-抑制因子（一种能抑制流感病毒的巨球蛋白）等多种活性成份。有免疫增强和免疫调节作用，能增强机体抵抗力；能促进睾丸、乳腺、子宫、阴道、卵巢等的发育；有抗过敏作用。临床上用于肾气不足，精血虚亏，阳痿遗精，腰酸耳鸣，或不孕；肺肾两虚，喘息短气；气血不足，消瘦少食，体倦乏力，或产后乳少。胎盘在本质上是一种特殊的半透膜，对于人体来说具有并超越一切生物膜的优秀品质，在母体，胎盘具有为新的生命（胎儿）提供各种营养要素、免疫体系及确保新生的生命体健康生长所必须的各种生命要素和特殊环境的功能，因而其调节生命的功效肯定。
紫河车因其来自胎生生物的有机体，其对人体的免疫功能的培植和提升作用肯定，因此倍受世人追奉，然因其来自有机体，故其安全性亦一直受到学术界的关注，本发明采用金银花、甘草、生姜进行特殊处理，不但确保其使用的安全性，还增强其疗效。在以下表述中提示，甘草能调和某些药物的烈性。如调味承气汤用本品缓和大黄、芒硝的泻下作用及其对胃肠道的刺激；金银花增强机体免疫，增强机体抗病毒功能；姜具有的温中和胃，缓和诸腥臭味药材的不良腥味对人体的不良刺激等作用。所以本发明用甘草、金银花、姜，调和胎盘、冬虫夏草及其人工培养品，强烈的腥臭味对人的味觉、及胃肠的不良刺激，同时经体外的特殊处理，及服用后通过增强机体的免疫功能等一系列的生理生化过程，减少胎盘等其他药材中对人体潜在不利的毒副作用，增加本制剂的疗效和用药的安全性。
金银花 ，自古被誉为清热解毒的良药。它性甘寒气芳香，甘寒清热而不伤胃，芳香透达又可祛邪，入肺、心、胃经，具有清热解毒、抗炎、补虚疗风的功效，主治胀满下疾、温病发热，热毒痈疡和肿瘤等症。现代研究证明，金银花含有绿原酸、木犀草素苷等药理活性成分，对溶血性链球菌、金黄葡萄球菌等多种致病菌及上呼吸道感染致病病毒等有较强的抑制力，另外还可增强免疫力、抗早孕、护肝、抗肿瘤、消炎、解热、止血（凝血）、抑制肠道吸收胆固醇等，其临床用途非常广泛，可与其它药物配伍用于治疗呼吸道感染、菌痢、急性泌尿系统感染、高血压等40余种病症。
1、抗病原微生物作用：体外实验表明，花和藤对多种致病菌如金黄色葡萄球菌、溶血性链球菌、大肠杆菌、痢疾杆菌、霍乱弧菌、伤寒杆菌、副伤寒杆菌等均有一定抑制作用，对肺炎球菌、脑膜炎双球菌、绿脓杆菌、结核杆菌亦有效。水浸剂比煎剂作用强，叶煎剂比花煎剂作用强。若和连翘合用，抗菌范围还可互补；与青霉素合用，能加强青霉素对耐药金黄色葡萄球菌的抗菌作用，这可能是在抑制细菌体内蛋白质合成上有协同的作用。
2、抗炎和解热作用：腹腔注射金银花提取液0.25g/kg，能抑制大鼠角叉菜胶性脚肿。另有报道金银花注射液30～40g/kg能减轻蛋清性脚肿程度。腹腔注射金银花提取液8g/kg，2次/天，连续6天，对大鼠巴豆油性肉芽囊，也有明显抗渗出和抗增生的作用。早期报道金银花具有明显的解热作用，但用霍乱菌苗、马铃薯杆菌、枯草浸液等给家兔耳静脉注射，致热，未证实金银花煎剂5g/kg灌胃有退热作用，认为这可能和使用的金银花制剂、剂量或家兔的耐受性不同有关。
3、加强免疫机能作用：金银花煎剂稀释至1：1280的浓度，仍能促进白细胞的吞噬功能。小鼠腹腔注射金银花注射液，也有明显促进炎性细胞吞噬功能的作用。
4、中枢兴奋作用：经电休克、转笼等多种实验方法证明口服绿原酸后，可引起大鼠、小鼠等动物中枢神经系统兴奋，其作用强度为咖啡因的1/6，二者合用无相加及增强作用。
5、降血脂作用：大鼠灌胃金银花2.5g/kg能减少肠内胆固醇吸收，降低血浆中胆固醇含量。体外实验也发现金银花可和胆固醇相结合，但四妙勇安汤（金银花、玄参、当归、甘草）治疗家兔实验性动脉粥样硬化。未观察到有降血脂和主动脉壁胆固醇含量的作用。
6、抗内毒素：用鲎试验法测定内毒素含量，300%金银花（忍冬）注射液以1:2～1:64稀释，体外试验无论用凹片法或试管法，均明显降低试液中的内毒素含量，其中1:2～1:8的稀释管与阴性对照管一样呈液态，阳性对照呈凝胶状。金银花（忍冬）蒸馏液6g/kg静脉注射，对绿脓杆菌内毒互2.8mg/kg静脉注射引起的兔体温下降及白细胞数下降有对抗作用，金银花（忍冬）蒸馏液7.5g/kg或注射液2.5g/kg腹腔注射，对绿脓杆菌内毒素65mg/kg腹腔注射的小鼠有保护作用，减少小鼠死亡率。
7、其它作用：曾有体外筛选实验报告金银花的水及酒浸液对肉瘤180及艾氏腹水癌有明显的细胞毒作用。金银花提取物口服对大鼠实验性胃溃疡有轻度预防效果。口服大剂量绿原酸能增加胃肠蠕动，促进胃液及胆汁分泌。绿原酸及其分解产物对大鼠离体子宫有兴奋作用。此外，绿原酸还能轻微增强肾上腺素及其去甲肾上腺素对猫和大鼠的升压作用，但对猫的瞬膜反应无影响。
甘草，别名：国老、甜草，多年生草本，根与根状茎粗壮，根和根状茎供药用，是一种补益中草药。气微，味甜而特殊。清热解毒、祛痰止咳、脘腹等。在临床上甘草主要用于心气虚，心悸怔忡，脉结代，以及脾胃气虚，倦怠乏力等；痈疽疮疡、咽喉肿痛等。可单用，内服或外敷，或配伍应用。痈疽疮疡，常与金银花、连翘等同用，共奏清热解毒之功，如仙方活命饮。咽喉肿痛，常与桔梗同用，如桔梗汤。若农药、食物中毒，常配绿豆或与防风水煎服；气喘咳嗽。可单用，亦可配伍其他药物应用。如治湿痰咳嗽的二陈汤；治寒痰咳喘的苓甘五味姜辛汤；治燥痰咳嗽的桑杏汤；治热毒而致肺痈咳唾腥臭脓痰的桔梗汤；治咳唾涎沫的甘草干姜汤等。另风热咳嗽、风寒咳嗽、热痰咳嗽亦常配伍应用；胃痛、腹痛及腓肠肌挛急疼痛等，能显著增强治挛急疼痛的疗效；调和某些药物的烈性。如调味承气汤用本品缓和大黄、芒硝的泻下作用及其对胃肠道的刺激。另外，在许多处方中也常用本品调和诸药；甘草有类似肾上腺皮质激素样作用。对组胺引起的胃酸分泌过多有抑制作用；并有抗酸和缓解胃肠平滑肌痉挛作用；甘草黄酮、甘草浸膏及甘草次酸均有明显的镇咳作用；祛痰作用也较显著，其作用强度为甘草酸>甘草黄酮>甘草浸膏；抗炎，抗过敏作用，能保护发炎的咽喉和气管粘膜。甘草浸膏和甘草酸对某些毒物有类似葡萄糖醛酸的解毒作用；治疗随更年期而来的症状.因为甘草里含有甘草素，是一种类似激素的化合物，它有助于平衡女性体内的激素含量；甘草所含的次酸能阻断致癌物诱发肿瘤生长的作用。
甘草含有多种化学成分，主要成分有甘草酸、甘草甙等。甘草的化学组成极为复杂，目前为止从甘草中分离出的化合物有甘草甜素、甘草次酸、甘草甙、异甘草甙、新甘草甙、新异甘草甙、甘草素、异甘草素以及甘草西定、甘草醇、异甘草醇、7-甲基香豆精、伞形花内酯等数十种化合物，但这些成分和数量通常会随甘草的种类、种植区域、采收时间等因素的不同而异。大量的研究表明，甘草甜素和黄酮类物质是甘草中最重要的生理活性物质，主要存在于甘草根表皮以内的部分。
姜（学名：Zingiber officinale Rosc.），姜科姜属多年生草本植物。根茎供药用，其中药性表现为：发散风寒、化痰止咳，又能温中止呕、解毒等，常常用于外感风寒及胃寒呕逆等症的治疗。 现代药理研究表明，干姜的甲醇或醚提取物有镇静、镇痛、抗炎、止呕及短暂升高血压的作用；水提取物或挥发油能明显延长血栓形成时间；醇提取物及其所含姜辣素和姜辣烯酮有显著灭螺和抗血吸虫作用。生姜还有抗菌、抗癌，以及抗氧化、抗衰老作用，其特有的“姜辣素”能有效治疗因过食寒凉食物而引起的腹胀、腹痛、腹泻、呕吐等症。此外，生姜能增进食欲，促进消化液的分泌;生姜中的姜酚还有较强的利胆作用。
综上所述，本发明选料精良，组方科学合理，疗效确切，尤其能疗愈诸如系统性红斑狼疮、肺纤维化肺纤维化（阻塞性肺病）、系统性红斑狼疮、强直性脊柱炎、硬皮病、恶病质、消化道（如溃疡性结肠炎、口腔溃疡等）、类风湿性关节炎、再生不良性贫血、易患感冒及其他感染性疾病，易疲劳或易过敏等自体免疫性疾病与免疫相关性疾病；ＥＢ病毒等病毒感染等免疫与免疫相关性疾病，以及癌肿（肺癌、肝癌、消化道（包括食道、胃、肠、肠粘膜系统）恶性肿瘤）等普遍认为世界性医学难治性疾病开创历史性的意义，是对人类健康的重大发明与贡献，具有特别意义。
Claims (8)
1.治疗自体免疫性与免疫相关性疾病的中成药，其特征在于：冬虫夏草或虫草菌粉0.5-50份，金银花20－50份，胎盘10-30份，甘草10－50份，姜0.5-50份，以上重量份原料部分经粉碎、部分经提取有效物质混合后，制成胶囊、或粉剂、或片剂、或颗粒剂、或粉（散）剂、或混悬剂，或其他适宜的应用形式。
2.根据权利要求1所述的治疗自体免疫性及免疫相关性疾病的中成药，其特征在于：冬虫夏草或虫草菌粉0.9-5份，金银花10－25份，胎盘19-30份，甘草20－25份，姜5-15份。
3.治疗自体免疫性及免疫相关性疾病的中成药的制备方法，其特征在于：
（1）取金银花、姜放入蒸馏容器内，加水6倍重量，浸泡40－70分钟，水蒸气蒸馏2.5-3.5h，得到油水混合物，再对油水混合物进行蒸馏得到挥发油，然后以10倍重量β-环糊精包合挥发油，在60±5℃包合2小时，得到包合物；对蒸馏后的剩余物料进行液固分离，得到药渣和药液；
（2）将步骤（1）所得药渣，用乙醇回流提取2次，第一次加10倍重量浓度为60%－85%乙醇，回流提取1.5-2.5小时，过滤后的药渣再加8倍重量浓度为60%－85%乙醇，回流提取1.5-2.5小时，合并两次提取液，并在负压状态下回收乙醇，直至提取液无醇味得到含脂溶性物质的液体；对回流后的剩余物料进行液固分离，得到药渣；
（3）将步骤（2）所得药渣与甘草混合，加入胎盘煎煮二次，每次40-70分钟，第一次加9.5倍重量水，第二次加6倍重量水，分离煎煮液，取出胎盘，合并两次煎煮过滤后的药液，以及步骤（1）得到的药液，负压浓缩至相对密度为1.10-1.15后得提取浓缩液，备用；
（4）将步骤（3）煎煮后的胎盘于80-85℃烘干1.5-2.5小时，烘干后粉碎，过70目药筛备用；或将步骤（3）煎煮后的胎盘于绞浆机中灭菌状态下绞浆，用酶切技术将其酶解成300-400Da≥85%备用；
（5）取步骤（3）制得的提取浓缩液加入步骤（1）的包合物、步骤（2）的含脂溶性物质的液体，以及步骤（4）制成的药粉或酶切物，混合均匀后，喷雾干燥成粉状，然后加入粉碎好的冬虫夏草粉或虫草菌粉混合均匀，采用负压干燥至含水量≤5％后，将其制成胶囊，或片剂、颗粒剂、粉（散）剂、片剂、混悬剂，或其他适宜的应用形式。
4.根据权利要求3所述的治疗自体免疫性及免疫相关性疾病的中成药的制备方法，其特征在于：步骤（3）所述的负压浓缩是容器内的液体温度在75-80℃之间的浓缩；步骤（5）所述的喷雾干燥，干燥塔内的烘干压力为100—150Pa，干燥塔的进口温度为180±5℃，出口温度为80±5℃；所述的负压干燥是容器内的固体处于75-80℃之间的干燥，或于-40±2℃冷冻后减压干燥。
5.治疗自体免疫性与免疫相关性疾病的特殊医疗用食品，其特征在于：冬虫夏草或虫草菌粉0.5-50份，金银花20－50份，胎盘10-30份，甘草10－50份，姜0.5-50份，营养组件即麦芽糊精0.9-60份，膳食纤维0.5-30份，中链甘油三酯0.1-45份，微量元素0.1-19份，水溶性维生素0.1-27份，脂溶性维生素0.1-5份，奶味调味剂0.9-15份，以上重量份原料部分经粉碎、部分经提取有效物质混合后，制成胶囊、或粉剂、或片剂、或颗粒剂、或粉（散）剂、或混悬剂，或其他适宜的应用形式。
6.根据权利要求5所述的治疗自体免疫性及免疫相关性疾病的特殊医疗用食品，其特征在于：冬虫夏草或虫草菌粉0.9-5份，金银花10－25份，胎盘19-30份，甘草20－25份、姜5-15份，营养组件即麦芽糊精9-20份，膳食纤维1-15份，中链甘油三酯0.1-9份，微量元素0.1-9份，水溶性维生素0.2-17份，脂溶性维生素0.1-5份，奶味调味剂0.9-10份。
7.治疗自体免疫性及免疫相关性疾病的特殊医疗用食品的制备方法，其特征在于：
（1）取金银花、姜放入蒸馏容器内，加水6倍重量，浸泡40－70分钟，水蒸气蒸馏2.5-3.5h，得到油水混合物，再对油水混合物进行蒸馏得到挥发油，然后以10倍重量β-环糊精包合挥发油，在60±5℃包合2小时，得到包合物；对蒸馏后的剩余物料进行液固分离，得到药渣和药液；
（2）将步骤（1）所得药渣，用乙醇回流提取2次，第一次加10倍重量浓度为60%－85%乙醇，回流提取1.5-2.5小时，过滤后的药渣再加8倍重量浓度为60%－85%乙醇，回流提取1.5-2.5小时，合并两次提取液，并在负压状态下回收乙醇，直至提取液无醇味得到含脂溶性物质的液体；对回流后的剩余物料进行液固分离，得到药渣；
（3）将步骤（2）所得药渣与甘草混合，加入胎盘煎煮二次，每次40-70分钟，第一次加9.5倍重量水，第二次加6倍重量水，分离煎煮液，取出胎盘，合并两次煎煮过滤后的药液，以及步骤（1）得到的药液，负压浓缩至相对密度为1.10-1.15后得提取浓缩液，备用；
（4）将步骤（3）煎煮后的胎盘于80-85℃烘干1.5-2.5小时，烘干后粉碎，过70目药筛备用；或将步骤（3）煎煮后的胎盘于绞浆机中灭菌状态下绞浆，用酶切技术将其酶解成300-400Da≥85%备用；
（5）取步骤（3）制得的提取浓缩液加入步骤（1）的包合物、步骤（2）的含脂溶性物质的液体，以及步骤（4）制成的药粉或酶切物，混合均匀后，喷雾干燥成粉状，然后加入粉碎好的冬虫夏草粉或虫草菌粉、营养组件混合均匀，采用负压干燥至含水量≤5％后，将其制成胶囊，或片剂、颗粒剂、粉（散）剂、片剂、混悬剂，或其他适宜的应用形式。
8.根据权利要求3所述的治疗自体免疫性及免疫相关性疾病的特殊医疗用食品的制备方法，其特征在于：步骤（3）所述的负压浓缩是容器内的液体温度在75-80℃之间的浓缩；步骤（5）所述的喷雾干燥，干燥塔内的烘干压力为100—150Pa，干燥塔的进口温度为180±5℃，出口温度为80±5℃；所述的负压干燥是容器内的固体处于75-80℃之间的干燥，或于-40±2℃冷冻后减压干燥。
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