阅读说明：本技术 一种改善膀胱收缩力的药物组合物及其应用 (Pharmaceutical composition for improving bladder contractility and application thereof ) 是由 谷猛 蔡志康 刘冲 王�忠 陈其 徐欢 于 2021-09-08 设计创作，主要内容包括：本申请公开了一种改善膀胱收缩力的药物组合物及其应用,药物组合物包括伸筋草、黄芪、车前子、王不留行、川牛膝、菟丝子和茯苓皮。药物组合物的剂型包括水煎剂、丸剂、片剂、胶囊剂、颗粒剂、冲剂或口服液。本申请的药物组合物可以增加膀胱逼尿肌收缩力,对由前列腺增生引起的膀胱逼尿肌功能受损疗效显著。(The application discloses a pharmaceutical composition for improving bladder contractility and application thereof. The dosage form of the pharmaceutical composition comprises decoction, pills, tablets, capsules, granules or oral liquid. The pharmaceutical composition can increase the contraction force of the detrusor muscle of the bladder, and has a remarkable curative effect on the function damage of the detrusor muscle of the bladder caused by the hyperplasia of prostate.)

1. A pharmaceutical composition is characterized by comprising lycopodium clavatum, astragalus membranaceus, semen plantaginis, cowherb seed, radix cyathulae, semen cuscutae and poria peel.

2. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises the following components by mass: 13-17 g of common clubmoss herb, 13-17 g of astragalus and plantain seed

4-8 g of cowherb seed, 13-17 g of medicinal cyathula root, 7-11 g of south dodder seed and 7-11 g of poria peel.

3. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises the following components by mass: herba lycopodii 15g, radix astragali 15g, semen plantaginis 6g, cowherb seed 6g, radix cyathulae 15g, semen cuscutae 9g, and poria peel 9 g.

4. A pharmaceutical composition formulation comprising the pharmaceutical composition of any one of claims 1 to 3 and a pharmaceutical carrier.

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

6. The pharmaceutical composition preparation as claimed in claim 5, wherein the oral preparation is in the form of decoction, pill, tablet, capsule, granule or oral liquid.

7. The pharmaceutical composition preparation of claim 5, wherein the oral preparation is a water decoction.

8. The formulation of a pharmaceutical composition according to claim 7, wherein the method of preparing the aqueous decoction comprises: adding water into the medicinal composition, decocting, and filtering to obtain residue and first filtrate; adding water into the dregs of a decoction, decocting, and filtering to obtain a second filtrate.

9. The formulation of a pharmaceutical composition according to claim 8, wherein the method of preparing the aqueous decoction further comprises: and combining the first filtrate and the second filtrate to obtain the decoction.

10. Use of a pharmaceutical composition according to any one of claims 1 to 3 as a medicament for relaxing the detrusor muscle of the bladder.

Technical Field

The application relates to the technical field of pharmacy, in particular to a pharmaceutical composition for improving bladder contractility and application thereof.

Background

The incidence of prostatic hyperplasia (BPH) is high, and the life quality of men is seriously affected. Clinically, the urethra is blocked due to the hyperplasia of prostate, and the bladder function is damaged or even the condition of incapability of urination is caused after long-time urination and labor waste. The BPH syndrome comprises three symptoms of bladder outlet obstruction, bladder detrusor instability and bladder detrusor contractility impairment. Wherein the degree of the damaged detrusor contractility of the bladder directly influences the problems of clinical diagnosis, treatment method selection, curative effect evaluation, prognosis and the like. Therefore, the symptoms caused by the impaired detrusor contractility are distinguished from the BPH syndrome, and the clinical significance is realized for the treatment of the patients with poor western medicine treatment effect by adopting the traditional Chinese medicine.

It is clinically found that in BPH patients, 25-30% of the BPH patients do not have bladder outlet obstruction, and the micturition abnormality only reflects the abnormality of bladder function, such as detrusor instability and detrusor contraction function damage, and it is obviously unreasonable to perform prostate operation for relieving bladder outlet obstruction on the part of patients. Therefore, it is very important to treat bladder detrusor dysfunction. The current drug treatment mainly aims at the dynamic factor and the static factor of BPH, and no drug which is specifically aimed at the function damage of bladder detrusor muscle is provided. Therefore, it is very important to search for a medicine for treating the impaired contraction function of the detrusor muscle of the bladder, which has strong pertinence, exact curative effect and small side effect.

The traditional Chinese medicine treatment utilizes the traditional Chinese medicine theory, improves the immunity of the organism by regulating qi and blood circulation and carrying out treatment based on syndrome differentiation on the basis of the overall view, has the advantages of quick response, thorough treatment, direct drug effect on focus, safety, effectiveness, short treatment course, difficult generation of drug resistance, low cost, convenient administration and easy acceptance by patients, can obviously improve the cure rate, reduce complications, reduce the recurrence rate and obviously improve the life quality of the patients.

Disclosure of Invention

The application provides a pharmaceutical composition for improving bladder contractility and an application thereof, which can relieve bladder detrusor muscle function damage caused by prostatic hyperplasia.

The application provides a pharmaceutical composition, which comprises lycopodium clavatum, astragalus membranaceus, semen plantaginis, cowherb seed, radix cyathulae, semen cuscutae and poria peel.

Optionally, in some embodiments of the present application, the mass of each component in the pharmaceutical composition is: 13-17 g of lycopodium clavatum, 13-17 g of astragalus membranaceus, 4-8 g of semen plantaginis, 4-8 g of cowherb seed, 13-17 g of medicinal cyathula root, 7-11 g of semen cuscutae and 7-11 g of poria peel.

Optionally, in some embodiments of the present application, the mass of each component in the pharmaceutical composition is: 14-16 g of lycopodium clavatum, 14-16 g of astragalus membranaceus, 5-7 g of semen plantaginis, 5-7 g of cowherb seed, 14-16 g of medicinal cyathula root, 8-10 g of semen cuscutae and 8-10 g of poria peel.

Optionally, in some embodiments of the present application, the mass of each component in the pharmaceutical composition is: herba lycopodii 15g, radix astragali 15g, semen plantaginis 6g, cowherb seed 6g, radix cyathulae 15g, semen cuscutae 9g, and poria peel 9 g.

Correspondingly, the application also provides a pharmaceutical composition preparation, and the pharmaceutical composition preparation comprises the pharmaceutical composition and a pharmaceutical carrier.

Optionally, in some embodiments of the present application, the pharmaceutical composition formulation is an oral formulation.

Optionally, in some embodiments of the present application, the oral preparation is in the form of decoction, pill, tablet, capsule, granule, or oral liquid.

Optionally, in some embodiments of the present application, the oral formulation is a water decoction.

Optionally, in some embodiments of the present application, the method for preparing the decoction comprises: adding water into the medicinal composition, decocting, and filtering to obtain residue and first filtrate; adding water into the residue, decocting, and filtering to obtain a second filtrate.

Optionally, in some embodiments of the present application, the method for preparing a decoction further comprises: and combining the first filtrate and the second filtrate to obtain the decoction.

Optionally, in some embodiments of the present application, the method for preparing the decoction comprises: adding water with the weight being 8-10 times of the total weight of the medicinal composition into each component of the medicinal composition, decocting for 1-2 hours, and filtering to obtain medicine residues and first filtrate; adding water with the weight being 3-5 times of the total weight of the medicine composition into the medicine residues, decocting for 30-40 minutes, and filtering to obtain a second filtrate; mixing the first filtrate and the second filtrate to obtain a decoction; the obtained decoction is administered twice daily.

In addition, the application also provides application of the pharmaceutical composition as a medicine for relaxing bladder detrusor.

The application adopts a medicine composition and is applied to the medicine for relaxing bladder detrusor, and has the following beneficial effects:

1) the Chinese medicinal materials with different medicinal properties are scientifically matched, so that the contraction force of the detrusor muscle of the bladder can be improved, and the treatment effect is ideal;

2) the medicine composition is safe and has no toxic or side effect;

3) the preparation process of the pharmaceutical composition is simple and convenient, and the cost is low.

Detailed Description

The technical solutions in the embodiments of the present application will be described clearly and completely below, and it should be understood that the described embodiments are only a part of the embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

The application provides a pharmaceutical composition for improving bladder contractility and application thereof. The following are detailed below. It should be noted that the following description of the embodiments is not intended to limit the preferred order of the embodiments.

The embodiment of the application provides a pharmaceutical composition, which comprises the following components in parts by mass: 13-17 g of lycopodium clavatum, 13-17 g of astragalus membranaceus, 4-8 g of semen plantaginis, 4-8 g of cowherb seed, 13-17 g of medicinal cyathula root, 7-11 g of semen cuscutae and 7-11 g of poria peel. The formula can also be added with other components for blending, and the other components are preferably medicines which have the effects of promoting urination, reducing swelling, promoting defecation and enhancing the contraction force of smooth muscle and have no conflict with the components in the pharmaceutical composition; the quality of each component in the formula can be adjusted correspondingly according to the difference of other added components.

Wherein the pharmacology of the components is as follows:

b, common clubmoss herb: is the dried whole herb of lycopodium clavatum of lycopodaceae, bitter, pungent and warm in nature, entering liver meridian. Expelling wind and cold, removing dampness and swelling, relaxing muscles and tendons, promoting blood circulation, promoting urination, and eliminating pathogenic factors, and can be used for treating numbness of skin, arthralgia due to wind-cold-dampness, and spasm and pain of tendons and vessels. The lycopodium clavatum is used as a monarch drug in the formula of the application. The traditional Chinese medicine composition mainly has the functions of detumescence and relaxation, and is beneficial to reducing the apparent volume of prostate after being taken according to the treatment course, so that the oppression of prostatic hyperplasia to urethra is relieved, the contractility of bladder detrusor is enhanced, the resistance of urethra is reduced during urination, the pushing force of bladder detrusor to urine is enhanced, the resistance of urine during discharge is reduced, the residual urine volume is reduced, and the urine retention phenomenon is effectively prevented.

Astragalus root: is the root of Astragalus mongholicus (Fisch.) bge of Leguminosae, and has sweet and slightly warm flavor and enters lung, spleen, liver and kidney meridians. Consolidating superficial resistance, arresting sweating, inducing diuresis to alleviate edema, promoting pus discharge, and regulating water passage. The astragalus root is used for enhancing the heart contractility and improving the blood circulation of the whole body; can improve the nonspecific immunity ability of the matrix; can significantly influence the information conduction of spleen lymphocytes and realize the immunoregulation effect. The traditional Chinese medicine composition mainly plays a role in warming kidney and inducing diuresis, and is used as a ministerial medicine for assisting the efficacy of the lycopodium clavatum.

Plantain seed: is dry mature seed of Plantago asiatica or Plantago depressa of Plantaginaceae, and has sweet and slightly cold taste, and has effects of clearing heat, promoting diuresis, eliminating dampness, relieving diarrhea, improving eyesight, and eliminating phlegm.

Seed of cowherb: is dry and mature seed of Vaccinium arvense of Caryophyllaceae, and has bitter taste and mild property, and enters liver and stomach meridians. Promoting blood circulation, dredging channels, promoting lactation, relieving swelling, inducing diuresis, and treating stranguria.

Dodder seed: is dry mature seed of south dodder seed or dodder seed of Convolvulaceae, has sweet taste and warm nature, and has the effects of tonifying kidney yang and kidney yin, and securing essence and reducing urination. The dodder has the effect of inducing astringency, and can nourish vital essence of a human body and relieve damp heat of lower jiao.

Poria peel: is dry outer skin of sclerotium of Poria cocos (Schw.) wolf of Polyporaceae, has sweet and light taste and mild nature, enters lung, spleen and kidney channels, induces diuresis to alleviate edema, and can be used for treating edema and dysuria.

Semen plantaginis, semen Vaccariae, semen Cuscutae and Poria peel are used as adjuvant drugs to assist herba Lycopodii and radix astragali to strengthen the therapeutic effect.

Radix cyathulae: is dried root of Cyathula officinalis Royle of Amaranthaceae, and has sweet, slightly bitter and neutral nature, and enters liver and kidney meridians. Dispel stasis, dredge meridians, dredge joints, induce diuresis and treat stranguria. Cyathula root has the function of dredging and plays a role of guiding drugs in the application.

The medicines supplement each other to ensure that the symptoms and the treatment are combined, and the medicines are combined to play the efficacies of tonifying qi and kidney, removing blood stasis and dredging orifices, and promoting urination and eliminating evil, thereby achieving good treatment effect.

EXAMPLE I Water decoction of pharmaceutical composition

This example provides a method for preparing a decoction of a pharmaceutical composition:

the formula of the pharmaceutical composition is as follows:

herba lycopodii 15g, radix astragali 15g, semen plantaginis 6g, cowherb seed 6g, radix cyathulae 15g, semen cuscutae 9g, and poria peel 9 g.

The preparation method of the water decoction of the pharmaceutical composition comprises the following steps:

1) adding water 8 times of the total mass of the medicinal composition into each component of the medicinal composition, decocting for 1 hour, and filtering to obtain medicinal residue and first filtrate;

2) adding water 3 times the total weight of the medicinal composition into the residue, decocting for 30 minutes, and filtering to obtain a second filtrate;

3) combining the first filtrate and the second filtrate to obtain the water decoction of the pharmaceutical composition.

EXAMPLE II Water decoction of pharmaceutical composition

This example provides a method for preparing a decoction of a pharmaceutical composition:

the formula of the pharmaceutical composition is as follows:

16g of common clubmoss herb, 15g of astragalus, 5g of plantain seed, 6g of cowherb seed, 17g of medicinal cyathula root, 9g of south dodder seed and 7g of poria peel.

The preparation method of the water decoction of the pharmaceutical composition comprises the following steps:

1) adding water 9 times the total weight of the medicinal composition into each component of the medicinal composition, decocting for 2 hours, and filtering to obtain medicinal residue and first filtrate;

2) adding water 5 times the total weight of the medicinal composition into the residue, decocting for 35 min, and filtering to obtain a second filtrate;

3) combining the first filtrate and the second filtrate to obtain the water decoction of the pharmaceutical composition.

EXAMPLE III Capsule of pharmaceutical composition

The present example provides a method for preparing a capsule of a pharmaceutical composition:

the formula of the pharmaceutical composition is as follows:

herba lycopodii 15g, radix astragali 15g, semen plantaginis 6g, cowherb seed 6g, radix cyathulae 15g, semen cuscutae 9g, and poria peel 9 g.

The preparation method of the capsule of the pharmaceutical composition comprises the following steps:

1) adding water 8 times of the total mass of the medicinal composition into each component of the medicinal composition, decocting for 1 hour, and filtering to obtain medicinal residue and first filtrate;

2) adding water 3 times the total weight of the medicinal composition into the residue, decocting for 30 minutes, and filtering to obtain a second filtrate;

3) mixing the first filtrate and the second filtrate, and concentrating under reduced pressure to obtain water extract thick paste;

4) adding adjuvants selected from sucrose, dextrin, sodium carboxymethyl cellulose and sodium carboxymethyl starch, and stirring to obtain soft material;

5) sieving the soft material with 24 mesh sieve to obtain wet granules;

6) and drying the wet granules at 50-60 ℃ to obtain dry granules, cooling the dry granules, sieving the cooled dry granules by a 24-mesh sieve, grading, adding magnesium stearate, and encapsulating to obtain the capsule of the pharmaceutical composition.

EXAMPLE four granules of pharmaceutical composition

The present example provides a method for preparing granules of a pharmaceutical composition:

the formula of the pharmaceutical composition is as follows:

16g of common clubmoss herb, 16g of astragalus, 5g of plantain seed, 5g of cowherb seed, 15g of medicinal cyathula root, 9g of south dodder seed and 9g of poria peel.

The preparation method of the granules of the pharmaceutical composition comprises the following steps:

1) adding water 9 times of the total mass of the medicinal composition into each component of the medicinal composition, decocting for 1 hour, and filtering to obtain medicinal residue and first filtrate;

2) adding water 3 times the total weight of the medicinal composition into the residue, decocting for 30 minutes, and filtering to obtain a second filtrate;

3) mixing the first filtrate and the second filtrate, and concentrating under reduced pressure to obtain water extract thick paste;

4) adding adjuvants selected from sucrose, dextrin, and sodium carboxymethyl cellulose, and stirring to obtain soft material;

5) sieving the soft material with a 10-mesh sieve to obtain wet granules;

6) and drying the wet granules at 50-60 ℃ to obtain dry granules, cooling the dry granules, and sieving with a 10-mesh sieve and a 65-mesh sieve respectively to complete granules of the pharmaceutical composition.

EXAMPLE V clinical trial

Clinical data: 20 patients are selected, wherein the patients are diagnosed due to difficult urination, the single-pass uroflow rate is low, the type-B ultrasonic indicates that the residual urine is more than 100ml, and the patients are indicated to reduce the contraction force of the detrusor muscle of the bladder through urodynamic examination after indwelling catheterization.

The treatment method comprises the following steps: the decoction prepared in the first step of the application is taken 2 doses a day, twice in the morning and at night, and the medicine is continuously taken for 1 month.

Detection indexes are as follows: before and after administration, urinary bladder contractility in urodynamic index, residual urine and urodynamic index were examined.

The treatment results are shown in table 1:

TABLE 1

The results in table 1 show that the maximum uroflow rate after 1 month of administration is improved compared with that before administration, the residual urine amount after 1 month of administration is reduced compared with that before administration, and the bladder detrusor contractility after 1 month of administration is reduced compared with that before administration, which suggests that the pharmaceutical composition of the present application has a better effect on improving bladder detrusor contractility and relieving dysuria symptoms.

The pharmaceutical composition provided by the application can increase the contraction force of the detrusor muscle of the bladder, has a remarkable curative effect on the function damage of the detrusor muscle of the bladder caused by the hyperplasia of prostate, and has the advantages of high safety and no toxic or side effect.

The pharmaceutical composition for improving bladder contractility and the application thereof provided by the present application are described in detail above, and the principle and the embodiment of the present application are illustrated herein by using specific examples, and the description of the above examples is only for helping to understand the method and the core concept thereof; meanwhile, for those skilled in the art, according to the idea of the present application, there may be variations in the specific embodiments and the application scope, and in summary, the content of the present specification should not be construed as a limitation to the present application.