阅读说明：本技术 一种中药组合物在制备治疗子宫切口假腔的药物中的应用 (Application of traditional Chinese medicine composition in preparation of medicine for treating uterine incision false cavity ) 是由 潘宏祚 高尚 李艳波 屈金艳 易小兰 吴慧慧 于 2019-11-22 设计创作，主要内容包括：本发明涉及一种中药组合物在制备治疗子宫切口假腔的药物中的应用；所述中药组合物由以下重量份的原料药制备而成：黄芪300～400份、阿胶300～400份、党参270～320份、白芍90～110份、当归70～90份、仙鹤草300～400份、茜草140～170份、佛手70～90份、续断70～90份。本发明首次将上述中药组合物应用于治疗子宫切口假腔,具有一定的疗效,且无毒副作用,为治疗子宫切口假腔提供了一种新的药物。(The invention relates to an application of a traditional Chinese medicine composition in preparing a medicine for treating a uterine incision false cavity; the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 300-400 parts of astragalus membranaceus, 300-400 parts of donkey-hide gelatin, 270-320 parts of codonopsis pilosula, 90-110 parts of white paeony root, 70-90 parts of angelica sinensis, 300-400 parts of hairyvein agrimony, 140-170 parts of madder, 70-90 parts of fingered citron and 70-90 parts of teasel root. The traditional Chinese medicine composition is applied to the treatment of the uterine incision false cavity for the first time, has a certain curative effect, has no toxic or side effect, and provides a new medicine for the treatment of the uterine incision false cavity.)

1. The application of a traditional Chinese medicine composition in preparing a medicine for treating the uterine incision false cavity is characterized in that the traditional Chinese medicine composition is mainly prepared from the following raw material medicines in parts by weight: 300-400 parts of astragalus membranaceus, 300-400 parts of donkey-hide gelatin, 270-320 parts of codonopsis pilosula, 90-110 parts of white paeony root, 70-90 parts of angelica sinensis, 300-400 parts of hairyvein agrimony, 140-170 parts of madder, 70-90 parts of fingered citron and 70-90 parts of teasel root.

2. The application of claim 1, wherein the traditional Chinese medicine composition is mainly prepared from the following raw material medicines in parts by weight: 300-350 parts of astragalus membranaceus, 300-350 parts of donkey-hide gelatin, 280-320 parts of codonopsis pilosula, 90-110 parts of white paeony root, 70-90 parts of angelica sinensis, 300-350 parts of hairyvein agrimony, 150-170 parts of madder, 70-90 parts of fingered citron and 70-90 parts of teasel root.

3. The application of claim 2, wherein the traditional Chinese medicine composition is mainly prepared from the following raw material medicines in parts by weight: 320 parts of astragalus, 320 parts of donkey-hide gelatin, 300 parts of codonopsis pilosula, 100 parts of white paeony root, 80 parts of angelica, 32 parts of hairyvein agrimony, 160 parts of madder, 80 parts of fingered citron and 80 parts of teasel root.

4. The use according to any one of claims 1 to 3, wherein the medicament is an oral formulation.

5. The use according to claim 4, wherein the oral formulation is selected from one of a tablet, a pill, a granule and an oral liquid formulation.

6. The use according to claim 5, wherein the medicament is a granule, and the preparation method of the medicament comprises the following steps:

weighing the raw materials according to a formula;

mixing the angelica and the fingered citron, extracting by adopting a distillation method, collecting volatile oil, and obtaining mixed water extract of the angelica and the fingered citron and mixed dregs of the angelica and the fingered citron, and clathrating the volatile oil by β -cyclodextrin to obtain β -cyclodextrin inclusion compound;

pulverizing the donkey-hide gelatin into donkey-hide gelatin powder; taking half amount of radix astragali, pulverizing, sieving to obtain radix astragali coarse powder and radix astragali fine powder, and pulverizing the radix astragali fine powder to obtain radix astragali superfine powder;

mixing the astragalus coarse powder, the other half of astragalus, the mixed dregs of angelica and fingered citron, codonopsis pilosula, white paeony root, hairyvein agrimony, madder and teasel root, carrying out water extraction and filtration to obtain a water extract, combining the water extract and the mixed water extract of angelica and fingered citron, and concentrating to obtain an extract with the specific gravity of 1.05-1.35;

drying the extract and preparing dry extract powder;

mixing the dry extract powder, the colla Corii Asini powder, the radix astragali superfine powder, the β -cyclodextrin clathrate, and pharmaceutically acceptable adjuvants, and making into granule.

7. The use of claim 6, wherein the adjuvant comprises 180 to 200 parts of pregelatinized starch and 250 to 300 parts of sucrose powder.

8. The use of claim 7, wherein the specific gravity of the extract is 1.25-1.35;

drying the extract by adopting a vacuum drying method, and then crushing the dried extract into dry extract powder, wherein the water content of the dry extract powder is 3-7 wt%;

and (3) granulating the granules by adopting dry granulation, namely uniformly mixing the dry extract powder, the donkey-hide gelatin powder, the astragalus superfine powder and the auxiliary materials, performing dry granulation, and then adding the β -cyclodextrin inclusion compound for total mixing to obtain the granules.

9. Use according to claim 8, wherein the process parameters of the dry granulation are:

the feeding speed is 65r/min to 75r/min, the pressure of a compression roller is 6MPa to 17.5MPa, the running speed of the compression roller is 8r/min to 20r/min, the liquid inlet temperature of cooling liquid of the compression roller is 6 ℃ to 16.5 ℃, and the whole grain speed is 60r/min to 100 r/min.

10. The use of claim 7, wherein the specific gravity of the extract is 1.05-1.25;

and drying the extract by adopting a spray drying method, wherein the air inlet temperature of the spray drying is 170-190 ℃, and the air outlet temperature of the spray drying is 70-80 ℃.

Technical Field

The invention belongs to the technical field of medicines, and relates to an application of a traditional Chinese medicine composition in preparation of a medicine for treating a uterine incision false cavity.

Background

The uterus incision false cavity (PCSD), also called the diverticulum of uterus, is a retention cavity gap formed by poor healing of the lower uterus incision after cesarean section operation, often causes menostaxis and incomplete menstruation dripping, and also causes placenta implantation after the second pregnancy or incision pregnancy, thereby having great influence on the life quality of patients.

At present, the main treatment methods of the diverticulum of the uterus comprise medicine conservative treatment and operation treatment, the conservative treatment adopts symptomatic medicine treatment such as menstruation regulation, hemostasis, anti-inflammation and the like, the curative effect is poor, if the vaginal bleeding time is long, the infection is prevented and treated by applying hemostatic or antibiotic, or the menstruation is adjusted by taking hormone, the abnormal vaginal bleeding caused by the diverticulum of the uterus is caused by the accumulation of menstrual blood in a false cavity and is not caused by insufficient secretion of sex hormone in vivo, the curative effect of the hormone is poor, and the potential risk of thrombus is increased by oral contraceptive of women in the childbearing period, so the diverticulum of the uterus is not suitable for long-term application, and the symptoms of menstrual disorder are easy to relapse after the medicine is. Compared with traditional Chinese medicine, hormone taking has more contraindications, and the acceptance of patients is poor; the operative treatment has the possibility of poor healing of the uterine incision, perforation of the uterus and the like, the symptoms of some patients are not obviously improved after the operation, and the operation cost is high, so the clinical acceptance is not high.

Disclosure of Invention

Based on the above, there is a need for an application of a Chinese medicinal composition in preparing a medicament for treating a uterine incision false cavity.

The invention aims to provide application of a traditional Chinese medicine composition in preparing a medicine for treating uterine incision false cavity, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 300-400 parts of astragalus membranaceus, 300-400 parts of donkey-hide gelatin, 270-320 parts of codonopsis pilosula, 90-110 parts of white paeony root, 70-90 parts of angelica sinensis, 300-400 parts of hairyvein agrimony, 140-170 parts of madder, 70-90 parts of fingered citron and 70-90 parts of teasel root.

The invention firstly uses the traditional Chinese medicine composition for treating the uterine incision false cavity and provides a new application of the traditional Chinese medicine composition. The research result shows that: the traditional Chinese medicine composition can effectively reduce the volume of unhealed incision of the uterine incision false cavity, shorten the menstrual period, has no toxicity, and provides a new idea and a new medicine for treating the uterine incision false cavity.

In one embodiment, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 300-350 parts of astragalus membranaceus, 300-350 parts of donkey-hide gelatin, 280-320 parts of codonopsis pilosula, 90-110 parts of white paeony root, 70-90 parts of angelica sinensis, 300-350 parts of hairyvein agrimony, 150-170 parts of madder, 70-90 parts of fingered citron and 70-90 parts of teasel root.

In one embodiment, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 320 parts of astragalus, 320 parts of donkey-hide gelatin, 300 parts of codonopsis pilosula, 100 parts of white paeony root, 80 parts of angelica, 32 parts of hairyvein agrimony, 160 parts of madder, 80 parts of fingered citron and 80 parts of teasel root.

In one embodiment, the medicament is an oral formulation.

In one embodiment, the oral formulation is selected from one of a tablet, a pill, a granule, and an oral liquid formulation.

In one embodiment, the medicament is a granule, and the preparation method of the medicament comprises the following steps:

weighing the raw materials according to a formula;

mixing the angelica and the fingered citron, extracting by adopting a distillation method, collecting volatile oil, and obtaining mixed water extract of the angelica and the fingered citron and mixed dregs of the angelica and the fingered citron, and clathrating the volatile oil by β -cyclodextrin to obtain β -cyclodextrin inclusion compound;

pulverizing the donkey-hide gelatin into donkey-hide gelatin powder; taking half amount of radix astragali, pulverizing, sieving to obtain radix astragali coarse powder and radix astragali fine powder, and pulverizing the radix astragali fine powder to obtain radix astragali superfine powder;

mixing the astragalus coarse powder, the other half of astragalus, the mixed dregs of angelica and fingered citron, codonopsis pilosula, white paeony root, hairyvein agrimony, madder and teasel root, carrying out water extraction and filtration to obtain a water extract, combining the water extract and the mixed water extract of angelica and fingered citron, and concentrating the mixture to obtain an extract with the specific gravity of 1.05-1.35 (measured at 60 ℃);

drying the extract and preparing dry extract powder;

mixing the dry extract powder, the colla Corii Asini powder, the radix astragali superfine powder, the β -cyclodextrin clathrate, and pharmaceutically acceptable adjuvants, and making into granule.

In one embodiment, the adjuvant comprises 180-200 parts of pregelatinized starch and 250-300 parts of sucrose powder.

In one embodiment, the specific gravity of the extract is 1.25-1.35;

drying the extract by adopting a vacuum drying method, and then crushing the dried extract into dry extract powder, wherein the water content of the dry extract powder is 3-7 wt%;

and (3) granulating the granules by adopting dry granulation, namely uniformly mixing the dry extract powder, the donkey-hide gelatin powder, the astragalus superfine powder and the auxiliary materials, performing dry granulation, and then adding the β -cyclodextrin inclusion compound for total mixing to obtain the granules.

In one embodiment, the process parameters of the dry granulation are as follows:

the feeding speed is 65r/min to 75r/min, the pressure of a compression roller is 6MPa to 17.5MPa, the running speed of the compression roller is 8r/min to 20r/min, the liquid inlet temperature of cooling liquid of the compression roller is 6 ℃ to 16.5 ℃, and the whole grain speed is 60r/min to 100 r/min.

In one embodiment, the specific gravity of the extract is 1.05-1.25;

and drying the extract by adopting a spray drying method, wherein the air inlet temperature of the spray drying is 170-190 ℃, and the air outlet temperature of the spray drying is 70-80 ℃.

Drawings

FIG. 1 is a gynecological B-mode ultrasound search report of a patient before treatment according to example 1 of the present invention;

FIG. 2 is a gynecological ultrasound retrieval report of the patient of FIG. 1 after treatment in accordance with the present invention;

FIG. 3 is another pre-treatment gynecological B-mode ultrasound search report of a patient in embodiment 1 of the present invention;

FIG. 4 is a gynecological ultrasound retrieval report of the patient of FIG. 3 after treatment in accordance with the present invention;

FIG. 5 is a gynecological B-mode ultrasound search report of another patient before treatment in embodiment 1 of the present invention;

FIG. 6 is a gynecological ultrasound retrieval report of the patient of FIG. 5 after treatment in accordance with the present invention.

Detailed Description

In order that the invention may be more fully understood, a more particular description of the invention will now be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The gynecological blood nourishing granule, named Baofixin, is a unique product of Hunan Anbang pharmaceutical Co. The blood-nourishing granule for gynecology comprises nine traditional Chinese medicine raw materials of donkey-hide gelatin, codonopsis pilosula, astragalus root, white paeony root, angelica, madder, hairyvein agrimony, fingered citron and teasel root, wherein the donkey-hide gelatin in the prescription enters three channels of liver, lung and kidney, thereby nourishing yin and blood, regulating menstruation and stopping bleeding, and the astragalus root enters two channels of spleen and lung, thereby being a medicine for tonifying qi and specially benefiting qi and controlling blood. The former can tonify blood and stop bleeding, while the latter can help blood and generate blood, they are the monarch drugs in the recipe. The codonopsis pilosula can tonify spleen qi and help the monarch drug astragalus to tonify qi and control blood; the white peony root has the effects of nourishing blood and liver, has the effects of relieving pain quickly, the Chinese angelica has the effects of tonifying blood and blood, regulating menstruation and relieving pain, and the two medicines are combined to assist the monarch medicine donkey-hide gelatin in enriching blood and regulating menstruation and are used as a Chinese and ministerial medicine in the prescription. Radix Rubiae has effects of clearing heat and cooling blood, removing blood stasis and stopping bleeding, herba et Gemma Agrimoniae has effects of astringing and stopping bleeding, fructus Citri Sarcodactylis has effects of invigorating spleen and regulating qi-flowing, activating spleen to produce blood, and eliminating the disadvantage of stomach obstruction due to nourishing and greasiness, such as colla Corii Asini, etc., and is used as adjuvant medicine in the formula. Xu Duan can tonify liver and kidney, strengthen meridians and stop bleeding, leading herbs into thoroughfare vessel as guiding drugs. The medicines are combined to play the effects of tonifying qi, enriching blood, regulating menstruation and stopping bleeding. The current functions are mainly as follows: can be used for treating menostaxis, listlessness, lusterless complexion, and pale lips and tongue due to deficiency of both qi and blood.

The researchers of the invention use the gynecological blood-nourishing granules for treating the uterine incision false cavity for the first time, and the clinical observation shows that the volume of the gynecological blood-nourishing granules for the unhealed incision of the false cavity can be reduced below 1/3 compared with the prior art, so that the gynecological blood-nourishing granules have a certain curative effect on the diverticulum of the uterus.

One embodiment of the invention provides an application of a traditional Chinese medicine composition in preparing a medicine for treating a uterine incision false cavity;

the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 300-400 parts of astragalus membranaceus, 300-400 parts of donkey-hide gelatin, 270-320 parts of codonopsis pilosula, 90-110 parts of white paeony root, 70-90 parts of angelica sinensis, 300-400 parts of hairyvein agrimony, 140-170 parts of madder, 70-90 parts of fingered citron and 70-90 parts of teasel root.

In one embodiment, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 300-350 parts of astragalus membranaceus, 300-350 parts of donkey-hide gelatin, 280-320 parts of codonopsis pilosula, 90-110 parts of white paeony root, 70-90 parts of angelica sinensis, 300-350 parts of hairyvein agrimony, 150-170 parts of madder, 70-90 parts of fingered citron and 70-90 parts of teasel root.

In one embodiment, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 320 parts of astragalus, 320 parts of donkey-hide gelatin, 300 parts of codonopsis pilosula, 100 parts of white paeony root, 80 parts of angelica, 32 parts of hairyvein agrimony, 160 parts of madder, 80 parts of fingered citron and 80 parts of teasel root.

In one embodiment, the medicament is an oral formulation

In one embodiment, the oral formulation is selected from one of a tablet, a pill, a granule, and an oral liquid formulation.

In one embodiment, the medicament is a granule, and the preparation method of the medicament comprises the following steps of S1-S6.

S1, weighing the raw materials according to the formula of the traditional Chinese medicine composition.

S2, mixing radix Angelicae sinensis and fructus Citri Sarcodactylis, distilling, collecting volatile oil, and obtaining mixed water extractive solution of radix Angelicae sinensis and fructus Citri Sarcodactylis and mixed residue of radix Angelicae sinensis and fructus Citri Sarcodactylis, and clathrating volatile oil with β -cyclodextrin to obtain β -cyclodextrin clathrate.

In one embodiment, 5-7 times of water is added into the angelica and the fingered citron, and the mixture is distilled and extracted for 3-5 hours.

In one embodiment, the volatile oil is added into a mixed solution of β -cyclodextrin and water in an amount of 7-10 times that of the volatile oil, and the mixture is ground for 20-30 minutes.

In one embodiment, the volatile oil is added into 8 times of the mixed solution of β -cyclodextrin and water and ground for 20 minutes.

Specifically, β -cyclodextrin with the quantity of 8 times of volatile oil is taken, a proper amount of purified water is added and mixed uniformly to be prepared into paste, the volatile oil is diluted by 95% ethanol with the quantity of 4 times of the volatile oil, then the volatile oil is added into the paste to be included for 20 minutes by a colloid mill, the mixture is filtered, and filter residue is dried at 50-60 ℃ to obtain the β -cyclodextrin inclusion compound.

S3, crushing the donkey-hide gelatin into donkey-hide gelatin powder; pulverizing half amount of radix astragali, sieving to obtain radix astragali coarse powder and radix astragali fine powder, and pulverizing radix astragali fine powder to obtain radix astragali superfine powder.

Furthermore, the weight of the astragalus membranaceus superfine powder is 15-20% of the total weight of the astragalus membranaceus.

S4, mixing the coarse powder of the astragalus, the other half of the astragalus, the mixed dregs of the angelica and the fingered citron, the codonopsis pilosula, the white paeony root, the hairyvein agrimony, the madder and the teasel root, carrying out water extraction and filtration to obtain a water extract, combining the water extract and the mixed water extract of the angelica and the fingered citron, and concentrating the mixture to obtain an extract with the specific gravity of 1.05-1.35 (measured at 60 ℃).

Specifically, extracting the coarse powder of the astragalus, the fine powder of the rest astragalus, the other half of the mixed dregs of the astragalus, the angelica and the fingered citron, the codonopsis pilosula, the white paeony root, the hairyvein agrimony, the madder and the teasel root twice, adding 8-10 times of water for boiling extraction for 1-2 hours for the first time, adding 6-8 times of water for boiling extraction for 1-1.5 hours for the second time; and combining the extracting solutions obtained by the two water extractions, and filtering to obtain the water extracting solution.

S5, drying the extract and preparing dry extract powder.

Specifically, the extract can be dried by vacuum drying or spray drying, and made into dry extract powder.

Further, concentrating to obtain an extract with the specific gravity of 1.25-1.35, drying the extract by adopting a vacuum drying method, and then crushing to obtain dry extract powder with the water content of 3-7 wt%.

Specifically, the temperature of the vacuum drying treatment is 60-80 ℃, the vacuum degree is-0.06 MPa-0.08 MPa, and the drying time is 15-20 h.

Further, concentrating to obtain an extract with the specific gravity of 1.05-1.25, and drying the extract by adopting a spray drying method to obtain dry extract powder.

Specifically, the air inlet temperature of spray drying is 170-190 ℃, and the air outlet temperature of spray drying is 70-80 ℃.

S6, mixing the dry extract powder, colla Corii Asini powder, radix astragali superfine powder, β -cyclodextrin clathrate, and pharmaceutically acceptable adjuvants, and making into granule.

Further, the auxiliary materials comprise pregelatinized starch and sucrose powder.

Specifically, the preparation of the granules can be carried out by adopting the processes of dry granulation, wet granulation, one-step granulation and the like.

The granulating method of the granules by adopting dry granulation comprises the steps of uniformly mixing dry extract powder, donkey-hide gelatin powder, astragalus superfine powder and auxiliary materials, setting the technological parameters of the dry method to be 65-75 r/min of feeding speed, 6-17.5 MPa of pressure of a compression roller, 8-20 r/min of operation speed of the compression roller, 6-16.5 ℃ of cooling liquid inlet temperature of the compression roller and 60-100 r/min of granule finishing speed, carrying out dry granulation, and then adding β -cyclodextrin inclusion compound for total mixing to obtain the granules.

The granulation of the granules by adopting wet granulation comprises the steps of uniformly mixing the donkey-hide gelatin powder, the astragalus superfine powder, the sucrose powder, 30-100 parts of pregelatinized starch, the dry extract powder and the β -cyclodextrin inclusion compound, adding the wetting adhesive for granulation, and then drying, granulating, and totally mixing to obtain the granules.

The following are specific examples