CN110898114A - A pharmaceutical composition for treating prostatic hyperplasia - Google Patents

A pharmaceutical composition for treating prostatic hyperplasia Download PDF

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Publication number
CN110898114A
CN110898114A CN201911033465.6A CN201911033465A CN110898114A CN 110898114 A CN110898114 A CN 110898114A CN 201911033465 A CN201911033465 A CN 201911033465A CN 110898114 A CN110898114 A CN 110898114A
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parts
extract
prostatic hyperplasia
pharmaceutical composition
treating prostatic
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李长润
曾雪
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Anhui University
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Anhui University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/01Hydrocarbons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/3533,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355Tocopherols, e.g. vitamin E
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/04Sulfur, selenium or tellurium; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/30Zinc; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate

Abstract

The invention provides a pharmaceutical composition for treating prostatic hyperplasia, which comprises an African pygeum bark extract, a stinging nettle root extract, β -sitosterol, lycopene, zinc citrate, selenium and vitamin E.

Description

A pharmaceutical composition for treating prostatic hyperplasia
Technical Field
The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a pharmaceutical composition for treating prostatic hyperplasia.
Background
At present, the drugs for treating prostatic hyperplasia in the market are mainly divided into three types, namely α -adrenergic receptor blocker, which can relax contracted muscles, reduce the resistance of urethra and simplify urination, and is suitable for patients with light symptoms of prostatic hyperplasia, but the common drugs such as silodosin have the side effects of retrograde ejaculation and erectile dysfunction, 5 α -reductase inhibitor, and other plant inhibitor, and the two types of drugs have the principle that 5 α -reductase is inactivated and changed into a pendulum, namely testosterone is not changed into dihydrotestosterone even meeting 5 α -reductase, and the prostatic hyperplasia is controlled by reducing the generation of dihydrotestosterone for stimulating the overgrowth of the prostate, but the drugs are generally expensive, and can also produce 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.
In recent years, traditional Chinese medicine is more and more concerned by patients, and some traditional Chinese medicine compositions for treating prostatic hyperplasia appear, however, the compositions are all derived from ancient prescriptions, are not improved by combining with modern medicine, and generally have the problems of slow treatment effect, single function, long treatment course, easy repetition and the like.
Disclosure of Invention
The invention provides a pharmaceutical composition for treating prostatic hyperplasia, which is used for solving the problems that western medicines cannot be thoroughly cured, traditional Chinese medicines are few in clinical application, and are slow in treatment effect, single in function, long in treatment course, easy to repeat and the like in the existing clinical medicines.
A pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight:
100-300 parts of prunus africana bark extract,
180 portions of stinging nettle root extract,
β -sitosterol 65-195 parts,
10-20 parts of lycopene, namely 10-20 parts of lycopene,
20-30 parts of zinc citrate, and the active ingredients are zinc citrate,
0.05-0.15 part of selenium;
the composition further comprises vitamin E in an amount of 50-150 International Units (IU) per 200mg of Pygeum africanum bark extract.
The preparation method of the Pygeum africanum bark extract comprises the following steps: the African pygeum stem bark extract is prepared by drying and crushing African pygeum stem bark, adding 35-50% vol ethanol water solution 5-7 times the weight of the African pygeum stem bark, soaking at 35-40 deg.C for 0.3-0.5h, performing auxiliary ultrasonic extraction at constant temperature of 45-60 deg.C for 0.5-1h with ultrasonic frequency of 26KHz, reflux-extracting for 1.5-2h, filtering to obtain filtrate, and drying to obtain the African pygeum stem bark extract.
The drying method is vacuum drying or freeze-drying after rotary evaporation and concentration.
The preparation method of the urtica stingica root extract comprises the following steps: cleaning Urtica dioica root, drying, pulverizing, adding 35-50% vol ethanol water solution 5-7 times the weight of Urtica dioica root, performing auxiliary ultrasonic extraction at 35-40 deg.C for 0.5-1 hr with ultrasonic frequency of 26KHz, reflux extracting for 0.5-1 hr, filtering to obtain filtrate, and drying to obtain Urtica dioica root extract.
The drying method is vacuum drying or freeze-drying after rotary evaporation and concentration.
Preferably, the pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight:
100-120 parts of the prunus africana bark extract,
180 portions of urtica armandi root extract,
β -sitosterol 65-195 parts,
10-20 parts of lycopene, namely 10-20 parts of lycopene,
20-30 parts of zinc citrate, and the active ingredients are zinc citrate,
0.05-0.15 part of selenium;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
Preferably, the pharmaceutical composition for treating prostatic hyperplasia further comprises a ginkgo biloba extract, and the ginkgo biloba extract is composed of the following components in parts by weight:
100-300 parts of prunus africana bark extract,
180 portions of stinging nettle root extract,
β -sitosterol 65-195 parts,
10-20 parts of lycopene, namely 10-20 parts of lycopene,
20-30 parts of zinc citrate, and the active ingredients are zinc citrate,
0.05 to 0.15 portion of selenium,
5-30 parts of ginkgo leaf extract;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
The preparation method of the ginkgo leaf extract comprises the following steps: cleaning, drying and crushing ginkgo leaves, adding 35-50 vol% ethanol water solution which is 10-15 times the mass of the ginkgo leaves, carrying out auxiliary ultrasonic extraction for 0.5-1h at the constant temperature of 35-40 ℃, wherein the ultrasonic frequency is 26KHz, then carrying out reflux extraction for 0.5-1h, filtering to obtain filtrate, concentrating the filtrate according to the proportion of 1.5g of dry ginkgo leaves to ml of concentrated solution to obtain concentrated solution, putting the concentrated solution on a D101 macroporous resin column, firstly carrying out drip washing by deionized water, then carrying out elution by 70 vol% ethanol deionized water solution, collecting eluent, and drying to obtain the ginkgo leaf extract.
Preferably, the pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight:
100-120 parts of the prunus africana bark extract,
180 portions of urtica armandi root extract,
β -sitosterol 65-195 parts,
10-20 parts of lycopene, namely 10-20 parts of lycopene,
20-30 parts of zinc citrate, and the active ingredients are zinc citrate,
0.05 to 0.15 portion of selenium,
5-10 parts of ginkgo leaf extract;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
The pharmaceutical composition for treating prostatic hyperplasia can be prepared into powder, granules, powder, capsules, tablets, oral liquid, buccal agents and medicinal granules.
The pharmaceutical composition for treating prostatic hyperplasia can be applied to the preparation of the drugs for treating prostatic hyperplasia.
Advantageous effects
The pharmaceutical composition for treating prostatic hyperplasia provided by the invention forms a compound by combining Chinese and western medicines, has quick response, can quickly relieve symptoms of prostatic hyperplasia, quickly relieve the pain of patients, can realize radical cure, and has short treatment course and difficult recurrence.
Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the formulations and methods of manufacture particularly pointed out in the written description and claims.
The technical solution of the present invention is further described in detail by the following examples.
Detailed Description
The following description of the preferred embodiments of the present invention is provided for the purpose of illustration and description, and is in no way intended to limit the invention.
Preparation example 1 preparation of prunus africana bark extract:
the African pygeum prunifolium bark extract is prepared by drying and crushing African pygeum prunifolium bark, adding 40% vol ethanol water solution 7 times the weight of the African pygeum prunifolium bark, soaking at 40 ℃ for 0.5h, performing auxiliary ultrasonic extraction at constant temperature of 60 ℃ for 1h with ultrasonic frequency of 26KHz, performing reflux extraction for 2h, filtering to obtain filtrate, and drying to obtain the African pygeum prunifolium bark extract.
The method does not need to use organic solvents such as ethyl acetate and dichloromethane, adopts heating soaking combined with ultrasonic extraction, has high extraction rate in one-time extraction, does not need repeated extraction, uses ethanol as a reagent, has low toxicity and high recovery rate, and is environment-friendly and economical.
The drying method is freeze-drying after rotary evaporation and concentration.
Hydrotestosterone is one of the main substances causing prostatic hyperplasia, and the Pygeum africanum bark extract can block the formation of dihydrotestosterone, thereby slowing the continued enlargement of the focus.
Preparation example 2 preparation of nettle root extract:
cleaning, drying and crushing urtica punctata roots, adding 40% vol ethanol water solution 7 times the mass of the urtica punctata roots, carrying out auxiliary ultrasonic extraction at constant temperature of 40 ℃ for 1h, carrying out ultrasonic frequency of 26KHz, carrying out reflux extraction for 1h, filtering to obtain filtrate, and drying to obtain the urtica punctata root extract.
The drying method is vacuum drying.
The method adopts heating combined with ultrasonic extraction, and has high extraction rate at one time without repeated extraction. The combination of Pygeum africanum and Urtica dioica root related extracts is only reported to be used for treating alopecia at present, and researchers judge that Pygeum africanum fruit extract and Urtica dioica root extract may generate certain synergistic effect with certain components (saw palmetto fruit extract, grape seed extract, red sage extract, green tea extract, biotin, methionine, cysteine, dimethyl sulfone, sitosterol, linolenic acid, diindolylmethane, zinc picolinate and copper sulfate) in a compound so as to achieve better curative effect for treating alopecia, and no report is found that the combination of the Pygium africanum fruit extract and the Urtica dioica root related extracts is used for treating prostatic hyperplasia and no interaction mechanism exists.
Phytosterol in the stinging nettle root extract can effectively relieve the symptoms of prostatitis.
Preparation example 3 preparation of ginkgo biloba leaf extract:
cleaning, drying and crushing ginkgo leaves, adding 40% vol ethanol water solution 15 times the mass of the ginkgo leaves, carrying out auxiliary ultrasonic extraction at constant temperature of 40 ℃ for 1h, wherein the ultrasonic frequency is 26KHz, then carrying out reflux extraction for 1h, filtering to obtain filtrate, concentrating the filtrate into concentrated solution according to the proportion of 1.5g of dry ginkgo leaves to ml of concentrated solution, loading the concentrated solution onto a D101 macroporous resin column, eluting with deionized water, then eluting with 70% vol ethanol deionized water solution, collecting eluent, and drying to obtain the ginkgo leaf extract.
The drying method is freeze-drying after rotary evaporation and concentration.
The method does not need repeated extraction, and saves time cost and reagent cost. The ginkgo leaf extract has wide application value and application, but is mainly used for treating diseases such as memory loss, stomach pain, dysentery, hypertension, mental stress and respiratory tract problems such as asthma, bronchitis, poor circulation and anxiety caused by the asthma by Chinese medicines at present, and the ginkgo leaf extract can relieve or treat the prostate disease and can play a role in relieving or treating the prostate disease by the synergistic effect of the ginkgo leaf extract and any component in the formula provided by the invention.
Example 1 a pharmaceutical composition a for treating prostatic hyperplasia, which comprises the following components in parts by weight:
200 parts of prunus africana bark extract,
360 parts of nettle root extract,
β -130 parts of sitosterol,
15 parts of lycopene, namely 15 parts of lycopene,
25 parts of zinc citrate, namely zinc citrate,
0.1 part of selenium;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
The components are uniformly mixed to prepare powder for standby.
According to the formula, due to the combined action of the Pygeum africanum bark extract and the Urtica dioica root extract, the lycopene is a strong antioxidant, the prostatitis symptom can be effectively relieved, the sperm quality is improved, β -sitosterol can obviously increase the urine flow, the vitamin E and other antioxidant substances have synergistic effect, and the antioxidant effect is greatly improved.
Example 2
A pharmaceutical composition B for treating prostatic hyperplasia comprises the following components in parts by weight:
100 parts of Pygeum africanum bark extract,
180 parts of urtica armandi root extract,
β -195 parts of sitosterol,
20 parts of lycopene, namely 20 parts of lycopene,
30 parts of zinc citrate, namely 30 parts of zinc citrate,
0.15 part of selenium;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
The components are uniformly mixed to prepare powder for standby.
Example 3
A pharmaceutical composition C for treating prostatic hyperplasia comprises the following components in parts by weight:
200 parts of prunus africana bark extract,
360 parts of nettle root extract,
β -130 parts of sitosterol,
15 parts of lycopene, namely 15 parts of lycopene,
25 parts of zinc citrate, namely zinc citrate,
0.1 part of selenium, and the balance of selenium,
20 parts of ginkgo leaf extract;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
The components are uniformly mixed to prepare powder for standby.
Example 4
A pharmaceutical composition D for treating prostatic hyperplasia comprises the following components in parts by weight:
100 parts of Pygeum africanum bark extract,
180 parts of urtica armandi root extract,
β -195 parts of sitosterol,
20 parts of lycopene, namely 20 parts of lycopene,
30 parts of zinc citrate, namely 30 parts of zinc citrate,
0.15 part of selenium, namely,
5 parts of ginkgo leaf extract;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
The components are uniformly mixed to prepare powder for standby.
And (3) clinical trials:
1. case selection
125 outpatient patients with confirmed benign prostatic hyperplasia (all presenting with different degrees of prostatitis, large gland volume and uneven surface typical symptoms) are selected, the course of the disease is more than 3 years, the patients are randomly divided into 5 groups, each group comprises 25 patients, the groups of the treatment groups are respectively a group, b group, c group and d group corresponding to the groups taking the pharmaceutical composition A, B, C, D prepared in examples 1-4, and the control group is o group.
2. Clinical trial
Treatment groups (a, b, c, d): the A, B, C, D powders of the pharmaceutical composition prepared in examples 1-4 of the present invention were each orally administered 2 times a day for 1 dose each (in terms of the amount of each dose/body weight of the patient of 1g/50 Kg). The administration is continued for 5 weeks as a treatment course.
Control group (o group): the tablet is orally administered according to the instruction for 5 weeks.
After the treatment course is over, the control group and the treatment group are examined simultaneously, and the control group is examined again after being taken for 5 weeks, and is examined for the third time after being taken for 5 weeks.
The treatment group and the control group are periodically checked and observed for relapse within 10 months after the medicine is stopped.
3. Analysis of efficacy
The curative effect standard is as follows: according to the relevant chronic prostatitis treatment standard in the disease clinical diagnosis and treatment effect standards, the evaluation comprises the following steps:
and (3) curing: the symptoms disappear, the prostate fluid examination is normal for 3 times, and the prostate B ultrasonic examination and the digital rectal examination are basically normal;
improvement: symptoms are improved, the leucocyte is less than 10/HP in the prostate fluid examination, the lecithin is more than 10/HP, the dense ball disappears, the prostate B ultrasonic examination and the rectal digital examination show mild inflammatory changes;
and (4) invalidation: symptoms before and after treatment and no change in examination.
After clinical trials, the data of therapeutic effects are shown in the following table:
Figure BDA0002250799400000101
the% percentages in the table above represent the percentage of the therapeutic population in each group to the total population in that group.
The total effective rate (including cure and improvement) is respectively: 80% of group a, 84% of group b, 92% of group c, 96% of group d and 32% of group o, wherein after the group o is continuously taken for 5 weeks, the total effective rate is increased to 72%, and after the group o is continuously taken for 5 weeks, the total effective rate is increased to 84%.
Within 10 months after drug withdrawal, the relapse rates of the treatment groups were 12% in group a, 12% in group b, 4% in group c, 0% in group d and 32% in group o, respectively. The recurrence rate calculation method comprises the following steps: according to the judgment of the curative effect standard, the cases which are changed from 'cure' to 'improvement' or 'ineffectiveness' and from 'improvement' to 'ineffectiveness' are all relapse cases, and the relapse rate is the percentage of the total number of the relapse cases to the total number of the group.
From the data, the composition provided by the invention can realize higher cure rate for the patients with the prostatic hyperplasia in a short time, has faster effect than the existing medicaments for treating the prostatic hyperplasia on the market, realizes the cure rate of more than 80, only needs 5 weeks by using the composition provided by the invention, and needs about 15 weeks by using other medicaments on the market. In addition, the recurrence rate of the composition for treating the prostatic hyperplasia is obviously lower than that of the commercially available medicine, and the curative effect is stable. By comparing the curative effect data of the treatment groups, the curative rate and the total effective rate of the groups c and d are obviously higher than those of the groups a and b, which shows that the addition of the ginkgo biloba extract has the effect of obviously improving the two groups of data, however, in the existing reports, no document is recorded and mentioned about the effect of the ginkgo biloba extract on the prostate disease, and no report is provided that the effect of the ginkgo biloba extract and any other component in the formula of the composition provided by the invention can generate the effect of treating the prostate disease, which is an effect that cannot be expected in advance by the technical personnel in the field, including the inventor, and the inventor thinks that one or more substances in the ginkgo biloba extract and other traditional Chinese medicine components (especially, the bark extract of prunus africana) in the formula of the invention have a synergistic effect, so that the original treatment effect of the formula is improved. In addition, by comparing the data of the treatment groups c and d, it can be seen that the data of the group d is obviously superior to that of the group c, however, in the formula, the content of the ginkgo biloba extract in the group d is obviously lower than that of the group c, which indicates that the synergistic effect addition of the ginkgo biloba extract to the curative effect of other components in the formula is enhanced along with the reduction of the content of the ginkgo biloba extract, and the results of the inventor are the same after many experiments, which cannot be predicted by the skilled person.
In conclusion, the invention provides the pharmaceutical composition for treating the prostatic hyperplasia, which has the advantages of quick response and low recurrence rate, the curative effect data is obviously improved after the ginkgo biloba extract is added into the pharmaceutical composition, and the improvement range of the curative effect data is larger along with the reduction of the content of the ginkgo biloba composition.
It will be apparent to those skilled in the art that various modifications can be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is intended to include such modifications.

Claims (9)

1. The pharmaceutical composition for treating prostatic hyperplasia is characterized by comprising the following components in parts by weight:
100-300 parts of prunus africana bark extract,
180 portions of stinging nettle root extract,
β -sitosterol 65-195 parts,
10-20 parts of lycopene, namely 10-20 parts of lycopene,
20-30 parts of zinc citrate, and the active ingredients are zinc citrate,
0.05-0.15 part of selenium;
the composition further comprises vitamin E in an amount of 50-150 International Units (IU) per 200mg of Pygeum africanum bark extract.
2. The pharmaceutical composition for treating prostatic hyperplasia according to claim 1, wherein the Pygeum africanum bark extract is prepared by the following steps: the African pygeum stem bark extract is prepared by drying and crushing African pygeum stem bark, adding 35-50% vol ethanol water solution 5-7 times the weight of the African pygeum stem bark, soaking at 35-40 deg.C for 0.3-0.5h, performing auxiliary ultrasonic extraction at constant temperature of 45-60 deg.C for 0.5-1h with ultrasonic frequency of 26KHz, reflux-extracting for 1.5-2h, filtering to obtain filtrate, and drying to obtain the African pygeum stem bark extract. The method does not need to use organic solvents such as ethyl acetate, dichloromethane and the like, and the used reagent is ethanol, so that the method is low in toxicity, high in recovery rate, environment-friendly and economical.
3. The pharmaceutical composition for treating prostatic hyperplasia according to claim 1, wherein the nettle root extract is prepared by the following steps: cleaning Urtica dioica root, drying, pulverizing, adding 35-50% vol ethanol water solution 5-7 times the weight of Urtica dioica root, performing auxiliary ultrasonic extraction at 35-40 deg.C for 0.5-1 hr with ultrasonic frequency of 26KHz, reflux extracting for 0.5-1 hr, filtering to obtain filtrate, and drying to obtain Urtica dioica root extract.
4. The pharmaceutical composition for treating prostatic hyperplasia according to claim 1, wherein the pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight:
100-120 parts of the prunus africana bark extract,
180 portions of urtica armandi root extract,
β -sitosterol 65-195 parts,
10-20 parts of lycopene, namely 10-20 parts of lycopene,
20-30 parts of zinc citrate, and the active ingredients are zinc citrate,
0.05-0.15 part of selenium;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
5. The pharmaceutical composition for treating prostatic hyperplasia according to claim 1, wherein the pharmaceutical composition for treating prostatic hyperplasia further comprises ginkgo biloba extract, and the pharmaceutical composition comprises the following components in parts by weight:
100-300 parts of prunus africana bark extract,
180 portions of stinging nettle root extract,
β -sitosterol 65-195 parts,
10-20 parts of lycopene, namely 10-20 parts of lycopene,
20-30 parts of zinc citrate, and the active ingredients are zinc citrate,
0.05 to 0.15 portion of selenium,
5-30 parts of ginkgo leaf extract;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
6. The pharmaceutical composition for treating prostatic hyperplasia according to claim 5, wherein the preparation method of the ginkgo biloba leaf extract comprises: cleaning, drying and crushing ginkgo leaves, adding 35-50 vol% ethanol water solution which is 10-15 times the mass of the ginkgo leaves, carrying out auxiliary ultrasonic extraction for 0.5-1h at the constant temperature of 35-40 ℃, wherein the ultrasonic frequency is 26KHz, then carrying out reflux extraction for 0.5-1h, filtering to obtain filtrate, concentrating the filtrate according to the proportion of 1.5g of dry ginkgo leaves to ml of concentrated solution to obtain concentrated solution, putting the concentrated solution on a D101 macroporous resin column, firstly carrying out drip washing by deionized water, then carrying out elution by 70 vol% ethanol deionized water solution, collecting eluent, and drying to obtain the ginkgo leaf extract.
7. The pharmaceutical composition for treating prostatic hyperplasia according to claim 5, wherein the pharmaceutical composition for treating prostatic hyperplasia comprises the following components in parts by weight:
100-120 parts of the prunus africana bark extract,
180 portions of urtica armandi root extract,
β -sitosterol 65-195 parts,
10-20 parts of lycopene, namely 10-20 parts of lycopene,
20-30 parts of zinc citrate, and the active ingredients are zinc citrate,
0.05 to 0.15 portion of selenium,
5-10 parts of ginkgo leaf extract;
the composition further comprises vitamin E in an amount of 100 International Units (IU) per 200mg of Pygeum africanum bark extract.
8. The pharmaceutical composition for treating prostatic hyperplasia according to any one of claims 1 to 7, wherein the pharmaceutical composition for treating prostatic hyperplasia is prepared into powder, granules, powder, capsules, tablets, oral liquid, buccal agents and granules.
9. Use of a pharmaceutical composition for the treatment of prostatic hyperplasia according to any one of claims 1 to 7 in the preparation of a medicament for the treatment of prostatic hyperplasia.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112656915A (en) * 2020-12-28 2021-04-16 完美(中国)有限公司 Composition for inhibiting prostatic hyperplasia
WO2023161184A1 (en) * 2022-02-23 2023-08-31 Kevehazi Laura Mann Herbal composition for prostate health and prostate cancer prevention

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