阅读说明：本技术 一种治疗痔上粘膜环切术后并发症的软膏及其制备方法 (Ointment for treating complications after superior hemorrhoidal mucosa circumcision and preparation method thereof ) 是由 江洪亮 杜菡 葛任新 陈宗文 于 2019-11-13 设计创作，主要内容包括：本发明公开了一种治疗痔上粘膜环切术后并发症的软膏及其制备方法,一种治疗痔上粘膜环切术后并发症的中药组合物,每1000份所述中药组合物包括以下质量份的组分：黄连115～140份、珍珠母38～47份、紫草57～70份、荷叶115～141份和延胡索57～70份；本发明中药组合物具有清热燥湿,化瘀止痛生肌的作用,配以药学上可接受的辅料制备成软膏,可促进药物的吸收,提高疗效；通过将药膏直接作用于痔上粘膜环切术后的创口,对肛门坠胀、尿潴留、排便困难等术后并发症疗效显著,并可进一步促进患者的术后恢复。本发明还提供了所述软膏的制备方法,其制备过程简便,成本低,具有重要的医药和经济价值。(The invention discloses an ointment for treating complications after superior hemorrhoidal mucosa circumcision and a preparation method thereof, wherein each 1000 parts of the traditional Chinese medicine composition comprises the following components in parts by mass: 115-140 parts of coptis chinensis, 38-47 parts of mother-of-pearl, 57-70 parts of lithospermum, 115-141 parts of lotus leaves and 57-70 parts of corydalis tuber; the traditional Chinese medicine composition has the effects of clearing heat, eliminating dampness, removing blood stasis, relieving pain and promoting granulation, and can be prepared into ointment by matching with pharmaceutically acceptable auxiliary materials, so that the absorption of the medicine can be promoted, and the curative effect is improved; the ointment is directly applied to the wound after superior hemorrhoidal mucotomy, has remarkable curative effect on postoperative complications such as anal pendulous distension, urinary retention, difficult defecation and the like, and can further promote postoperative recovery of patients. The invention also provides a preparation method of the ointment, which has simple and convenient preparation process, low cost and important medical and economic values.)

1. The traditional Chinese medicine composition for treating the complications after the superior hemorrhoidal mucosa circumcision is characterized in that each 1000 parts of the composition comprises the following components in parts by mass: 115-140 parts of coptis chinensis, 38-47 parts of mother-of-pearl, 57-70 parts of lithospermum, 115-141 parts of lotus leaves and 57-70 parts of corydalis tuber.

2. The traditional Chinese medicine composition of claim 1, wherein each 1000 parts of the composition comprises the following components in parts by mass: 128 parts of coptis chinensis, 43 parts of mother-of-pearl, 64 parts of lithospermum, 128 parts of lotus leaves and 64 parts of corydalis tuber.

3. Use of a composition according to claim 1 for the preparation of a pharmaceutical preparation for the treatment of complications of suprahemorrhoid mucocyclotomy.

4. A pharmaceutical preparation for treating complications after superior hemorrhoidal mucosal annulotomy, characterized in that the preparation comprises the traditional Chinese medicine composition according to claim 1 or 2.

5. The pharmaceutical formulation of claim 4, wherein the pharmaceutical formulation is an ointment.

6. The pharmaceutical formulation of claim 5, further comprising an ointment base.

7. The pharmaceutical preparation according to claim 5, wherein the ointment base comprises white petrolatum and glycerin, and the mass ratio of white petrolatum to glycerin is 10: 1-2.5.

8. A process for the preparation of a pharmaceutical formulation according to any one of claims 5 to 7, comprising the steps of:

(1) weighing the traditional Chinese medicine components, adding water for decoction, and filtering to obtain filtrate;

(2) concentrating the filtrate in the step (1) into clear paste;

(3) and (3) mixing the clear paste obtained in the step (2) with ointment base to obtain the ointment of the invention.

9. The method of claim 8, wherein the step (1) is: weighing the traditional Chinese medicine components, adding water, decocting for two times, decocting for 2 hours for the first time and 1.5 hours for the second time, mixing decoctions, and filtering to obtain a filtrate; in the step (2), the relative density of the clear paste at 80 ℃ is 1.10-1.20; in the step (3), the mass ratio of the clear paste to the ointment matrix is 3: 22.

10. the preparation method according to claim 9, wherein in step (3), after the fluid extract is mixed with the ointment base, ethylparaben is added and mixed uniformly; the ethylparaben is 0.05% of the mass of the mixture of the clear paste and the ointment matrix.

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to ointment for treating complications after superior hemorrhoidal mucosa circumcision and a preparation method thereof.

Background

The mixed hemorrhoid is the most common disease in clinical anorectal department, and the treatment method mainly comprises conservative treatment and operative treatment. For circular mixed hemorrhoids, the hemorrhoids are usually treated by suprahemorrhoidal mucotomy (PPH) or external dissection and internal ligation, and have good treatment effect. However, after PPH surgery, patients often develop complications such as pain, anal distention, urinary retention, and difficulty in defecation. Among them, pain, dyschezia, anal effusion and urinary retention are the most common causes, and are also the common causes of the patients fear to treat hemorrhoids. Although the patient is controlled to a certain extent, complications are easy to occur, and the defecation effect is not well improved.

There are many clinical methods to prevent and treat these complications, such as using analgesic, sedative or suppository or paste to receive anus or external application of Chinese medicine, acupuncture or hip bath, western medicine treatment means is oral non-steroidal anti-inflammatory drug, sedative or α receptor blocker, but may cause gastrointestinal bleeding, dizziness, postural hypotension and other disadvantages.

Disclosure of Invention

The invention aims to provide the ointment for treating the complications after the superior hemorrhoidal mucosa circumcision, which has the advantages of comprehensive effect, obvious effect and low cost aiming at the defects of the prior art. Meanwhile, the invention also provides a preparation method of the ointment.

In order to achieve the purpose, the invention adopts the technical scheme that: a traditional Chinese medicine composition for treating complications after superior hemorrhoidal mucosa circumcision comprises the following components in 1000 parts by mass: 115-140 parts of coptis chinensis, 38-47 parts of mother-of-pearl, 57-70 parts of lithospermum, 115-141 parts of lotus leaves and 57-70 parts of corydalis tuber.

The coptis root is bitter and cold, and the rhizome contains various alkaloids, mainly berberine which is also called berberine; has the effects of clearing heat and drying dampness, purging pathogenic fire and removing toxicity, and is commonly used for various symptoms such as damp-heat fullness, vomiting and acid regurgitation, dysentery, jaundice, high fever and coma, hyperactivity of heart-fire, vexation and insomnia, blood heat and hematemesis and epistaxis, conjunctival congestion, toothache, diabetes, carbuncle swelling and furuncle, and the like. The Concha Margaritifera is derived from the nacreous layer of shells of shellfish such as hyriopsis cumingii and Cristaria plicata of Unionidae or Pinctada martensii of Pinctada; has effects in suppressing hyperactive liver, subsiding yang, removing liver heat, improving eyesight, eliminating dampness, and astringing. Radix Arnebiae is root of Lithospermum erythrorhizon and Sinkiang radix Arnebiae of perennial herb of Boraginaceae, and has effects of cooling blood, promoting blood circulation, promoting eruption, removing toxic substance and clearing pathogenic fire. The lotus leaf is bitter in taste and is used for clearing summer heat, resolving dampness, ascending the hair, clearing yang, cooling blood and stopping bleeding; can be used for treating summer heat, polydipsia, summer damp diarrhea, spleen deficiency diarrhea, hematemesis, epistaxis, hematochezia, metrorrhagia, and metrostaxis. Rhizoma corydalis has effects of promoting blood circulation, activating qi-flowing, and relieving pain, and can be used for treating chest and hypochondrium, abdominal pain, thoracic obstruction, cardialgia, amenorrhea, dysmenorrhea, puerperal blood stasis, and traumatic injury. The Chinese medicinal composition has the effects of clearing heat, drying dampness, removing blood stasis, relieving pain and promoting granulation.

The cause of complications after the superior hemorrhoidal mucotomy is caused by various factors, and the mechanism thereof has not been clearly elucidated. Modern medicine considers that complications after superior hemorrhoidal mucosa circumcision are inflammatory edema of rectum and anus caused by operation injury, nerves of perineum are stimulated by operation, muscles related to perineum area are caused to shrink violently, anus plumpness and pain, urine retention, constipation and the like are caused, and the severe shrinkage can cause ischemia and anoxia of local tissues, aggravate inflammation and form a bad cycle. And because the surgical wound surface of the mixed hemorrhoid is a relatively polluted incision, the postoperative patient defecates, local growth of intestinal bacteria and the like, the complications can last for a long time and the healing of the surgical opening is delayed. The tissues in the rectum and around the anus are continuously inflamed, and local exudation is increased, so that the pollution of the operation opening is increased, and the symptoms are further aggravated.

Through practice, the applicant believes that the pathogenesis of complications after the superior hemorrhoidal mucotomy is the mutual combination of damp heat and extravasated blood, local qi and blood obstruction is caused, pain and vault closure appear when the disease is not caused, the damp heat is coalesced in the large intestine anus, so that anus swelling pain, effusion, defecation and the like are caused, and the healing of the operative incision is delayed due to the qi and blood obstruction. For treatment, it should clear heat and promote diuresis, resolve blood stasis and alleviate pain and promote granulation. The traditional Chinese medicine composition for treating the complications after the superior hemorrhoidal mucosa circumcision and the proportion thereof are obtained according to years of experience summary.

As a preferred embodiment of the present invention, the composition comprises the following components in parts by mass per 1000 parts of the composition: 128 parts of coptis chinensis, 43 parts of mother-of-pearl, 64 parts of lithospermum, 128 parts of lotus leaves and 64 parts of corydalis tuber.

The composition can be used for treating complications after superior hemorrhoidal mucosa circumcision, and has good effect.

Further, the composition can be applied in the process of preparing a medicinal preparation for treating complications after superior hemorrhoidal mucosal circumcision.

As a preferred embodiment of the invention, the composition can be prepared into a pharmaceutical preparation for treating complications after superior hemorrhoidal mucosal ring-cutting surgery.

More preferably, the pharmaceutical formulation is an ointment.

The traditional Chinese medicine composition is prepared into ointment in combination with the symptom of treating the complications after the superior hemorrhoidal mucosa circumcision, and the ointment directly acts on the wound; a proper amount of ointment is injected into a rectal cavity by using a sterile syringe, 30-50 g of ointment is injected once every day, a treatment course is continuously used, and the treatment course is 5-7 days, so that postoperative complications such as anal pendant expansion, urine retention, difficult defecation and the like can be effectively improved and treated. Modern medical research has shown that the major mechanisms of action of the ointment of the present invention include:

(1) a protective medicinal oil film is formed on the local part, so that the wound surface is prevented from being polluted by bacteria and excrement, the growth of the bacteria is inhibited, and the flora of the bacteria on the local anus and rectum is adjusted;

(2) can promote local blood circulation, improve tissue ischemia and anoxia state, and relieve operative edema;

(3) regulating cell factors, promoting the growth of granulation tissues and accelerating the healing of the operative orifice;

(4) and (4) immunoregulation effect.

Further, the pharmaceutical preparation also comprises an ointment base when being prepared into an ointment.

According to a preferred embodiment of the invention, the ointment base comprises white vaseline and glycerol, wherein the mass ratio of the white vaseline to the glycerol is 10: 1-2.5. The preparation method of the ointment base comprises the following steps: taking white vaseline, heating and sterilizing at 121-136 ℃, melting, cooling, adding glycerol into the white vaseline, and stirring uniformly.

The white vaseline can improve the texture of the preparation, has no irritation to skin, and has certain moisturizing effect. The glycerin can make the principal drug rapidly absorbed by mucosa and skin, and has adhesive force, stable property, and water absorption, and is not easy to rancidity; the water absorption and penetrability of the white vaseline can be improved by combining the white vaseline with the water absorbent; further improving the drug effect of the traditional Chinese medicine composition.

In addition, the invention also provides a preparation method of the ointment, which comprises the following steps:

(1) weighing the traditional Chinese medicine components, adding water for decoction, and filtering to obtain filtrate;

(2) concentrating the filtrate in the step (1) into clear paste;

(3) and (3) mixing the clear paste obtained in the step (2) with ointment base to obtain the ointment of the invention.

As a preferred embodiment of the present invention, the step (1) is: weighing the traditional Chinese medicine components, adding water, decocting for two times, decocting for 2 hours for the first time and 1.5 hours for the second time, mixing decoctions, and filtering to obtain a filtrate; in the step (2), the relative density of the clear paste at 80 ℃ is 1.10-1.20 (taking water as reference); in the step (3), the mass ratio of the clear paste to the ointment matrix is 3: 22.

further, the step (3) also comprises adding ethylparaben after mixing the clear paste and the ointment base, and uniformly mixing; the ethylparaben is 0.05% of the mass of the mixture of the clear paste and the ointment matrix.

The composition is prepared from a plurality of traditional Chinese medicines, and is safe in components; the ointment is prepared by matching with an ointment matrix, achieves the focus of infection by adopting rectal local administration treatment, has no toxic or side effect on human body basically, has the effects of protecting the wound surface, relaxing bowel, reducing swelling and relieving pain, obviously relieves the symptoms of postoperative complications, and obviously improves the life quality of patients; the ointment also has certain promotion effect on wounds, and shortens hospitalization time of patients. The ointment has low cost and simple preparation process, has obvious treatment effect on the complications after the superior hemorrhoidal mucosa circumcision, can reach more than 98 percent, and has important medical and economic values.

Detailed Description

To better illustrate the objects, aspects and advantages of the present invention, the present invention will be further described with reference to specific examples.