CN116077606A - Pharmaceutical composition for treating prostatic hyperplasia, preparation method and application - Google Patents
Pharmaceutical composition for treating prostatic hyperplasia, preparation method and application Download PDFInfo
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- CN116077606A CN116077606A CN202310234052.4A CN202310234052A CN116077606A CN 116077606 A CN116077606 A CN 116077606A CN 202310234052 A CN202310234052 A CN 202310234052A CN 116077606 A CN116077606 A CN 116077606A
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- A—HUMAN NECESSITIES
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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
Technical Field
The application relates to the technical field of medicines, in particular to a pharmaceutical composition for treating prostatic hyperplasia, a preparation method and application.
Background
The prostatic hyperplasia (benign prostatic hyperplasia, BPH) is a common disease of old men, and is manifested by symptoms such as hesitancy to urinate, frequent urination, urgent urination, nocturia, urinary retention and the like, and can cause symptoms such as urinary tract infection, vesical calculus, even kidney function damage and the like, and seriously affects the normal life of patients. Epidemiological statistics indicate that men have a lower incidence before age 40, begin to increase after age 50, reaching 50% at age 60 and up to approximately 90% at age 80. The prostatic hyperplasia is a chronic process, and long-term urinary tract obstruction is easy to be complicated with infection, hydronephrosis, renal insufficiency, vesical calculus, uremia, renal hypertension and the like. Along with the aggravation of the aging society in China, the treatment of the disease is particularly urgent.
Western medicine considers that the cause of prostatic hyperplasia is not completely elucidated, and functional testes and advanced age are two important conditions for pathogenesis. Surgical therapy is an important method for treating prostatic hyperplasia by western medicine, but patients generally suffer from great pain and risk, and the cost of surgical treatment is high. Western medicines for treating prostatic hyperplasia have various varieties and certain curative effects, but have large toxic and side effects, and are extremely easy to cause adverse effects on the bodies of patients, especially the elderly patients.
At present, a plurality of reports for treating the prostatoplasia by adopting a method of dialectical treatment of traditional Chinese medicine exist, for example, the prior art discloses a pharmaceutical composition for treating prostatitis and prostatic hyperplasia, and the composition is prepared from the following raw materials in parts by weight: 10-30 parts of turtle shell, 10-20 parts of tortoise shell, 0.5-3 parts of ground beetle, 0.1-1 part of leech, 0.2-2 parts of centipede, 3-9 parts of bulb of edible tulip, 0.5-3 parts of pangolin scales, 10-20 parts of astragalus membranaceus, 5-15 parts of ginseng, 10-20 parts of rhizoma corydalis, 10-20 parts of herba lycopi, 1-6 parts of pseudo-ginseng, 5-12 parts of peach kernel, 9-15 parts of dogwood, 1-6 parts of amber, 3-9 parts of green tangerine peel, 9-15 parts of red bean, 9-15 parts of fennel, 9-15 parts of sappan wood, 5-12 parts of pinellia tuber, 10-20 parts of semen cuscutae, 5-15 parts of rehmannia glutinosa, 3-9 parts of fritillary bulb, 10-20 parts of white gourd seed, 9-15 parts of grassleaf sweelflag rhizome, 5-15 parts of szechwan chinaberry fruit, 9-15 parts of Chinese yam, 5-12 parts of rhizoma zedoariae, 10-20 parts of red vine, 5-15 parts of white mustard seed, 0.5-2 parts of medicinal cyathula root, 9-15 parts of Chinese eaglewood, 9-15 parts of szechuan lovage rhizome and 1-4 parts of dragon's blood. The composition can be used for treating prostatitis and prostatic hyperplasia, but the composition has complicated components, and the effect of treating prostatic hyperplasia is required to be further improved.
It is therefore desirable to provide a pharmaceutical composition which is simple in composition and has a remarkable effect of treating prostatic hyperplasia.
Disclosure of Invention
In order to solve the defects of the prior art, the application provides a novel pharmaceutical composition for treating the prostatic hyperplasia, the pharmaceutical composition is simple in formula, has a remarkable treatment effect on the prostatic hyperplasia, and can be better applied to the treatment of the prostatic hyperplasia.
For this reason, the first aspect of the present application provides a pharmaceutical composition for treating prostatic hyperplasia, wherein the raw materials for preparing the pharmaceutical composition include the following components in parts by weight:
5 to 15 parts of white pepper, 5 to 10 parts of turmeric, 3 to 8 parts of costustoot, 3 to 8 parts of sappan wood, 1 to 5 parts of centella asiatica, and 1 to 5 parts of emblic leafflower fruit
And 10-20 parts of stiff silkworm.
In the application, the white pepper in the pharmaceutical composition is the fruit of the pepper plant of the piperaceae, has the effects of warming the middle-jiao and dispelling cold, descending qi and the like, and has activities in various aspects such as anticancer, pain relieving, sedation, cytoprotection, anti-inflammatory, bacteriostasis and disinsection; piperine in fructus Piperis is active ingredient of fructus Piperis, and has effects of resisting tumor, oxidation, digestive system ulcer and depression. Turmeric is the dried rhizome of Curcuma longa belonging to the family Zingiberaceae, has pungent and bitter taste, and has effects of removing blood stasis, activating qi-flowing, dredging channels and relieving pain; curcumin in turmeric has good anti-tumor effect, can effectively inhibit proliferation of tumor cells, increase apoptosis of the tumor cells, reduce the number of tumors, reduce the volume of the tumors, and reverse malignant phenotype of cancer cells to a certain extent. The white pepper in the pharmaceutical composition and the piperine and curcumin in the turmeric can be mutually promoted to achieve the aim of synergy, and can be better applied to the treatment of the prostatic hyperplasia.
In the application, the common name of the costustoot and the costustoot in the asteraceae plant of costustoot in the pharmaceutical composition has the effects of promoting qi circulation, relieving pain, warming the middle-jiao, regulating the stomach, relieving diarrhea with astringents and the like; the sappan wood is a plant of Caesalpinia genus of Leguminosae family, is a common medicine in clinic, is recorded in the 'materia medica schema', is a blood component medicine of Sanyinjiao, is used for regulating blood when used for a small amount, is used for breaking blood when used for a large amount, has the effects of promoting qi circulation, breaking blood stasis, relieving swelling and pain, can promote blood circulation and enhance immunity when used for a large amount, and is used for calming the liver meridian; centella asiatica is the whole herb of centella asiatica of the family Umbelliferae, has the effects of clearing heat and promoting diuresis, promoting blood circulation and stopping bleeding, and detoxifying and relieving swelling, and asiaticoside and madecassoside in centella asiatica have a plurality of pharmacological effects, such as collagen fiber inhibition, fibrous tissue proliferation inhibition and skin ulcer treatment; the phyllanthus emblica is a plant of phyllanthus of Euphorbiaceae, has sweet, sour, astringent and cool nature, has the effects of promoting digestion, invigorating stomach, clearing heat and detoxicating, and has the excellent effects of scavenging free radicals and resisting tumors, and modern pharmacology shows that the phyllanthus emblica contains a large amount of superoxide dismutase and 11.8% of vitamins. The costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica in the pharmaceutical composition can be mutually promoted to achieve the aim of synergy, and further the effect of the pharmaceutical composition on treating the prostatic hyperplasia can be further improved.
In the application, the stiff silkworm in the pharmaceutical composition has the effects of dispelling wind, relieving spasm, reducing phlegm, resolving masses and the like, has flat nature, salty and pungent taste, and enters liver, lung and stomach meridians, and is clinically used for treating tangible masses such as nodules, sore throat, scrofula, wind sore and urticaria and the like, and all take the effects of dredging and resolving. The stiff silkworm in the pharmaceutical composition can be mutually complemented and matched with the plant components in the pharmaceutical composition, so that the pharmaceutical composition can be better applied to the treatment of the prostatic hyperplasia.
Further, the present application can make the effect of the pharmaceutical composition better by controlling the content of each drug substance in the pharmaceutical composition within the above-described range.
In some embodiments, the weight fraction of white pepper is 8-10 parts, the weight fraction of turmeric is 6-8 parts, and the weight ratio of white pepper to turmeric is (1-2): 1.
In some preferred embodiments, the weight fraction of white pepper is 9 parts, the weight fraction of turmeric is 6 parts, and the weight ratio of white pepper to turmeric is 1.5:1.
According to the application, the weight parts of the white pepper and the turmeric in the pharmaceutical composition and the weight relation of the white pepper and the turmeric are controlled within the above range, so that the synergistic effect of the white pepper and the turmeric can be better exerted, and the curative effect of the pharmaceutical composition is further improved.
In some embodiments, the weight portion of the costustoot is 5-6, the weight portion of the sappan wood is 5-6, the weight portion of the centella asiatica is 2-4, and the weight portion of the phyllanthus emblica is 2-4; and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is (2-3) (1-2).
In some preferred embodiments, the weight part of the costustoot is 6 parts, the weight part of the sappan wood is 6 parts, the weight part of the centella asiatica is 3 parts, and the weight part of the phyllanthus emblica is 3 parts; and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
According to the preparation method, the weight parts of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica in the pharmaceutical composition and the weight relation of the four are controlled within the range, so that the synergistic effect of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica can be better exerted, and the curative effect of the pharmaceutical composition is further improved.
In some specific embodiments, the weight parts of stiff silkworm in the pharmaceutical composition may be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, or the like. In some preferred embodiments, the weight fraction of stiff silkworm in the pharmaceutical composition is 14-16 parts. In some more preferred embodiments, the weight fraction of stiff silkworm in the pharmaceutical composition is 15 parts.
In the application, the stiff silkworm in the pharmaceutical composition belongs to animal components, the content of the stiff silkworm can be controlled within the range and can be better matched with plant components in the composition in a mutually compensating way, the curative effect of the plant components on the prostatic hyperplasia is improved, and simultaneously the toxic and side effects of the components on the body are reduced, so that the effect of the pharmaceutical composition for treating the prostatic hyperplasia is exerted to the best.
Thus, in a preferred embodiment of the present application, the raw materials for preparing the pharmaceutical composition comprise the following components in parts by weight: 9 parts of white pepper, 6 parts of turmeric, 6 parts of costustoot, 6 parts of sappan wood, 3 parts of centella asiatica, 3 parts of phyllanthus emblica and 15 parts of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1.5:1, and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
In the application, pharmaceutically acceptable auxiliary materials or auxiliary components can be added into the pharmaceutical composition according to the requirement so as to prepare a preparation, such as an oral preparation. The oral preparation can be, for example, decoction, paste, oral liquid, granule, capsule, pill, tablet or powder, etc.
A second aspect of the present application provides a method of preparing a pharmaceutical composition as described in the first aspect of the present application, the method comprising the steps of:
s1, preparing ethanol extracts of white pepper and turmeric;
s2, parching Bombyx Batryticatus, and grinding into powder to obtain Bombyx Batryticatus powder;
s3, crushing the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica to obtain mixed powder, and adding the mixed powder and the stiff silkworm powder into the ethanol extract of the white pepper and the turmeric to obtain the pharmaceutical composition.
In the application, the white pepper and the turmeric in the pharmaceutical composition are ethanol extract of the white pepper and the turmeric, and piperine in the white pepper and curcumin in the turmeric can be fully extracted by preparing the ethanol extract of the white pepper and the turmeric, so that the curative effect of the pharmaceutical composition is more favorably exerted.
In some embodiments, the step S1 specifically includes: pulverizing fructus Piperis and Curcuma rhizome, adding into ethanol solution, and reflux extracting under heating to obtain ethanol extractive solution of fructus Piperis and Curcuma rhizome.
In the application, the effective components in the white pepper and the turmeric can be extracted in one step, so that the preparation steps are simplified, and the production cost is reduced.
In some embodiments, the parameters of the heated reflux extraction are: the concentration of ethanol in the ethanol solution is 75% -95%; the feed liquid ratio is 1g (3-8) mL; the extraction times are 2-3 times; the extraction temperature is 65-75 ℃; the time of single extraction is 0.5-1.5 h.
In some preferred embodiments, the parameters of the heated reflux extraction are: the concentration of ethanol in the ethanol solution is 85%; the feed liquid ratio is 1g to 5mL; the extraction times are 2 times; the extraction temperature is 70 ℃; the time of single extraction was 1h.
In the present application, the concentration of ethanol in the ethanol solution refers to the volume fraction of ethanol; the feed liquid ratio refers to the mass-volume ratio of the total mass of white pepper and turmeric to the ethanol solution. The ethanol extracting solution of the white pepper and the turmeric is prepared under the extracting conditions, so that the effective components in the white pepper and the turmeric can be extracted in one step, and the content of piperine and curcumin in the extracting solution is optimized, so that the pharmaceutical composition can better treat the prostatic hyperplasia.
In some embodiments, the stir-frying process of the stiff silkworm in step S2 is as follows: heating the frying pan, uniformly spreading bran, adding Bombyx Batryticatus to be fried when the bran is coked to give strong smoke, rapidly parching to brown yellow surface, taking out, sieving to remove Jiao Fuzha, and spreading for cooling.
In a third aspect the present application provides the use of a pharmaceutical composition as described in the first aspect of the present application or a pharmaceutical composition prepared by a method as described in the second aspect of the present application in the manufacture of a medicament for the treatment and/or prophylaxis of prostate hyperplasia.
The pharmaceutical composition contains the raw materials with specific proportion, and can effectively treat the prostatic hyperplasia through the synergistic cooperation of the raw materials, and the pharmaceutical composition has a simple formula and a simple and easy preparation method, and can be well applied to the preparation of the medicaments for treating and/or preventing the prostatic hyperplasia.
The beneficial technical effect of this application: 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 simple formula, simple and feasible preparation method and good application prospect, and can be well applied to the preparation of medicaments for treating and/or preventing the prostatic hyperplasia.
Detailed Description
In order that the present application may be more readily understood, the following examples are presented in conjunction with the following detailed description, which are intended to be illustrative only and are not intended to limit the scope of application of the present application. The starting materials or components used in the present application may be prepared by commercial or conventional methods unless specifically indicated.
Example 1: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 9g of white pepper, 6g of turmeric, 6g of costustoot, 6g of sappan wood, 3g of centella asiatica, 3g of phyllanthus emblica and 15g of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1.5:1, and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
Preparation: pulverizing the weighed white pepper and turmeric together, putting into a round-bottom flask, adding 75mL of ethanol solution with the ethanol concentration of 85% (the ratio of feed to liquid is 1g:5 mL) into the round-bottom flask, placing into a constant-temperature water bath with the temperature of 70 ℃ for heating and reflux extraction, extracting for 1 hour each time, and combining the filtrates to obtain the ethanol extract of the white pepper and turmeric.
Heating the frying pan, uniformly spreading bran, adding Bombyx Batryticatus to be fried when the bran is coked to give strong smoke, rapidly parching to brown yellow surface, taking out, sieving to remove Jiao Fuzha, and spreading for cooling. And grinding the fried stiff silkworm into powder to obtain stiff silkworm powder.
Pulverizing radix aucklandiae, lignum sappan, herba Centellae and fructus Phyllanthi together to obtain mixed powder, adding the mixed powder and Bombyx Batryticatus powder into ethanol extractive solution of fructus Piperis and Curcuma rhizome, and making into pharmaceutical composition.
Example 2: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 15g of white pepper, 10g of turmeric, 6g of costustoot, 6g of sappan wood, 3g of centella asiatica, 3g of phyllanthus emblica and 15g of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1.5:1, and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
Preparation: pulverizing the weighed white pepper and turmeric together, then placing into a round-bottom flask, adding 125mL of ethanol solution with the ethanol concentration of 85% (the ratio of feed to liquid is 1g:5 mL) into the round-bottom flask, placing into a constant-temperature water bath with the temperature of 70 ℃ for heating and reflux extraction, extracting for 1 hour each time, and combining the filtrates to obtain the ethanol extract of the white pepper and turmeric.
The subsequent procedure is as in example 1.
Example 3: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 8g of white pepper, 8g of turmeric, 6g of costustoot, 6g of sappan wood, 3g of centella asiatica, 3g of phyllanthus emblica and 15g of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1:1, and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
Preparation: pulverizing the weighed white pepper and turmeric together, then placing into a round-bottom flask, adding 80mL of ethanol solution with the ethanol concentration of 85% (the ratio of feed to liquid is 1g:5 mL) into the round-bottom flask, placing into a constant-temperature water bath with the temperature of 70 ℃ for heating and reflux extraction, extracting for 1 hour each time, and combining the filtrates to obtain the ethanol extract of the white pepper and turmeric.
The subsequent procedure is as in example 1.
Example 4: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 9g of white pepper, 6g of turmeric, 3g of costustoot, 3g of sappan wood, 1.5g of centella asiatica, 1.5g of emblic leafflower fruit and 15g of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1.5:1, and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
Preparation: as in example 1.
Example 5: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 9g of white pepper, 6g of turmeric, 8g of costustoot, 8g of sappan wood, 2g of centella asiatica, 2g of phyllanthus emblica and 15g of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1.5:1, and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 4:4:1:1.
Preparation: as in example 1.
Example 6: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 9g of white pepper, 6g of turmeric, 6g of costustoot, 6g of sappan wood, 3g of centella asiatica, 3g of phyllanthus emblica and 10g of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1.5:1, and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
Preparation: as in example 1.
Example 7: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 9g of white pepper, 6g of turmeric, 6g of costustoot, 6g of sappan wood, 3g of centella asiatica, 3g of phyllanthus emblica and 20g of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1.5:1, and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
Preparation: as in example 1.
Example 8: preparation of pharmaceutical compositions
The formula comprises the following components: as in example 1.
Preparation: pulverizing the weighed white pepper and turmeric together, then placing into a round-bottom flask, adding 75mL of ethanol solution with the concentration of 95% (the ratio of the feed to the liquid is 1g:5 mL) into the round-bottom flask, placing into a constant-temperature water bath with the temperature of 70 ℃ for heating and reflux extraction, extracting for 1 hour each time, and combining the filtrates to obtain the ethanol extract of the white pepper and turmeric.
The rest of the procedure is the same as in example 1.
Example 9: preparation of pharmaceutical compositions
The formula comprises the following components: as in example 1.
Preparation: pulverizing the weighed white pepper and turmeric together, then placing into a round-bottom flask, adding 45mL of ethanol solution with the concentration of 85% (the ratio of the feed to the liquid is 1g:3 mL) into the round-bottom flask, placing into a constant-temperature water bath with the temperature of 70 ℃ for heating and reflux extraction, extracting for 1 hour each time, and combining the filtrates to obtain the ethanol extract of the white pepper and turmeric.
The rest of the procedure is the same as in example 1.
Example 10: preparation of pharmaceutical compositions
The formula comprises the following components: as in example 1.
Preparation: pulverizing the weighed white pepper and turmeric together, putting into a round-bottom flask, adding 75mL of ethanol solution with the ethanol concentration of 85% (the ratio of feed to liquid is 1g:5 mL) into the round-bottom flask, placing into a constant-temperature water bath with the temperature of 65 ℃ for heating and reflux extraction, extracting for 1 hour each time, and combining the filtrates to obtain the ethanol extract of the white pepper and turmeric.
The rest of the procedure is the same as in example 1.
Comparative example 1: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 15g of white pepper, 6g of costustoot, 6g of sappan wood, 3g of centella asiatica, 3g of phyllanthus emblica and 15g of stiff silkworm; wherein the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
Preparation: crushing the weighed white pepper, putting the crushed white pepper into a round-bottom flask, adding 75mL of ethanol solution with the ethanol concentration of 85% (the ratio of feed to liquid is 1g:5 mL) into the round-bottom flask, placing the mixture into a constant-temperature water bath with the temperature of 70 ℃ for heating and reflux extraction, extracting for 1 hour each time, and combining the filtrates to obtain the ethanol extract of the white pepper.
The rest of the procedure is the same as in example 1.
Comparative example 2: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 15g of turmeric, 6g of costustoot, 6g of sappan wood, 3g of centella asiatica, 3g of phyllanthus emblica and 15g of stiff silkworm; wherein the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1.
Preparation: crushing the weighed turmeric, putting the crushed turmeric into a round-bottom flask, adding 75mL of ethanol solution with the concentration of 85% (the ratio of feed to liquid is 1g:5 mL) into the round-bottom flask, placing the mixture into a constant-temperature water bath with the temperature of 70 ℃ for heating reflux extraction, extracting for 1 hour each time, and combining the filtrates to obtain the ethanol extract of turmeric.
The rest of the procedure is the same as in example 1.
Comparative example 3: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 9g of white pepper, 6g of turmeric, 9g of costustoot, 9g of sappan wood and 15g of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1.5:1.
Preparation: basically, the same as in example 1, except that the costustoot and the sappan wood were pulverized together to prepare a mixed powder, and the mixed powder and the stiff silkworm powder were added to an ethanol extract of white pepper and turmeric to prepare a pharmaceutical composition.
Comparative example 4: the preparation formula of the pharmaceutical composition comprises the following steps: weighing the raw materials according to the following weight for later use: 9g of white pepper, 6g of turmeric, 9g of centella asiatica, 9g of phyllanthus emblica and 15g of stiff silkworm; wherein the weight ratio of the white pepper to the turmeric is 1.5:1.
Preparation: basically, the same as in example 1, except that centella asiatica and phyllanthus emblica are pulverized together to prepare a mixed powder, and the mixed powder and the stiff silkworm powder are added to an ethanol extract of white pepper and turmeric to prepare a pharmaceutical composition.
Test case
The pharmaceutical compositions prepared in examples 1 to 10 and comparative examples 1 to 4 were each concentrated to a paste by rotary evaporation, and then 10g of maltodextrin and 5g of magnesium stearate were each added, mixed to prepare wet granules, and machine-punched into tablets each weighing 0.3g.
1. Effects on rats with pathological model of prostatic hyperplasia
80 adult healthy SD male rats are selected and weighing 190+ -20 g. Randomly taking 5 rats as a normal group, taking 75 rats which are successfully anesthetized by injecting 10% chloral hydrate into the abdominal cavity according to 0.3mL/100g, anesthetizing, fixing the anesthetized rats on an operating table, sterilizing scrotum skin, removing bilateral testes under aseptic conditions, and suturing. Intramuscular injection of penicillin at the medial thigh muscle was 20 ten thousand U/kg/d for 7 consecutive days. After one week, castrated rats were randomly divided into 15 groups of 5 animals each: model group, 14 drug groups (tablets prepared from the pharmaceutical compositions of examples 1-10 and comparative examples 1-4 were administered, respectively). The experimental animals are fed in separate cages, except for normal groups15 groups of rats are infused with testosterone propionate (1 mg/300g of body weight) once a day, and the drug administration group is simultaneously infused with the liquid medicine prepared by the tablets (the tablets are crushed and then are mixed with water), 0.3g of the tablets/100 g of body weight is added, and the normal group is given with equal volume of water to be infused into the stomach. The administration was continued for 30 days from 7 days after the operation. After 5 hours from the last dose, the rats were weighed, the rat was sacrificed, the rat prostate was isolated by dissection, the wet weight was weighed by an electronic balance, the prostate volume was measured by a volumetric method, and the prostate weight coefficient (wet prostate weight/rat weight (mg/100 g)) and the prostate volume coefficient (prostate volume/rat weight (cm)) were calculated 3 100 g) and the results are shown in Table 1. In addition, during the administration period and 30 days after the withdrawal, the growth state and active diet of rats were observed, and hematology, hematochemistry, organ tissue structure, urine regulation, and the like were identified. The result shows that all rats live healthily without any toxic or side effect; anatomical observation of hemogram, liver function and tissue state of each organ is not different from that of normal rats, which shows that the pharmaceutical composition of the application has no toxic or side effect and can be safely used.
TABLE 1
As can be seen from Table 1, the rats taking the pharmaceutical compositions prepared in examples 1 to 10 have significantly lower prostate weight and prostate volume coefficients than the model group and rats taking the pharmaceutical compositions prepared in comparative examples 1 to 4. The medicine composition provided by the application has obvious effect on treating the prostatic hyperplasia. The detection results of the example 1 and the comparative examples 1-2 show that the white pepper and the turmeric in the pharmaceutical composition have a synergistic effect; the results of the test in example 1 and comparative examples 3-4 show that the medicinal composition of the present application has the same synergistic effect as the banksia rose, sappan wood, centella asiatica and phyllanthus emblica. From the detection results of examples 1 to 10, when the pharmaceutical composition comprises the following raw materials in parts by weight: 9 parts of white pepper, 6 parts of turmeric, 6 parts of costustoot, 6 parts of sappan wood, 3 parts of centella asiatica, 3 parts of phyllanthus emblica and 15 parts of stiff silkworm; wherein, when the weight ratio of the white pepper to the turmeric is 1.5:1, and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is 2:2:1:1, the effect of the pharmaceutical composition for treating the prostatic hyperplasia can be optimized.
2. Therapeutic effect on patients with prostatic hyperplasia
(1) Patient data
The patients were 60 cases total, aged 45 years above and 65 years below.
(2) Diagnostic criteria: the observed patient refers to the diagnosis standard of the Chinese medicine New drug clinical study guidelines issued by the Ministry of health:
history of dysuria: hesitancy to urinate, time and effort consuming, thin urine line, no force, residual urine feeling, frequent nocturia, and even incontinence; anus referring to the diagnosis: the lobes on both sides of the prostate gland enlarge, or the middle groove disappears;
ultrasonic inspection: the transrectal ultrasonic tomography is most ideal, the density of the large part of the prostate is uniform, the symmetry is enlarged, and the weight is more than 20g; urine flow rate measurement: the urine volume is preferably more than or equal to 200mL, and the maximum urine flow rate is less than 15mL/s;
urinary bladder imaging: it can be seen that the upward pressure on the bladder and the posterior urethra are prolonged, and the lateral aspect presents a half-spread fan-shaped image.
Urocystoscopy: hyperplasia of both lateral and medial lobes of the prostate can be found, protruding toward the urethra or bladder.
(3) Therapeutic method
The pharmaceutical composition of example 1 of the present application was orally administered to the patient once a day, 3 tablets each time, and the course of treatment was 1 month.
(4) Curative effect judgment criteria: the curative effect judgment standard of the 'Chinese medicine new medicine clinical research guidelines' issued by the ministry of health is referred to;
and (3) curing: the symptoms completely disappear, and the routine examination result of the prostatic fluid is normal;
the effect is shown: the volume of the prostate is reduced to 60 percent of the original volume, and the maximum urine flow rate is more than or equal to 18mL/s;
the method is effective: the volume of the prostate is reduced to be less than 80 percent of the original volume, the residual urine quantity is reduced by more than 50 percent, and the maximum urine flow rate is more than or equal to 12mL/s; invalidation: the volume of the prostate does not change significantly.
(5) Therapeutic effects
Of 60 patients, 32 patients are cured, 14 patients are treated effectively, 9 patients are treated effectively, 5 patients are treated effectively, and the total effective rate reaches 91.67%.
It should be noted that the above-described embodiments are only for explaining the present application, and do not constitute any limitation to the present application. The present application has been described with reference to exemplary embodiments, but it is understood that the words which have been used are words of description and illustration, rather than words of limitation. Modifications may be made to the present application as defined within the scope of the claims of the present application, and the invention may be modified without departing from the scope and spirit of the present application. Although the present application is described herein with reference to particular methods, materials and embodiments, the present application is not intended to be limited to the particular examples disclosed herein, but rather, the present application is intended to extend to all other methods and applications having the same functionality.
Claims (10)
1. The pharmaceutical composition for treating the prostatic hyperplasia is characterized by comprising the following raw materials 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.
2. The pharmaceutical composition according to claim 1, wherein the weight part of the white pepper is 8-10 parts, the weight part of the turmeric is 6-8 parts, and the weight ratio of the white pepper to the turmeric is (1-2): 1.
3. The pharmaceutical composition according to claim 1 or 2, wherein the weight part of the costustoot is 5-6 parts, the weight part of the sappan wood is 5-6 parts, the weight part of the centella asiatica is 2-4 parts, and the weight part of the phyllanthus emblica is 2-4 parts; and the weight ratio of the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica is (2-3) (1-2).
4. The pharmaceutical composition according to claim 3, wherein the weight part of the costustoot is 6 parts, the weight part of the sappan wood is 6 parts, the weight part of the centella asiatica is 3 parts, and the weight part of the phyllanthus emblica is 3 parts; and the weight ratio of the costustoot to the sappan wood to the centella asiatica to the phyllanthus emblica is 2:2:1:1.
5. The pharmaceutical composition according to claim 1 or 2, wherein the stiff silkworm is 14-16 parts by weight.
6. A method of preparing a pharmaceutical composition according to any one of claims 1-5, comprising the steps of:
s1, preparing ethanol extracts of white pepper and turmeric;
s2, parching Bombyx Batryticatus, and grinding into powder to obtain Bombyx Batryticatus powder;
s3, crushing the costustoot, the sappan wood, the centella asiatica and the phyllanthus emblica to obtain mixed powder, and adding the mixed powder and the stiff silkworm powder into the ethanol extract of the white pepper and the turmeric to obtain the pharmaceutical composition.
7. The method according to claim 6, wherein the step S1 specifically includes: pulverizing fructus Piperis and Curcuma rhizome, adding into ethanol solution, and reflux extracting under heating to obtain ethanol extractive solution of fructus Piperis and Curcuma rhizome.
8. The method of claim 7, wherein the parameters of the heated reflux extraction are: the concentration of ethanol in the ethanol solution is 75% -95%; the feed liquid ratio is 1g (3-8) mL; the extraction times are 2-3 times; the extraction temperature is 65-75 ℃; the time of single extraction is 0.5-1.5 h.
9. The method of claim 8, wherein the parameters of the heated reflux extraction are: the concentration of ethanol in the ethanol solution is 85%; the feed liquid ratio is 1g to 5mL; the extraction times are 2 times; the extraction temperature is 70 ℃; the time of single extraction was 1h.
10. Use of a pharmaceutical composition according to any one of claims 1-5 or a pharmaceutical composition prepared by a method according to any one of claims 6-8 for the manufacture of a medicament for the treatment and/or prevention of prostatic hyperplasia.
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