CN116920052B - 一种治疗原发性干燥综合征伴抑郁症的中药组合物及其制备方法和应用 - Google Patents
一种治疗原发性干燥综合征伴抑郁症的中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种用于治疗原发性干燥综合征伴抑郁症的中药组合物，所述的中药组合物由以下重量份的各原料药制成：地黄28‑32份、山茱萸8‑12份、山药8‑12份、柴胡8‑15份、炒白芍8‑12份、北沙参8‑12份、麦冬8‑15份、茯神14‑18份、石斛8‑12份、丹参14‑18份、石榴皮4‑8份、甘草4‑8份，并公开了其制备方法，本发明通过益肾疏肝、阴阳调和、养血补气、活血化瘀达到治疗原发性干燥综合征伴抑郁症的目的。
Description
技术领域
本发明涉及一种中药组合物及其制备方法和用途，特别涉及一种治疗原发性干燥综合征伴抑郁症的中药组合物及其制备方法和应用。本发明属于中药研究技术领域。
背景技术
原发性干燥综合症是一种自身免疫性疾病，典型的临床表现为口、眼干燥，并可累及肾、肺、神经系统、消化系统等多个系统，引起的全身器官受累。表现有肌肉无力、全身酸痛、干咳、胸闷、癫痫、软瘫、原因不明的肝炎、肝硬化、慢性腹泻等。干燥综合征好发于绝经期以后或30-40岁的女性，发病率约0.3-0.4％，在老年人群中高达0.77％。现代医学多以激素、免疫抑制剂治疗，但因本病病程长，症状易反复、加重，长期的心理压力和沉重的经济负担给患者带来诸多负面情绪。原发性干燥综合症的疾病症状、神经系统受损、免疫系统紊乱等均可影响患者，使其产生焦虑、抑郁。目前没有良好的解决办法。
发明内容
本发明的目的在于提供一种用于治疗原发性干燥综合征伴抑郁症的中药组合物及其制备方法和应用。
为了达到上述目的，本发明采用了以下技术手段：
一种用于治疗原发性干燥综合征伴抑郁症的中药组合物，所述的中药组合物由以下重量份的各中药原料药制成：地黄28-32份、山茱萸8-12份、山药8-12份、柴胡8-15份、炒白芍8-12份、北沙参8-12份、麦冬8-15份、茯神14-18份、石斛8-12份、丹参14-18份、石榴皮4-8份、甘草4-8份。
所述治疗原发性干燥综合征伴抑郁症的中药组合物，所述的中药组合物由以下重量份的各中药原料药制成：地黄30份、山茱萸10份、山药10份、柴胡12份、炒白芍10份、北沙参10份、麦冬12份、茯神16份、石斛10份、丹参16份、石榴皮6份、甘草6份。
所述治疗原发性干燥综合征伴抑郁症的中药组合物，地黄为生地黄、山茱萸为酒炙山茱萸。
所述的中药组合物在制备治疗原发性干燥综合征伴抑郁症药物中的应用。
所述治疗原发性干燥综合征伴抑郁症的中药组合物，制备方法包括以下步骤：
(1)按照所述的重量份称取各中药原料药，将各中药原料药混合均匀后，加入药物重量20-30倍的蒸馏水，浸泡2.5-3.5h后，100℃下煎煮1-3h，冷却；
(2)将步骤(1)冷却后的药液用纱布过滤，得到第一次滤液；
(3)步骤(2)剩余的药物残渣，重复步骤(1)和(2)得到第二次滤液；
(4)合并第一次滤液及第二次滤液，使用干燥箱60-70℃烘烤6-8天，获得中药组合物干膏；
(5)将得到的干膏放在粉碎机内粉碎，过筛，得到所述中药组合物的干粉，加入制剂成型所需的辅料，按照制备药物制剂的常规方法制成。
所述治疗原发性干燥综合征伴抑郁症的中药组合物，制备方法步骤(2)中所述的用纱布过滤是指依次用6层纱布过滤、8层纱布过滤、12层纱布过滤。
所述治疗原发性干燥综合征伴抑郁症的中药组合物，制备方法步骤(5)中所述的过筛是指依次选择10目筛网、20目筛网、40目筛网、80目筛网进行过筛。
所述治疗原发性干燥综合征伴抑郁症的中药组合物，中药组合物，其特征在于，药物制剂为片剂、胶囊剂、丸剂、颗粒剂、口服液中的一种。
所述的中药组合物在制备治疗原发性干燥综合征伴抑郁症药物中的应用，原发性干燥综合征属于肝肾阴虚津亏证，抑郁症属于肝气郁结证。
中医理论认为原发性干燥综合征分为四种证型：1.肝肾阴虚津亏证：口干、眼干、鼻干、咽干、干咳少痰、吞咽干涩、头晕耳鸣、五心烦热、腰膝酸软、夜尿频数。舌红少苔或裂纹，脉细数。2.气阴两虚证：口干、眼干、神疲乏力、心悸气短、食少纳呆、大便溏泄。舌淡少苔，脉细弱。3.阴虚血瘀证：口干、眼干、关节肿痛、肌肤甲错、肢体瘀斑瘀点、肢端变白变紫交替、皮下脉络隐隐。舌质暗或瘀斑、苔少或无苔、脉细涩。4.阴虚热毒证：口干、眼干、咽干、咽痛、牙龈肿痛、鼻干鼻衄、目赤多眵、发颐或瘰疬、身热或低热羁留、大便干结、小便黄赤。舌质干红或有裂纹、苔少或黄燥苔、脉弦细数。其中肝肾阴虚津亏证最为常见，由于肝肾阴虚津亏证干燥综合征津液输布不畅，常常表现为肝阴不足，肝主疏泄，开窍于目，肝血上注于目则能视，津液上注于目而能润，而津液输布需要肝气条达，因此阴虚津亏证干燥综合征往往会导致肝气郁结证，临床中常见。
“燥痹致郁”——干燥综合征发展过程中引起情绪障碍的内在机理。郁证为情志病，《中医内科学》将郁证定义为“由于情志不舒、气机郁滞所致，以心情抑郁、情绪不宁、胸部满闷、胁肋胀痛，或易怒易哭，或咽中如有异物梗塞等症为主要临床表现的一类病证。”
情志为病是中医学对于疾病病因认识的一个特色。早在《黄帝内经》中已有情志致病的论述“淫气忧思,痹聚在心”，指出五脏痹的成因与情志有关。中医情志致病多因肝火旺极，伤及阴津，久病之后，伤津耗气，导致气阴均伤，而燥痹前期亦因燥毒瘀滞，加之好发于围绝经期女性，病位在肝肾，久则伤及肝肾阴气，导致气阴两虚，这与中医郁证机不谋而合，体现出燥痹与郁证的相关性。“情志”一词首见于明代张景岳的《类经》，现在是后世医家对七情五志的总称，对于中医情志病与干燥综合征病机探讨的报道较少，焦虑、抑郁是情志与脏腑功能失调的一种表现，即“形神失和”。根据其临床症状属中医学“郁证”“脏躁”“百合病”等范畴。采用中医药治疗具有其独特的优势。
原发性干燥综合征可归属于中医学“燥痹”范畴，女性经带胎产乳，素体亏虚，燥邪由外入里，耗气伤津，阴液渐失，久则阴虚津亏，以致口干眼干。本发明方中重用生地黄，补益肝肾，滋阴潜阳，为君药。山茱萸补益肝肾涩精；山药补脾益阴固肾；柴胡疏肝解郁，白芍柔肝健脾、养血敛阴，柴胡解郁而治在气分，白芍柔肝缓急而治在血分，二药相配伍，气血兼顾，上四药共为臣药。北沙参清补肺阴，麦冬养阴生津；茯神宁心安神，石斛滋养胃阴、生津润燥，丹参活血化瘀，石榴皮以防清利太过，涩肠止泻，上六味共为佐药；甘草为使药，可起到健脾益气的功效，调和诸药；全方具有益肾疏肝、阴阳调和的功效。
“滋水涵木”治法中，滋、涵有滋养、滋润之意，水指肾脏，木指肝脏，即通过滋肾壮水来滋养肝脏。若肾阴亏虚，则不能滋养肝木，而致肝阴不足，称“水不涵木”；肝阴不足又常引起肝阳上亢和虚风内动。此时，采取滋补肾阴方药不仅使阴虚得补，而且使亢阳平复，虚火自熄。肝主疏泄，开窍于目，肝血上注于目则能视，津液上注于目而能润，而津液输布需要肝气条达。故对于本病的治疗，以滋水涵木法作为基础，滋补肝肾，疏风明目。
阴虚的患者多伴随有肝气不舒的兼证，临床仅仅滋补肝肾之阴是远远不够的。肾精蕴含一身之元阴元阳，是生命的源动力。情志不舒者既有大病久病心理压力过大肝气郁滞不畅达之故，又有生命动力不足的表现。
肾精通过化生肾气，从而发挥着激发身体机能与支持人体脏腑功能活动的作用。对于长期慢性病患者，“滋水涵木”的指导意义是在滋肾精补肝阴的基础上，还需要稍补肾气以“益火之源”，激发生命活力，疏肝气以兼顾肝气郁滞之情。纵观全方，滋补肝肾之阴以治其本的同时，养血补气、活血化瘀以扶正祛邪，对肝肾阴虚、瘀血阻络之老龄患者兼情志抑郁尤为适用。抑郁久者有生命动力不足的表现，如“掉进深井”或“处于暗屋”，生命源动力蕴于肾之中，即元阳。阴虚患者浮阳上越才致生风邪，故对于这类患者，在滋肾精补肝阴的基础上，还需要稍补肾气以“益火之源”，引火归元。如清·程国彭《医学心悟》提出：“肾气虚寒，逼其无根失守之火，浮游于上，当用辛热杂于壮水药中导之下行，所谓导龙入海，引火归元”。方中大剂量生地黄配麦冬，即引火归元之意。
具体实施方式
下面结合具体实施方式，进一步阐述本发明。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解，在阅读了本发明记载的内容之后，本领域技术人员可以对本发明作各种改动或修改，但这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1：
取地黄300g、山茱萸100g、山药100g、柴胡120g、炒白芍100g、北沙参100g、麦冬120g、茯神160g、石斛100g、丹参160g、石榴皮60g、甘草60g，其中地黄为生地黄、山茱萸为酒炙山茱萸，制备方法包括以下步骤：
(1)按照所述的重量份称取各中药原料药，将各中药原料药混合均匀后，加入药物重量20倍的蒸馏水，浸泡3.5h后，100℃下煎煮1h，冷却；
(2)将步骤(1)冷却后的药液用纱布过滤，得到第一次滤液；
(3)步骤(2)剩余的药物残渣，重复步骤(1)和(2)得到第二次滤液；
(4)合并第一次滤液及第二次滤液，使用干燥箱60-70℃烘烤6天，获得中药组合物干膏；
(5)将得到的干膏放在粉碎机内粉碎，过筛，得到所述中药组合物的干粉，加入淀粉，压片，制备成颗粒剂。
实施例2：
取地黄280g、山茱萸120g、山药80g、柴胡150g、炒白芍80g、北沙参120g、麦冬80g、茯神180g、石斛80g、丹参180g、石榴皮40g、甘草80g，其中地黄为生地黄、山茱萸为酒炙山茱萸，制备方法包括以下步骤：
(1)按照所述的重量份称取各中药原料药，将各中药原料药混合均匀后，加入药物重量30倍的蒸馏水，浸泡2.5h后，100℃下煎煮3h，冷却；
(2)将步骤(1)冷却后的药液用纱布过滤，得到第一次滤液；
(3)步骤(2)剩余的药物残渣，重复步骤(1)和(2)得到第二次滤液；
(4)合并第一次滤液及第二次滤液，使用干燥箱60℃烘烤8天，获得中药组合物干膏；
(5)将得到的干膏放在粉碎机内粉碎，过筛，得到所述中药组合物的干粉，加入糊精，灌胶囊，制备成胶囊剂。
实施例3：
取地黄320g、山茱萸80g、山药120g、柴胡80g、炒白芍120g、北沙参80g、麦冬150g、茯神140g、石斛120g、丹参140g、石榴皮80g、甘草40g，其中地黄为生地黄、山茱萸为酒炙山茱萸，制备方法包括以下步骤：
(1)按照所述的重量份称取各中药原料药，将各中药原料药混合均匀后，加入药物重量25倍的蒸馏水，浸泡3h后，100℃下煎煮2h，冷却；
(2)将步骤(1)冷却后的药液用纱布过滤，得到第一次滤液；
(3)步骤(2)剩余的药物残渣，重复步骤(1)和(2)得到第二次滤液；
(4)合并第一次滤液及第二次滤液，使用干燥箱65℃烘烤7天，获得中药组合物干膏；
(5)将得到的干膏放在粉碎机内粉碎，过筛，得到所述中药组合物的干粉，加入微晶纤维素，制备成片剂。
实施例4：临床研究
1.一般资料
本研究病例来源于南京市中医院(南京中医药大学附属医院)住院及门诊原发性干燥综合征伴抑郁症患者。本研究纳入200例原发性干燥综合征伴抑郁症患者，每组各100例。纳入患者中女性185例，年龄48-67岁，病程24-96月；男性15例，年龄42-65岁，病程24-72月。
1.1纳入标准：1)年龄18-75岁；2)原发性干燥综合征符合2016年原发性干燥综合征分类诊断标准，中医诊断为肝肾阴虚津亏证，临床表现为：口干、眼干、鼻干、咽干、干咳少痰、吞咽干涩、头晕耳鸣、五心烦热、腰膝酸软、夜尿频数。舌红少苔或裂纹，脉细数；3)抑郁症符合西医诊断标准，参照中国精神障碍分类与诊断标准第三版(精神障碍分类)中相关诊断标准:有心境低落的临床表现,并至少有下列4项及以上表现即可诊断:(1)兴趣丧失、无愉快感；(2)精力减退或疲乏感；(3)精神运动性迟滞或激越；(4)自我评价过低、自责,或有内疚感；(5)联想困难或自觉思考能力下降；(6)反复出现想死的念头或有自杀、自杀行为；(7)睡眠障碍,如失眠、早醒,或睡眠过多；(8)食欲降低或体重明显减轻；(9)性欲减退。中医证候诊断标准参照《中医内科学》即辨证标准制定，属于肝气郁结证，见有精神抑郁,情绪低落,胸胁胀痛,痛无定处,纳呆少寐,脘闷嗳气,大便不调。在进行证候诊断时,具有精神抑郁或情绪不宁为主症之一,其他主症与次症具有2项及以上，即可诊断。4)受试者知情，自愿签署知情同意书。
1.2排除标准:1)合并其他结缔组织病；2)严重精神、神经病患者；3)妊娠、准备妊娠或哺乳期患者；4)伴有循环、呼吸系统等严重病变者；5)合并肿瘤；6)正在参与其他药物试验者。
2.治疗方案
2.1给药方案
试验组：按实施例1所述中药原料配比制备的颗粒剂，口服，每日用量(地黄30g、山茱萸10g、山药10g、柴胡12g、炒白芍10g、北沙参10g、麦冬12g、茯神16g、石斛10g、丹参16g、石榴皮6g、甘草6g，其中地黄为生地黄、山茱萸为酒炙山茱萸)，疗程3个月。对照组：硫酸羟氯喹片，口服，每日2次，每次200mg，疗程3个月。
2.2观察指标
原发性干燥综合征主要疗效指标：ESSPRI评分，于入组时、3个月、6个月各采集1次。
原发性干燥综合征次要疗效指标：1)主观症状：口干VAS评分、眼干VAS评分、肢痛VAS评分、疲乏VAS评分，分别于入组时、3个月、6个月各采集1次。2)疾病活动度评估：ESSDAI评分，于入组时、3个月时各采集1次。3)双眼Schirmer试验，于入组时、3个月时各采集1次。4)免疫炎症指标：包括血清免疫球蛋白、红细胞沉降率(Erythrocyte sedimentationrate,ESR)、C-反应蛋白(C-reaction protein,CRP)，于入组时、3个月时各采集1次。
抑郁症疗效指标：观察指标及方法各量表评估均于实验入组0、4、8周记录。(1)抑郁症肝气郁结证症状计分:主症(精神抑郁,情绪低落,胸胁胀痛,痛无定处):无(0分)、轻度(2分)、中度(4分)、重度(6分)；次症(纳呆少寐，脘闷嗳气,大便不调,苔薄白或薄腻，脉弦):无(0分)、轻度(1分)、中度(2分)、重度(3分)；(2)治疗前后汉密尔顿抑郁量表(HAMD-17)、匹兹堡睡眠质量指数量表(PSQI)、中医证候总积分、单项症候疗效评价、疾病疗效评价的变化。
中医证候总积分疗效标准(1)临床近期痊愈：临床症状、体征积分减少≥95％；(2)显效：临床症状、体征积分减少≥70％且<95％；(3)有效：临床症状、体征积分减少≥30％且<70％。(4)无效：抑郁的症状、体征积分减少不足30％。
安全性指标：于入组时、3个月时各采集1次血常规、肝肾功，并随时记录不良反应。
3.治疗结果
针对原发性干燥综合征伴抑郁症本发明试验组痊愈32例，显效38例，有效15例，无效15例，总有效率85％，对照组痊愈13例，显效18例，有效20例，无效49例，总有效率41％，说明本发明治疗原发性干燥综合征伴抑郁症效果显著，而且本发明效果好于对照组。
典型病例：患者女，48岁，符合2016年原发性干燥综合征分类诊断标准，中医诊断为肝肾阴虚津亏证，临床表现为：口干、眼干、鼻干、咽干、干咳少痰、吞咽干涩、头晕耳鸣、五心烦热、腰膝酸软、夜尿频数。舌红少苔或裂纹，脉细数；抑郁症属于肝气郁结证，见有精神抑郁,情绪低落，胸胁胀痛，痛无定处，纳呆少寐，脘闷嗳气，大便不调。另兼有(1)兴趣丧失、无愉快感；(2)精力减退或疲乏感；(3)精神运动性迟滞或激越；(4)自我评价过低、自责,或有内疚感；服用实施例1的药物组合物每日用量(地黄30g、山茱萸10g、山药10g、柴胡12g、炒白芍10g、北沙参10g、麦冬12g、茯神16g、石斛10g、丹参16g、石榴皮6g、甘草6g，其中地黄为生地黄、山茱萸为酒炙山茱萸)，疗程3个月。治疗一个月后，患者觉身体有力，食欲增加，心慌减轻，继续服用两个月，体质明显改善，口干及眼睛干燥症状明显减轻，特异性抗体抗SSA抗体和抗SSB抗体从“+++”降为“+”，停药半年后随访，未见复发。
尽管已经示出和描述了本发明的实施例，对于本领域的普通技术人员而言，可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由所附权利要求及其等同物限定。
Claims (9)
1.一种用于治疗原发性干燥综合征伴抑郁症的中药组合物，其特征在于，所述的中药组合物由以下重量份的各中药原料药制成：地黄28-32份、山茱萸8-12份、山药8-12份、柴胡8-15份、炒白芍8-12份、北沙参8-12份、麦冬8-15份、茯神14-18份、石斛8-12份、丹参14-18份、石榴皮4-8份、甘草4-8份。
2.如权利要求1所述治疗原发性干燥综合征伴抑郁症的中药组合物，其特征在于，所述的中药组合物由以下重量份的各中药原料药制成：地黄30份、山茱萸10份、山药10份、柴胡12份、炒白芍10份、北沙参10份、麦冬12份、茯神16份、石斛10份、丹参16份、石榴皮6份、甘草6份。
3.如权利要求1所述治疗原发性干燥综合征伴抑郁症的中药组合物，其特征在于，地黄为生地黄、山茱萸为酒炙山茱萸。
4.如权利要求1或2所述的中药组合物在制备治疗原发性干燥综合征伴抑郁症药物中的应用。
5.如权利要求1所述治疗原发性干燥综合征伴抑郁症的中药组合物，其特征在于，制备方法包括以下步骤：
(1)按照所述的重量份称取各中药原料药，将各中药原料药混合均匀后，加入药物重量20-30倍的蒸馏水，浸泡2.5-3.5h后，100℃下煎煮1-3h，冷却；
(2)将步骤(1)冷却后的药液用纱布过滤，得到第一次滤液；
(3)步骤(2)剩余的药物残渣，重复步骤(1)和(2)得到第二次滤液；
(4)合并第一次滤液及第二次滤液，使用干燥箱60-70℃烘烤6-8天，获得中药组合物干膏；
(5)将得到的干膏放在粉碎机内粉碎，过筛，得到所述中药组合物的干粉，加入制剂成型所需的辅料，按照制备药物制剂的常规方法制成。
6.如权利要求5所述治疗原发性干燥综合征伴抑郁症的中药组合物，其特征在于，制备方法步骤(2)中所述的用纱布过滤是指依次用6层纱布过滤、8层纱布过滤、12层纱布过滤。
7.如权利要求5所述治疗原发性干燥综合征伴抑郁症的中药组合物，其特征在于，制备方法步骤(5)中所述的过筛是指依次选择10目筛网、20目筛网、40目筛网、80目筛网进行过筛。
8.如权利要求5所述治疗原发性干燥综合征伴抑郁症的中药组合物，其特征在于，所述药物制剂为片剂、胶囊剂、丸剂、颗粒剂、口服液中的一种。
9.如权利要求4所述的中药组合物在制备治疗原发性干燥综合征伴抑郁症药物中的应用，其特征在于，所述原发性干燥综合征属于肝肾阴虚津亏证，抑郁症属于肝气郁结证。
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