CN112826881A - A pharmaceutical composition for treating prostatic hyperplasia, and its preparation method - Google Patents
A pharmaceutical composition for treating prostatic hyperplasia, and its preparation method Download PDFInfo
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- CN112826881A CN112826881A CN202110133337.XA CN202110133337A CN112826881A CN 112826881 A CN112826881 A CN 112826881A CN 202110133337 A CN202110133337 A CN 202110133337A CN 112826881 A CN112826881 A CN 112826881A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/36—Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/11—Aldehydes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/12—Ketones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A—HUMAN NECESSITIES
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- A61K2236/30—Extraction of the material
- A61K2236/35—Extraction with lipophilic solvents, e.g. Hexane or petrol ether
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- Bioinformatics & Cheminformatics (AREA)
- Urology & Nephrology (AREA)
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention belongs to the technical field of medicine preparation, and particularly relates to a medicine composition for treating prostatic hyperplasia and a preparation method thereof. The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 39-56 parts of plant extract, 6-10 parts of decanoyl acetaldehyde, 7-12 parts of tanshinone and 2-8 parts of paeonol. The pharmaceutical composition for treating prostatic hyperplasia provided by the invention can quickly relieve symptoms of prostatic hyperplasia, has quick response, has a total effective rate of up to 91%, is short in treatment course, is not easy to relapse, quickly relieves the pain of patients, and treats prostatic hyperplasia from multiple aspects and multiple targets.
Description
Technical Field
The invention belongs to the technical field of medicine preparation, and particularly relates to a medicine composition for treating prostatic hyperplasia and a preparation method thereof.
Background
The prostatic hyperplasia (BPH) is the condition that the hyperplastic prostate presses the prostatic urethra or causes obstruction of the urethral meatus of the bladder, which causes frequent micturition, difficult urination and even urine can not be eliminated, and can cause urinary system infection, bladder calculi, hematuria and other complications, the main causes of the prostatic hyperplasia are dynamic factors and static factors, the dynamic factors are mainly the prostatic capsule containing abundant alpha-receptors and the increase of the tension of smooth muscle, thereby causing bladder irritation, which is represented by frequent micturition, urgent micturition and urgent incontinence in severe cases. The static factors are mainly that the enlarged gland protrudes to both sides and into the bladder, pressing the urethra and causing the bladder outlet to be blocked, which causes the symptoms of hesitancy of urination, weak stream of urine, and the like. The initial clinical manifestations of prostatic hyperplasia are Lower Urinary Tract Symptoms (LUTS), which, as they progress, eventually lead to problems such as bladder infection, bladder stones and renal failure. The prostatic hyperplasia is a common disease and a frequently encountered disease of the old men, the senile disease is increased along with the increase of the global population, and the life quality of the old men is seriously influenced.
The drugs for treating prostatic hyperplasia on the market are mainly divided into three categories: the first category, alpha-adrenergic receptor blockers, are suitable for patients with a mild symptom of prostatic hyperplasia, but the common drugs such as silodosin have adverse effects such as retrograde ejaculation and erectile dysfunction; the second group, 5 alpha-reductase inhibitors, the third group and other plant inhibitors, the principle of the two groups of drugs is that 5 alpha-reductase is inactivated and changed into furnishings, namely testosterone is not changed into dihydrotestosterone even meeting 5 alpha-reductase, and the hyperplasia of prostate is controlled by reducing the generation of dihydrotestosterone which stimulates the overgrowth of prostate, but the drugs are generally expensive and can also cause diseases such as gynecomastia, male sexual dysfunction and the like.
It can be seen from the action principle of the above drugs that the drugs can only alleviate symptoms of prostatic hyperplasia and can not play a therapeutic role. At present, the traditional Chinese medicine is concerned more and more by the majority of patients, and some traditional Chinese medicine compositions for treating the prostatic hyperplasia appear along with the traditional Chinese medicine compositions. Chinese patent application CN 110339306 a discloses a traditional Chinese medicine formula for treating prostatic hyperplasia, which comprises raw materials of 0.8-1.2 parts by weight of mulberry, 0.5 parts by weight of diaphragma juglandis, 0.5 parts by weight of pumpkin seed, 0.5 parts by weight of lophatherum gracile, 0.5 parts by weight of houttuynia cordata, 0.3 parts by weight of elsholtzia, and 0.2 parts by weight of platycodon grandiflorum. Chinese patent application CN 107412400A discloses a traditional Chinese medicine formula for treating prostatic hyperplasia, which consists of 8-12 g of cricket, 18-23 g of south diverse wormwood herb, 8-13 g of liquorice root, 25-35 g of astragalus root, 8-13 g of phellodendron bark, 15-22 g of raw peach kernel, 25-35 g of medicinal cyathula root, 25-35 g of combined spicebush root, 25-35 g of epimedium herb, 3-7 g of bloody amber, 8-13 g of pseudo-ginseng, 3-7 g of raw leech and 5g of cinnamon. However, the compositions are all from ancient prescriptions, are not improved by combining modern medicine, and have the problems of slow treatment effect, single function, long treatment course, easy repetition or great side effect and the like.
Therefore, it is highly desirable to provide a pharmaceutical composition for treating prostatic hyperplasia that has a rapid onset of action and no side effects.
Disclosure of Invention
In order to solve the problems in the prior art, the invention aims to provide a pharmaceutical composition for treating prostatic hyperplasia. The pharmaceutical composition for treating prostatic hyperplasia provided by the invention can quickly relieve symptoms of prostatic hyperplasia, has quick response, has a total effective rate of up to 91%, is short in treatment course, is not easy to relapse, quickly relieves the pain of patients, and treats prostatic hyperplasia from multiple aspects and multiple targets.
The technical scheme of the invention is as follows:
a pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 39-56 parts of plant extract, 6-10 parts of decanoyl acetaldehyde, 7-12 parts of tanshinone and 2-8 parts of paeonol.
The plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract in a weight ratio of (20-25): 13-17: 6 to 14.
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 44-50 parts of plant extract, 7-9 parts of decanoyl acetaldehyde, 8-10 parts of tanshinone and 3-6 parts of paeonol;
the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract in a weight ratio of (22-24): 14-16: 8 to 10.
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 47 parts of plant extract, 8 parts of decanoyl acetaldehyde, 9 parts of tanshinone and 5 parts of paeonol;
the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract according to a weight ratio of 23: 15: 9.
The preparation method of the dianthus superbus extract comprises the following steps:
s1, crushing the fringed pink, sieving the crushed fringed pink through a 40-60-mesh sieve, adding petroleum ether with the volume being 6-15 times of that of the fringed pink, refluxing and extracting for 3 hours in water bath at 50-70 ℃, filtering medicine dregs, and volatilizing the petroleum ether to obtain filtrate, wherein the reflux extraction is performed for 2 times and 1 hour each time;
s2, adding ethanol with the mass concentration of 50-70% and the weight of 5-8 times of that of the filtrate obtained in the step S1, performing ultrasonic extraction for 20-30 min, filtering, concentrating the filtrate under reduced pressure to 1/4-1/2 of the original volume, and collecting the concentrated solution for later use;
and S3, passing the concentrated solution obtained in the step S2 through a D101 macroporous adsorption resin column, eluting with water with 2-6 times of column volume, eluting with 5-15% ethanol with 2-4 times of column volume, eluting with 40-60% ethanol with 3-5 times of column volume, collecting ethanol eluate, concentrating under reduced pressure until no alcohol smell exists, collecting concentrated solution, and drying under reduced pressure to obtain the dianthus superbus extract.
The preparation method of the cherokee rose fruit extract comprises the following steps:
pulverizing cherokee rose fruit, sieving with a 20-60-mesh sieve, adding distilled water with the volume of 8-16 times of the weight of a medicinal material, soaking for 2-5 hours, heating, refluxing and extracting for 1-3 times, wherein the extraction time is 2-3 hours each time, filtering, combining filtrates, concentrating the combined solution under reduced pressure until each milliliter contains 1-1.5 g of the crude drug, adding 70-80% ethanol aqueous solution with the volume of 2-3 times of the concentrated solution, standing for 6-10 hours, separating supernatant, recovering ethanol under reduced pressure, and vacuum drying to obtain the cherokee rose fruit extract.
The preparation method of the pinellia ternata extract comprises the following steps:
crushing pinellia ternate, sieving with a 20-60-mesh sieve, adding distilled water with the volume 6-10 times of the weight of pinellia ternate, soaking for 1-2 hours, placing in a microwave reactor with the microwave power of 300-600W for microwave radiation for 5-12 min,
and then heating, refluxing and extracting for 1-2 hours, filtering to obtain a primary filtrate, adding distilled water with the volume 10-15 times of the weight of the primary filtrate into the decoction dregs, continuously refluxing for 1-2 hours, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, concentrating the combined solution, and drying in vacuum to obtain the pinellia ternata extract.
The preparation method of the pharmaceutical composition for treating prostatic hyperplasia comprises the following steps:
weighing the dianthus superbus extract, the cherokee rose fruit extract, the pinellia ternate extract, decanoyl acetaldehyde, tanshinone and paeonol according to the formula ratio, grinding, sieving, uniformly mixing, adding conventional auxiliary materials, and preparing into clinically acceptable dosage forms according to a conventional process.
The pharmaceutical composition is powder, granules, powder, capsules, tablets and oral liquid.
In addition, the invention also provides application of the composition in preparing a medicament for treating prostatic hyperplasia.
The added plant extracts comprise extracts of dianthus superbus, cherokee rose fruit and pinellia ternate according to a certain proportion, wherein the part of the dianthus superbus used as a medicine is the dry overground part of the plant, is bitter in taste and cold in nature, has the effects of promoting urination, treating stranguria, activating blood circulation and stimulating menstrual flow, and is used for treating heat stranguria, bloody stranguria, urolithic stranguria, urinary stuttering, painful dripping, and menstrual blood stasis and yin stasis. The part of the cherokee rose-hip used as medicine is dry mature fruit. Sour, sweet and astringent in flavor, neutral in nature, entering kidney, bladder and large intestine channels, securing essence and reducing urination, securing metrorrhagia and stopping leukorrhagia, astringing intestine to stop diarrhea, and can be used for treating spermatorrhea, enuresis, frequent micturition, metrorrhagia, leukorrhagia, chronic diarrhea and chronic dysentery. Pinellia ternata, which is used as a medicine part, is dried tuber of plant, is pungent in taste and warm in nature, enters spleen, stomach and lung channels, eliminates dampness and phlegm, lowers adverse qi and stops vomiting, dissolves masses and dissipates stagnation, and is used for treating damp phlegm and cold phlegm, cough, asthma, excessive phlegm, phlegm retention, dizziness, palpitation, wind phlegm dizziness, phlegm syncope and headache, vomiting and regurgitation, fullness and stuffiness in chest and epigastrium and globus; it is indicated for abscess with phlegm nodule. In the prior art, when western medicines or traditional Chinese medicine components are used independently for treating the prostatic hyperplasia, the action is relatively weak, but the inventor of the application discovers that decanoyl acetaldehyde, tanshinone, paeonol and plant extracts form a compound, the medicines with different action mechanisms are organically combined according to various known causes of the prostatic hyperplasia, the synergistic action is mutually exerted, the symptom of the prostatic hyperplasia can be quickly relieved, the effect is quick, the total effective rate is up to 91 percent, the treatment course is short, the recurrence is not easy, the pain of a patient is quickly relieved, the prostatic hyperplasia is treated from various aspects and multiple targets, the corresponding component proportion is determined according to experiments, the synergistic treatment effect among the effective components is enhanced, compared with other medicines, the medicine is safer, has smaller toxic and side effects, the curative effect is more quick and obvious, and a new choice is provided for treating the prostatic hyperplasia, unexpected technical effects are achieved.
Compared with the prior art, the pharmaceutical composition for treating prostatic hyperplasia provided by the invention has the following advantages:
(1) according to the pharmaceutical composition for treating prostatic hyperplasia provided by the invention, decanoyl acetaldehyde, tanshinone, paeonol and plant extracts are formed into a compound, the prepared pharmaceutical composition has the effect of treating prostatic hyperplasia, the curative effect is remarkable, the total effective rate is up to 91%, the pharmaceutical composition is safe and has no toxic or side effect, and the use of traditional medicines with large side effects and undesirable treatment effect can be avoided.
(2) The pharmaceutical composition for treating prostatic hyperplasia provided by the invention has the advantages of simple preparation method, low production cost, stable quality, small toxic and side effects, high safety and popularization and application.
Detailed Description
The present invention is further illustrated by the following description of specific embodiments, which are not intended to limit the invention, and various modifications and improvements can be made by those skilled in the art based on the basic idea of the invention, but the invention is within the protection scope of the invention.
Wherein, the reagents used in the invention are all common reagents and can be purchased from common reagent production and sale companies.
EXAMPLE 1A pharmaceutical composition for the treatment of prostatic hyperplasia
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 39 parts of plant extract, 6 parts of decanoyl acetaldehyde, 7 parts of tanshinone and 2 parts of paeonol;
the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract in a weight ratio of 20: 13: 6.
The preparation method of the dianthus superbus extract comprises the following steps:
s1, crushing the fringed pink, sieving the crushed fringed pink through a 40-mesh sieve, adding petroleum ether with the weight 6 times of that of the fringed pink, refluxing for 3 hours in water bath at 50-70 ℃, extracting for 2 times in a refluxing manner, filtering medicine dregs for 1 hour each time, and volatilizing the petroleum ether to obtain filtrate;
s2, adding ethanol with the mass concentration of 50% and the weight of 5 times of that of the filtrate obtained in the step S1, performing ultrasonic extraction for 20min, filtering, concentrating the filtrate under reduced pressure to 1/4 of the original volume, and collecting the concentrated solution for later use;
s3, loading the concentrated solution obtained in the step S2 on a D101 macroporous adsorption resin column, eluting with 2 times of column volume of water, then eluting with 2 times of column volume of 5% ethanol, finally eluting with 3 times of column volume of 40% ethanol, collecting ethanol eluate, concentrating under reduced pressure until no alcohol smell exists, collecting concentrated solution, and drying under reduced pressure to obtain the dianthus superbus extract.
The preparation method of the cherokee rose fruit extract comprises the following steps:
pulverizing fructus Rosae Laevigatae, sieving with 20 mesh sieve, adding 8 times of distilled water, soaking for 2 hr, heating under reflux for 1 time for 2 hr, filtering, concentrating the filtrate under reduced pressure, concentrating to obtain 1g crude drug per ml, adding 2 times of 70% ethanol water solution, standing for 6 hr, separating supernatant, recovering ethanol under reduced pressure, and vacuum drying to obtain fructus Rosae Laevigatae extract.
The preparation method of the pinellia ternata extract comprises the following steps:
crushing pinellia ternata, sieving with a 20-mesh sieve, adding distilled water with the volume 6 times of the weight of the pinellia ternata, soaking for 1 hour, placing the pinellia ternata in a microwave reactor with the microwave power of 300W for microwave radiation for 5 minutes, heating and refluxing for extraction for 1 hour, filtering to obtain a primary filtrate, adding distilled water with the volume 10 times of the weight of the pinellia ternata into the decoction dregs, continuously refluxing for 1 hour, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, concentrating the combined solution, and drying in vacuum to obtain the pinellia ternata extract.
The preparation method of the pharmaceutical composition for treating prostatic hyperplasia comprises the following steps:
weighing herba Dianthi extract, fructus Rosae Laevigatae extract, rhizoma Pinelliae extract, decanoyl acetaldehyde, tanshinone, and paeonol, grinding, sieving, mixing, adding conventional adjuvants, and making into clinically acceptable dosage forms such as powder according to conventional process.
EXAMPLE 2A pharmaceutical composition for the treatment of prostatic hyperplasia
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 47 parts of plant extract, 8 parts of decanoyl acetaldehyde, 9 parts of tanshinone and 5 parts of paeonol;
the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract according to a weight ratio of 23: 15: 9.
The preparation method of the dianthus superbus extract comprises the following steps:
s1, crushing the fringed pink, sieving the crushed fringed pink through a 50-mesh sieve, adding petroleum ether with the volume being 12 times of the weight of the fringed pink, refluxing the mixture for 3 hours in a water bath at 50-70 ℃, extracting the mixture for 2 times in a refluxing way, filtering medicine dregs for 1 hour each time, and volatilizing the petroleum ether to obtain filtrate;
s2, adding 7 times of ethanol with the mass concentration of 60% into the filtrate obtained in the step S1, performing ultrasonic extraction for 25min, filtering, concentrating the filtrate under reduced pressure to 1/3 of the original volume, and collecting the concentrated solution for later use;
s3, loading the concentrated solution obtained in the step S2 on a D101 macroporous adsorption resin column, eluting with 4 times of column volume of water, eluting with 3 times of column volume of 10% ethanol, eluting with 4 times of column volume of 50% ethanol, collecting ethanol eluate, concentrating under reduced pressure until no alcohol smell exists, collecting concentrated solution, and drying under reduced pressure to obtain the Dianthus superbus extract.
The preparation method of the cherokee rose fruit extract comprises the following steps:
pulverizing fructus Rosae Laevigatae, sieving with 40 mesh sieve, adding 12 times of medicinal material weight of distilled water, soaking for 3 hr, heating and reflux extracting for 2 times (each extraction time is 2.5 hr), filtering, mixing filtrates, concentrating under reduced pressure to obtain concentrated solution containing 1.3g crude drug per ml, adding 2.5 times of 75% ethanol water solution, standing for 8 hr, separating supernatant, recovering ethanol under reduced pressure, and vacuum drying to obtain fructus Rosae Laevigatae extract.
The preparation method of the pinellia ternata extract comprises the following steps:
crushing pinellia ternate, sieving with a 40-mesh sieve, adding distilled water with the volume 8 times of the weight of the pinellia ternate, soaking for 1.5 hours, placing in a microwave reactor with the microwave power of 450W for microwave radiation for 8 minutes, heating and refluxing for extraction for 1.5 hours, filtering to obtain a primary filtrate, adding distilled water with the volume 12 times of the weight of the pinellia ternate into the decoction dregs, continuously refluxing for 1.5 hours, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, concentrating the combined solution, and drying in vacuum to obtain the pinellia ternate extract.
The preparation method of the pharmaceutical composition for treating prostatic hyperplasia comprises the following steps:
weighing herba Dianthi extract, fructus Rosae Laevigatae extract, rhizoma Pinelliae extract, decanoyl acetaldehyde, tanshinone, and paeonol, grinding, sieving, mixing, adding conventional adjuvants, and making into clinically acceptable dosage forms, such as granule, according to conventional process.
EXAMPLE 3A pharmaceutical composition for the treatment of prostatic hyperplasia
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 56 parts of plant extract, 10 parts of decanoyl acetaldehyde, 12 parts of tanshinone and 8 parts of paeonol;
the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract in a weight ratio of 25: 17: 14.
The preparation method of the dianthus superbus extract comprises the following steps:
s1, crushing the dianthus superbus, sieving the dianthus superbus by a 60-mesh sieve, adding petroleum ether with the volume 15 times of that of the dianthus superbus, refluxing for 3 hours in a water bath at 70 ℃, extracting for 2 times by refluxing for 1 hour each time, filtering medicine residues, and volatilizing the petroleum ether to obtain filtrate;
s2, adding ethanol with the weight concentration of 8 percent and the mass concentration of 70 percent into the filtrate obtained in the step S1, carrying out ultrasonic extraction for 30min, filtering, concentrating the filtrate under reduced pressure to 1/2 of the original volume, and collecting the concentrated solution for later use;
s3, loading the concentrated solution obtained in the step S2 on a D101 macroporous adsorption resin column, eluting with 6 times of column volume of water, then eluting with 4 times of column volume of 15% ethanol, finally eluting with 5 times of column volume of 60% ethanol, collecting ethanol eluate, concentrating under reduced pressure until no alcohol smell exists, collecting concentrated solution, and drying under reduced pressure to obtain the dianthus superbus extract.
The preparation method of the cherokee rose fruit extract comprises the following steps:
pulverizing fructus Rosae Laevigatae, sieving with 60 mesh sieve, adding 16 times of medicinal material weight of distilled water, soaking for 5 hr, heating and reflux extracting for 3 times, each time for 3 hr, filtering, mixing filtrates, concentrating under reduced pressure to obtain concentrated solution containing 1.5g crude drug per ml, adding 3 times of 80% ethanol water solution, standing for 10 hr, separating supernatant, recovering ethanol under reduced pressure, and vacuum drying to obtain fructus Rosae Laevigatae extract.
The preparation method of the pinellia ternata extract comprises the following steps:
crushing pinellia ternata, sieving with a 60-mesh sieve, adding distilled water with the volume 10 times of the weight of the pinellia ternata, soaking for 2 hours, placing the pinellia ternata in a microwave reactor with the microwave power of 600W for 12 minutes, heating and refluxing for extraction for 2 hours, filtering to obtain a primary filtrate, adding distilled water with the volume 15 times of the weight of the pinellia ternata into dregs, continuously refluxing for 2 hours, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, concentrating the combined solution, and drying in vacuum to obtain the pinellia ternata extract.
The preparation method of the pharmaceutical composition for treating prostatic hyperplasia comprises the following steps:
weighing herba Dianthi extract, fructus Rosae Laevigatae extract, rhizoma Pinelliae extract, decanoyl acetaldehyde, tanshinone, and paeonol, grinding, sieving, mixing, adding conventional adjuvants, and making into clinically acceptable dosage forms such as tablet.
Comparative example 1A pharmaceutical composition for treating prostatic hyperplasia
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 47 parts of plant extract, 8 parts of decanoyl acetaldehyde, 9 parts of tanshinone and 5 parts of paeonol;
the plant extract is prepared from a fringed pink extract and a pinellia ternate extract according to a weight ratio of 23: 9.
The Dianthus superbus extract was prepared in a similar manner to example 2.
The preparation method of the cherokee rose fruit extract is similar to that of example 2.
The preparation method of the pinellia ternata extract is similar to that of example 2.
The preparation method of the pharmaceutical composition for treating prostatic hyperplasia is similar to that of the example 2.
The difference from example 2 is that no cherokee rose fruit extract was added to the plant extract.
Comparative example 2A pharmaceutical composition for the treatment of prostatic hyperplasia
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 47 parts of plant extract, 8 parts of decanoyl acetaldehyde, 9 parts of tanshinone and 5 parts of paeonol;
the plant extract is prepared from a dianthus superbus extract and a cherokee rose fruit extract according to a weight ratio of 23: 15.
The Dianthus superbus extract was prepared in a similar manner to example 2.
The preparation method of the cherokee rose fruit extract is similar to that of example 2.
The preparation method of the pinellia ternata extract is similar to that of example 2.
The preparation method of the pharmaceutical composition for treating prostatic hyperplasia is similar to that of the example 2.
The difference from example 2 is that the plant extract is not added with pinellia ternata extract.
Comparative example 3A pharmaceutical composition for the treatment of prostatic hyperplasia
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 47 parts of plant extract, 8 parts of decanoyl acetaldehyde, 9 parts of tanshinone and 5 parts of paeonol;
the plant extract comprises a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract in a weight ratio of 1:1: 1.
The Dianthus superbus extract was prepared in a similar manner to example 2.
The preparation method of the cherokee rose fruit extract is similar to that of example 2.
The preparation method of the pinellia ternata extract is similar to that of example 2.
The preparation method of the pharmaceutical composition for treating prostatic hyperplasia is similar to that of the example 2.
The difference from example 2 is that the plant extract is composed of dianthus superbus extract, cherokee rose fruit extract and pinellia ternate extract in a weight ratio of 1:1: 1.
Comparative example 4A pharmaceutical composition for the treatment of prostatic hyperplasia
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 47 parts of plant extract, 17 parts of tanshinone and 5 parts of paeonol;
the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract according to a weight ratio of 23: 15: 9.
The Dianthus superbus extract was prepared in a similar manner to example 2.
The preparation method of the cherokee rose fruit extract is similar to that of example 2.
The preparation method of the pinellia ternata extract is similar to that of example 2.
The preparation method of the pharmaceutical composition for treating prostatic hyperplasia is similar to that of the example 2.
The difference from example 2 is that decanoyl acetaldehyde is not added in the pharmaceutical composition, and the weight part of tanshinone is increased to 17 parts.
Comparative example 5A pharmaceutical composition for treating prostatic hyperplasia
The pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight: 47 parts of plant extract, 8 parts of decanoyl acetaldehyde and 14 parts of tanshinone;
the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract according to a weight ratio of 23: 15: 9.
The Dianthus superbus extract was prepared in a similar manner to example 2.
The preparation method of the cherokee rose fruit extract is similar to that of example 2.
The preparation method of the pinellia ternata extract is similar to that of example 2.
The preparation method of the pharmaceutical composition for treating prostatic hyperplasia is similar to that of the example 2.
The difference from the embodiment 2 is that the weight part of the tanshinone is increased to 14 parts without adding paeonol in the pharmaceutical composition.
Test example I Effect of the drug of the present invention on prostate weight in rats
1. Test materials: the pharmaceutical composition for treating prostatic hyperplasia, prepared in the embodiments 1-3 and the comparative examples 1-5, is provided.
2. Test subjects: the male SD rats are 110 male, have the weight of 200-230 g and are provided by the laboratory animal department of medical colleges of Nanchang university.
3. The test method comprises the following steps:
(1) grouping: 100 SD rats are taken, are subjected to intraperitoneal injection of 10% chloral hydrate for anesthesia, bilateral testicles are removed, stumps are ligated, and after 1 week of natural recovery, the SD rats are randomly divided into a model group and a positive control (prostaglandins) group, examples 1 to 3 groups and comparative examples 1 to 5 groups, and after 10 rats are cut open the abdomen, the SD rats are immediately sutured without removing the testicles and are taken as a blank control group after 1 week of natural recovery.
(2) Molding and administration: except for the blank group, rats of other groups are injected with testosterone propionate 10mg/Kg subcutaneously every other day, normal control groups are injected with the same amount of sesame oil, and meanwhile, the rats are subjected to gastric lavage every day, positive control (prostacyclin) groups are administered with 0.5g/Kg/d, examples 1 to 3, comparative examples 1 to 5 groups are administered with the corresponding pharmaceutical composition 3g/Kg/d, and the blank group and model groups are administered with the same amount of physiological saline for 28 days continuously.
(3) Rat prostate wet weight and Prostate Index (PI) determination: after the last injection and gavage for 24h, the rats were weighed, sacrificed, the prostate was removed, washed with ice saline, the periprostatic fat and connective tissue were carefully removed, the wet weight of the prostate of the rats was weighed with an electronic balance after drying the surface moisture with filter paper, and the prostate index, which is the wet weight of the prostate (mg)/the weight of the rat (g), was calculated.
4. Test results
The test results are shown in table 1.
TABLE 1 rat body mass, prostate wet weight and prostate index for each group
As can be seen from table 1, compared with the model group, the mice perfused with the pharmaceutical composition for treating prostatic hyperplasia prepared in the groups of examples 1 to 3 of the present invention have significantly reduced prostate wet weight and prostate index, wherein the group of example 2 has the best effect, and the overall effect is better than that of the positive control (prostate health), which is the best embodiment of the present invention. The test results of the comparative examples 1-5 and the example group show that the components of the pharmaceutical composition for treating prostatic hyperplasia interact with the plant extract, the synergistic effect is obvious, the prostate wet weight and the prostate index of a model SD rat can be effectively reduced, the effect is quick, and the effect is obvious.
Test example two, clinical test
1. Case selection and criteria:
1.1 diagnostic criteria: the standard of diagnosis is referred to modern prostatosis.
The clinical manifestations are as follows: the initial frequent urination and nocturia of the patient are obviously increased, and symptoms of difficult urination, weak urination, thin urine line, incomplete residual urine and the like gradually appear. Auxiliary inspection: the abdominal ultrasound indicates that the prostate is enlarged and the residual urine volume in the bladder exceeds 60mL or is confirmed by examination.
1.2 inclusion criteria: the medicine accords with the diagnosis standard of the prostatic hyperplasia, and 200 cases with the age of 50-80 years.
1.3 the standard for judging the curative effect of the following gland hyperplasia:
(1) the effect is shown: I-PSS score is less than or equal to 7, L index is less than or equal to 1, or the total disease score is reduced by more than 90%; ② the prostate volume is reduced to below 60 percent of the original volume; ③ the maximum urine flow rate is more than or equal to 18 ml/s.
(2) The method has the following advantages: the I-PSS score is less than or equal to 13, the index L before treatment is 4-6, and is reduced to 2-3, or the total integral of the disease condition is reduced by more than 60%; ② the prostate volume is reduced to be less than 80 percent of the original volume, the residual urine volume is reduced by more than 50 percent; ③ the maximum urine flow rate is more than or equal to 12 ml/s.
(2) And (4) invalidation: not reaching the effective standard
2. The treatment method comprises the following steps: the 200 cases are averagely divided into 2 groups which are respectively a treatment group and a control group, patients in the treatment group take the granules prepared by the preparation 2 of the invention three times a day, the weight of each time of the granules is 1.0 g/50 Kg of the weight of the patients, the granules are taken after meals, and the control group is oral prostaglandins tablets which are taken according to the instructions and are continuously taken for 4 weeks.
3. Clinical results
The clinical results are shown in table 2.
TABLE 2 effective rate of two groups of patients after treatment
| Group of | Number of cases | Number of effective people | Number of effective persons | Number of invalid persons | Total effective rate |
| Treatment group | 100 | 73 | 18 | 9 | 91％ |
| Control group | 100 | 52 | 13 | 35 | 65％ |
As can be seen from the clinical data in Table 2, the pharmaceutical composition provided by the embodiment 2 of the invention can realize higher cure rate for patients with prostatic hyperplasia in four weeks, has faster effect than the existing drugs for treating prostatic hyperplasia in the market, and realizes more than 90% of total effective rate.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.
Claims (9)
1. The pharmaceutical composition for treating prostatic hyperplasia is characterized by comprising the following components in parts by weight: 39-56 parts of plant extract, 6-10 parts of decanoyl acetaldehyde, 7-12 parts of tanshinone and 2-8 parts of paeonol; the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract in a weight ratio of (20-25): 13-17: 6 to 14.
2. The pharmaceutical composition for treating prostatic hyperplasia according to claim 1, which comprises the following components in parts by weight: 44-50 parts of plant extract, 7-9 parts of decanoyl acetaldehyde, 8-10 parts of tanshinone and 3-6 parts of paeonol;
the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract in a weight ratio of (22-24): 14-16: 8 to 10.
3. The pharmaceutical composition for treating prostatic hyperplasia according to claim 1, which is prepared from the following components in parts by weight: 47 parts of plant extract, 8 parts of decanoyl acetaldehyde, 9 parts of tanshinone and 5 parts of paeonol;
the plant extract is prepared from a dianthus superbus extract, a cherokee rose fruit extract and a pinellia ternate extract according to a weight ratio of 23: 15: 9.
4. The pharmaceutical composition for treating prostatic hyperplasia according to claim 1, wherein said Dianthus superbus extract is prepared by:
s1, crushing the fringed pink, sieving the crushed fringed pink through a 40-60-mesh sieve, adding petroleum ether with the volume being 6-15 times of that of the fringed pink, refluxing and extracting for 3 hours in water bath at 50-70 ℃, filtering medicine dregs, and volatilizing the petroleum ether to obtain filtrate, wherein the reflux extraction is performed for 2 times and 1 hour each time;
s2, adding ethanol with the mass concentration of 50-70% and the weight of 5-8 times of that of the filtrate obtained in the step S1, performing ultrasonic extraction for 20-30 min, filtering, concentrating the filtrate under reduced pressure to 1/4-1/2 of the original volume, and collecting the concentrated solution for later use;
and S3, passing the concentrated solution obtained in the step S2 through a D101 macroporous adsorption resin column, eluting with water with 2-6 times of column volume, eluting with 5-15% ethanol with 2-4 times of column volume, eluting with 40-60% ethanol with 3-5 times of column volume, collecting ethanol eluate, concentrating under reduced pressure until no alcohol smell exists, collecting concentrated solution, and drying under reduced pressure to obtain the dianthus superbus extract.
5. The pharmaceutical composition for treating prostatic hyperplasia according to claim 1, wherein the preparation method of the cherokee rose fruit extract comprises the following steps:
pulverizing cherokee rose fruit, sieving with a 20-60-mesh sieve, adding distilled water with the volume of 8-16 times of the weight of a medicinal material, soaking for 2-5 hours, heating, refluxing and extracting for 1-3 times, wherein the extraction time is 2-3 hours each time, filtering, combining filtrates, concentrating the combined solution under reduced pressure until each milliliter contains 1-1.5 g of the crude drug, adding 70-80% ethanol aqueous solution with the volume of 2-3 times of the concentrated solution, standing for 6-10 hours, separating supernatant, recovering ethanol under reduced pressure, and vacuum drying to obtain the cherokee rose fruit extract.
6. The pharmaceutical composition for treating prostatic hyperplasia according to claim 1, wherein the pinellia ternata extract is prepared by the following method:
crushing pinellia ternate, sieving with a 20-60-mesh sieve, adding distilled water with the weight 6-10 times of the weight of the pinellia ternate, soaking for 1-2 hours, placing the pinellia ternate in a microwave reactor with the microwave power of 300-600W for microwave radiation for 5-12 min, heating, refluxing and extracting for 1-2 hours, filtering to obtain a primary filtrate, adding distilled water with the weight 10-15 times of the weight of the pinellia ternate into the decoction dregs, continuously refluxing for 1-2 hours, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, concentrating the combined solution, and drying in vacuum to obtain the pinellia ternate extract.
7. A method for preparing the pharmaceutical composition for treating prostatic hyperplasia according to any one of claims 1-6, which comprises the following steps:
weighing the dianthus superbus extract, the cherokee rose fruit extract, the pinellia ternate extract, decanoyl acetaldehyde, tanshinone and paeonol according to the formula ratio, grinding, sieving, uniformly mixing, adding conventional auxiliary materials, and preparing into clinically acceptable dosage forms according to a conventional process.
8. The preparation method of claim 7, wherein the pharmaceutical composition is in the form of powder, granule, powder, capsule, tablet, or oral liquid.
9. Use of a composition according to any one of claims 1 to 8 in the manufacture of a medicament for the treatment of prostatic hyperplasia.
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Application publication date: 20210525 |