CN116077606A - Pharmaceutical composition for treating prostatic hyperplasia, preparation method and application - Google Patents

Abstract

The application relates to a pharmaceutical composition for treating prostatic hyperplasia, a preparation method and application. The preparation raw materials of the pharmaceutical composition comprise the following components in parts by weight: 5-15 parts of white pepper, 5-10 parts of turmeric, 3-8 parts of costustoot, 3-8 parts of sappan wood, 1-5 parts of centella asiatica, 1-5 parts of phyllanthus emblica and 10-20 parts of stiff silkworm. The bulk drugs of the pharmaceutical composition comprise white pepper, turmeric, costustoot, sappan wood, centella asiatica, emblic leafflower fruit and stiff silkworm, the white pepper and piperine and curcumin in the turmeric are matched to realize synergistic interaction, and the costustoot, sappan wood, centella asiatica and emblic leafflower fruit are matched to realize synergistic interaction; meanwhile, the muscardine silkworm and the plant components in the pharmaceutical composition are mutually complemented and matched, so that the pharmaceutical composition can be better applied to the treatment of the prostatic hyperplasia. In addition, the pharmaceutical composition has a simple formula and a simple and feasible preparation method.

Description

A kind of pharmaceutical composition, preparation method and application for treating benign prostatic hyperplasia

technical field

The application relates to the technical field of medicine, in particular to a pharmaceutical composition, preparation method and application for treating hyperplasia of the prostate gland.

Background technique

Benign prostatic hyperplasia (BPH) is a common disease in elderly men, manifested as urinary hesitancy, frequency, urgency, nocturia, urinary retention and other symptoms, and may cause urinary tract infection, bladder stones, and even renal dysfunction Symptoms seriously affect the normal life of patients. Epidemiological statistics show that the incidence rate of men before the age of 40 is relatively low, and the incidence rate begins to increase after the age of 50. The incidence rate can reach 50% at the age of 60, and nearly 90% at the age of 80. Prostatic hyperplasia is a chronic process. Long-term urinary tract obstruction is prone to be complicated by infection, hydronephrosis, renal insufficiency, bladder stones, uremia and renal hypertension. With the aggravation of my country's aging society, the treatment of this disease is particularly urgent.

Western medicine believes that the etiology of benign prostatic hyperplasia has not been fully elucidated, and it is generally believed that functional testis and advanced age are two important conditions for the onset. Surgical therapy is an important method for the treatment of benign prostatic hyperplasia by Western medicine, but patients generally have to bear greater pain and risks, and the cost of surgical treatment is relatively high. There are many kinds of western medicines for the treatment of benign prostatic hyperplasia, which have a certain curative effect, but have large toxic and side effects, which can easily cause adverse effects on the health of patients, especially elderly patients.

At present, there are also many reports on the treatment of prostatitis using TCM syndrome differentiation and treatment. As disclosed in the prior art, a pharmaceutical composition for the treatment of prostatitis and benign prostatic hyperplasia, the composition is prepared from each crude drug comprising the following parts by weight: Ingredients: 10-30 parts of turtle shells, 10-20 parts of tortoise shells, 0.5-3 parts of ground beetles, 0.1-1 parts of leeches, 0.2-2 parts of centipedes, 3-9 parts of Shanzi mushrooms, 0.5-3 parts of pangolins, 10 parts of astragalus -20 parts, 5-15 parts of ginseng, 10-20 parts of Corydalis, 10-20 parts of Eupatorium, 1-6 parts of Panax notoginseng, 5-12 parts of peach kernel, 9-15 parts of dogwood, 1-6 parts of amber, 3 parts of green bark -9 parts, 9-15 parts of red bean, 9-15 parts of cumin, 9-15 parts of sumac, 5-12 parts of pinellia, 10-20 parts of dodder, 5-15 parts of rehmannia, 3-9 parts of Fritillaria , 10-20 parts of winter melon kernel, 9-15 parts of Shichangpu, 5-15 parts of Toosendan, 9-15 parts of yam, 5-12 parts of Curcuma, 10-20 parts of red vine, 5-15 parts of white mustard seed, agarwood 0.5-2 parts, 9-15 parts of Sichuan Achyranthes bidentata, 9-15 parts of Chuanxiong and 1-4 parts of blood. The composition can be used for treating prostatitis and benign prostatic hyperplasia, but the components of the composition are too complicated, and the effect of treating benign prostatic hyperplasia needs to be further improved.

Therefore, it is necessary to provide a pharmaceutical composition with simple ingredients and significant effect in treating benign prostatic hyperplasia.

Contents of the invention

In order to solve the deficiencies in the prior art, the application provides a new pharmaceutical composition for the treatment of benign prostatic hyperplasia. in treatment.

To this end, the first aspect of the present application provides a pharmaceutical composition for the treatment of benign prostatic hyperplasia, in parts by weight, the preparation raw materials of the pharmaceutical composition include the following components:

5-15 parts of white pepper, 5-10 parts of turmeric, 3-8 parts of woody fragrance, 3-8 parts of sumac, 1-5 parts of centella asiatica, 1-5 parts of emblica

And 10-20 copies of silkworm.

In the present application, the white pepper in the pharmaceutical composition is the fruit of Piperaceae plant pepper, which has the functions of warming the middle and expelling cold, lowering the qi, etc. There are many activities such as insecticidal; piperine in pepper is the active ingredient of white pepper, which has anti-tumor, anti-oxidation, anti-digestive ulcer and anti-depression effects. Turmeric is the dried rhizome of turmeric, a plant in the ginger family. It tastes pungent and bitter, and has the effects of breaking blood and promoting qi, dredging menstruation and relieving pain; curcumin in turmeric has a good anti-tumor effect, which can effectively inhibit the proliferation of tumor cells and increase tumor growth. Apoptosis of cells reduces the number of tumors and shrinks the volume of tumors, which can reverse the malignant phenotype of cancer cells to a certain extent. The combination of the white pepper in the pharmaceutical composition and the piperine and curcumin in the turmeric can promote each other and achieve the purpose of synergistic effect, and thus can be better used in the treatment of benign prostatic hyperplasia.

In this application, the general name of the Compositae plants of the woody woody woody woody and Chuankiyaki in the pharmaceutical composition has the effects of promoting qi and relieving pain, warming the stomach, astringent intestines and antidiarrheal; sumac is a plant of the genus Yunshi , is a commonly used medicine in clinical practice. It is recorded in "Compendium of Materia Medica" that sumac is a blood-dividing medicine for the three yin meridians. Qi, blood stasis, swelling, pain relief, can promote blood circulation, enhance immunity; The asiaticoside and madecassoside in the grass have many pharmacological effects, such as inhibiting collagen fibers, inhibiting the proliferation of fibrous tissue, and treating skin ulcers; Sweet, sour, astringent, cool in nature and flavor, it belongs to the lung and stomach meridians, and has the effects of digesting food and invigorating the stomach, clearing away heat and detoxifying. Free radicals and anti-tumor effects. The combination of woody incense, sumac, centella asiatica and emblica in the pharmaceutical composition can promote each other to achieve the purpose of synergistic effect, and further enhance the effect of the pharmaceutical composition for treating hyperplasia of the prostate gland.

In the present application, the silkworm in the pharmaceutical composition is flat in nature, salty and pungent in taste, and belongs to the liver, lung and stomach meridian. Rheumatoid arthritis, sore throat, scrofula, rheumatic sore rash, etc., all take its ability to clear and disperse. The silkworm in the pharmaceutical composition can complement each other with the plant components in the pharmaceutical composition, so that the pharmaceutical composition of the present application can be better applied in the treatment of benign prostatic hyperplasia.

Furthermore, the present application can make the effect of the pharmaceutical composition better by controlling the content of each raw drug in the pharmaceutical composition within the above range.

In some embodiments, the parts by weight of the white pepper are 8-10 parts, the parts by weight of the turmeric are 6-8 parts, and the weight ratio of the white pepper and turmeric is (1-2): 1.

In some preferred embodiments, the parts by weight of the white pepper are 9 parts, the parts by weight of the turmeric are 6 parts, and the weight ratio of the white pepper to turmeric is 1.5:1.

In the present application, by controlling the parts by weight of white pepper and turmeric in the pharmaceutical composition and the weight relationship between the two within the above range, the synergistic effect of white pepper and turmeric can be better exerted, thereby further improving the curative effect of the pharmaceutical composition.

In some embodiments, the parts by weight of the woody fragrance is 5-6 parts, the parts by weight of the sumac is 5-6 parts, and the parts by weight of the centella asiatica are 2-4 parts, so The parts by weight of the emblica are 2-4 parts; and the weight ratio of the woody, sumac, centella asiatica and emblica is (2-3):(2-3):(1-2): (1~2).

In some preferred embodiments, the parts by weight of the woody fragrance is 6 parts, the parts by weight of the sumac is 6 parts, the parts by weight of the centella asiatica is 3 parts, and the parts by weight of the emblica The parts by weight are 3 parts; and the weight ratio of the woody fragrance, sumac, centella asiatica and emblica is 2:2:1:1.

The present application controls the weight parts of woody, sumac, centella asiatica and emblica in the pharmaceutical composition and the weight relationship of the four within the above-mentioned range, and can better play the role of woody, sumac, centella asiatica and emblica. The synergistic effect of emblica further enhances the curative effect of the medicinal composition.

In some specific embodiments, the parts by weight of the silkworm in the pharmaceutical composition can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts or 20 servings etc. In some preferred embodiments, the weight parts of silkworms in the pharmaceutical composition are 14-16 parts. In some more preferred embodiments, the weight part of the silkworm in the pharmaceutical composition is 15 parts.

In the present application, the silkworm in the pharmaceutical composition is an animal component, and controlling the content of the silkworm in the above range can better complement and cooperate with the plant components in the composition, and improve the effect of the plant components on benign prostatic hyperplasia. curative effect, while reducing the toxic and side effects of the above ingredients on the body, and then the application of the pharmaceutical composition to the best effect of the treatment of benign prostatic hyperplasia.

Therefore, in the most preferred embodiment of the present application, in parts by weight, the preparation raw materials of the pharmaceutical composition include the following components: 9 parts of white pepper, 6 parts of turmeric, 6 parts of woody fragrance, 6 parts of sumac, 3 parts of Centella asiatica, 3 parts of Emlical emblica and 15 parts of silkworm; wherein the weight ratio of white pepper and turmeric is 1.5:1, and the weight ratio of woody fragrance, sumac, Centella asiatica and Emlical seed is 2:2: 1:1.

In the present application, pharmaceutically acceptable adjuvants or auxiliary components can be added to the pharmaceutical composition as required to prepare preparations, such as oral preparations. The oral preparations can be, for example, decoctions, ointments, oral liquids, granules, capsules, pills, tablets or powders.

The second aspect of the present application provides a method for preparing the pharmaceutical composition as described in the first aspect of the present application, the method comprising the following steps:

S1, preparing the ethanol extract of white pepper and turmeric;

S2, fry the silkworm and grind it into powder to obtain silkworm powder;

S3, pulverizing woody incense, sumac, centella asiatica and emblica to obtain a mixed powder, adding the mixed powder and silkworm powder to the ethanol extract of white pepper and turmeric to obtain the drug combination things.

In the present application, the white pepper and turmeric in the pharmaceutical composition are ethanol extracts of white pepper and turmeric, and the piperine in white pepper and curcumin in turmeric can be fully extracted by preparing the ethanol extract of white pepper and turmeric, Thereby, it is more beneficial to bring into play the curative effect of the pharmaceutical composition.

In some embodiments, the step S1 specifically includes: crushing the white pepper and turmeric, adding them to the ethanol solution, and performing heating and reflux extraction to obtain an ethanol extract of the white pepper and turmeric.

In the present application, the active ingredients in white pepper and turmeric can be extracted in one step, which simplifies the preparation steps and reduces the production cost.

In some embodiments, the parameters of the heating and reflux extraction are: the concentration of ethanol in the ethanol solution is 75% to 95%; the ratio of solid to liquid is 1g: (3 to 8) mL; the number of extractions is 2 to 3 times; The temperature is 65-75°C; the time for a single extraction is 0.5-1.5h.

In some preferred embodiments, the parameters of the heating reflux extraction are: the concentration of ethanol in the ethanol solution is 85%; the ratio of solid to liquid is 1g:5mL; the number of extractions is 2 times; the extraction temperature is 70°C; The time is 1h.

In this application, the concentration of ethanol in the ethanol solution refers to the volume fraction of ethanol; the ratio of solid to liquid refers to the mass volume ratio of the total mass of white pepper and turmeric to the ethanol solution. The present application prepares the ethanol extract of white pepper and turmeric under the above extraction conditions, can extract the active ingredients in white pepper and turmeric in one step, and make the content of piperine and curcumin in the extract optimal, and then make the present application The pharmaceutical composition can better treat benign prostatic hyperplasia.

In some embodiments, the process of frying silkworms described in step S2 is as follows: heat the frying pan, sprinkle bran evenly, and when the bran burns into thick smoke, add silkworms to be fried immediately, and turn over quickly Stir-fry until the surface of the silkworm is brownish yellow, take it out, sieve off the burnt bran residue, and spread it out to cool.

The third aspect of the present application provides an application of the pharmaceutical composition described in the first aspect of the application or the pharmaceutical composition prepared by the method described in the second aspect in the preparation of a medicament for treating and/or preventing hyperplasia of the prostate gland.

The pharmaceutical composition described in this application contains raw materials with specific proportions, and the pharmaceutical composition described in this application can effectively treat benign prostatic hyperplasia through the synergy between each raw material drug, and the formula of the pharmaceutical composition is simple, and the preparation method It is simple and easy to implement, and can be well applied in the preparation of medicines for treating and/or preventing hyperplasia of the prostate gland.

Beneficial technical effects of the present application: the raw materials of the pharmaceutical composition described in the present application include white pepper, turmeric, woody fragrance, sumac, centella asiatica, emblica and silkworm, piperine and turmeric in white pepper and turmeric The synergistic effect can be achieved through the combination of the elements, and the combination of woody fragrance, sumac wood, centella asiatica and emblica can also promote each other to achieve the purpose of synergistic effect; at the same time, the botanical components in the silkworm and the medicinal composition complement each other, Furthermore, the pharmaceutical composition of the present application can be better applied in the treatment of benign prostatic hyperplasia. In addition, the pharmaceutical composition described in the present application has a simple formula, a simple and easy preparation method, and good application prospects, all of which can be well used in the preparation of drugs for treating and/or preventing benign prostatic hyperplasia.

Detailed ways

In order to make the present application easier to understand, the present application will be further described in detail below in conjunction with examples, and these examples are for illustrative purposes only, and do not limit the scope of application of the present application. The raw materials or components used in this application can be prepared by commercial channels or conventional methods unless otherwise specified.

Example 1: The preparation formula of the pharmaceutical composition: weigh each raw material according to the following weight and set aside: 9g of white pepper, 6g of turmeric, 6g of woody incense, 6g of sumac, 3g of centella asiatica, 3g of emblica and 15g of silkworm; Wherein the weight ratio of white pepper and turmeric is 1.5:1, and the weight ratio of woody incense, sumac, centella asiatica and emblica is 2:2:1:1.

Preparation: Put the weighed white pepper and turmeric together into a round bottom flask, then add 75mL of ethanol solution with an ethanol concentration of 85% (the ratio of solid to liquid is 1g:5mL) in the round bottom flask, and place at 70°C Heated and refluxed extraction in a constant temperature water bath, extracted twice, 1 hour each time, combined filtrates to obtain ethanol extracts of white pepper and turmeric.

Heat the frying pan, sprinkle the bran evenly, when the bran burns and smoke, then add the silkworms to be fried, stir-fry quickly until the surface of the silkworms turns brown, take it out, sieve off the burnt bran residue, and let it dry cold. Then the fried silkworm is ground into powder to obtain silkworm powder.

Pulverize woody incense, sumac, centella asiatica and emblica together to prepare a mixed powder, add the mixed powder and silkworm powder to ethanol extracts of white pepper and turmeric to prepare a pharmaceutical composition.

Example 2: The preparation formula of the pharmaceutical composition: take each raw material according to the following weight and set aside: 15g of white pepper, 10g of turmeric, 6g of woody fragrance, 6g of sumac, 3g of centella asiatica, 3g of emblica and 15g of silkworm; Wherein the weight ratio of white pepper and turmeric is 1.5:1, and the weight ratio of woody incense, sumac, centella asiatica and emblica is 2:2:1:1.

Preparation: Put the weighed white pepper and turmeric together into a round bottom flask, then add 125mL of ethanol solution with an ethanol concentration of 85% (the ratio of solid to liquid is 1g:5mL) in the round bottom flask, and place at 70°C Heated and refluxed extraction in a constant temperature water bath, extracted twice, 1 hour each time, combined filtrates to obtain ethanol extracts of white pepper and turmeric.

Subsequent steps are the same as in Example 1.

Example 3: The preparation formula of the pharmaceutical composition: take the raw materials according to the following weights and set aside: 8g of white pepper, 8g of turmeric, 6g of woody incense, 6g of sumac, 3g of centella asiatica, 3g of emblica and 15g of silkworm; Wherein the weight ratio of white pepper and turmeric is 1:1, and the weight ratio of woody incense, sumac, centella asiatica and emblica is 2:2:1:1.

Preparation: Put the weighed white pepper and turmeric together into a round bottom flask, then add 80mL of ethanol solution with an ethanol concentration of 85% (the ratio of solid to liquid is 1g:5mL) in the round bottom flask, and place at 70°C Heated and refluxed extraction in a constant temperature water bath, extracted twice, 1 hour each time, combined filtrates to obtain ethanol extracts of white pepper and turmeric.

Subsequent steps are the same as in Example 1.

Example 4: The preparation formula of the pharmaceutical composition: Take the raw materials according to the following weights for later use: 9g of white pepper, 6g of turmeric, 3g of woody incense, 3g of sumac, 1.5g of centella asiatica, 1.5g of emblica and silkworm 15g; wherein the weight ratio of white pepper and turmeric is 1.5:1, and the weight ratio of woody incense, sumac, centella asiatica and emblica is 2:2:1:1.

Preparation: with embodiment 1.

Example 5: The preparation formula of the pharmaceutical composition: take each raw material according to the following weight and set aside: 9g of white pepper, 6g of turmeric, 8g of woody fragrance, 8g of sumac, 2g of centella asiatica, 2g of emblica and 15g of silkworm; Wherein the weight ratio of white pepper and turmeric is 1.5:1, and the weight ratio of woody incense, sumac, centella asiatica and emblica is 4:4:1:1.

Preparation: with embodiment 1.

Example 6: The preparation formula of the pharmaceutical composition: Weigh the raw materials according to the following weights for later use: 9g of white pepper, 6g of turmeric, 6g of woody incense, 6g of sumac, 3g of centella asiatica, 3g of emblica and 10g of silkworm; Wherein the weight ratio of white pepper and turmeric is 1.5:1, and the weight ratio of woody incense, sumac, centella asiatica and emblica is 2:2:1:1.

Preparation: with embodiment 1.

Example 7: The preparation formula of the pharmaceutical composition: weigh each raw material according to the following weight and set aside: 9g of white pepper, 6g of turmeric, 6g of woody incense, 6g of sumac, 3g of centella asiatica, 3g of emblica and 20g of silkworm; Wherein the weight ratio of white pepper and turmeric is 1.5:1, and the weight ratio of woody incense, sumac, centella asiatica and emblica is 2:2:1:1.

Preparation: with embodiment 1.

Embodiment 8: the preparation of pharmaceutical composition

Prescription: with embodiment 1.

Preparation: Put the weighed white pepper and turmeric together into a round bottom flask, then add 75mL of ethanol solution with an ethanol concentration of 95% (the ratio of solid to liquid is 1g:5mL) in the round bottom flask, and place at 70°C Heated and refluxed extraction in a constant temperature water bath, extracted twice, 1 hour each time, combined filtrates to obtain ethanol extracts of white pepper and turmeric.

All the other steps are the same as in Example 1.

Embodiment 9: the preparation of pharmaceutical composition

Prescription: with embodiment 1.

Preparation: Put the weighed white pepper and turmeric together into a round bottom flask, then add 45mL of ethanol solution with an ethanol concentration of 85% (the ratio of solid to liquid is 1g:3mL) in the round bottom flask, and place at 70°C Heated and refluxed extraction in a constant temperature water bath, extracted twice, 1 hour each time, combined filtrates to obtain ethanol extracts of white pepper and turmeric.

All the other steps are the same as in Example 1.

Embodiment 10: the preparation of pharmaceutical composition

Prescription: with embodiment 1.

Preparation: Put the weighed white pepper and turmeric together into a round bottom flask, then add 75mL of ethanol solution with an ethanol concentration of 85% (the ratio of solid to liquid is 1g:5mL) in the round bottom flask, and place at 65°C Heated and refluxed extraction in a constant temperature water bath, extracted twice, 1 hour each time, combined filtrates to obtain ethanol extracts of white pepper and turmeric.

All the other steps are the same as in Example 1.

Comparative Example 1: The preparation formula of the pharmaceutical composition: take each raw material medicine according to the following weight and set aside: white pepper 15g, woody wood 6g, sumac 6g, centella asiatica 3g, emblica 3g and silkworm 15g; The weight ratio of sapphire, sumac, centella asiatica and emblica is 2:2:1:1.

Preparation: Put the weighed white pepper into a round-bottomed flask, then add 75mL of ethanol solution with an ethanol concentration of 85% (the ratio of solid to liquid is 1g:5mL) into the round-bottomed flask, and place it in a constant temperature water bath at 70°C Heating and reflux extraction in the middle, extraction twice, 1 hour each time, combining the filtrates to obtain the ethanol extract of white pepper.

All the other steps are the same as in Example 1.

Comparative example 2: the preparation formula of pharmaceutical composition: according to the following weights, take each crude drug for later use: turmeric 15g, woody wood 6g, sumac 6g, centella asiatica 3g, emblica 3g and silkworm 15g; The weight ratio of sumac, centella asiatica and emblica is 2:2:1:1.

Preparation: put the weighed turmeric into a round-bottomed flask, then add 75mL of ethanol solution with an ethanol concentration of 85% (the ratio of solid to liquid is 1g:5mL) in the round-bottomed flask, and place it in a constant temperature water bath at 70°C Carry out heating and reflux extraction, extract twice, extract 1 hour each time, combine the filtrates, and obtain the ethanol extract of turmeric.

All the other steps are the same as in Example 1.

Comparative Example 3: The preparation formula of the pharmaceutical composition: take each raw material according to the following weight for later use: 9g of white pepper, 6g of turmeric, 9g of woody fragrance, 9g of sumac and 15g of silkworm; wherein the weight ratio of white pepper to turmeric It is 1.5:1.

Preparation: basically the same as in Example 1, the difference is that the coriander and sumac are pulverized together to obtain a mixed powder, and the mixed powder and silkworm powder are added to the ethanol extract of white pepper and turmeric to obtain pharmaceutical composition.

Comparative Example 4: The preparation formula of the pharmaceutical composition: take each raw material medicine according to the following weight and set aside: white pepper 9g, turmeric 6g, centella asiatica 9g, emblica 9g and silkworm 15g; wherein the weight of white pepper and turmeric The ratio is 1.5:1.

Preparation: basically the same as in Example 1, the difference is that Centella asiatica and Emlical emblica are pulverized together to obtain a mixed powder, and the mixed powder and silkworm powder are added to the ethanol extract of white pepper and turmeric to prepare obtain the pharmaceutical composition.

test case

The pharmaceutical compositions prepared in Examples 1-10 and Comparative Examples 1-4 were concentrated to a paste by rotary evaporation respectively, and then 10 g of maltodextrin and 5 g of magnesium stearate were added respectively, mixed to form wet granules, and machine punched into Tablets were made into tablets, each weighing 0.3 g.

1. Effects on pathological model rats with benign prostatic hyperplasia

80 adult healthy SD male rats, weighing 190±20g, were selected. Randomly select 5 rats as the normal group, and another 75 rats are injected intraperitoneally with 0.3mL/100g of 10% chloral hydrate for anesthesia. The anesthetized rats are fixed on the operating table, the skin of the scrotum is disinfected, and the bilateral testes are removed under aseptic conditions. , stitched. Penicillin 200,000 U/kg/d was injected intramuscularly into the inner thigh muscle for 7 consecutive days. After one week, castrated rats were randomly divided into 15 groups, 5 in every group, respectively: model group, 14 medication groups (administration was prepared by the pharmaceutical composition of embodiment 1-10 and comparative example 1-4 respectively) tablet). The experimental animals were raised in separate cages. Except the normal group, the remaining 15 groups of rats were fed with testosterone propionate (1mg/300g body weight) once a day, and the drug group was fed with the medicinal solution prepared from the above tablets simultaneously (the tablets were ground to Add water and mix after crushing), 0.3g tablet/100g body weight, and the normal group is given an equal volume of water for gavage. The drug was administered continuously for 30 days from the 7th day after the operation. After 5 hours after the last administration, the body weight of the rats in each group was weighed, then the rats were killed, the rat prostate was dissected and separated, the wet weight was weighed with an electronic balance, the volume of the prostate was measured by the volumetric method, and the weight coefficient of the prostate was calculated (wet weight of the prostate/large Rat body weight (mg/100g)) and prostate volume coefficient (prostate volume/rat body weight (cm ³ /100g)), the results are shown in Table 1. In addition, during the administration period and 30 days after drug withdrawal, the growth status, activity and diet of the rats were observed, and the hematology, blood biochemistry, organ tissue structure, and urine routine were identified. As a result, all rats were found to be healthy and survived without any toxic or side effects; the blood picture, liver function, and the state of various organs and tissues were observed by dissection, and there was no difference compared with normal rats, indicating that the pharmaceutical composition of the present application has no toxic and side effects and can be used safely.

Table 1

As can be seen from Table 1, compared with the rats of the model group and the rats taking the pharmaceutical composition prepared in Comparative Examples 1-4, the prostate weight coefficient and prostate volume coefficient of the rats taking the pharmaceutical composition prepared in Examples 1-10 were both be significantly reduced. It shows that the pharmaceutical composition provided by the application has obvious effect on treating benign prostatic hyperplasia. The detection results of Example 1 and Comparative Example 1-2 show that the white pepper and turmeric in the pharmaceutical composition of the present application have a synergistic effect; the detection results of Example 1 and comparison 3-4 show that the pharmaceutical composition of the application The woody wood, sumac, centella asiatica and emblica also have a synergistic effect. From the detection result of embodiment 1-10 as can be known, when the formula (parts by weight) of each crude drug in the pharmaceutical composition is: 9 parts of white pepper, 6 parts of turmeric, 6 parts of woody fragrance, 6 parts of sumac, 3 parts of centella asiatica Parts, 3 parts of emblica and 15 parts of silkworm; wherein the weight ratio of white pepper and turmeric is 1.5:1, and the weight ratio of woody fragrance, sumac, centella asiatica and emblica is 2:2:1:1 , can make the effect of the pharmaceutical composition for treating hyperplasia of the prostate best.

2. Curative effect on patients with benign prostatic hyperplasia

(1) Patient information

There are a total of 60 patients, aged over 45 and under 65.

(2) Diagnostic criteria: The observed patients refer to the "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine" promulgated by the Ministry of Health as the diagnostic criteria:

History of dysuria: hesitancy, time-consuming and laborious urination, thin and weak urine stream, residual urine sensation, frequent nocturia, and even urinary incontinence; DRE: enlargement of both lobes of the prostate gland, or disappearance of the middle sulcus;

Ultrasound examination: transrectal ultrasound is the most ideal, most of the prostate gland has uniform density, symmetrical enlargement, and weight > 20g; urine flow rate measurement: urine volume ≥ 200mL is appropriate, and the maximum urine flow rate is < 15mL/s;

Urethrocystography: upward pressure on the bladder can be found and the posterior urethra is compressed and elongated, and the lateral view shows a semi-expanded fan-shaped image.

Urethral cystoscopy: Hyperplasia on both sides or middle lobes of the prostate can be found, protruding toward the urethra or bladder.

(3) Treatment method

The patient took the pharmaceutical composition of Example 1 of the present application orally, once a day in the morning, noon and evening, taking 3 tablets each time, and the course of treatment was 1 month.

(4) Curative effect judgment standard: refer to the curative effect judgment standard of "Guiding Principles for Clinical Research of New Chinese Medicines" promulgated by the Ministry of Health;

Cure: all symptoms disappear, and the results of routine examination of prostatic fluid are normal;

Significantly effective: the volume of the prostate gland is reduced to 60% of its original size, and the maximum urine flow rate is ≥18mL/s;

Effective: the volume of the prostate is reduced to less than 80% of the original volume, the residual urine volume is reduced by more than 50%, and the maximum urinary flow rate is ≥12mL/s; Ineffective: the volume of the prostate does not change significantly.

(5) Treatment effect

Among the 60 patients, 32 were cured, 14 were markedly effective, 9 were effective, and 5 were ineffective. The total effective rate was 91.67%.

It should be noted that the above-mentioned embodiments are only used to explain the present application, and do not constitute any limitation to the present application. This application has been described with reference to typical embodiments, but the words which have been used therein are words of description and explanation rather than words of limitation. Amendments may be made to the application as prescribed within the scope of the claims of the application, and the invention may be amended without departing from the scope and spirit of the application. Although the application described therein relates to specific methods, materials, and examples, it does not mean that the application is limited to the specific examples disclosed therein. On the contrary, the application can be extended to all other methods and applications having the same function.

Claims (10)

1. a pharmaceutical composition for the treatment of prostatic hyperplasia, characterized in that, in parts by weight, the preparation raw materials of the pharmaceutical composition comprise the following components: 5-15 parts of white pepper, 5-10 parts of turmeric, 3-8 parts of woody fragrance, 3-8 parts of sumac, 1-5 parts of centella asiatica, 1-5 parts of emblica and 10-20 parts of silkworm. 2. pharmaceutical composition according to claim 1, is characterized in that, the parts by weight of described white pepper is 8～10 parts, and the parts by weight of described turmeric is 6～8 parts, and described white pepper and The weight ratio of turmeric is (1~2):1. 3. The pharmaceutical composition according to claim 1 or 2, characterized in that, the parts by weight of the woody fragrance is 5~6 parts, the parts by weight of the sumac is 5~6 parts, and the parts by weight of the product The parts by weight of Centella emblica are 2~4 parts, the parts by weight of the emblica are 2~4 parts; : (2~3): (1~2): (1~2). 4. The pharmaceutical composition according to claim 3, wherein the parts by weight of the woody fragrance is 6 parts, the parts by weight of the sumac is 6 parts, and the parts by weight of the Centella asiatica are 6 parts by weight. 3 parts, the parts by weight of the emblical seed are 3 parts; 5. The pharmaceutical composition according to claim 1 or 2, characterized in that the parts by weight of the silkworm are 14-16 parts. 6. A method for preparing the pharmaceutical composition according to any one of claims 1-5, characterized in that the method comprises the following steps: S1, preparing the ethanol extract of white pepper and turmeric; S2, fry the silkworm and grind it into powder to obtain silkworm powder; S3, pulverizing woody incense, sumac, centella asiatica and emblica to obtain a mixed powder, adding the mixed powder and silkworm powder to the ethanol extract of white pepper and turmeric to obtain the drug combination things. 7. The method according to claim 6, wherein the step S1 specifically comprises: adding the ground white pepper and turmeric to the ethanol solution, heating and refluxing extraction to obtain the ethanol extract of the white pepper and turmeric . 8. The method according to claim 7, characterized in that, the parameters of the heating and reflux extraction are: the concentration of ethanol in the ethanol solution is 75%~95%; the ratio of solid to liquid is 1g:(3~8)mL; The number of extractions is 2~3 times; the extraction temperature is 65~75°C; the time for a single extraction is 0.5~1.5h. 9. method according to claim 8, is characterized in that, the parameter of described heated reflux extraction is: the concentration of ethanol in the ethanol solution is 85%; Solid-liquid ratio is 1g:5mL; Extraction number of times is 2 times; Extraction temperature 70°C; the time for a single extraction is 1h. 10. A pharmaceutical composition as described in any one of claims 1-5 or a pharmaceutical composition prepared by any one of the methods described in claims 6-8 is used for the treatment and/or prevention of benign prostatic hyperplasia. application in medicine.