CN1284594C - Compound Chinese medicine prepn for treating benign prostate hyperplasia and its prepn process - Google Patents

Abstract

The present invention belongs to the technical field of Chinese medicine preparations, and more specifically relates to a compound Chinese medicine preparation for treating benign prostate hyperplasia and a preparation technology thereof. The preparation contains epimedium herb, milkvetch root and twotoothed achyranthes root, or further contains red peony root, glossy privet fruit, zedoray rhizome, common prism tuber, eucommia bark, angelica and talc; after extracted, concentrated and spray-dried, the medicines are granulated into granules, filled to capsules, or pressed and packed into film-coated tablets. The preparation of the present invention treats both manifestations and root cause of diseases, has conspicuous curative effect and security without toxic effect, and is easy to take.

Description

A kind of Chinese traditional compound medicine and preparation technology who treats benign prostate hyperplasia

Technical field:

The invention belongs to the Chinese medicine preparation technical field.Be specifically related to a kind of Chinese traditional compound medicine and preparation technology who treats benign prostate hyperplasia.

Hyperplasia of prostate is one of principal disease of elderly men urinary system, and sickness rate rose later on gradually from 40 years old, surpasses 50%.The foreign data report, the male prostatic hyperplasia sickness rate is more than 95% more than 80 years old.The a lot of urban populations of world developed country and China have been stepped into aging, and therefore, the development of treatment prostatic hyperplasia disease drug is significant.

Background technology:

The medicine of treatment benign prostate hyperplasia mostly is chemotherapeutic drug at present, and not only curative effect is still owed, and certain untoward reaction is arranged, and lacks comparatively ideal curative so far.

Summary of the invention:

The objective of the invention is to develop Chinese medicine preparation, the Chinese medicine preparation of benign prostate hyperplasia can be effectively treated in design.

The invention provides a kind of Chinese traditional compound medicine for the treatment of benign prostate hyperplasia.Said preparation is to be used for the treatment of developing through proved recipe of difficulty in urination card for a long time according to the professor of old docter of TCM king's silk floss is clinical.According to theory of Chinese medical science, the difficulty in urination because of, the different of cold and heat and asthenia and sthenia arranged, we cure mainly disease and belong to the stasis of blood resistance of suffering from a deficiency of the kidney, failure in functioning of QI, urine retention, the syndrome of deficiency complicated with excess.Fang Zhongyong Herba Epimedii, the Radix Astragali are monarch drug also, warming YANG and invigorating QI, tonneau three warmers, dredging water channel.The Cortex Eucommiae, Fructus Ligustri Lucidi, Radix Achyranthis Bidentatae are ministerial drug, and three medicines are gone into Liver and kidney, sharp waist knee joint, and the meridian dredging, blood circulation promoting and blood stasis dispelling, clear sharp two just, and principal drug assistance is tonified Qi of the kidney and dredging water passages.Rhizoma sparganic, Rhizoma Curcumae eliminating stagnation removing blood stasis with potent drugs, Radix Paeoniae Rubra, Radix Angelicae Sinensis blood circulation promoting and blood stasis dispelling, four medicines are assistant, and it is clean that blood stasis dispelling disappears, and Talcum is sweet cold, the going or staying knot.10 flavors are played altogether and are tonified Qi of the kidney, promoting blood flow and remove blood stasis, the merit of sharp part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels gas, the suffer from a deficiency of the kidney hyperplasia of prostate of disease of stasis of blood resistance of suitable old people.

Chinese traditional compound medicine of the present invention (the infirmity granule of opening) contains Herba Epimedii, the Radix Astragali, Radix Achyranthis Bidentatae, the Cortex Eucommiae, Fructus Ligustri Lucidi, rhizoma sparganic, Rhizoma Curcumae, Radix Paeoniae Rubra, Radix Angelicae Sinensis, steatitic granule, capsule or tablet, its composition is by dry product weight, Herba Epimedii 6～12, the Radix Astragali 12～24, Radix Achyranthis Bidentatae 6～12, the Cortex Eucommiae (salt stir-fry) 6～12, Radix Paeoniae Rubra 8～16, Fructus Ligustri Lucidi (processed with wine) 10～20, rhizoma sparganic 6～12, Rhizoma Curcumae 6～12, Radix Angelicae Sinensis 6～12, Talcum 12～24.Icariin content 〉=8mg/ bag in the preparation,＞the 1.0mg/ grain,＞the 1.0mg/ sheet.

Chinese traditional compound medicine of the present invention (the infirmity granule of opening) the treatment benign prostate hyperplasia stasis-eliminating disease clinical test results of suffering from a deficiency of the kidney is as follows:

For investigating infirmity open particulate curative effect and safety thereof, formed the clinical trial cooperative groups by four tame hospitals such as Guang-amen Hospital, China Traditional Chinese Medicine Instl, Longhua Hospital affiliated Shanghai University Of Chinese Traditional Medicine, Huashan Hospital, Attached to Shanghai Medical Univ., Zhejiang Province Affiliated Hospital of university of TCM, through one-year age, according at random, blind method, the contrast principle, the infirmity granule of opening has been carried out the II clinical trial phase.This test of cure group (the infirmity granule of opening) 339 examples, matched group (Longbishu Jiaonang.) 146 examples.

The result shows:

(1) infirmity opening in granule (treatment group) the 339 example test cases, clinic control 33 examples, produce effects 110 examples, effective 125 examples, invalid 71 examples, total effective rate is 79.06%, total obvious effective rate is 42.18%; In Longbishu Jiaonang. (matched group) the 146 example test cases, clinic control 4 examples, produce effects 21 examples, effective 63 examples, invalid 58 examples, total effective rate is 60.27%, total obvious effective rate is 17.2%, statistical procedures, two groups of P＜0.01 show that infirmity the suffer from a deficiency of the kidney effect of blood stasis blocking type benign prostate hyperplasia of granule therapy of opening is better than Longbishu Jiaonang..

(2) infirmityly open particulate clinical characters and be: 1. can obviously improve the suffer from a deficiency of the kidney cardinal symptom of stasis-eliminating disease of benign prostate hyperplasia, improve the nocturia frequency, soreness of the waist and knees, dysuria, few distention and fullness in the abdomen aspect is better than matched group; (2) can obviously improve Qmax.The treatment group is brought up to by Qmax 10.40 ± 3.20ml/s before treating and is treated back 14.44 ± 4.77ml/s, is better than matched group; (3) can obviously reduce residual urine volume.The treatment group reduces to 25.2 ± 43.7ml by treating preceding 47.4 ± 76.4ml; (4) effect that reduces prostate size (prostate palpation) and ease the pain is arranged, prostate volume reduces to 38.92 ± 20.17 grams by 41.83 ± 20.59 grams before treating, but not statistically significant; (5) can reduce the I-PSS score value and improve the patients ' life quality index, both all are better than matched group; (6) treatment group is that slight patient curative effect better less than 70 years old, the course of disease less than 5 years, the state of an illness to the age; (7) in the treatment group, slight stomach discomfort 3 examples appear in the back of taking medicine because of flavour of a drug are uncomfortable; Laxativeness 1 example occurs, but do not make drug withdrawal and anti symptom treatment, symptom is died away after a couple of days; Vomiting 1 example occurs, but do not make drug withdrawal and anti symptom treatment, symptom is died away after a couple of days; Vomiting 1 example appears, through having looked into serious gastric ulcer history; Yu Wei sees obvious adverse reaction; (8) infirmity opening before and after the granule therapy, patient's hepatic and renal function, hematuria routine, electrocardiogram, blood pressure, PSA level do not have tangible ANOMALOUS VARIATIONS; (9) 87 routine clinic control or produce effects case were followed up a case by regular visits to stable curative effect three months.

Test objective: investigate infirmity curative effect and safety of opening granule to the blood stasis blocking type hyperplasia of prostate of suffering from a deficiency of the kidney.

The case history choice criteria

One, diagnostic criteria

1. Western medicine diagnose

1. male more than 50 years old.Dysuria, hesitate, urinate thin, the interruption that wastes time and energy, urinates of line,

Frequent micturition, nocturia frequency, very the person has urine retention or urinary incontinence.

2. anus touch: two lateral lobes increase, smooth, flexible, Rolandic fissure shoals or disappears.

3. ultrasound diagnosis, prostate increases, weight＞20g.

4. uroflometry urine amount＞150ml, Qmax Qmax＜15ml/s is if urine amount＜150ml should consider urine amount factor.As through making great efforts repeatedly, patient can not reach above standard, can adopt the Qmax result of existing urine amount.

5. residual urine volume is measured bladder and is had or not residual urine through abdomen ultrasound diagnosis or urethral catheterization method.

Allly possess 1., 2., 3., 4. item person, can be diagnosed as benign prostate hyperplasia.

2. the hyperplasia of prostate blood stasis blocking type Chinese medical discrimination of suffering from a deficiency of the kidney

1. thin and delicate, time-consuming, effort of urinating of dysuria, urine line or urine stream tiny drop do not become line, under the drop difficulty.The nocturia increased frequency.

2. soreness of the waist and knees.

3. lack distention and fullness in the abdomen pain.

4. tongue dimness, deep-thready pulse, empty late big or see puckery.

All possess 1. and other 3 in 2, can examine and be the blood stasis blocking type benign prostate hyperplasia of suffering from a deficiency of the kidney.

Two, state of an illness standards of grading

1, according to the method for international prostate gland symptoms scoring (I-PSS) and appraisal of life quality, the relevant symptom of urinating is divided into 0-35 scoring section, total scoring scope (QOL) (asymptomatic-very serious symptom) is expressed with S=0～35.Appraisal of life quality is divided into 0-6, and 7 scorings are expressed with QOL=0～6.

Table 1.IPSS relevant issues and single appraisal of life quality grade form

(international prostate gland symptoms scoring I-PSS)

The situation of urinating	Do not have	Be less than 1/5	Be less than 1/2	About 1/2	More than half	Almost always have
							Past one month vesical tenesmus	0	1	2	3	4	5
Past one month urinated and urinated again with interior in back 2 hours	0	1	2	3	4	5
							Past one month stopped and beginning repeatedly when urinating	0	1	2	3	4	5
Past one month urinated and can not wait for	0	1	2	3	4	5
							Past one month sensation urine line attenuates	0	1	2	3	4	5
Past one month sensation trouble urinating	0	1	2	3	4	5
							Night past one month, sleep was to the number of micturitions of getting up	Do not have	1 time	2 times	3 times	4 times	〉=5 times
0	1	2	3	4	5
						I-PSS total points S=

Table 2. influence (quality of life index L) of symptom of urinating to quality of life

	Very good	Good	Most satisfied	Bitterness and happiness half and half	Most dissatisfied	Unhappy	Very painful
								How the situation of urinating now you think	0	1	2	3	4	5	6

2. symptom and objective indicator standards of grading

Table 3. symptom and objective indicator standards of grading

The relative score value of IPSS	0 (0 minute)	1-7 branch (2 minutes)	8-19 branch (4 minutes)	20-35 branch (6 minutes)
					The nocturia number of times	0-1 time (0 minute)	2 times (1 minute)	3-4 time (2 minutes)	〉=5 times (3 minutes)
Soreness of the waist and knees	Normally (0 minute)	Idol has outbreak (1 minute)	Outbreak (2 minutes) repeatedly	Continue outbreak (3 minutes)
					Little distention and fullness in the abdomen	Asymptomatic (0 minute)	Full vexed sense (1 minute)	Expand, expire (2 minutes)	Expand, full, (3 minutes) bitterly
Qmax	〉=15ml/s (0 minute)	〉=10ml/s (1 minute)	〉=6ml/s (2 minutes)	＜6ml/s (3 minutes)
					Residual urine volume	＜10ml (0 minute)	10-50ml (1 minute)	51-100ml (2 minutes)	＞100ml (3 minutes)
Quality of life relative score value	0-1 (0 minute)	2 (1 minutes)	3-4 (2 minutes)	5-6 (3 minutes)

Heavy standards of grading during the state of an illness is light:

Slightly≤9 minute, moderate 10-16 branch, severe 〉=17 minute

3, tcm syndrome standards of grading:

Table 4. tcm syndrome standards of grading

	0 minute	1 minute	2 minutes	3 minutes
					The nocturia number of times	1 time	2 times	3～4 times	〉=5 times
Dysuria	Normally	Urine thin becomes line	The interrupted one-tenth of urine stream line	Urine stream tiny drop becomes line
					Soreness of the waist and knees	Normally	Idol has outbreak	Outbreak repeatedly	Continue outbreak

Little distention and fullness in the abdomen	Normally	Full vexed sense	Expand, expire	Expand, full, bitterly
					Picture of the tongue	Normally	Unusually
Pulse condition	Normally	Unusually

Three, test case standard

1. include standard in

All primary disease diagnosis and Chinese medical discrimination standards of meeting, age 50-80 year male person, by clinical stages standard belong to the 1st, 2 phase patients, stop relevant administration more than one month, can include the test case in.

Table 5. clinical stages standard

By stages	Clinical manifestation
		The 1st phase (irritation phase)	Bladder, urethra, perineum are slightly uncomfortable, frequent micturition, and slight dysuria mainly shows as the nocturia frequency, residual urine＜50ml.International prostate gland symptoms scoring (I-PSS)≤7 minute.
The 2nd phase (residual urine phase)	Carrying out property dysuria, conscious exerting oneself when urinating, residual urine volume 50-150ml, acute urinary retention, urinary tract infection can take place in this phase.I-PSS scoring 8-9 branch.
		The 3rd phase (bladder loses the compensatory phase)	Residual urine volume＞150ml, bladder enlarges, and renal function begins impaired, the urinary retention with overflow incontinence symptom occurs.I-PSS scoring 20-35 branch.

2. get rid of and the rejecting standard

1. less than 50 years old male.

2. oliguria or anuria due to lithangiuria, carcinoma of prostate, the acute or chronic renal failure.

3. the dysuria that causes of neurogenic bladder, neck of bladder fibrosis, urethral stricture.

4. the frequent micturition that causes such as gonorrhea, urinary tract infection.

5. have cardiovascular and cerebrovascular vessel, liver and hemopoietic system, etc. serious primary disease, intractable diabetes and diabetic neuropathy is arranged.The psychotic.

6. benign prostate blocks invasive treatment loser.

7. operation on pelvis is arranged or decrease the wounded.

8. to this medicine allergy.

9. all standards of including in that do not meet, not medication in accordance with regulations, or share other drug can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.

Observe and Therapeutic Method

One, follows principle

At random, contrast, blind method.

Two, test method

1. double-blind trial:

Because being subjected to reagent is granule, the contrast medicine is a capsule, and the two dosage form difference is so establish simulation granule and simulation capsule.This clinical research intends adopting the simulation double-blind method.

The treatment group comprises infirmity granule two boxes (every box 24 bags) and simulation two bottles of the capsules (45 every bottle) opened, matched group Longbishu Jiaonang. two bottles of (45 every bottle) and simulation granule two boxes (every box 24 bags).The treatment group is similar in shape in outward appearance to matched group.

Usage and dosage: granule, each bag, is used mixing in water for oral taking at every day three times; Capsule, each three, every day secondary, water is swallowed.

Test sequence: press the random order table, with reference to " medical statistics methodology " random table.Clinical trial finishes back " broken blind " fully.

2. single blind trial:

The treatment group is a granule, and label is called " prostatic hyperplasia I number ", and matched group is a capsule, and label is called " prostatic hyperplasia II number ".

Two parts of each case medicated bags, every part by clinical using dosage preparation in 15 days.Treatment group: prostatic hyperplasia I number (being subjected to reagent) two boxes, every box 24 bags; Matched group: prostatic hyperplasia II number (contrast medicine) two bottles, 45 every bottle.

Usage and dosage: prostatic hyperplasia I number (being subjected to reagent), each bag, is used mixing in water for oral taking at every day three times; Prostatic hyperplasia II number (contrast medicine), each three, every day secondary, water is swallowed.

Test sequence: press the random order table, with reference to " medical statistics methodology " random table.Clinical trial finishes back " broken blind ".

Three, contrast medicine

Medicine name: Longbishu Jiaonang..

Manufacturer: Shijiazhuang Ke Di pharmaceutical Co. Ltd.

Form: Fructus Psoraleae, Herba Leonuri etc.

Function: the kidney warming activating QI, clearing heat and freeing strangury, blood circulation promoting and blood stasis dispelling, removing obstruction for relieving pain.

Cure mainly: frequent micturition, urgent micturition, dark coloured urine, dysurea, urine thin such as line due to the deficiency of kidney-QI, the difficulty in urination of dampness and heat stasis, lower abdomen contracture pain, diseases such as soreness of the waist and knees.Prostatic hyperplasia has above patient also can use.

Four, the course of treatment

Be 30 days a course of treatment.

Curative effect judging standard

One, clinic control

1) cardinal symptom disappears, and total mark reduces more than 90%;

2) Qmax＞15/ml/S;

3) residual urine volume＜10ml;

4) prostate volume dwindles more than 20%.

All possess first and other and get final product.

Two, produce effects

1) cardinal symptom disappears, and total mark reduces 60-89%;

2) Qmax increases by 30%;

3) residual urine volume reduces by 50% above person;

4) prostate volume dwindles more than 10%.

All possess first and other and get final product.

Three, effective

1) cardinal symptom is improved, and total mark reduces 30-59%;

2) Qmax increases more than 10%.

3) residual urine volume reduces more than 20%.

4) prostate volume has and dwindles.

All possess first and other and get final product.

Four, invalid

Cardinal symptom and every index change not obvious.

The infirmity granule pharmacology summary of opening:

The infirmity granule of opening is made up of Chinese medicines such as Herba Epimedii, the Radix Astragali, Radix Achyranthis Bidentatae, Rhizoma Curcumae, Radix Angelicae Sinensis, Talcums, have tonify Qi of the kidney, the function of blood circulation promoting and blood stasis dispelling, cure mainly the difficulty in urination (benign prostate hyperplasia suffer from a deficiency of the kidney stasis-eliminating disease).To this, research has been observed this medicine to the normal influence that the mice prostate was grown and brought out the mice prostatic hyperplasia by androlin or implantation tire Mus urogenital sinus childhood.The result significantly influences.The result shows:

1, to the normal influence that childhood, the mice prostate was grown: infirmity granule 1.8～7.2/kg (the suitable crude drug 10～40g/kg) of opening of normal mouse gavaging childhood, once a day, continuous 20 days, can obviously alleviate prostate weight in wet base and prostate dna content, show that infirmity opening has inhibitory action to prostate growth.

2, to the influence of androlin induced mice prostatic hyperplasia: mouse stomach is infirmity opens granule 1.8～7.2g/kg (suitable crude drug 10～40g/kg), once a day, continuous 10 days, its prostate siphonal lobe obviously alleviates, and can reduce prostate dna content and phosphatase acid serum activity, show that infirmity opening has preventive effect to androgen caused by abnormal prostatic hyperplasia.

3, implantation tire Mus urogenital sinus is brought out the influence of mice prostatic hyperplasia: animal pattern is irritated infirmity granule 3.6～7.2g/kg (the suitable crude drug 20～40g/kg) of opening of stomach, once a day, continuous 30 days, can reduce hypertrophy and the prostata tissue dna content of prostate siphonal lobe, show that infirmity recovery again of opening bringing out prostate peripheral region embryonal tissue energy for growth has certain therapeutical effect.

The to sum up infirmity granule of opening has remarkable inhibiting Pharmacodynamic test of active extract result to preceding gland hypertrophy, has verified that it prevents and treats the effect and the effect of the difficulty in urination (benign prostate hyperplasia suffer from a deficiency of the kidney stasis-eliminating disease) on tcm clinical practice.

Infirmity open granule with mice the dose of tolerant maximum concentration and maximum volume irritate stomach, tangible toxic reaction is not also seen in none death of animal, shows the suitable crude drug 200g/kg of its maximum dosage-feeding.

The infirmity granule of opening is irritated the stomach rat with suitable crude drug 10,40,100g/kg dosage, or with suitable crude drug 12,60g/kg dosage filling stomach Beagle dog, once a day, continuous three months, each treated animal active situation, expression react all no abnormal, and the situation of ingesting is normal substantially, and the average weight growth is observed with general behavior and compared with corresponding control animal, the overt toxicity reaction does not also take place with dead in no significant difference.Administration and convalescent period, animal hematology, serum biochemistry were learned, uroscopy is not all found obviously unusual when finishing.Histopathologic examination finds that when administration finished, high dose (quite crude drug 100g/kg) group male rat prostate was slight atrophing state, glandular epithelium is by the column Pedicellus et Pericarpium Trapae or flatly move life, lumen of gland diminishes, and does not see disappearance, notable difference between each treated animal of other internal organs around recovering.

To sum up the toxicological study result shows: the infirmity suitable crude drug 20g/kg of maximum dosage-feeding that opens granule to mice is 100 times of clinical plan consumption.The infirmity granule of opening is irritated the stomach rat with suitable crude drug 10,40,100g/kg dosage, or irritated stomach Beagle dog continuous three months with suitable crude drug 12,60g/kg dosage, high dose (quite crude drug 100g/kg) group male rat prostate is slight atrophing state, and the general symptom of each treated animal is normal, hematology, serum biochemistry are learned, every index of urine, and the pathologic finding of other internal organs, have no significant change, pointing out and infirmityly open particulate effect target organ mainly in prostatic, is relevant with the drug action of this medicine.

Another object of the present invention provides above-mentioned a kind of Chinese traditional compound medicine and preparation technology who treats hyperplasia of prostate, it is characterized in that this technology is by formula proportion, add 6～10 times of water gagings, soak time＞0.5 hour, decocting time＞1 hour decocts number of times 1～3 time, decoction liquor concentrates, spray drying is granulated, in the aluminium plastic bag of packing into; Or encapsulated, in dress aluminum platinum plate or the polyethylene bottle; Or tabletting, the bag film-coat, in dress aluminum platinum plate or the polyethylene bottle, above-mentioned three kinds of product icariin content difference 〉=8mg/ bags,＞the 1.0mg/ grain,＞the 1.0mg/ sheet.

Preparation of the present invention have tonify Qi of the kidney, the blood circulation promoting and blood stasis dispelling function, cure mainly the blood stasis blocking type benign prostate hyperplasia of suffering from a deficiency of the kidney, treating both the principal and secondary aspects of a disease, evident in efficacy, safety non-toxic, taking convenience.

Preparation of the present invention have tonify Qi of the kidney, the blood circulation promoting and blood stasis dispelling function, cure mainly the blood stasis blocking type benign prostate hyperplasia of suffering from a deficiency of the kidney, treating both the principal and secondary aspects of a disease, evident in efficacy, safety non-toxic, taking convenience.

The specific embodiment:

Embodiment 1.

Prescription: Herba Epimedii 9g Radix Astragali 18g Radix Achyranthis Bidentatae 9g Rhizoma Curcumae 9g

Method for making:

Granule: in prescription ratio batching, add 10 times of water gagings and decoct twice (1.5 hours, 1 hour), merging filtrate is concentrated into relative density 1.06 (60 ℃), adds 15～20% adjuvants, adds right amount of auxiliary materials and granulates (dry pressing), surveys content, qualified immediate shipment aluminium plastic bag.

Tablet: prepare burden in the prescription ratio, adding 10 times of water gagings decocted 2 hours, filtrate is concentrated into relative density 1.04 (60 ℃), adds 2 times of amount ethanol precipitations, and cold preservation is got supernatant (or centrifugal) and reclaimed ethanol, be concentrated into relative density 1.06 (60 ℃), add 15～20% adjuvant spray dryinges (or vacuum decompression drying), add appropriate amount of auxiliary materials and granulate tabletting, the bag film-coat, dress aluminium foil plate or polyethylene bottle.

Capsule: prepare burden in the prescription ratio, adding 10 times of water gagings decocted 2 hours, filtrate is concentrated into relative density 1.04 (60 ℃), add 2 times of amount ethanol precipitations, cold preservation is got supernatant (or centrifugal) and is reclaimed ethanol, is concentrated into relative density 1.06 (60 ℃), add 15～20% adjuvant spray dryinges (or vacuum decompression drying), add appropriate amount of auxiliary materials and granulate, encapsulated, in dress aluminium foil plate or the polyethylene bottle.

Embodiment 2,

Prescription: Herba Epimedii 9g Radix Astragali 18g Radix Achyranthis Bidentatae 9g Radix Paeoniae Rubra 12g Rhizoma Curcumae 9g Radix Angelicae Sinensis 9g

Method for making: with example one.

Embodiment 3,

Prescription: Herba Epimedii 9g Radix Astragali 18g Radix Achyranthis Bidentatae 9g Fructus Ligustri Lucidi 15g Cortex Eucommiae 9g

Radix Paeoniae Rubra 12g Rhizoma Curcumae 9g rhizoma sparganic 9g Radix Angelicae Sinensis 9g Talcum 18g

Method for making: with example one.

Claims (3)

1, a kind of Chinese traditional compound medicine for the treatment of benign prostate hyperplasia is characterized in that said preparation made by following materials of weight proportions:

Herba Epimedii 6～12, the Radix Astragali 12～24, Radix Achyranthis Bidentatae 6～12, the Cortex Eucommiae 6～12, Radix Paeoniae Rubra 8～16, Fructus Ligustri Lucidi 10～20, rhizoma sparganic 6～12, Rhizoma Curcumae 6～12, Radix Angelicae Sinensis 6～12, Talcum 12～24.

2, a kind of Chinese traditional compound medicine for the treatment of benign prostate hyperplasia according to claim 1 is characterized in that said preparation is granule, tablet or capsule; The content of icariin in preparation is respectively: granule: 〉=8mg/ bag, tablet: 1.0mg/ sheet, capsule 1.0mg/ grain.

3, a kind of preparation technology of Chinese traditional compound medicine of treatment benign prostate hyperplasia as claimed in claim 1 is characterized in that this technology comprises the following steps:

(1) commercial weight: weight proportion is:

Herba Epimedii 6～12, the Radix Astragali 12～24, Radix Achyranthis Bidentatae 6～12, the Cortex Eucommiae 6～12, Radix Paeoniae Rubra 8～16, Fructus Ligustri Lucidi 10～20, rhizoma sparganic 6～12, Rhizoma Curcumae 6～12, Radix Angelicae Sinensis 6～12, Talcum 12～24;

(2) technology:

Get the Chinese medicine of respectively distinguishing the flavor of, add 10 times of water gagings, decocted 2 hours, filtrate is concentrated into 1.04/60 ℃ of relative density, adds 15～20% adjuvant spray dryinges or vacuum decompression drying, makes preparation after the granulation.