CN102846728A - 一种治疗胃溃疡藏药的制备方法 - Google Patents
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Abstract
本发明公开了一种治疗胃溃疡藏药的制备方法。该藏药是由活性组分组成或者是由活性成分和药学上可接受的辅料组成，其中所述的活性组分是由寒水石、碱花、石榴子、大黄、翼首草、岩精膏按一定重量配比制备而成。该藏药可以制备成任何一种常用内服剂型。该藏药具有清胃热，健胃消食的功效。藏医：用于由“培根”引起的胃部疾病。中医：用于消化不良，萎缩性胃炎，浅表性胃炎，胃窦炎，糜烂性胃炎，胃溃疡，十二指肠球部溃疡、食道炎。
Description
技术领域
本发明涉及一种治疗胃溃疡藏药的制备方法。
背景技术
胃溃疡是一种常见的消化系统疾病、多发病，本病秋冬季节天气变化、寒凉刺激时较易发作。其症状是上腹部疼痛、嗳气反酸、恶心、呕吐；疼痛性质为灼痛，冷痛，隐痛，胀痛，刺痛。其病因和发病机制至今尚未完全清楚，目前较为公认的是由于致溃疡的攻击因子与胃黏膜保护因子失去平衡，攻击因子过强或者保护因子减弱而形成。胃溃疡发病率较高，胃溃疡好发于胃角切迹及胃小弯胃窦等部位，多发生于青壮年，病理经过常常是慢性而反复发作。
现代医学使胃溃疡的治愈率得到了明显的提高，但复发率高达80%以上，由于本病属于慢性病，难于根治，容易复发，严重者还会出现如上消化道出血、穿孔、幽门梗阻等并发症，严重危害人类健康。
因此，人们对疗效更好的治疗胃溃疡的藏药制剂存在强烈需求。至今为止，还未发现任何有关这种治疗胃溃疡藏药组合物的报道。本发明人经过反复研究，并通过动物和临床试验的反复验证，终于找到了有更好疗效的治疗胃溃疡的藏药口服药物及其制备方法，从而完成了本发明。
发明内容
本发明目的就是提供了这种更为有效治疗胃溃疡藏药的制备方法。
本发明是一种治疗胃溃疡藏药的制备方法，这种治疗胃溃疡藏药是由活性组分组成或者是由活性成分和药学上可接受的辅料组成，其中所述的活性组分是由下列原料药制成：寒水石、碱花、石榴子、大黄、翼首草、岩精膏。
它选择了寒水石、碱花、石榴子、大黄、翼首草、岩精膏进行组合作为原料，其中（1）寒水石为硫酸盐类矿物芒硝的晶体。性味辛咸，寒；入心、胃、肾经。具有清热降火，利窍，消肿之功效。治时行热病，积热烦渴，吐泻，水肿，尿闭，齿衄，丹毒，烫伤。（2）碱花为硫酸盐类苏打石水碱族矿物天然碱。主含碳酸钠（Na2CO3）。性味甘、咸，温。具有解毒排脓，消食化痰，驱虫通便之功能。用于培根胃胀，消化不良，疮疡，虫病，中毒性肝炎，大便不利。（3）石榴子为安石榴科植物安石榴安石榴Punica granatum L.的干燥种子。性味酸、甘，温、润；入肾、大肠经。主治培根培根寒症，胃寒症及一切胃病。有助消化、抗胃溃疡、涩肠止血、软化血管、降血脂和血糖，降低胆固醇等多种功能。（4）大黄为蓼科植物掌叶大黄Rheum palmatum L.、唐古特大黄Rheum
tanguticum Maxim. Ex Balf. 或药用大黄Rheum officinale
Baill. 的干燥根及根茎。味苦，性寒；归胃、脾、大肠、肝、心包经。具有泻热通便、解毒消痈、行瘀通经、清热除湿、凉血止血之功效。用于胃肠实热积滞、大便秘结、腹部胀满、疼痛拒按，甚至高热不退、神昏谵语或脾阳不足之冷积便秘，热毒疮疡、暴赤眼痛、口舌生疮、齿龈肿痛，瘀血阻滞之月经闭止、产后瘀阻、症瘕积聚及跌打损伤、瘀血肿痛，湿热壅滞之黄疸、小便不利、大便干结、热淋、石淋，亦可用于热伤血络之吐血、衄血、便血、崩漏、赤白带下等；现代临床可用于治疗流行性脑膜炎、大叶性肺炎、急性胆道感染、急性腮腺炎、急性阑尾炎、急性传染性黄疸型肝炎、急性肠炎、细菌性痢疾、消化道出血、咽喉炎、牙龈脓肿、皮炎、湿疹、淋病、带状疱疹等。（5）翼首草为川续断科植物匙叶翼首草Pterocephalus Hookeri(C.B.Clarke) Hoeck的干燥全草。味苦，性寒；有小毒。具有解毒除瘟，清热止痢，祛风通痹的功能。用于治疗瘟毒，新旧热病、垢甲病、痹症、痢疾、关节炎等症。传统藏医认为其具有干黄水（即中医清热解毒除湿）调培根（即中医通痹止痛）之功效，多用于瘟病时疫、感冒发热、痢疾、关节炎等疾病的治疗。具有抗炎、镇痛及免疫调节作用。（6）岩精膏为兔形目鼠兔科哺乳动物红耳鼠兔Ochotona erythrotis Buchner的粪便经炮制加工而成；性味平、甘、苦；具有清胃、肝、肾热，培根、木布合并症，通经祛瘀的功效；用于消化道溃疡、日久肝病、痛风、月经不调、产后腹痛等。将这些药物组合使用使得各药物功效产生协同作用，从而能够有效治疗胃溃疡。
这种治疗胃溃疡藏药组分的用量也是经过发明人进行大量摸索总结得出的，各原料药用量为在下述重量份范围都具有较好疗效：
寒水石150～600g、碱花25～100g、石榴子25～100g、大黄10～50g、翼首草10～50g、岩精膏25～100g。
优选为：寒水石300g、碱花50g、石榴子50g、大黄25g、翼首草25g、岩精膏50g。
这种治疗胃溃疡藏药活性组分的制备可以是将上述用量的原料药直接干燥粉碎制成；也可以将上述用量的原料药采用中药制剂的常规方法如水提醇沉法或醇提水沉法（参见曹春林主编的《中药制剂学》第73～74页，上海科技出版社1986年11月出版）制得。
这种治疗胃溃疡藏药的活性组分可以加入制备不同剂型时所需的各种常规辅料，如崩解剂、润滑剂、粘合剂等以常规的中药制剂方法（参见曹春林主编的《中药制剂学》，上海科技出版社1986年11月出版）制备成任何一种常用口服剂型，如散剂、丸剂、胶囊剂、颗粒剂、片剂等。
这种治疗胃溃疡藏药具有清胃热，健胃消食的功效。藏医：用于由“培根”引起的胃部疾病。中医：用于消化不良，萎缩性胃炎，浅表性胃炎，胃窦炎，糜烂性胃炎，胃溃疡，十二指肠球部溃疡、食道炎。
这种治疗胃溃疡藏药的用法用量为：口服；一次2g，一日1～3次。
【具体实施方式】
以下通过实施例来进一步阐述这种治疗胃溃疡藏药的制备方法。
【实施例1】这种治疗胃溃疡藏药的散剂制备：
称取寒水石200g、碱花100g、石榴子100g、大黄50g、翼首草25g、岩精膏25g，混合后共同粉碎成细粉，混匀，分装，即得散剂。
【实施例2】这种治疗胃溃疡藏药的丸剂制备：
称取寒水石250g、碱花30g、石榴子30g、大黄40g、翼首草50g、岩精膏100g，混合后共同粉碎成细粉，混匀，用水泛丸，在60℃以下干燥，打光，包装，即得丸剂。
【实施例3】这种治疗胃溃疡藏药的颗粒剂制备：
称取寒水石500g、碱花100g、石榴子80g、大黄40g、翼首草40g、岩精膏80g，混合后共同粉碎成细粉，混匀，加入辅料制成颗粒，在60℃以下干燥，整粒，分装，即得颗粒剂。
【实施例4】这种治疗胃溃疡藏药的胶囊剂制备：
称取寒水石400g、碱花70g、石榴子60g、大黄30g、翼首草30g、岩精膏30g，混合后共同粉碎成细粉，混匀，装入明胶胶囊，即得胶囊剂。
【实施例5】这种治疗胃溃疡藏药的片剂制备：
称取寒水石200g、碱花40g、石榴子80g、大黄50g、翼首草10g、岩精膏100g，混合后共同粉碎成细粉，混匀，加入辅料制成颗粒，在60℃以下干燥，整粒，压片，即得片剂。
以下通过试验例来进一步阐述这种治疗胃溃疡藏药的有益效果，这些试验例包括了这种治疗胃溃疡藏药实施例1的药效学试验和临床疗效观察试验。
【试验例1】这种治疗胃溃疡藏药实施例1对多种实验性胃溃疡模型的作用：
试验材料：选这种治疗胃溃疡藏药实施例1；雷尼替丁，批号：20100312，由杭州赛诺菲民生制药有限公司生产；消炎痛，批号：20100418，由湖北制药厂生产；戊巴比妥钠，批号：20090910，由上海化学实际采购供应站分装厂生产；SD大鼠，由青海省实验动物中心提供。
实验方法与结果：1、水浸拘束法（应激法）致大鼠胃溃疡的影响：取SD大鼠50只，雌雄各半，随机分成5组，分别为：生理盐水组；这种治疗胃溃疡藏药实施例1（6g、3g、1.5g生药/kg．d-l）高、中、低剂量组；雷尼替丁阳性对照组（3ml/kg）。每组10只，每天灌胃给药2次，连续15d，于末次给药后，将大鼠四肢固定，浸于水温23±0.5℃水箱中，水面浸至剑突部，18h后处死动物，取胃镜检，测定胃溃疡总长度作为溃疡指数，计算溃疡抑制率，胃溃疡抑制率=（对照组胃溃疡指数-实验组胃溃疡指数）/对照组胃溃疡指数×100%，结果见表1。
表1 这种治疗胃溃疡藏药实施例1对水浸拘束法所致大鼠胃溃疡的影响(x±s，n＝10)
组别 动物数 剂量(g/kg)
溃疡指数（mm）抑制率（%）
生理盐水组
10 −
2.37±0.65
−
阳性对照组 10
3ml/kg 1.31±0.66**
44.72
低剂量组
10
1.5 1.58±0.72*
33.33
中剂量组
10
3 1.46±0.63*
38.39
高剂量组
10
6 1.21±0.71**
48.94
注：与生理盐水组相比：*P<0.05，**P<0.01。
结果表明：这种治疗胃溃疡藏药实施例1高、中、低剂量组与生理盐水对照组比较，溃疡指数间差异显著（P<0.05或P<0.01），表明其对应激引起的消化性溃疡有抑制作用。
2、消炎痛致大鼠胃溃疡的影响：取SD大鼠50只，雌雄不拘。禁食24h，随机分成5组，分别为：生理盐水组；这种治疗胃溃疡藏药实施例1（6g、3g、1.5g生药/kg．d-l）高、中、低剂量组；雷尼替丁阳性对照组（0.3ml/kg）。每组10只，每天灌胃给药2次，连续15d，于末次给药18h后灌胃给予消炎痛（0.5ml/kg），2次/d，连续7d，于末次给药后18h处死，取胃镜检，测定溃疡指数，计算溃疡抑制率，结果见表2。
表2 这种治疗胃溃疡藏药实施例1对消炎痛所致大鼠胃溃疡的影响(x±s，n＝10)
组别 动物数 剂量(g/kg)
溃疡指数（mm）抑制率（%）
生理盐水组
10 −
3.87±1.39
−
阳性对照组 10
0.3ml/kg 2.40±1.27**
37.98
低剂量组
10
1.5 2.65±1.17* 31.52
中剂量组
10
3 2.48±1.25* 35.91
高剂量组
10
6 2.26±1.02** 41.60
注：与生理盐水组相比：*P＜0.05，**P＜0.01。
结果表明：这种治疗胃溃疡藏药实施例1对药物所引起的消化性溃疡具有抑制作用。
3、幽门结扎法致大鼠胃溃疡的影响：实验用SD大鼠50只，雌雄不拘，随机分成5组，分组和给药同1项下。于末次给药后，禁食24h，戊巴比妥钠麻醉下结扎幽门，18h后处死动物，取胃镜检，结果见表3。
表3 这种治疗胃溃疡藏药实施例1对幽门结扎所致大鼠胃溃疡的影响(x±s，n＝10)
组别 动物数 剂量(g/kg)
溃疡指数（mm）抑制率（%）
生理盐水组
10 −
11.03±2.73
−
阳性对照组 10
3ml/kg 7.07±2.18**
35.90
低剂量组
10
1.5 8.46±2.21*
23.30
中剂量组
10
3 7.99±2.62*
27.56
高剂量组
10
6 7.29±2.05**
33.90
注：与生理盐水组相比：*P＜0.05，**P＜0.01。
结果表明：这种治疗胃溃疡藏药实施例1对幽门结扎法所致大鼠胃溃疡的消化性溃疡具有抑制作用。
本研究显示：这种治疗胃溃疡藏药实施例1具有对抗多种实验性胃溃疡模型作用，对水浸拘束法和幽门结扎法所致的胃溃疡均具有明显的对抗作用，还能够较好地抑制消炎痛所致的大鼠胃溃疡。
【试验例2】这种治疗胃溃疡藏药实施例1治疗胃溃疡的临床疗效观察：
一般资料：80例胃溃疡病人均为门诊病人。其中男性44例，女性36例；病程10个月至23年，平均4.85年。按门诊先后顺序随机分为两组，治疗组40例，对照组40例，无统计学差异(P>0.05)。上述病例均符合卫生部制定的《中医中药新药临床研究指导原则》中“胃脘痛”的制定标准。西医诊断根据均符合卫生部制定的《新药西药临床研究指导原则》的诊断标准。属于中医“胃脘痛”的症候范畴。
治疗方法：1、对照组：采用泰胃美2片/次，3次/d，饭前0.5 h服用。30日为一疗程。
2、治疗组：采用这种治疗胃溃疡藏药实施例1，口服，一次2g，一日1～3次。30日为一疗程。
临床疗效评定标准：依据卫生部制定的《中医中药新药临床研究指导原则》制定的临床症候疗效评定标准如下。临床治愈：主要症候、体征全部消失，半年至一年内不复发，胃镜疗效判定炎症消失或溃疡完全愈合；显效：主要症候、体征大部分消失，半年至一年内不复发，镜检炎症及溃疡基本消失；有效：主要症候、体征基本消失，半年至一年内虽有发作，但疼痛减轻，持续时间缩短，镜检溃疡部分愈合，有炎症，溃疡面缩小50%以上；无效：主要症候体征均无改善，镜检炎症无变化。
治愈加显效加有效合计为总有效率。
临床观察结果 见表4。
表4 两组临床疗效比较（例，%）
组别 例数 治愈 显效 有效 无效 总有效率
治疗组 40
30 3
4 3
92.5
对照组 40
25 5
6 4
90.0
临床观察结果表明：这种治疗胃溃疡藏药实施例1治疗胃溃疡疗效确切，值得临床推广使用，具有一定的应用前景。
Claims (6)
1.一种治疗胃溃疡藏药的制备方法，该藏药是由活性组分组成或者是由活性成分和药学上可接受的辅料组成，其中所述的活性组分是由下列重量份的原料药制成：寒水石150～600g、碱花25～100g、石榴子25～100g、大黄10～50g、翼首草10～50g、岩精膏25～100g，其特征在于它是口服剂型。
2.根据权利要求1所述藏药的剂型，它是散剂、丸剂、颗粒剂、胶囊剂或片剂。
3.权利要求1所述藏药的制备方法，它包括下列步骤：称取下列重量份的原料：寒水石150～600g、碱花25～100g、石榴子25～100g、大黄10～50g、翼首草10～50g、岩精膏25～100g；混合，之后共同粉碎成细粉，混匀，制成活性组分。
4.权利要求1所述藏药的制备方法，它包括下列步骤：称取下列重量份的原料：寒水石150～600g、碱花25～100g、石榴子25～100g、大黄10～50g、翼首草10～50g、岩精膏25～100g；混合，采用水提醇沉法或醇提水沉法制成活性组分。
5.根据权利要求3或4所述的制备方法，其中称取下列重量份的原料：寒水石300g、碱花50g、石榴子50g、大黄25g、翼首草25g、岩精膏50g。
6.根据权利要求3、4或5所述的制备方法，它还包括下列步骤：将活性组分与药学上可接受的辅料制成片剂、丸剂、颗粒剂、胶囊剂或散剂。
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Denomination of invention: Preparation method of Tibetan medicine for treating gastric ulcer Effective date of registration: 20180704 Granted publication date: 20140312 Pledgee: Datong silver rich village bank limited liability company Pledgor: Qinghai Jiumei Zang Drug Drug Co.Ltd.|Qinghai Tibetan Hospital Co., Ltd.|Jiumei Pengcuo Registration number: 2018630000005 |
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| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
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Date of cancellation: 20210108 Granted publication date: 20140312 Pledgee: Datong silver rich village bank LLC Pledgor: Qinghai Jiumei Zang Drug Drug Co.,Ltd. Registration number: 2018630000005 |
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| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A preparation method of Tibetan medicine for treating gastric ulcer Effective date of registration: 20210125 Granted publication date: 20140312 Pledgee: Datong silver rich village bank LLC Pledgor: Qinghai Jiumei Zang Drug Drug Co.,Ltd. Registration number: Y2021630000001 |