CN1522727A - Prostate hyperplasia pharmaceutical and method for making same - Google Patents
Prostate hyperplasia pharmaceutical and method for making same Download PDFInfo
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- CN1522727A CN1522727A CNA031175325A CN03117532A CN1522727A CN 1522727 A CN1522727 A CN 1522727A CN A031175325 A CNA031175325 A CN A031175325A CN 03117532 A CN03117532 A CN 03117532A CN 1522727 A CN1522727 A CN 1522727A
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Abstract
The present invention discloses a Chinese medicine in treating hyperplasia of prostate. It is a preparation consisted of mole cricket or its extract component, and add other Chinese medicinal materials ase as auxiliary medicine. Said invention not only can reduce the volume of prostate and relieve the patient's condition, but also can inhibit alpha-receptor so as to quickly relieve clinical symptoms of the patient with hyperplasia of prostate. Said invention also provides its preparation process.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of prostatic hyperplasia.Be the Chinese patent medicine that primary raw material is prepared from Gryllotalpa or Gryllotalpa and Pollen Tyjphae specifically.The invention still further relates to manufacturing method for above mentioned medicine.
Background technology
Hyperplasia of prostate (BPH) is the common disease of elderly men, and its sickness rate increases with the increase at age, reports according to documents and materials, 50～60 years old sickness rate is 50%, 60～70 years old sickness rate is that 60%, 70～80 years old sickness rate is that sickness rate more than 80%, 90 years old is 100%.According to reports, China more than 60 years old elderly men population reached 1.5 hundred million people, calculate by 60% sickness rate, add and suffered from BPH person in the past in 60 years old, China has 100,000,000 people to suffer from BPH approximately at present.
BPH can cause that controlled micturition difficulty, difficulty in micturition, urine urgency-frequency, nocturia increase etc., further develops complication such as can causing serious urinary tract infection, vesical calculus, hematuria, urine retention, kidney merit decline, inguinal hernia, has a strong impact on patient's quality of life.
The treatment means of BPH is a lot, but the various means of existing both at home and abroad treatment BPH run into following thorny problem:
1. operative treatment has certain traumaticly, and complication is many, and the old people is poor to the toleration of operation and anesthesia.
2. relief of symptoms in a short time such as naturopathy such as microwave, radio frequency, high-energy focusing also has complication such as urethral stricture.
3. dwindle the medicine such as the finasteride (proscar) of prostate volume, prostate volume is dwindled, but price more expensive (9 yuan/day), and onset slow (onset in March); And can cause side effect such as hyposexuality, sexual impotence.
4. alleviate the medicine example hydrochloric acid Tamsulosin (breathing out happy) of BPH patient's symptom, price is 8 yuan/day, can comparatively fast alleviate the clinical symptoms of BPH controlled micturition difficulty, but prostate volume is dwindled and delays BPH patient's disease progression; Can cause as headache, orthostatic hypotension even make us unacceptable side-effects.
Though research at present has the Chinese patent medicine of some treatment hyperplasia of prostates, but still can not satisfy patient's needs, and its prescription composition is all complicated, flavour of a drug are more, and price is higher, unsatisfactory curative effect.
Summary of the invention
The object of the present invention is to provide the Chinese medicine and the corresponding preparations thereof for the treatment of the prostatic hyperplasia determined curative effect simply.Its characteristics have: can comparatively fast alleviate BPH patient's clinical symptoms, can dwindle prostate volume again, and low price, have no side effect.
Solution of the present invention is based on the pathogenetic understanding of motherland's medical science to BPH, according to oneself clinical experience for many years, determines the effective Chinese medicine of a series of treatment BPH earlier from numerous Chinese medicines, verify repeatedly through clinical again, and the single medicinal material that screens.Can this single medicinal material be the basis also, add other Chinese medicine and form compound Chinese medicinal preparation.Can comparatively fast alleviate BPH controlled micturition difficulty symptom and remove its misery, can dwindle prostate volume again and delay its disease progression, and low price, have no side effect.
Medicine of the present invention is formed and is mainly Gryllotalpa: perhaps be Gryllotalpa and Pollen Tyjphae (its weight proportion is 1～100: 0～99, is preferably 40～60: 40～60, the best is 50: 50).
Medicine composition of the present invention can also contain one or more in the Chinese medicines such as Cortex Cinnamomi, Herba Leonuri, Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, Spina Gleditsiae, Fructus Psoraleae.
Medicine of the present invention can be the medicine of said dosage form on any pharmaceutics.
The preparation of this medicine can prepare by the conventional method on the various medicaments, as:
Directly Gryllotalpa is ground into fine powder, perhaps Gryllotalpa is used solvent extraction, reclaim solvent, remove degrease, drying gets Gryllotalpa extract, is made into the medicine of required dosage form.
Pollen Tyjphae etc. extract according to a conventional method with ethanol or water etc., then Gryllotalpa or Gryllotalpa extract are mixed evenly with each extracts such as Pollen Tyjphae, make the medicine of required dosage form.
The solvent that is used for extracting Gryllotalpa can be the mixed solvent of one or more compositions of water, methanol, ethanol, ethyl acetate, petroleum ether, acetone, chloroform, cyclohexane extraction or normal hexane etc.
In the above preparation process, if necessary, can add adjuvant commonly used in an amount of pharmaceutics, as starch, dextrin, microcrystalline cellulose, amylum pregelatinisatum, magnesium stearate, micropowder silica gel, sucrose, carboxymethyl starch sodium etc.
Clinical drug of the present invention uses the result to show that following advantage is arranged:
(1) symptoms such as the nocturia that causes of treatment BPH, dysuria, lower abdomen distension reduce international prostate gland symptoms scoring (I-PSS scoring), improve the quality of living.
(2) obviously improve the urine flow rate.
(3) obviously reduce residual urine volume.
(4) have no side effect.
(5) stable curative effect.
For showing clinical effectiveness of the present invention, with reference to " new Chinese medicine clinical research guideline " (1997), select more than 50 years old, be diagnosed as patient's 30 examples of prostatic hyperplasia, through the objective clinical observation of system.Minimum 51 years old of age, maximum 69 years old, average 61.53 ± 6.48 years old.The course of disease is the shortest 4 months, and is the longest 280 months, average 58.10 ± 42.35 months.6 examples that the state of an illness is slight (20%), moderate 13 examples (43.33%), severe 11 examples (36.67%).One month observation period.Instructions of taking: 10g/ day, divide 3 times oral.Respectively at taking medicine preceding and taking medicine the back observation:
(1) safety indexes: blood pressure, pulse, blood, urine, excrement three big routines and electrocardiogram, liver, kidney brake are checked
(2) health giving quality index:
(a) urine flow rate inspection: Qmax, AFR detect.
(b) residual urine volume is measured: adopt through abdomen B ultrasonic method.
(c) prostate volume detects: adopt per rectum B ultrasonic method.
(3) untoward reaction is observed
Comprise that gastrointestinal reaction, nervous system abnormality, skin and muscle are unusual etc.
Every index changes shown in table 1～4 before and after the treatment
International prostate gland symptoms scoring of table 1 (I-PSS) and quality of life index (QOL) change
I-PSS (branch) QOL (branch)
N
After treating before treating after treating before treating
30 23.4±6.2 8.9±6.3
*** 3.8±0.8 2.6±0.8
***
Annotate:
*Represent self cross-reference p＞0.05,
*Expression and preceding relatively p＜0.05 of treatment,
* *Compare p＜0.01 (down together) before expression and the treatment.
Table 2 Qmax (MFR), AFR (AFR) are relatively
MFR(ml/s) AFR(ml/s)
N
After treating before treating after treating before treating
30 9.3±2.8 15.2±3.7
*** 5.4±2.2 9.5±2.3
***
Annotate: the p value representation is the same.
Table 3 residual urine volume (PVR) relatively
After treating before N treats
30 56.0±21.5 29.8±14.2
***
Annotate: the p value representation is the same.
Table 4 prostate volume (ml) relatively
After treating before N treats
30 35.5±11.5 28.2±9.2
**
Annotate: the p value representation is the same.
Do not see obvious adverse reaction in the drug administration process, electrocardiogram before and after taking medicine, liver, renal function, blood, routine urinalysis do not have significant change.
For further checking the present invention dwindles the effect of prostate volume, adopt SD rat castration after subcutaneous injection testosterone propionate method duplicate the BPH model, with 5 times, 10 times, 20 times gastric infusion January that are equivalent to clinical adult's consumption, and establish the proscar matched group.Behind last administration 24h, behind the title rat body weight,, extract prostate through the femoral artery sacrificed by exsanguination.Claim rat prostate weight with electronic balance, and calculate prostate index (weight of prostate/rat body weight * 100%); The water method of substitution is measured prostate volume, unit/ml.Get the same area prostata tissue, liquid-solid fixed 48 hours of FAA, dehydration of alcohol, waxdip step by step, paraffin embedding, section, thickness 4 μ m do conventional H E dyeing, the variation of observation HE staining section prostata tissue structure under 4 * 10 mirrors.
The rat prostate volume is respectively organized in test and weight sees Table 5
Table 5 is respectively organized relatively (x ± SD) of rat prostate weight, volume, index
Group n rat body weight (g) weight of prostate (g) prostate volume (ml) prostate index (%)
Normal group 8 304.00 ± 28.07 0.84 ± 0.25 0.73 ± 0.17 0.27 ± 0.07
Model group 8 323.75 ± 26.69 1.57 ± 0.28
△ △1.39 ± 0.25
△ △0.49 ± 0.08
△ △
Heavy dose of group 8 306.86 ± 31.16 1.02 ± 0.28
※ ※0.88 ± 0.18
※ ※0.34 ± 0.12
※ ※
Middle dosage group 8 290.63 ± 34.48 0.91 ± 0.19
※ ※0.79 ± 0.16
※ ※0.32 ± 0.06
※ ※
Small dose group 8 291.25 ± 19.59 1.03 ± 0.23
※ ※0.89 ± 0.21
※ ※0.35 ± 0.07
※ ※
Proscar group 8 312.63 ± 33.75 0.95 ± 0.27
※ ※0.82 ± 0.20
※ ※0.33 ± 0.13
※ ※
Annotate: △ represents to compare with the normal control group, P＜0.05, and △ △ represents to compare P＜0.01 with the normal control group;
※ represents to compare with the model group group, P＜0.05, and ※ ※ represents to compare P＜0.01 with the model group group.
The result shows: the model group prostate volume increases, and the present invention can dwindle BPH rat prostate volume.
The prostata tissue constructed observation is respectively organized in test: normal control group body of gland is arranged clear, between body of gland visible significantly between matter, lumen of gland does not have expansion, glandular epithelium monolayer column, as seen a little basal cell and obvious basement membrane. model group body of gland dense arrangement, lumen of gland become big, the expansion of part body of gland, the luminal sectetion thing increases, and epithelial cell is the monolayer column, the glandular epithelium thickening, the subregion is false multiple layer, it is prominent to intracavity that the part body of gland is mamillary, visible more basal cell, the little vasodilation hyperemia of a matter; Between the matter smooth muscle increase.The above various changes of each dosage group of the present invention and proscar group all have improvement in various degree.
For clearly inventing the mechanism of alleviating BPH patient's clinical symptoms, designed the test of " influence that the stripped trigone of bladder flesh of the inductive rabbit of norepinephrine (NE) shrinks ", setting up distilled water simultaneously is blank, the positive matched group of terazosin hydrochloride.Result of the test is as shown in table 6.
The influence that the rabbit trigone of bladder flesh that each group of table 6 test is brought out NE shrinks (x ± S)
Group sample number (N) suppression ratio (%)
Of the present invention group 10 21.4730 ± 9.1559
△ △
Hytrin 10 47.9650 ± 11.1554
△ △
Distilled water 10 0.5510 ± 8.7201
△ △ represents to compare P＜0.01 with the distilled water group.
The result shows, the present invention can suppress the rabbit trigone of bladder flesh contraction that NE brings out, the receptor that distributes because of trigone of bladder flesh, neck of bladder, capsula prostatica is alpha-receptor, illustrates that this invention can comparatively fast alleviate the clinical symptoms of BPH controlled micturition difficulty by suppressing alpha-receptor.
The specific embodiment
The invention will be further described below in conjunction with embodiment.
Medicine of the present invention can be made up of and different proportion relations multiple heterogeneity, as (consumption is weight percentage):
(1) Gryllotalpa 20 Fructus Psoraleaes 15 Herba Leonuris 20 Cortex Cinnamomis 10 Radix Paeoniae Rubra 10 Radix Salviae Miltiorrhizaes 15 Herba Lycopi 10
(2) Gryllotalpa 30 Pollen Tyjphae 20 Herba Leonuris 20 Herba Lycopi 20 Cortex Cinnamomis 10
(3) Gryllotalpa 30 Pollen Tyjphae 20 Radix Paeoniae Rubra 20 Radix Salviae Miltiorrhizaes 20 Spina Gleditsiae 10
(4) Gryllotalpa 50 Pollen Tyjphae 50
(5) Gryllotalpa 60 Pollen Tyjphae 40
(6) Gryllotalpa 70 Pollen Tyjphae 30
(7) Gryllotalpa 65 Pollen Tyjphae 35
(8) Gryllotalpa 40 Pollen Tyjphae 60
(9) Gryllotalpa 30 Pollen Tyjphae 70
(10) Gryllotalpa 10 Pollen Tyjphae 90
(11) Gryllotalpa 90 Pollen Tyjphae 10
(12) Gryllotalpa 20 Pollen Tyjphae 80
(13) Gryllotalpa 80 Pollen Tyjphae 20
(14) Gryllotalpa 100
The preparation method of medicine of the present invention is an example with Gryllotalpa, Pollen Tyjphae (percentage by weight 50: 50), can be with reference to following method:
(1) directly Gryllotalpa is ground into fine powder; The Pollen Tyjphae alcohol reflux reclaims solvent, and drying gets the Pollen Tyjphae extract, then Gryllotalpa is mixed evenly with the Pollen Tyjphae extract, adds appropriate amount of starch, granulates, and is processed into granule.
(2) Gryllotalpa is used alcohol reflux, behind the recovery solvent that extract is freezing, to remove degrease, drying gets Gryllotalpa extract; Pollen Tyjphae is pressed the percolation method with ethanol and is extracted, and reclaims solvent, and drying gets the Pollen Tyjphae extract, then Gryllotalpa extract is mixed evenly with the Pollen Tyjphae extract, makes the medicine of required dosage form, adds an amount of microcrystalline cellulose, granulates, and is processed into tablet.
(3) Gryllotalpa is used ethyl acetate extraction, reclaim solvent, drying gets Gryllotalpa extract; The Pollen Tyjphae water is pressed decocting method and is extracted, and concentrates, and drying gets the Pollen Tyjphae extract, then Gryllotalpa extract is mixed evenly with the Pollen Tyjphae extract, makes the medicine of required dosage form.Add an amount of dextrin, granulate, be processed into capsule.
And for example, consist of Gryllotalpa 20, Fructus Psoraleae 15, Herba Leonuri 20, Cortex Cinnamomi 10, Radix Paeoniae Rubra 10, Radix Salviae Miltiorrhizae 15, Herba Lycopi's 10 tablet, its preparation method is:
Gryllotalpa is pressed the percolation method with ethanol extract, behind the recovery solvent that extract is freezing, to remove degrease, drying gets Gryllotalpa extract; Other each medicines with water boiling and extraction repeatedly filter, and merge each extracting solution, concentrate, and drying with the Gryllotalpa extract mix homogeneously, adds an amount of amylum pregelatinisatum, granulate, and tabletting, promptly.
Claims (10)
1. medicine for the treatment of prostatic hyperplasia, the composition that contains Gryllotalpa in it is characterized in that writing out a prescription or extract by Gryllotalpa.
2. according to the medicine of claim 1, it is characterized in that also containing Pollen Tyjphae in the prescription.
3. according to the medicine of claim 2, it is characterized in that writing out a prescription and form by Gryllotalpa and Pollen Tyjphae two herbal medicines.
4. according to the medicine of claim 3, weight (part) ratio range of Gryllotalpa and Pollen Tyjphae is in it is characterized in that writing out a prescription: Pollen Tyjphae 0～99%, Gryllotalpa 1～100%.
5. according to the medicine of claim 4, weight (part) ratio range of Gryllotalpa and Pollen Tyjphae is in it is characterized in that writing out a prescription: Pollen Tyjphae 40～60%, Gryllotalpa 40～60%.
6. according to the medicine of claim 4, weight (part) ratio range of Gryllotalpa and Pollen Tyjphae is in it is characterized in that writing out a prescription: Pollen Tyjphae 50%, Gryllotalpa 50%.
7. according to claim 1,2,3,4,5 or 6 described medicines, it is characterized in that said medicine is the medicine of said dosage form on any pharmaceutics.
8. the preparation method of the medicine of the described treatment prostatic hyperplasia of claim 7 is characterized in that directly Gryllotalpa being ground into fine powder, perhaps Gryllotalpa is used solvent extraction, reclaims solvent, removes degrease, and drying gets Gryllotalpa extract, makes the medicine of required dosage form again.
9. preparation method according to Claim 8, the solvent that it is characterized in that being used for extracting Gryllotalpa can be the mixed solvent of one or more compositions of water, methanol, ethanol, ethyl acetate, petroleum ether, acetone, chloroform, cyclohexane extraction or normal hexane.
10. preparation method according to Claim 8 is characterized in that Pollen Tyjphae etc. extracts according to a conventional method with ethanol or water etc., then each extract is mixed evenly, makes the medicine of required dosage form.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031175325A CN1259943C (en) | 2003-03-25 | 2003-03-25 | Prostate hyperplasia pharmaceutical and method for making same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031175325A CN1259943C (en) | 2003-03-25 | 2003-03-25 | Prostate hyperplasia pharmaceutical and method for making same |
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| Publication Number | Publication Date |
|---|---|
| CN1522727A true CN1522727A (en) | 2004-08-25 |
| CN1259943C CN1259943C (en) | 2006-06-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB031175325A Expired - Fee Related CN1259943C (en) | 2003-03-25 | 2003-03-25 | Prostate hyperplasia pharmaceutical and method for making same |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939431B (en) * | 2005-09-30 | 2011-01-12 | 邵继春 | Medicine for treating prostatic accrementition |
| CN104667027A (en) * | 2015-03-31 | 2015-06-03 | 华梅 | Traditional Chinese medicine liquor for treating prostatic hyperplasia and preparation method of traditional Chinese medicine liquor |
| CN110772623A (en) * | 2019-12-18 | 2020-02-11 | 张吉方 | Traditional Chinese medicine for treating prostate |
-
2003
- 2003-03-25 CN CNB031175325A patent/CN1259943C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939431B (en) * | 2005-09-30 | 2011-01-12 | 邵继春 | Medicine for treating prostatic accrementition |
| CN104667027A (en) * | 2015-03-31 | 2015-06-03 | 华梅 | Traditional Chinese medicine liquor for treating prostatic hyperplasia and preparation method of traditional Chinese medicine liquor |
| CN110772623A (en) * | 2019-12-18 | 2020-02-11 | 张吉方 | Traditional Chinese medicine for treating prostate |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1259943C (en) | 2006-06-21 |
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Granted publication date: 20060621 Termination date: 20160325 |