CN117159674A - A gynecological traditional Chinese medicine composition for treating dampness-heat stasis syndrome - Google Patents

A gynecological traditional Chinese medicine composition for treating dampness-heat stasis syndrome Download PDF

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CN117159674A
CN117159674A CN202311451517.8A CN202311451517A CN117159674A CN 117159674 A CN117159674 A CN 117159674A CN 202311451517 A CN202311451517 A CN 202311451517A CN 117159674 A CN117159674 A CN 117159674A
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CN117159674B (en
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赵荣
邢利威
徐金龙
张琼
王睿睿
袁卓珺
倪广惠
李俊
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Yunnan University of Traditional Chinese Medicine TCM
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Abstract

本发明公开一种治疗湿热瘀阻证候的妇科中药组合物,包括败酱草,蒲公英,虎杖,鸡血藤,川芎,丹参,莪术,苍术,赤芍,藿香,生黄芪。本发明所涉及的妇科中药组合物具有化湿清热,活血祛瘀的功效,可用于治疗慢性盆腔炎、盆腔炎性疾病后遗症、反复移植失败、输卵管积液、宫腔粘连、内膜血流灌注不良、子宫内膜薄、子宫腺肌病、继发性痛经、不孕症、卵巢囊肿、促排卵及预防妇科术后盆腔粘连等疾病。本发明还保护了该中药组合物制成的灌肠液、直肠给药制剂及其应用。The invention discloses a gynecological traditional Chinese medicine composition for treating damp-heat stasis syndrome, which includes soybean root, dandelion, Polygonum cuspidatum, Millet Spatholobus, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoarya, Atractylodes rhizome, red peony root, Agastache rugosa and Astragalus membranaceus. The gynecological traditional Chinese medicine composition involved in the present invention has the effects of removing dampness and heat, promoting blood circulation and removing blood stasis, and can be used to treat chronic pelvic inflammatory disease, sequelae of pelvic inflammatory disease, repeated transplantation failure, fallopian tube effusion, intrauterine adhesions, and endometrial blood perfusion. Diseases such as dysmenorrhea, thin endometrium, adenomyosis, secondary dysmenorrhea, infertility, ovarian cysts, ovulation induction and prevention of pelvic adhesions after gynecological surgery. The invention also protects the enema liquid, rectal administration preparations and their applications made from the traditional Chinese medicine composition.

Description

一种治疗湿热瘀阻证候的妇科中药组合物A gynecological traditional Chinese medicine composition for treating damp-heat stasis syndrome

技术领域Technical field

本发明属于中药技术领域,具体涉及一种用于治疗湿热瘀阻证候的妇科中药组合物及其灌肠液与直肠给药制剂。The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a gynecological traditional Chinese medicine composition for treating damp-heat stasis syndrome, its enema solution and rectal administration preparation.

背景技术Background technique

盆腔炎是指女性上生殖道和周围组织炎性疾病,包括子宫内膜炎、输卵管卵巢囊肿,若急性期迁延不愈则会发展为慢性,导致慢性盆腔痛、输卵管妊娠,甚至不孕。临床多采用抗生素治疗,但慢性盆腔炎多为混合感染,单一抗生素的治疗效果不佳,且长期使用抗生素易产生耐药性及菌群失调,复发率较高。Pelvic inflammatory disease refers to inflammatory diseases of the female upper reproductive tract and surrounding tissues, including endometritis and fallopian tube and ovarian cysts. If the acute phase is not healed, it will develop into chronic disease, leading to chronic pelvic pain, fallopian tube pregnancy, and even infertility. Antibiotics are often used in clinical treatment, but chronic pelvic inflammatory disease is mostly mixed infections. The therapeutic effect of a single antibiotic is not good, and long-term use of antibiotics can easily lead to drug resistance and bacterial imbalance, and the recurrence rate is high.

中药内服药物存在首过消除效应,影响药效发挥,市面现存灌肠药物因配伍及剂型问题,易造成腹泻、过敏等不良反应。Oral administration of traditional Chinese medicine has a first-pass elimination effect, which affects the effectiveness of the medicine. Existing enema drugs on the market can easily cause diarrhea, allergies and other adverse reactions due to issues with compatibility and dosage forms.

发明内容Contents of the invention

本发明的第一目的在于提供一种用于制备治疗湿热瘀阻证候药物的妇科中药组合物,包括败酱草,蒲公英,虎杖,鸡血藤,川芎,丹参,莪术,苍术,赤芍,藿香,生黄芪。The first object of the present invention is to provide a gynecological traditional Chinese medicine composition for preparing drugs for treating damp-heat stasis syndrome, including soybean root, dandelion, Polygonum cuspidatum, Millet Spatholobus, Chuanxiong rhizome, Salvia miltiorrhiza, Curcuma zedoary, Atractylodes rhizome, and red peony root. Patchouli, raw astragalus.

败酱草1-20份,蒲公英1-20份,虎杖1-30份,鸡血藤1-20份,川芎1-20份,丹参1-20份,莪术1-20份,苍术1-20份,赤芍1-20份,藿香1-30份,生黄芪1-30份。1-20 parts of soybean root, 1-20 parts of dandelion, 1-30 parts of Polygonum cuspidatum, 1-20 parts of Millet Spatholobus, 1-20 parts of Chuanxiong, 1-20 parts of Salvia miltiorrhiza, 1-20 parts of Curcuma zedoary, 1-20 parts of Atractylodes. 1-20 parts of red peony root, 1-30 parts of Patchouli 1-30 parts, 1-30 parts of raw astragalus.

败酱草10份,蒲公英10份,虎杖15份,鸡血藤10份,川芎10份,丹参10份,莪术10份,苍术10份,赤芍10份,藿香15份,生黄芪15份。10 parts of soybean root, 10 parts of dandelion, 15 parts of Polygonum cuspidatum, 10 parts of Spatholobus, 10 parts of Ligusticum chuanxiong, 10 parts of Salvia miltiorrhiza, 10 parts of Curcuma zedoaria, 10 parts of Atractylodes, 10 parts of red peony root, 15 parts of Agastache rugosa, 15 parts of raw astragalus. .

以上所述的妇科中药组合物,还包括傣药罗埋亮龙和中航。The above-mentioned gynecological traditional Chinese medicine composition also includes Dai medicine Luomialianglong and Zhonghang.

败酱草1-20份,蒲公英1-20份,虎杖1-30份,鸡血藤1-20份,川芎1-20份,丹参1-20份,莪术1-20份,苍术1-20份,赤芍1-20份,藿香1-30份,生黄芪1-30份,罗埋亮龙1-20份,中航2-10份。1-20 parts of soybean root, 1-20 parts of dandelion, 1-30 parts of Polygonum cuspidatum, 1-20 parts of Millet Spatholobus, 1-20 parts of Chuanxiong, 1-20 parts of Salvia miltiorrhiza, 1-20 parts of Curcuma zedoary, 1-20 parts of Atractylodes. 1-20 parts of red peony root, 1-30 parts of Agastache rugosa, 1-30 parts of raw astragalus, 1-20 parts of Luobian Lianglong, and 2-10 parts of Zhonghang.

败酱草10份,蒲公英10份,虎杖15份,鸡血藤10份,川芎10份,丹参10份,莪术10份,苍术10份,赤芍10份,藿香15份,生黄芪15份,罗埋亮龙10份,中航10份。10 parts of soybean root, 10 parts of dandelion, 15 parts of Polygonum cuspidatum, 10 parts of Spatholobus, 10 parts of Ligusticum chuanxiong, 10 parts of Salvia miltiorrhiza, 10 parts of Curcuma zedoaria, 10 parts of Atractylodes, 10 parts of red peony root, 15 parts of Agastache rugosa, 15 parts of raw astragalus. , Luo Mi Lianglong 10 copies, AVIC 10 copies.

本发明的第二目的在于提供一种用于制备治疗湿热瘀阻证候药物的妇科中药组合物的灌肠液,由颗粒剂药盒与灌肠袋组成,颗粒剂药盒中有小格子,每个小格子分别存放以上所述的药材颗粒剂。The second object of the present invention is to provide an enema liquid for preparing a gynecological traditional Chinese medicine composition for treating damp-heat stasis syndrome, which is composed of a granule box and an enema bag. The granule box has small grids, each of which is composed of a granule box and an enema bag. Small grids store the above-mentioned medicinal granules respectively.

灌肠液的制备方法为将颗粒剂药盒中的所有小格子全部打开,将药物倒出放在合适的容器中,加入100~150mL温水,搅拌均匀之后,注入灌肠袋中。The preparation method of enema solution is to open all the small compartments in the granule box, pour the medicine out into a suitable container, add 100~150mL warm water, stir evenly, and then pour it into the enema bag.

温水的温度为37~45℃。The temperature of warm water is 37~45℃.

妇科中药组合物的灌肠液在制备治疗慢性盆腔炎、盆腔炎性疾病后遗症、反复移植失败、输卵管积液、宫腔粘连、内膜血流灌注不良、子宫内膜薄、子宫腺肌病、继发性痛经、不孕症、卵巢囊肿、促排卵及预防妇科术后盆腔粘连等疾病的药物中的应用。The enema solution of the gynecological traditional Chinese medicine composition is used in the preparation and treatment of chronic pelvic inflammatory disease, sequelae of pelvic inflammatory disease, repeated transplantation failure, fallopian tube effusion, intrauterine adhesions, poor endometrial blood perfusion, thin endometrium, adenomyosis, secondary Application in medicines for episodic dysmenorrhea, infertility, ovarian cysts, ovulation induction and prevention of pelvic adhesions after gynecological surgery.

本发明的第三目的在于提供一种妇科中药组合物的直肠给药制剂,加药学上可接受的辅料,制成直肠给药制剂。The third object of the present invention is to provide a rectal administration preparation of a gynecological traditional Chinese medicine composition, which is prepared by adding pharmaceutically acceptable auxiliary materials.

本发明所涉及的罗埋亮龙为傣药,又名为朱槿。The Luo Mi Liang Long involved in the present invention is a Dai medicine, also known as Zhu Hibiscus.

本发明所涉及的中航为傣药,又名为双籽棕。The AVIC involved in the present invention is a Dai medicine, also known as Shuangseed Palm.

本发明优点:Advantages of the invention:

本发明提供了一种用于治疗湿热瘀阻证候的妇科中药组合物,将其制成灌肠液之后,在临床上用于治疗慢性盆腔炎、盆腔炎性疾病后遗症、反复移植失败、输卵管积液、宫腔粘连、内膜血流灌注不良、子宫内膜薄、子宫腺肌病、继发性痛经、不孕症、卵巢囊肿、促排卵及预防妇科术后盆腔粘连等疾病得到了很好的效果。The invention provides a gynecological traditional Chinese medicine composition for treating dampness-heat stasis syndrome. After being made into an enema liquid, it can be used clinically to treat chronic pelvic inflammatory disease, sequelae of pelvic inflammatory disease, repeated transplantation failure, fallopian tube effusion, etc. Diseases such as fluid, intrauterine adhesions, poor endometrial blood perfusion, thin endometrium, adenomyosis, secondary dysmenorrhea, infertility, ovarian cysts, ovulation induction and prevention of pelvic adhesions after gynecological surgery have been well treated. Effect.

败酱草清热解毒、消痈排脓,蒲公英消痈散结,虎杖、鸡血藤祛风散瘀、清热利湿,川芎、丹参活血化瘀,莪术、苍术行气祛湿,活血止痛,赤芍清热凉血,散瘀止痛,藿香祛湿行气,生黄芪益气固表,罗埋亮龙除风解毒,通血止痛,中航止血清热,通经收敛,诸药合用,共奏化湿清热,活血祛瘀之功。Herba can clear away heat and detoxify, eliminate carbuncle and expel pus; Dandelion can eliminate carbuncle and stagnation; Polygonum cuspidatum and Chicken Spatholobus can dispel wind and blood stasis, clear away heat and diuresis; Ligusticum chuanxiong and Salvia miltiorrhiza can activate blood circulation and remove blood stasis; Curcuma and Atractylodes can promote qi and remove dampness, activate blood circulation and relieve pain. Paeony clears away heat and cools blood, dissipates blood stasis and relieves pain, Patchouli dispels dampness and promotes qi, raw Astragalus replenishes qi and strengthens the surface, Luobianlianglong removes wind and detoxifies, promotes blood circulation and relieves pain, Zhonghang relieves serum heat, stimulates menstruation and astringes, all the medicines are used together to form a harmonious effect. It has the effect of clearing away heat and promoting blood circulation and removing blood stasis.

本发明所涉及的灌肠液的优势在于减少肝脏首过效应,减轻对肝脏的副作用。药物经吸收直接进入盆腔静脉丛,局部药物浓度更高,治疗作用增强,作用时间长,生物利用度高。The advantage of the enema solution involved in the present invention is to reduce the first-pass effect of the liver and reduce side effects on the liver. The drug is absorbed directly into the pelvic venous plexus, with higher local drug concentration, enhanced therapeutic effect, long action time, and high bioavailability.

具体实施方式Detailed ways

下面对本发明作进一步的说明,但不以任何方式对本发明加以限制,基于本发明所作的任何变换,均属于本发明的保护范围。The present invention will be further described below, but the present invention will not be limited in any way. Any transformation made based on the present invention shall fall within the protection scope of the present invention.

一种用于制备治疗湿热瘀阻证候药物的妇科中药组合物,包括败酱草,蒲公英,虎杖,鸡血藤,川芎,丹参,莪术,苍术,赤芍,藿香,生黄芪。A gynecological traditional Chinese medicine composition for preparing drugs for treating dampness-heat stasis syndrome, including soybean root, dandelion, polygonum cuspidatum, millipede, chuanxiong, salvia, zedoary, atractylodes, red peony root, rugosa, and raw astragalus.

败酱草1-20份,蒲公英1-20份,虎杖1-30份,鸡血藤1-20份,川芎1-20份,丹参1-20份,莪术1-20份,苍术1-20份,赤芍1-20份,藿香1-30份,生黄芪1-30份。1-20 parts of soybean root, 1-20 parts of dandelion, 1-30 parts of Polygonum cuspidatum, 1-20 parts of Millet Spatholobus, 1-20 parts of Chuanxiong, 1-20 parts of Salvia miltiorrhiza, 1-20 parts of Curcuma zedoary, 1-20 parts of Atractylodes. 1-20 parts of red peony root, 1-30 parts of Patchouli 1-30 parts, 1-30 parts of raw astragalus.

败酱草10份,蒲公英10份,虎杖15份,鸡血藤10份,川芎10份,丹参10份,莪术10份,苍术10份,赤芍10份,藿香15份,生黄芪15份。10 parts of soybean root, 10 parts of dandelion, 15 parts of Polygonum cuspidatum, 10 parts of Spatholobus, 10 parts of Ligusticum chuanxiong, 10 parts of Salvia miltiorrhiza, 10 parts of Curcuma zedoaria, 10 parts of Atractylodes, 10 parts of red peony root, 15 parts of Agastache rugosa, 15 parts of raw astragalus. .

以上所述的妇科中药组合物,还包括傣药罗埋亮龙和中航,即包括败酱草,蒲公英,虎杖,鸡血藤,川芎,丹参,莪术,苍术,赤芍,藿香,生黄芪,罗埋亮龙和中航。The above-mentioned gynecological traditional Chinese medicine composition also includes the Dai medicine Luomia Lianglong and Zhonghang, that is, it includes soyrel, dandelion, polygonum cuspidatum, millipedia, chuanxiong, salvia, zedoary, atractylodes, red peony root, agastache, and raw astragalus. , Luo Mi Lianglong and AVIC.

败酱草1-20份,蒲公英1-20份,虎杖1-30份,鸡血藤1-20份,川芎1-20份,丹参1-20份,莪术1-20份,苍术1-20份,赤芍1-20份,藿香1-30份,生黄芪1-30份,罗埋亮龙1-20份,中航2-10份。1-20 parts of soybean root, 1-20 parts of dandelion, 1-30 parts of Polygonum cuspidatum, 1-20 parts of Millet Spatholobus, 1-20 parts of Chuanxiong, 1-20 parts of Salvia miltiorrhiza, 1-20 parts of Curcuma zedoary, 1-20 parts of Atractylodes. 1-20 parts of red peony root, 1-30 parts of Agastache rugosa, 1-30 parts of raw astragalus, 1-20 parts of Luobian Lianglong, and 2-10 parts of Zhonghang.

败酱草10份,蒲公英10份,虎杖15份,鸡血藤10份,川芎10份,丹参10份,莪术10份,苍术10份,赤芍10份,藿香15份,生黄芪15份,罗埋亮龙10份,中航10份。10 parts of soybean root, 10 parts of dandelion, 15 parts of Polygonum cuspidatum, 10 parts of Spatholobus, 10 parts of Ligusticum chuanxiong, 10 parts of Salvia miltiorrhiza, 10 parts of Curcuma zedoaria, 10 parts of Atractylodes, 10 parts of red peony root, 15 parts of Agastache rugosa, 15 parts of raw astragalus. , Luo Mi Lianglong 10 copies, AVIC 10 copies.

妇科中药组合物的灌肠液由颗粒剂药盒与灌肠袋组成,颗粒剂药盒中有小格子,每个小格子分别存放药材颗粒剂。The enema solution of the gynecological traditional Chinese medicine composition consists of a granule box and an enema bag. The granule box has small grids, and each small grid stores medicinal granules.

灌肠液的制备方法为将颗粒剂药盒中的所有小格子全部打开,将药物倒出放在合适的容器中,加入100~150mL温水,搅拌均匀之后,注入灌肠袋中。The preparation method of enema solution is to open all the small compartments in the granule box, pour the medicine out into a suitable container, add 100~150mL warm water, stir evenly, and then pour it into the enema bag.

温水的温度为37~45℃。The temperature of warm water is 37~45℃.

妇科中药组合物的直肠给药制剂,加药学上可接受的辅料,制成直肠给药制剂。The rectal administration preparation of the gynecological traditional Chinese medicine composition is prepared by adding pharmaceutically acceptable excipients.

妇科中药组合物的灌肠液在制备治疗慢性盆腔炎、盆腔炎性疾病后遗症、反复移植失败、输卵管积液、宫腔粘连、内膜血流灌注不良、子宫内膜薄、子宫腺肌病、继发性痛经、不孕症、卵巢囊肿、促排卵及预防妇科术后盆腔粘连等疾病的药物中的应用。The enema solution of the gynecological traditional Chinese medicine composition is used in the preparation and treatment of chronic pelvic inflammatory disease, sequelae of pelvic inflammatory disease, repeated transplantation failure, fallopian tube effusion, intrauterine adhesions, poor endometrial blood perfusion, thin endometrium, adenomyosis, secondary Application in medicines for episodic dysmenorrhea, infertility, ovarian cysts, ovulation induction and prevention of pelvic adhesions after gynecological surgery.

本发明所涉及的罗埋亮龙为傣药,又名为朱槿。The Luo Mi Liang Long involved in the present invention is a Dai medicine, also known as Zhu Hibiscus.

本发明所涉及的中航为傣药,又名为双籽棕。The AVIC involved in the present invention is a Dai medicine, also known as Shuangseed Palm.

实施例1:Example 1:

败酱草10g,蒲公英10g,虎杖15g,鸡血藤10g,川芎10g,丹参10g,莪术10g,苍术10g,赤芍10g,藿香15g,生黄芪15g。10g of soybean root, 10g of dandelion, 15g of Polygonum cuspidatum, 10g of Spatholobus, 10g of Chuanxiong, 10g of Salvia miltiorrhiza, 10g of Curcuma zedoary, 10g of Atractylodes, 10g of red peony root, 15g of Patchouli 15g, and 15g of raw astragalus.

实施例2:Example 2:

败酱草10g,蒲公英10g,虎杖15g,鸡血藤10g,川芎10g,丹参10g,莪术10g,苍术10g,赤芍10g,藿香15g,生黄芪15g,罗埋亮龙(傣药,朱槿)10克,中航(傣药,双籽棕)10g。10g of soybean grass, 10g of dandelion, 15g of Polygonum cuspidatum, 10g of Millet Spatholobus, 10g of Chuanxiong, 10g of Salvia miltiorrhiza, 10g of Curcuma zedoary, 10g of Atractylodes, 10g of red peony root, 15g of Agastache rugosa, 15g of raw astragalus, Luomia Lianglong (Dai medicine, hibiscus) 10g, AVIC (Dai medicine, double seed palm) 10g.

实施例3:Example 3:

中药保留灌肠操作流程:Traditional Chinese medicine retention enema operation process:

中药观察组成部分:第一部分:颗粒剂药盒。药盒中装有实施例1所述的中药颗粒。一个盒子里面的是一次的量,将盒子所有小格子全部打开,将药物倒出放在合适的容器中,加入100~150mL温水,稍高于体温而不烫。第二部分:灌肠袋(类似输液袋)。Components of traditional Chinese medicine observation: Part 1: Granule kit. The traditional Chinese medicine particles described in Example 1 are contained in the medicine box. What is in a box is a single amount. Open all the small compartments in the box, pour the medicine out into a suitable container, and add 100~150mL of warm water, which is slightly above body temperature but not hot. Part 2: Enema bag (similar to an infusion bag).

步骤:(1)将灌肠袋的阀门完全关闭(平时输液袋调节滴数快慢的那个位置);(2)将第一部分中用温水调好的药从灌肠袋上方开口处倒入(前提是完全关闭阀门);(3)人采取平卧或者侧卧位,把灌肠袋挂至高于人水平的位置,将灌肠袋最末端管子10~15cm涂上润滑剂(凡士林、甘油等),然后慢慢将管子放入肛门(不是阴道),慢慢打开灌肠袋的阀门,让配好的药剂全部流入体内。(4)药物进入体内后,尽量躺在床上,使药物至少在体内保留30分钟,做得好的话可以保留至第二天早上,上卫生间时排出即可。(5)若药物保留至第二日,上卫生间发现大便呈稀状,不必紧张,是正常现象。Steps: (1) Completely close the valve of the enema bag (the position where the infusion bag usually adjusts the number of drops); (2) Pour the medicine mixed with warm water in the first part from the upper opening of the enema bag (provided that it is completely (Close the valve); (3) The person should lie down on his back or side, hang the enema bag higher than the person's level, apply lubricant (Vaseline, glycerin, etc.) to the 10~15cm end tube of the enema bag, and then slowly Put the tube into the anus (not the vagina), slowly open the valve of the enema bag, and let all the prepared medicine flow into the body. (4) After the drug enters the body, try to lie on the bed to keep the drug in the body for at least 30 minutes. If done well, it can be retained until the next morning and can be excreted when going to the bathroom. (5) If you keep the medicine until the second day and go to the bathroom and find that your stool is watery, don’t be nervous. It is normal.

注意事项Precautions

1.插入肛管时,动作务必保持轻柔,如患者有不适感或有阻力时,应轻轻按揉肛门周围,待放松后或无阻力后,再缓慢插入,不得强行插入。1. When inserting into the anal canal, the action must be gentle. If the patient feels discomfort or resistance, gently massage the area around the anus. After it is relaxed or there is no resistance, insert slowly and do not insert forcefully.

2.挤压灌肠袋注入药液时,应缓慢,保持匀速,密切观察患者反应,如有不适,放慢注入速度或暂停注入,待患者不适感消失后,再缓慢挤压注入。2. When squeezing the enema bag to inject the liquid, do so slowly and at a constant speed, and closely observe the patient's reaction. If there is any discomfort, slow down the injection speed or pause the injection. After the patient's discomfort disappears, slowly squeeze and inject again.

3.在灌肠期间,要密切观察患者反应,如患者出现面色苍白、心慌、汗出、头晕等症状,应立即停止操作,对症处理。3. During the enema period, the patient's reaction should be closely observed. If the patient develops symptoms such as paleness, palpitation, sweating, dizziness, etc., the operation should be stopped immediately and symptomatic treatment should be provided.

4.灌肠操作结束后,患者应保持卧位,继续观察,建议患者最好有人陪伴。4. After the enema operation is completed, the patient should remain in a lying position and continue to observe. It is recommended that the patient be accompanied by someone.

5.如患者患有痔疮,操作时,尤其需注意防止触碰出血,痔疮急性发作期或症状严重,则暂不给予灌肠治疗。5. If the patient suffers from hemorrhoids, special attention should be paid to preventing bleeding during the operation. In the acute attack of hemorrhoids or if the symptoms are severe, enema treatment will not be given temporarily.

临床疗效评价:Clinical efficacy evaluation:

自拟化湿祛瘀灌肠方并初步证实其可以改善慢性盆腔炎患者的盆腔体征量表(McCormack)积分、McGill疼痛量表积分、中医证候积分、血清炎症因子水平,现报道如下。The self-made enema prescription for removing dampness and blood stasis has been preliminarily confirmed to improve the pelvic sign scale (McCormack) scores, McGill pain scale scores, TCM syndrome scores, and serum inflammatory factor levels in patients with chronic pelvic inflammatory disease. The report is as follows.

1临床资料1Clinical data

1.1一般资料1.1 General information

招募从云南中医药大学第一附属医院生殖医学科、云南中医药大学第一附属医院针灸科门诊、云南省第二人民医院生殖科自2019年1月1日至2023年3月30日的门诊及住院部符合慢性盆腔炎诊断标准的患者,中医辨证为湿热瘀阻证,随机分为对照组和中药组各30例,共60例。Recruitment from the Department of Reproductive Medicine of the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, the Acupuncture Department of the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, and the Reproductive Department of the Second People's Hospital of Yunnan Province from January 1, 2019 to March 30, 2023. and patients in the inpatient department who met the diagnostic criteria for chronic pelvic inflammatory disease and whose TCM syndrome was dampness-heat and blood stasis syndrome were randomly divided into a control group and a traditional Chinese medicine group, 30 cases each, for a total of 60 cases.

1.2诊断标准1.2 Diagnostic criteria

(1)西医诊断标准:符合《妇产科学》慢性盆腔炎的诊断标准:既往有急性盆腔炎史;伴随下腹部坠胀、疼痛和腰骶酸痛;月经不调、白带多、有异味;子宫活动受限或粘连固定伴有压痛,附件区压痛;超声检查可探及输卵管增粗、盆腔积液或盆腔炎性包块。(1) Western medicine diagnostic criteria: in line with the diagnostic criteria of chronic pelvic inflammatory disease in "Obstetrics and Gynecology": past history of acute pelvic inflammatory disease; accompanied by lower abdominal distension, pain and lumbosacral soreness; irregular menstruation, excessive leucorrhea, and odor; uterus Limited movement or fixed adhesions are accompanied by tenderness and tenderness in the adnexal area; ultrasound examination can detect thickening of the fallopian tubes, pelvic effusion or pelvic inflammatory mass.

(2)中医辨证标准:湿热瘀阻证辨证标准:主症:腰骶部、小腹胀痛或刺痛;带下色黄,量多;次症:性交痛;低热;经期腹痛加重,经期延长、月经量多、有血块;尿黄;大便干燥或便溏;口苦咽干;肢体困倦,舌质紫暗,有瘀斑,苔黄腻,脉滑数。主症必备,次症具备至少2项,参考舌、脉即可诊断湿热瘀阻证。(2) TCM syndrome differentiation standards: Damp-heat stasis syndrome syndrome differentiation standards: Main symptoms: distending pain or tingling in the lumbosacral region and lower abdomen; vaginal discharge with yellow color and large amount; secondary symptoms: dyspareunia; low-grade fever; aggravation of abdominal pain during menstruation, and prolonged menstruation , heavy menstruation, blood clots; yellow urine; dry stool or loose stools; bitter mouth and dry throat; drowsiness in the limbs, dark purple tongue, ecchymosis, yellow and greasy coating, and slippery and rapid pulse. The main symptoms are required, and at least 2 of the secondary symptoms must be met. The syndrome of dampness, heat and blood stasis can be diagnosed by referring to the tongue and pulse.

1.3纳入标准1.3 Inclusion criteria

①符合上述诊断标准;②年龄24~45 岁;③可耐受灌肠治疗;认知、沟通无障碍,可配合相关调查诊治。① Meet the above diagnostic criteria; ② Aged 24 to 45 years old; ③ Can tolerate enema treatment; Have no barriers to cognition and communication, and can cooperate with relevant investigations, diagnosis and treatment.

1.4排除标准1.4 Exclusion criteria

①合并有盆腔结核、肿瘤等其它盆腔疾病;合并有其他系统疾病及有吸烟、饮酒等不良嗜好者。①Combined with other pelvic diseases such as pelvic tuberculosis and tumors; Those who are combined with other systemic diseases and have bad habits such as smoking and drinking.

2治疗方法2 treatments

2.1对照组2.1 Control group

给予盐酸左氧氟沙星片,每次0.4 g,每天1次,口服甲硝唑片(华润双鹤利民药,每次0.4 g,每天1次,连续14 d为1个疗程。Levofloxacin hydrochloride tablets, 0.4 g each time, once a day, and metronidazole tablets (China Resources Shuanghe Limin Medicine, 0.4 g each time, once a day) were given orally for 14 consecutive days as a course of treatment.

2.2观察组2.2 Observation group

在对照组的基础上予化湿祛瘀灌肠方。加入100~150mL温水于药物颗粒剂中冲泡,稍高于体温而不烫,将药置入灌肠袋,嘱患者排空大小便后侧卧位,将臀部垫高5~10cm,将一次性管子润滑后轻轻插入肛门14~15 cm,以每分钟60~70滴速度滴入,结束后嘱患者继续侧卧位保持20~30 min,每天1次,连续14 d为1个疗程。On the basis of the control group, enema prescription for removing dampness and blood stasis was given. Add 100~150mL warm water to brew the drug granules, slightly higher than body temperature but not hot, put the medicine into the enema bag, instruct the patient to lie on his side after emptying his bowels, raise his buttocks by 5~10cm, and place the disposable After the tube is lubricated, gently insert it into the anus 14 to 15 cm, and instill it at a rate of 60 to 70 drops per minute. After the end of the treatment, the patient is asked to continue to stay in the lateral position for 20 to 30 minutes, once a day, for 14 consecutive days as a course of treatment.

3疗效观察3. Curative effect observation

3.1观察指标3.1 Observation indicators

3.1.1主要结局指标3.1.1 Main outcome indicators

(1)采用盆腔体征量表(McCormack)对治疗前后的腹部压痛或反跳痛、子宫压痛、宫颈举摆痛、附件区压痛等进行0~3分评价,评分越高表示痛感越厉害。(1) Use the Pelvic Sign Scale (McCormack) to evaluate abdominal tenderness or rebound tenderness, uterine tenderness, cervical swing pain, adnexal area tenderness, etc. before and after treatment from 0 to 3 points. The higher the score, the more severe the pain.

(2)采用McGill疼痛量表对治疗前后的疼痛情感、疼痛程度进行0~3分评价,评分越高表示痛感越厉害。(2) Use the McGill Pain Scale to evaluate the pain emotion and pain level before and after treatment from 0 to 3 points. The higher the score, the more severe the pain.

3.1.2次要结局指标3.1.2 Secondary outcome indicators

(1)中医证候积分: 评价两组治疗前后的中医证候评分,分数越高,提示患者的症状越严重。(1) TCM syndrome score: Evaluate the TCM syndrome scores of the two groups before and after treatment. The higher the score, the more severe the patient's symptoms are.

(2)炎症水平:采用酶联免疫吸附试验ELISA检测白细胞介素6(Interleukin-6,IL-6)水平。(2) Inflammation level: ELISA was used to detect the level of interleukin-6 (IL-6).

3.2安全性评价3.2 Safety evaluation

针对患者治疗中的安全性问题(如药物不良反应等)做出及时有效处理。Promptly and effectively deal with safety issues during patient treatment (such as adverse drug reactions, etc.).

3.3统计学处理3.3 Statistical processing

采用SPSS26.0 软件进行统计分析, 计量资料满足正态分布采用均数±标准SPSS26.0 software was used for statistical analysis. If the measurement data met the normal distribution, the mean ± standard was used.

差( x ±s)表示,组内比较采用配对样本t 检验,组间比较采用两独立样本t检验;计数资料用频数或百分率(%)表示,采用χ2检验。以P<0.05 为差异有统计学意义。(角标(1)是组内前后对比具有统计学意义,角标(2)是组间治疗后对比具有统计学意义)Difference (x ± s) is expressed, and the paired sample t test is used for intra-group comparison, and the two independent samples t test is used for comparison between groups; count data is expressed as frequency or percentage (%), and χ2 test is used. P <0.05 was considered as a statistically significant difference. (The subscript (1) indicates that the before and after comparison within the group is statistically significant, and the subscript (2) indicates that the comparison between the groups after treatment is statistically significant)

3.4结果3.4 Results

(1)两组患者一般资料比较(1) Comparison of general information between the two groups of patients

两组患者年龄、盆腔体征量表、McGill疼痛量表、中医证候积分、血清IL-6水平等一般资料比较差异无统计学意义(P>0.05),具有可比性,见表1。There was no statistically significant difference in general data such as age, pelvic sign scale, McGill pain scale, TCM syndrome score, and serum IL-6 levels between the two groups ( P > 0.05), and they were comparable, see Table 1.

表1 两组患者一般资料比较Table 1 Comparison of general information of the two groups of patients

(2)两组患者治疗前后盆腔体征量表及McGill疼痛量表比较(2) Comparison of the pelvic sign scale and McGill pain scale between the two groups of patients before and after treatment

治疗后两组患者盆腔体征量表积分较治疗前降低(P<0.05),且观察组治疗后盆腔体征量表积分显著低于对照组(P<0.05);两组治疗后McGill疼痛量表显著低于治疗前(P<0.05),且观察组McGill疼痛量表较对照组相比显著下降(P<0.05),见表2。After treatment, the pelvic sign scale scores of the two groups of patients were lower than before treatment ( P <0.05), and the pelvic sign scale scores of the observation group were significantly lower than those of the control group ( P <0.05); the McGill pain scale scores of the two groups were significantly lower after treatment. It was lower than before treatment ( P <0.05), and the McGill pain scale of the observation group was significantly lower than that of the control group ( P <0.05), see Table 2.

表2 两组患者治疗前后盆腔体征量表及McGill疼痛量表比较Table 2 Comparison of pelvic sign scale and McGill pain scale between two groups of patients before and after treatment

注:与本组治疗前相比,(1) P<0.05;与对照组治疗后比较,(2) P<0.05。Note: Compared with this group before treatment, (1) P <0.05; compared with the control group after treatment, (2) P <0.05.

(3)两组患者治疗前后中医证候积分比较(3) Comparison of TCM syndrome scores between the two groups of patients before and after treatment

治疗后两组患者中医证候积分较治疗前降低(P<0.05),观察组治疗后子中医证候积分低于对照组(P<0.05)。详见表3。After treatment, the TCM syndrome scores of the two groups of patients were lower than before treatment ( P <0.05), and the TCM syndrome scores of the observation group after treatment were lower than those of the control group ( P <0.05). See Table 3 for details.

表3 两组患者治疗前后中医证候积分比较Table 3 Comparison of TCM syndrome scores between the two groups of patients before and after treatment

注:与本组治疗前相比,(1) P<0.05;与对照组治疗后比较,(2) P<0.05。Note: Compared with this group before treatment, (1) P <0.05; compared with the control group after treatment, (2) P <0.05.

(4)两组患者血清炎症水平比较(4) Comparison of serum inflammation levels between the two groups of patients

治疗后两组患者血清炎症指标IL-6、较治疗前降低(P<0.05),观察组治疗后子中医证候积分低于对照组(P<0.05)。详见表4。After treatment, the serum inflammatory index IL-6 of the two groups of patients was lower than before treatment ( P <0.05), and the TCM syndrome score of the observation group after treatment was lower than that of the control group ( P <0.05). See Table 4 for details.

表4 两组患者血清炎症水平比较Table 4 Comparison of serum inflammation levels between the two groups of patients

注:与本组治疗前相比,(1) P<0.05;与对照组治疗后比较,(2) P<0.05。Note: Compared with this group before treatment, (1) P <0.05; compared with the control group after treatment, (2) P <0.05.

结论in conclusion

本研究结果表明,化湿祛瘀灌肠方能有效降低慢性盆腔炎患者盆腔体征量表及McGill疼痛量表评分,改善患者湿热瘀阻的临床症状,降低血清炎症水平,缓解慢性盆腔炎症状。The results of this study show that Huashi Quyu enema prescription can effectively reduce the pelvic sign scale and McGill pain scale scores in patients with chronic pelvic inflammatory disease, improve the clinical symptoms of patients with damp-heat stasis, reduce serum inflammation levels, and relieve the symptoms of chronic pelvic inflammatory disease.

Claims (10)

1.一种用于制备治疗湿热瘀阻证候药物的妇科中药组合物,其特征在于,包括败酱草,蒲公英,虎杖,鸡血藤,川芎,丹参,莪术,苍术,赤芍,藿香,生黄芪。1. A gynecological traditional Chinese medicine composition for preparing drugs for treating damp-heat stasis syndrome, which is characterized in that it includes soybean root, dandelion, Polygonum cuspidatum, Milla sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoary, Atractylodes rhizome, red peony root, and Agastache rugosa. , raw astragalus. 2.如权利要求1所述的妇科中药组合物,其特征在于,包括败酱草1-20份,蒲公英1-20份,虎杖1-30份,鸡血藤1-20份,川芎1-20份,丹参1-20份,莪术1-20份,苍术1-20份,赤芍1-20份,藿香1-30份,生黄芪1-30份。2. The gynecological traditional Chinese medicine composition as claimed in claim 1, characterized in that it includes 1-20 parts of Ligusticum sibiricum, 1-20 parts of Dandelion, 1-30 parts of Polygonum cuspidatum, 1-20 parts of Millaplasia sinensis, and 1-20 parts of Ligusticum Chuanxiong. 20 parts, 1-20 parts of salvia, 1-20 parts of Curcuma, 1-20 parts of Atractylodes, 1-20 parts of red peony root, 1-30 parts of Patchouli, 1-30 parts of raw astragalus. 3.如权利要求1所述的妇科中药组合物,其特征在于,包括败酱草10份,蒲公英10份,虎杖15份,鸡血藤10份,川芎10份,丹参10份,莪术10份,苍术10份,赤芍10份,藿香15份,生黄芪15份。3. The gynecological traditional Chinese medicine composition as claimed in claim 1, characterized in that it includes 10 parts of Sophora sinensis, 10 parts of Dandelion, 15 parts of Polygonum cuspidatum, 10 parts of Spatholobus, 10 parts of Chuanxiong, 10 parts of Salvia miltiorrhiza and 10 parts of Curcuma. , 10 parts of Atractylodes, 10 parts of red peony root, 15 parts of Patchouli, and 15 parts of raw astragalus. 4.如权利要求1所述的妇科中药组合物,其特征在于,包括败酱草,蒲公英,虎杖,鸡血藤,川芎,丹参,莪术,苍术,赤芍,藿香,生黄芪,罗埋亮龙,中航。4. The gynecological traditional Chinese medicine composition as claimed in claim 1, characterized in that it includes soybean root, dandelion, Polygonum cuspidatum, Millet Spatholobus, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoary, Atractylodes rhizome, red peony root, Agastache rugosa, Astragalus membranaceus, Radix Spatholobus. Lianglong, AVIC. 5.如权利要求4所述的妇科中药组合物,其特征在于,包括败酱草1-20份,蒲公英1-20份,虎杖1-30份,鸡血藤1-20份,川芎1-20份,丹参1-20份,莪术1-20份,苍术1-20份,赤芍1-20份,藿香1-30份,生黄芪1-30份,罗埋亮龙1-20份,中航2-10份。5. The gynecological traditional Chinese medicine composition as claimed in claim 4, characterized in that it includes 1-20 parts of Ligusticum sibiricum, 1-20 parts of Dandelion, 1-30 parts of Polygonum cuspidatum, 1-20 parts of Millet Spatholobus, and 1-20 parts of Ligusticum Chuanxiong. 20 parts, Salvia miltiorrhiza 1-20 parts, Curcuma zedoaria 1-20 parts, Atractylodes 1-20 parts, Red peony root 1-20 parts, Agastache rugosa 1-30 parts, Raw Astragalus 1-30 parts, Luobian Lianglong 1-20 parts , AVIC 2-10 copies. 6.如权利要求4所述的妇科中药组合物,其特征在于,包括败酱草10份,蒲公英10份,虎杖15份,鸡血藤10份,川芎10份,丹参10份,莪术10份,苍术10份,赤芍10份,藿香15份,生黄芪15份,罗埋亮龙10份,中航10份。6. The gynecological traditional Chinese medicine composition as claimed in claim 4, characterized in that it includes 10 parts of Sophora sinensis, 10 parts of Dandelion, 15 parts of Polygonum cuspidatum, 10 parts of Spatholobus, 10 parts of Chuanxiong, 10 parts of Salvia miltiorrhiza and 10 parts of Curcuma. , 10 parts of Cangzhu, 10 parts of red peony root, 15 parts of Patchouli, 15 parts of raw astragalus, 10 parts of Luobian Lianglong, and 10 parts of Avic. 7.一种基于权利要求1或4所述的妇科中药组合物的灌肠液,其特征在于,由颗粒剂药盒与灌肠袋组成,颗粒剂药盒中有小格子,每个小格子分别存放药材颗粒剂。7. An enema liquid based on the gynecological traditional Chinese medicine composition according to claim 1 or 4, characterized in that it is composed of a granule medicine box and an enema bag. There are small grids in the granule medicine box, and each small grid is stored separately. Medicinal granules. 8.如权利要求7所述的灌肠液的制备方法,其特征在于,将颗粒剂药盒中的所有小格子全部打开,将药物倒出放在合适的容器中,加入100~150mL 37~45℃的温水,搅拌均匀之后,注入灌肠袋中。8. The preparation method of enema liquid as claimed in claim 7, characterized in that all small compartments in the granule medicine box are opened, the medicine is poured out and placed in a suitable container, and 100~150mL 37~45 ℃ warm water, stir evenly and pour into the enema bag. 9.一种基于权利要求1或4所述的妇科中药组合物的直肠给药制剂,其特征在于,还包括药学上可接受的辅料,制成直肠给药制剂。9. A rectal administration preparation based on the gynecological traditional Chinese medicine composition according to claim 1 or 4, characterized in that it further includes pharmaceutically acceptable auxiliary materials to form a rectal administration preparation. 10.如权利要求7所述的灌肠液在制备治疗慢性盆腔炎、盆腔炎性疾病后遗症、反复移植失败、输卵管积液、宫腔粘连、内膜血流灌注不良、子宫内膜薄、子宫腺肌病、继发性痛经、不孕症、卵巢囊肿、促排卵及预防妇科术后盆腔粘连的药物中的应用。10. The enema as claimed in claim 7 is useful in preparing and treating chronic pelvic inflammatory disease, sequelae of pelvic inflammatory disease, repeated transplantation failure, fallopian tube effusion, intrauterine adhesions, poor endometrial blood perfusion, thin endometrium, and uterine glands. Application of drugs in myopathy, secondary dysmenorrhea, infertility, ovarian cysts, ovulation induction and prevention of pelvic adhesions after gynecological surgery.
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