CN111481638A - 一种治疗溃疡性结肠炎的中药灌肠制剂及其制备方法 - Google Patents
一种治疗溃疡性结肠炎的中药灌肠制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗溃疡性结肠炎的中药灌肠制剂,所述中药灌肠制剂由以下重量分数的中药原材料制成:苦参80~120份、地榆炭80~120份、青黛30~40份、三七10~20份、白及60~80份、甘草40~60份、仙鹤草60~80份、黄连60~80份、黄柏60~80份、白头翁80~120份、秦皮60~80份、薏苡仁80~120份,本发明基本方为苦参、地榆炭、白及、青黛、甘草、三七、仙鹤草、薏苡仁、黄柏、黄连、秦皮和白头翁,能在溃疡面上形成保护膜,促进粘膜修复,抑制病菌生长,同时具有止血作用,本发明还设计开发了一种治疗溃疡性结肠炎的中药灌肠制剂制备方法,给出灌肠制剂的煎煮制备过程,得到浓缩的灌肠制剂,既保证了药效又方便患者使用。
Description
技术领域
本发明涉及溃疡性结肠炎治疗领域,尤其涉及一种治疗溃疡性结肠炎的中药灌肠制剂和一种治疗溃疡性结肠炎的中药灌肠制剂的制备方法。
背景技术
溃疡性结肠炎(ulcerative colitis,UC)是炎症性肠病(inflammatory boweldisease,IBD)的一种常见类型,病变主要侵犯黏膜层和黏膜下层,常形成糜烂、溃疡。本病的病理改变是非特异性的,多累及直肠、乙状结肠,然后向近端发展,甚至波及整个结肠。临床上以腹痛、腹泻、黏液脓血便、里急后重为主要症状。病情轻重不等,具有病程缠绵、迁延难愈、复发率高等特点,被世界卫生组织列为现代难治病之一。西医在治疗上多采用抗生素、氨基水杨酸制剂、糖皮质激素、免疫抑制剂及其他对症治疗,虽具有一定的疗效,但存在疗程较长、复发率较高、副作用较大等问题。
慢性溃疡性结肠炎,属中医“休息痢”范畴。由于湿热蕴积于肠中,熏灼日久,肠中血络受损,气血壅滞,腐败而成脓血便。该病发作期病机是以湿热蕴结大肠、血热妄行为主,故发作期治法以清热燥湿凉血为要。中药直肠滴注是治疗溃疡性结肠炎的一种重要手段,能使高浓度药物直达患处,提高肠内局部药物浓度,疗效确切,而且可以根据中医辨证随证加减药物,使治疗更具针对性,同时由于其能绕过肝脏的首过效应,故而副作用小。
申请号为201010254028.X的发明申请公开了一种治疗治疗结肠炎的中药灌肠汤剂,包含白芨、白头翁、红藤、黄柏、苦参、白菊、五倍子、地榆、血竭、三七粉、黄连和白矾等成分能够使药液直接作用于病变部位,减轻肠黏膜充血水肿,促进黏膜组织增生修复,但在临床治疗中治愈率为78%,仍需其他治疗方式配合治愈。
申请号为201410691271.6的发明申请文件公开了一种治疗溃疡性结肠炎的灌肠中药灌肠剂及其制备方法,包括黄芩、黄连、荆芥炭、地榆炭、焦三仙、白术、肉豆蔻、槐花、白头翁、茯苓、双花、连翘、白芍、木香、甘草和白芨成分,治愈率为29%,好转率为67.7%,仍需其他治疗方式配合完全治愈。
发明内容
本发明设计开发了一种治疗溃疡性结肠炎的中药灌肠制剂,基本方为苦参、地榆炭、白及、青黛、甘草、三七、仙鹤草、薏苡仁、黄柏、黄连、秦皮和白头翁,能在溃疡面上形成保护膜,促进粘膜修复,抑制病菌生长,同时具有止血作用。
本发明还设计开发了一种治疗溃疡性结肠炎的中药灌肠制剂制备方法,给出灌肠制剂的煎煮制备过程,得到浓缩的灌肠制剂,既保证了药效又方便患者使用。
本发明提供的技术方案为:
一种治疗溃疡性结肠炎的中药灌肠制剂,所述中药灌肠制剂由以下重量分数的中药原材料制成:
苦参80~120份、地榆炭80~120份、青黛30~40份、三七10~20份、白及60~80份、甘草40~60份、仙鹤草60~80份、黄连60~80份、黄柏60~80 份、白头翁80~120份、秦皮60~80份、薏苡仁80~120份。
优选的是,所述中药灌肠制剂由以下重量分数的中药原材料制成:
苦参90~110份、地榆炭90~110份、青黛30~35份、三七10~18份、白及60~70份、甘草40~55份、仙鹤草60~70份、黄连60~70份、黄柏60~70 份、白头翁90~110份、秦皮60~70份、薏苡仁90~110份。
优选的是,所述中药灌肠制剂由以下重量分数的中药原材料制成:
苦参100份、地榆炭100份、白及67份、青黛33份、甘草50份、三七 16.5份、仙鹤草50份、薏苡仁100份、黄柏67份、黄连67份、秦皮67份、白头翁100份。
优选的是,所述中药灌肠制剂由以下重量分数的中药原材料制成:
苦参80份、地榆炭80份、青黛30份、三七10份、白及60份、甘草 40份、仙鹤草60份、黄连60份、黄柏60份、白头翁80份、秦皮60份、薏苡仁80份;
苦参110份、地榆炭110份、青黛35份、三七18份、白及70份、甘草55份、仙鹤草70份、黄连70份、黄柏70份、白头翁110份、秦皮70份、薏苡仁110份;或者
苦参105份、地榆炭105份、青黛30份、三七12份、白及65份、甘草50份、仙鹤草65份、黄连65份、黄柏65份、白头翁105份、秦皮65份、薏苡仁105份。
一种治疗溃疡性结肠炎的中药灌肠制剂的制备方法,包括如下步骤:
步骤一、按重量份数称取所述中药灌肠制剂的中药原材料混合均匀;
步骤二、取原材料12~14倍重量分数的水加入所述中药原材料中,常温下浸泡,煎煮后过滤得到二次煎煮药材和第一煎煮药液;
取原料药材10~12倍重量份数的水加入所述二次煎煮药材中,煎煮后经过滤分离,得到三次煎煮药材和第二煎煮药液;
将第一煎煮药液、第二煎煮药液混合得到中药组合药液;
步骤三、将所述中药灌肠制剂浓缩处理后,静置12小时后,取上清液;
步骤四、在所述上清液中加入苯甲酸钠进行定容后得到成不同药物浓度的治疗溃疡性结肠炎的中药灌肠制剂;
其中,所述中药灌肠制剂组合物由以下重量份数的中药原材料组成:
苦参80~120份、地榆炭80~120份、青黛30~40份、三七10~20份、白及60~80份、甘草40~60份、仙鹤草60~80份、黄连60~80份、黄柏60~80 份、白头翁80~120份、秦皮60~80份、薏苡仁80~120份;
苦参90~110份、地榆炭90~110份、青黛30~35份、三七10~18份、白及60~70份、甘草40~55份、仙鹤草60~70份、黄连60~70份、黄柏60~70 份、白头翁90~110份、秦皮60~70份、薏苡仁90~110份;
苦参100份、地榆炭100份、白及67份、青黛33份、甘草50份、三七 16.5份、仙鹤草50份、薏苡仁100份、黄柏67份、黄连67份、秦皮67份、白头翁100份;
苦参80份、地榆炭80份、青黛30份、三七10份、白及60份、甘草 40份、仙鹤草60份、黄连60份、黄柏60份、白头翁80份、秦皮60份、薏苡仁80份;
苦参110份、地榆炭110份、青黛35份、三七18份、白及70份、甘草55份、仙鹤草70份、黄连70份、黄柏70份、白头翁110份、秦皮70份、薏苡仁110份;或者
苦参105份、地榆炭105份、青黛30份、三七12份、白及65份、甘草50份、仙鹤草65份、黄连65份、黄柏65份、白头翁105份、秦皮65份、薏苡仁105份。
优选的是,所述浓缩成的治疗溃疡性结肠炎的中药灌肠制剂中的生药密度为1.05~1.15g/mL。
优选的是,所述步骤二的浸泡时间为0.5~1h。
优选的是,所述步骤二中的煎煮时间均为1~1.2h。
优选的是,所述步骤四中苯甲酸钠的加入量为3g/L。
有益效果
本发明设计开发了一种治疗溃疡性结肠炎的中药灌肠制剂,基本方为苦参、地榆炭、白及、青黛、甘草、三七、仙鹤草、薏苡仁、黄柏、黄连、秦皮和白头翁,能在溃疡面上形成保护膜,促进粘膜修复,抑制病菌生长,同时具有止血作用,
本发明还设计开发了一种治疗溃疡性结肠炎的中药灌肠制剂制备方法,给出灌肠制剂的煎煮制备过程,得到浓缩的灌肠制剂,既保证了药效又方便患者使用。
附图说明
图1为本发明所述的治疗溃疡性结肠炎的中药灌肠制剂制备方法。
具体实施方式
下面结合附图对本发明做进一步的详细说明,以令本领域技术人员参照说明书文字能够据以实施。
本发明提供的一种治疗溃疡性结肠炎的中药灌肠制剂,所述中药灌肠制剂由以下重量分数的中药原材料制成:
苦参80~120份、地榆炭80~120份、青黛30~40份、三七10~20份、白及60~80份、甘草40~60份、仙鹤草60~80份、黄连60~80份、黄柏60~80 份、白头翁80~120份、秦皮60~80份、薏苡仁80~120份;
苦参90~110份、地榆炭90~110份、青黛30~35份、三七10~18份、白及60~70份、甘草40~55份、仙鹤草60~70份、黄连60~70份、黄柏60~70 份、白头翁90~110份、秦皮60~70份、薏苡仁90~110份;
苦参100份、地榆炭100份、白及67份、青黛33份、甘草50份、三七 16.5份、仙鹤草50份、薏苡仁100份、黄柏67份、黄连67份、秦皮67份、白头翁100份;
苦参80份、地榆炭80份、青黛30份、三七10份、白及60份、甘草 40份、仙鹤草60份、黄连60份、黄柏60份、白头翁80份、秦皮60份、薏苡仁80份;
苦参110份、地榆炭110份、青黛35份、三七18份、白及70份、甘草55份、仙鹤草70份、黄连70份、黄柏70份、白头翁110份、秦皮70份、薏苡仁110份;或者
苦参105份、地榆炭105份、青黛30份、三七12份、白及65份、甘草50份、仙鹤草65份、黄连65份、黄柏65份、白头翁105份、秦皮65份、薏苡仁105份。
在本发明中,上述提到的各组分具有传统组合物不具备的优点和性能,以下结合各组分的性能及药理进行详细阐述
君药:苦参为君药,苦参:味苦性寒,归心、肝、胃、大肠、膀胱经,有清热燥湿的功效。现代药理研究表明,苦参煎剂具有抑菌、抗炎、升高白细胞等功效;氧化苦参碱为苦参的主要成分,具有抑制体液免疫和调节细胞免疫的作用,是清热燥湿凉血方主要药物活性成分。
臣药:地榆炭、青黛、白及、三七、仙鹤草等共为臣药。
地榆炭:性味苦、酸、微寒,入大肠经,有凉血止血、解毒敛疮之功,现代药理研究表明,地榆含鞣质、三萜皂苷等,能缩短凝血时间,可使烫伤创面渗出减少,有抗菌、收敛止泄作用,该品炒炭后止血、收敛作用增强;地榆煎剂可明显缩短出血和凝血时间,降低毛细血管的通透性,减少渗出,减轻组织水肿,且可在伤口的创面上形成一层保护膜,促进伤口的愈合,亦有抑菌作用;青黛咸寒,长于清热解毒凉血,专清肠胃之邪热,并止暴注,力专而功宏,现代药理学研究表明青黛煎剂具有广谱抑菌作用,能降低毛细血管通透性,对平滑肌有抑制作用,可调节机体免疫功能,并具有类皮质激素样作用,能有效清除细胞中的氧自由基,稳定细胞膜通透性,具有较好的镇痛作用,其化学成分靛玉红还具有较强的抗肿瘤、抗病毒和抗菌功效。
青黛:咸寒,长于清热解毒凉血,专清肠胃之邪热,并止暴注,力专而效宏,能降低毛细血管通透性,对平滑肌有抑制作用,可调节机体免疫功能,并具有类皮质激素样作用,其化学成分靛玉红还具有较强的抗肿瘤、抗病毒和抗菌功效。青黛能有效清除细胞中的氧自由基,稳定细胞膜通透性,具有较好的镇痛作用。
白及:生肌止血,消肿敛疮,白及煎剂含有胶质成分,可明显缩短出血和凝血时间,并可保护胃肠黏膜,促进肉芽组织的生成,亦有抑菌效果,含有的胶质成分能在溃疡面上形成保护膜,促进粘膜修复,抑制病菌生长,同时其止血作用尤为明显,有较强的黏附能力,能将药物黏附于病变组织发挥作用;三七化瘀止血、活血定痛,具有止血不留瘀的特点,对出血而兼有瘀滞者尤为适宜,同时具有消肿止痛之功。仙鹤草收敛止血、止痢杀虫还有调补气血之功。
三七:味甘微苦,性平,无毒,具有止血、散瘀、定痛的功效;
仙鹤草:性平、味苦、涩,具有收敛止血,止痢,截疟,补虚的功效;
佐药:黄连、黄柏、白头翁、秦皮、薏苡仁共奏清热解毒,凉血止痢兼以燥湿之功,热清毒解,痢止而后重自除。
黄连:性寒,味苦,具有清热燥湿,泻火解毒的功效;
黄柏:性寒,味苦,具有清热燥湿,泻火除蒸,解读疗疮的功效;
白头翁:性寒,味苦,具有清热解毒,凉血止凉血止痢的功效;
秦皮:性寒、味苦、涩,具有清热燥湿,收涩的功效;主治热痢,泄泻。
薏苡仁:性凉、味甘、淡,具有健脾渗湿,除痹止泻,清热排脓的功效。
使药:甘草:有补脾益气、缓和药性、清热解毒等功效,为使药。
全方共收清热燥湿、凉血止血、祛腐生肌、消肿敛疮之效。
全方共收:可祛大肠湿热秽浊之邪,促进肠黏膜糜烂、溃疡的愈合,修复肠道黏膜屏障,减轻肠道的炎症反应,改善机体低下的免疫功能状态,适合临床推广使用。
结合临床辨证,观察病例均为近五年来住院治疗的辨证为大肠湿热证的溃疡性结肠炎活动期患者,共有200例。将患者随机分为两组:对照组100 例、试验组100例。实施例组给予本发明中的中药灌肠剂,并通过本发明中的制备方法进行制备,并按照本发明中的应用方法进行干预。
本发明的中药灌肠剂制备方法包括:
步骤一、称取中药灌肠制剂的中药原材料混合均匀;
其中,中药原材料包括:苦参100g、地榆炭100g、白及67g、青黛33g、甘草50g、三七16.5g、仙鹤草50g、薏苡仁100g、黄柏67g、黄连67g、秦皮 67g、白头翁100g;
步骤二、取原材料12~14倍重量分数的水加入所述中药原材料中,常温下浸泡,煎煮后过滤得到二次煎煮药材和第一煎煮药液;
取原料药材10~12倍重量份数的水加入所述二次煎煮药材中,煎煮后经过滤分离,得到三次煎煮药材和第二煎煮药液;
将第一煎煮药液、第二煎煮药液混合得到中药组合药液;
步骤三、将所述中药灌肠制剂浓缩处理后,静置12小时后,取上清液;
步骤四、在所述上清液中加入苯甲酸钠进行定容后得到成不同药物浓度的治疗溃疡性结肠炎的中药灌肠制剂
如表1-3所示,两组病例资料在年龄、性别、病程等比较经统计学分析无显著性差异(P>0.05),具有可比性。
表1两组年龄分布比较
组别 | 例数 | 18-30岁 | 31-40岁 | 41-50岁 | 51-65岁 |
试验组 | 100 | 13 | 23 | 44 | 20 |
对照组 | 100 | 16 | 30 | 37 | 17 |
经统计学分析:两组年龄分布比较无显著性差异(P>0.05)。
表2两组性别分布比较
经统计学分析:两组年龄分布比较无显著性差异(P>0.05)。
表3两组病程分布比较
组别 | 例数 | <1月 | 1-6月 | 7月-12月 | >1年 |
试验组 | 100 | 30 | 43 | 20 | 7 |
对照组 | 100 | 36 | 46 | 13 | 5 |
经统计学分析:两组病程时间长短分布比较无显著性差异(P>0.05)
试验组治疗方案:采用本发明提供的溃疡性结肠炎的灌肠制剂进行治疗,其中,中药灌肠剂的中药原材料质量份数为:苦参100g、地榆炭100g、白及 67g、青黛33g、甘草50g、三七16.5g、仙鹤草50g、薏苡仁100g、黄柏67g、黄连67g、秦皮67g、白头翁100g,2次/日,使用8周。
对照组治疗方案:对照组按照FDA推荐剂量,口服美沙拉嗪缓释颗粒,1次1g,每日3次,使用8周。
按照下列观察指标对两组患者的临床疗效及不良反应进行观察并对比;①治疗前及治疗1周后以患者排便情况作为活动度,观察疾病活动指数 (DAI);②治疗2周后观察临床缓解率;③各组患者症状积分;④以黏液血便、腹泻、腹胀、腹痛等症状消失作为缓解状态,通过临床观察及随访,记录病情缓解天数。缓解:临床症状消失,结肠镜复查见黏膜基本正常或无活动性炎症;有效:临床症状基本消失,结肠镜复查见黏膜轻度炎症;无效:临床症状、结肠镜复查均无改善。缓解率=[(缓解+有效)例数/总例数] ×100%;⑤记录各组患者的安全性指标。
其中,DAI疾病活动指数(Disease activity index DAI)结合患者体重下降百分率(体重不变为0,1-5为1分,5-10为2分,10-15为3分,大于15 为4分)、大便黏稠度(正常为0,松散的大便为2分,腹泻为4分)和大便出血(正常0分,隐血阳性为2分,显性出血为4分)三种情况进行综合评分,将3项结果的总分除以3即得到DAI值。即DAI=(体重指数+大便形状+出血情况)/3。
两组治疗前后DAI差值及病情缓解天数的比较,治疗后,治疗组DAI差值明显高于对照组(P<0.05),治疗组病情缓解天数明显低于对照组(P< 0.05)。见表4。
两组治疗前后单项症状积分比较,见表5
与治疗前比较△△P<0.01,△P<0.05,与对照组比较**P<0.01, *P<0.05。
结果表明:治疗前与治疗后:复方苦参灌肠剂组各症状积分组内比较,均有显著性差异(P<0.05),治疗后优于治疗前。对照组仅腹泻、腹痛、粘液脓血便症状的改善有显著性差异(P<0.05),其余症状改善无显著性差异(P> 0.05)。
治疗后组间比较:在里急后重症状改善方面,有非常显著性差异(P< 0.01);在***灼热、发热、口干口苦症状改善方面,有显著性差异(P<0.05),复方苦参灌肠剂组明显优于对照组。
两组治疗后临床疗效的比较
1个周期治疗后,试验组的缓解率明显高于对照组(P<0.05)。见表6。
表6两组临床疗效的比较(n=100,%)
组别 | 缓解 | 有效 | 无效 | 缓解率(%) |
试验组 | 91 | 9 | 0 | 91.0 |
对照组 | 71 | 26 | 3 | 71.0 |
与对照组比较,P<0.05。
对完成观察的200例患者进行如下项目检查,进行用药后不良反应分析
(1)一般体格检查项目
完成观察的200例患者中,治疗前后呼吸、血压、脉搏、体温、心率及心、肝、脾、肺、肾体检等未发现异常。
(2)血、尿、粪常规化验
完成观察的200例患者中,治疗前后血、尿、粪常规化验等未发现异常。
(3)肾功能(Scr、BUN)、肝功能(ALT、AST)
完成观察的200例患者中,治疗前后Scr、BUN、ALT、AST等指标未发现异常,说明治疗前后肝、肾功能相对稳定。
(4)心电图
在完成观察的200例患者中,心电图无异常征象。
(5)不良反应情况
在完成观察的200例患者中,未发现不良反应情况。
(6)剔除、脱落病例情况
无
可见,本发明提供的溃疡性结肠炎的灌肠制剂能有效改善大肠湿热证的溃疡性结肠炎活动期患者的临床症状,在腹泻、腹痛、粘液脓血便、里急后重、***灼热、发热、口干口苦等症状改善方面优于对照组。能有效改善黏膜血管纹理模糊、紊乱或消失、充血、水肿等内镜下肠道症状。在安全指标上,包括一般体格检查项目,血、尿、粪常规化验,肾功能(Scr、BUN)、肝功能(ALT、AST),心电图等均无不良反应情况,表明本方安全性高。结果明显表明溃疡性结肠炎的灌肠制剂治疗大肠湿热证的溃疡性结肠炎活动期的有效方剂,为临床治疗溃疡性结肠炎提供了新的、安全的治疗方法,值得临床推广。
为进一步验证灌肠制剂服用效果,下面结合具体的实施例1~6对本发明的灌肠制剂服用效果做进一步说明,中药原材料的质量份数如表7所示。
表7治疗溃疡性结肠炎的灌肠制剂的中药灌肠剂的中药原材料质量份数
实施例1~6的制备方法,包括如下步骤:
步骤一、按重量份数称取所述中药灌肠制剂的中药原材料混合均匀;
步骤二、取原材料12倍重量分数的水加入中药原材料中,常温下浸泡,煎煮后过滤得到二次煎煮药材和第一煎煮药液;
取原料药材10倍重量份数的水加入所述二次煎煮药材中,煎煮后经过滤分离,得到三次煎煮药材和第二煎煮药液;
将第一煎煮药液、第二煎煮药液混合得到中药组合药液;
应用方法包括:一次150ml,灌肠,一日2次。
对比例1
白芨10份、白头翁10份、红藤10份、黄柏10份、苦参15份、白菊12份、五倍子5份、地榆10份、血竭5份、三七粉6份、黄连3份和白矾3份。
对比例2
黄芩20份、黄连15份、荆芥炭10份、地榆炭10份、焦三仙6份、白术10份、肉豆蔻15份、槐花15份、白头翁15份、茯苓20份、双花9 份、连翘10份、白芍10份、木香10份、甘草6份、白芨10份。
对比例3
黄连12%、青黛12%、赤石脂16%、白芨16%、桃仁12%、赤芍12%、地榆12%。
对比例4
桔梗12份、秦皮10份、仙鹤草30份、三七3份、白芷10份、败酱草 10份、枳壳10份、山楂10份、猴头菌30份、苍术15份、泽泻10份、牡丹皮10份、香附10份、椿皮10份、丹参15份、赤石脂30份、槐胶30份、荆芥炭30份、白茅根60份、黄芩50份、山药25份、金银花15份、牛蒡6份。
对比例1~4的制备方法,包括如下步骤:
步骤一、按重量份数称取所述中药灌肠制剂的中药原材料混合均匀;
步骤二、取原材料12倍重量分数的水加入中药原材料中,常温下浸泡,煎煮后过滤得到二次煎煮药材和第一煎煮药液;
取原料药材10倍重量份数的水加入所述二次煎煮药材中,煎煮后经过滤分离,得到三次煎煮药材和第二煎煮药液;
将第一煎煮药液、第二煎煮药液混合得到中药组合药液。
结合临床辨证,将符合本发明中的中药灌肠剂所治疗的病症的患者随机分为实施例组及对比例组,实施例组给予本发明中的中药灌肠剂、并通过本发明中的制备进行制备,并按照本发明中的应用方法进行干预,按照下列疗效判定方法对两组患者的临床疗效及不良反应进行观察并对比;疗效判定:①显效:患者的不再出现腹痛症状,不再出现腹泻或便血情况,临床症状完全消失;②有效:腹痛、腹泻和临床症状均有一定程度的改善;③无效:腹痛、腹泻没有变化或者下降,临床症状未能有效缓解,总有效率=显效率+有效率;临床疗效结果如表8所示
表8两组患者的临床疗效比较[n(%)]
由实施例1~6和对比例1~4的试验结果表明,本发明中的中药灌肠剂通过本发明中的制备及应用方法,对比现有方法,可显著的提高临床有效率。
如图1所示,一种治疗溃疡性结肠炎的中药灌肠制剂的制备方法,其特征在于,包括如下步骤:
步骤一、按重量份数称取所述中药灌肠制剂的中药原材料混合均匀;
步骤二、取原材料12~14倍重量分数的水加入所述中药原材料中,常温下浸泡,煎煮后过滤得到二次煎煮药材和第一煎煮药液;
取原料药材10~12倍重量份数的水加入所述二次煎煮药材中,煎煮后经过滤分离,得到三次煎煮药材和第二煎煮药液;
将第一煎煮药液、第二煎煮药液混合得到中药组合药液;
其中,浸泡时间为0.5~1h,煎煮时间均为1~1.2h。
步骤三、将所述中药灌肠制剂浓缩处理后,静置12小时后,取上清液;
步骤四、在所述上清液中加入苯甲酸钠进行定容后得到成不同药物浓度的治疗溃疡性结肠炎的中药灌肠制剂;苯甲酸钠的加入量为3g/L。
浓缩成的治疗溃疡性结肠炎的中药灌肠制剂中的生药密度为1.05~ 1.15g/mL。
为验证本发明提供的治疗溃疡性结肠炎的中药灌肠制剂的制备方法的制备工艺可行性,下面结合具体的实验例2对本发明的口服制剂的制备做进一步说明。
采用正交试验法,选取加水量(饮片总量的倍数)、煎煮时间及煎煮次数三个因素,因素水平表见表9。
表9因素水平表
用L9(34)正交表安排试验,称取1/3倍处方量药材(77g),按设定方案进行提取,滤过,滤液合并,量取体积V。精密吸取25ml,置已干燥恒重的蒸发皿中,水浴蒸干,于105℃干燥3小时,置干燥器中冷却0.5小时,迅速称重,按下式计算得膏率,结果见表10。
表10正交试验设计表及结果
将正交试验结果进行方差分析,结果见表11
表11得膏率方差分析表
*F0.05(2,2)=19.00;F0.01(2,2)=99.00
试验结果
出膏率越高,提取效果越好。因此,以出膏率为考察指标,由表中极差R 值大小显示,各因素作用主次为D>B>A;方差分析结果表明D因素(煎煮次数)的影响具有显著意义(P<0.05),选择D3水平;A因素(加水量)的影响无显著性意义(P>0.05),因A3出膏率最高,选A3;B因素(煎煮时间)的影响无显著性意义(P>0.05),因B3出膏率最高,选择B3,故以A3B3D3组合为佳。从节约能源及临床应用考虑,如果沉淀过多,灌肠阻力加大,优化考虑A3B2D2组合为最佳。
验证试验
称取药材按A3B3D3、A3B2D2进行验证试验,结果见表12。
表12验证试验结果
验证试验结果与正交试验结果吻合,说明工艺可行。但是考虑临床应用,最终确定工艺参数为A3B2D2。
试放大试验
按上述试验研究确定的复方苦参灌肠剂制备工艺,进行了三批中试放大试验,每批投料为10个制剂处方量,采用提取罐加12倍量水,煎煮两次,每次1.5小时。经沉降、浓缩、稀释、分装、灭菌,制成成品,批号分别为 20170208、20170209、20170210,结果见表13。
表13中试数据表
三批中试试验结果表明,复方苦参灌肠剂按本制备工艺生产,所得成品质量稳定,均符合本品质量标准的规定,说明制备工艺合理可行。
近年来中医药治疗溃结报道也较多,方法多样,疗效肯定,无明显副作用。而直肠滴注疗法因其简便易行见效快,疗效肯定,无明显副作用。患者容易接受等优势在临床上更是广泛应用,经肠道给药能使高浓度药物直达患处,提高肠内局部血药浓度,使治疗更具针对性,同时由于其能绕过肝脏的首过效应,故而副作用小。二十多年的临床应用证明疗效确切,安全有效,已得到医生和患者的认可。
本发明设计开发了一种治疗溃疡性结肠炎的中药灌肠制剂,基本方为苦参、地榆炭、白及、青黛、甘草、三七、仙鹤草、薏苡仁、黄柏、黄连、秦皮和白头翁,能在溃疡面上形成保护膜,促进粘膜修复,抑制病菌生长,同时具有止血作用,本发明还设计开发了一种治疗溃疡性结肠炎的中药灌肠制剂制备方法,给出灌肠制剂的煎煮制备过程,得到浓缩的灌肠制剂,既保证了药效又方便患者使用。
尽管本发明的实施方案已公开如上,但其并不仅仅限于说明书和实施方式中所列运用,它完全可以被适用于各种适合本发明的领域,对于熟悉本领域的人员而言,可容易地实现另外的修改,因此在不背离权利要求及等同范围所限定的一般概念下,本发明并不限于特定的细节和这里示出与描述的图例。
Claims (9)
1.一种治疗溃疡性结肠炎的中药灌肠制剂,其特征在于,所述中药灌肠制剂由以下重量分数的中药原材料制成:
苦参80~120份、地榆炭80~120份、青黛30~40份、三七10~20份、白及60~80份、甘草40~60份、仙鹤草60~80份、黄连60~80份、黄柏60~80份、白头翁80~120份、秦皮60~80份、薏苡仁80~120份。
2.根据权利要求1所述的治疗溃疡性结肠炎的中药灌肠制剂,其特征在于,所述中药灌肠制剂由以下重量分数的中药原材料制成:
苦参90~110份、地榆炭90~110份、青黛30~35份、三七10~18份、白及60~70份、甘草40~55份、仙鹤草60~70份、黄连60~70份、黄柏60~70份、白头翁90~110份、秦皮60~70份、薏苡仁90~110份。
3.根据权利要求2所述的治疗溃疡性结肠炎的中药灌肠制剂,其特征在于,所述中药灌肠制剂由以下重量分数的中药原材料制成:
苦参100份、地榆炭100份、白及67份、青黛33份、甘草50份、三七16.5份、仙鹤草50份、薏苡仁100份、黄柏67份、黄连67份、秦皮67份、白头翁100份。
4.根据权利要求3所述的治疗溃疡性结肠炎的中药灌肠制剂,其特征在于,所述中药灌肠制剂由以下重量分数的中药原材料制成:
苦参80份、地榆炭80份、青黛30份、三七10份、白及60份、甘草40份、仙鹤草60份、黄连60份、黄柏60份、白头翁80份、秦皮60份、薏苡仁80份;
苦参110份、地榆炭110份、青黛35份、三七18份、白及70份、甘草55份、仙鹤草70份、黄连70份、黄柏70份、白头翁110份、秦皮70份、薏苡仁110份;或者
苦参105份、地榆炭105份、青黛30份、三七12份、白及65份、甘草50份、仙鹤草65份、黄连65份、黄柏65份、白头翁105份、秦皮65份、薏苡仁105份。
5.一种治疗溃疡性结肠炎的中药灌肠制剂的制备方法,其特征在于,包括如下步骤:
步骤一、按重量份数称取所述中药灌肠制剂的中药原材料混合均匀;
步骤二、取原材料12~14倍重量分数的水加入所述中药原材料中,常温下浸泡,煎煮后过滤得到二次煎煮药材和第一煎煮药液;
取原料药材10~12倍重量份数的水加入所述二次煎煮药材中,煎煮后经过滤分离,得到三次煎煮药材和第二煎煮药液;
将第一煎煮药液、第二煎煮药液混合得到中药组合药液;
步骤三、将所述中药灌肠制剂浓缩处理后,静置12小时后,取上清液;
步骤四、在所述上清液中加入苯甲酸钠进行定容后得到成不同药物浓度的治疗溃疡性结肠炎的中药灌肠制剂;
其中,所述中药灌肠制剂组合物由以下重量份数的中药原材料组成:
苦参80~120份、地榆炭80~120份、青黛30~40份、三七10~20份、白及60~80份、甘草40~60份、仙鹤草60~80份、黄连60~80份、黄柏60~80份、白头翁80~120份、秦皮60~80份、薏苡仁80~120份;
苦参90~110份、地榆炭90~110份、青黛30~35份、三七10~18份、白及60~70份、甘草40~55份、仙鹤草60~70份、黄连60~70份、黄柏60~70份、白头翁90~110份、秦皮60~70份、薏苡仁90~110份;
苦参100份、地榆炭100份、白及67份、青黛33份、甘草50份、三七16.5份、仙鹤草50份、薏苡仁100份、黄柏67份、黄连67份、秦皮67份、白头翁100份;
苦参80份、地榆炭80份、青黛30份、三七10份、白及60份、甘草40份、仙鹤草60份、黄连60份、黄柏60份、白头翁80份、秦皮60份、薏苡仁80份;
苦参110份、地榆炭110份、青黛35份、三七18份、白及70份、甘草55份、仙鹤草70份、黄连70份、黄柏70份、白头翁110份、秦皮70份、薏苡仁110份;或者
苦参105份、地榆炭105份、青黛30份、三七12份、白及65份、甘草50份、仙鹤草65份、黄连65份、黄柏65份、白头翁105份、秦皮65份、薏苡仁105份。
6.根据权利要求5所述的治疗溃疡性结肠炎的中药灌肠制剂的制备方法,其特征在于,所述浓缩成的治疗溃疡性结肠炎的中药灌肠制剂中的生药密度为1.05~1.15g/mL。
7.根据权利要求5所述的治疗溃疡性结肠炎的中药灌肠制剂的制备方法,其特征在于,所述步骤二的浸泡时间为0.5~1h。
8.根据权利要求6所述的治疗溃疡性结肠炎的中药灌肠制剂的制备方法,其特征在于,所述步骤二中的煎煮时间均为1~1.2h。
9.根据权利要求8所述的治疗溃疡性结肠炎的中药灌肠制剂的制备方法,其特征在于,所述步骤四中苯甲酸钠的加入量为3g/L。
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