Background technology
Hyperplasia of prostate (BPH) is the common disease of elderly men, and its sickness rate increases with the increase at age, according to reports, China's more than 60 years old elderly men population has reached 1.5 hundred million people, sickness rate by 60% is calculated, and adds and suffers from the past BPH person in 60 years old, and China approximately has 100,000,000 people to suffer from BPH 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 domestic and international existing treatment BPH run into following thorny problem: operative treatment is with certain traumatic, and complication is many, and old people is poor to the toleration of operation and anesthesia.Naturopathy, as the relief of symptoms in a short time such as microwave, radio frequency, high-energy focusing, also has the complication such as urethral stricture.Dwindle the medicine of prostate volume as finasteride (proscar), can make prostate volume dwindle, but price more expensive (9 yuan/day), and slow (onset in March) of onset; And can cause the side effect such as hyposexuality, sexual impotence.
Though research at present has the Chinese patent medicine of some treatment hyperplasia of prostates, but still can not meet patient's needs, and its prescription composition is all more 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 a kind of pharmaceutical composition prostatic hyperplasia, determined curative effect for the treatment of.The pharmaceutical composition for the treatment of prostatic hyperplasia of the present invention can comparatively fast be alleviated BPH patient's clinical symptoms, can dwindle prostate volume again, and low price, has no side effect.
To achieve these goals, technical scheme provided by the invention is:
Treat a pharmaceutical composition for prostatic hyperplasia, it is to be the medicament that medicinal raw material is made by Rhizoma Chuanxiong and Nidus Vespae.
The weight proportion of pharmaceutical composition of the present invention medicine material used can be: Rhizoma Chuanxiong 3-15 part, Nidus Vespae 3-15 part.
More preferably the proportioning of pharmaceutical composition of the present invention medicine material used is: Rhizoma Chuanxiong 6-12 part, Nidus Vespae 6-12 part.
The best proportioning of pharmaceutical composition of the present invention medicine material used is: 9 parts of Rhizoma Chuanxiongs, 9 parts, Nidus Vespae.
Medicine of the present invention can be prepared into said dosage form on any pharmaceutics, can be any existing pharmaceutical dosage form in injection, transfusion, powder pin, drop pill, tablet, slow releasing tablet, capsule, soft capsule, granule.
Pharmaceutical composition of the present invention can adopt but be not limited to following methods:
(1) get Ligusticum chuanxiong Hort, with the 50-95% alcohol reflux of 8-10 times of volume 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, obtain extractum, be dissolved in water, sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:15-1:20), first washes with water, and this water elution liquid is discarded, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying, obtains Rhizoma Chuanxiong extract.
(2) get Nidus Vespae medical material, with the ethanol percolation of the 60%-95% of 8-10 times of volume 2 times, collect and merge percolate, gained percolate is condensed into rare extractum; Above-mentioned rare extractum is crossed to macroporous adsorbent resin, and the low-concentration ethanol eluting of first water or 1-20%, removes the impurity that is dissolved in polar solvent, and the eluent of this water or low-concentration ethanol is discarded; Use again the high concentration ethanol eluting of 60-95%, collect this high concentration ethanol eluent, the eluent reclaiming after ethanol is dried, obtain Nidus Vespae extract.
(3) said extracted thing is mixed, make acceptable various pharmaceutical dosage form.
In above preparation process, if necessary, can add adjuvant conventional in appropriate pharmaceutics, as starch, dextrin, microcrystalline cellulose, amylum pregelatinisatum, magnesium stearate, micropowder silica gel, sucrose, carboxymethyl starch sodium etc.
Solution of the present invention is the pathogenetic understanding to BPH based on motherland's medical science, according to oneself clinical experience for many years, first from numerous Chinese medicine, determines the effective Chinese medicine of a series for the treatment of BPH, more repeatedly verifies through clinical, screens.In pharmaceutical composition of the present invention, Rhizoma Chuanxiong acrid in the mouth is warm in nature, returns Liver Channel, gallbladder meridian, pericardium channel, has the function of blood circulation promoting and blood stasis dispelling, activating QI to alleviate the depression, wind-expelling pain-stopping.Cure mainly: menoxenia; Amenorrhea dysmenorrhea; The stagnant raw meat pain of the stasis of blood in puerperal; Mass in the abdomen lump; Pain in chest and hypochondrium; Have a headache dizzy; Anemofrigid-damp arthralgia; Traumatic injury; Ulcer sores.Modern pharmacological research shows, Rhizoma Chuanxiong can increase coronary flow, improves myocardial ischemia situation, extends the platelet aggregation time of ADP induction in vitro, and the platelet of having assembled is had to depolymerisation.Nidus Vespae sweet in the mouth, property is flat.Return stomach warp.Detoxicating and killing parasites, wind-expelling pain-stopping.For sore swollen toxin, acute mastitis, scrofula, skin stubborn dermatitis, fungal infection of hand and foot, toothache, rheumatic arthralgia.Rhizoma Chuanxiong, Nidus Vespae share, promoting flow of QI and blood, and wind-expelling pain-stopping, can comparatively fast alleviate BPH controlled micturition difficulty symptom and remove its misery, can dwindle prostate volume again and delays its disease progression, and low price, have no side effect.
The present invention's various raw medicinal materials used are the Chinese crude drug that meets country or provincial standard regulation.
Compared with prior art, the invention has the beneficial effects as follows: clinical drug of the present invention uses result to show there is following advantage:
(1) can treat the symptoms such as nocturia that BPH causes, dysuria, lower abdomen distension, reduce international prostate gland symptoms scoring (I-PSS scoring), improve the quality of living.
(2) obviously improve urine flow rate.
(3) obviously reduce residual urine volume.
(4) have no side effect.
(5) stable curative effect.
The specific embodiment
Below in conjunction with the specific embodiment, the present invention is described in further detail.
Embodiment 1
The pharmaceutical composition of the treatment prostatic hyperplasia that the present embodiment is enumerated, is made up of the medicinal raw material of following weight: Rhizoma Chuanxiong 9g, Nidus Vespae 9g.
Above-mentioned medicinal raw material is prepared into soft capsule, and preparation method is as follows:
(1) get Ligusticum chuanxiong Hort by formula proportion, with 85% alcohol reflux of 10 times of volumes 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, obtain extractum, be dissolved in water, sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:20), first washes with water, and this water elution liquid is discarded, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying, obtains Rhizoma Chuanxiong extract.
(2) get Nidus Vespae medical material by formula proportion, with 85% ethanol percolation of 10 times of volumes 2 times, collect and merge percolate, gained percolate is condensed into rare extractum; Above-mentioned rare extractum is crossed to macroporous adsorbent resin, first wash with water, remove the impurity that is dissolved in polar solvent, this water elution liquid is discarded; Use again 95% high concentration ethanol eluting, collect this high concentration ethanol eluent, the eluent reclaiming after ethanol is dried, obtain Nidus Vespae extract.
(3) said extracted thing is mixed, add vegetable oil 15g, mix, make capsule casing material with gelatin, be pressed into soft capsule.
Embodiment 2
The pharmaceutical composition of the treatment prostatic hyperplasia that the present embodiment is enumerated, is made up of the medicinal raw material of following weight: Rhizoma Chuanxiong 3g, Nidus Vespae 3g.
Above-mentioned medicinal raw material is prepared into injectable powder, and preparation method is as follows:
(1) get Ligusticum chuanxiong Hort by formula proportion, with 50% alcohol reflux of 8 times of volumes 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, obtain extractum, be dissolved in water, sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:15), first washes with water, and this water elution liquid is discarded, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying, obtains Rhizoma Chuanxiong extract.
(2) get Nidus Vespae medical material by formula proportion, with 60% ethanol percolation of 8 times of volumes 2 times, collect and merge percolate, gained percolate is condensed into rare extractum; Above-mentioned rare extractum is crossed to macroporous adsorbent resin, first use 20% low-concentration ethanol eluting, remove the impurity that is dissolved in polar solvent, the eluent of this low-concentration ethanol is discarded; Use again 95% high concentration ethanol eluting, collect this high concentration ethanol eluent, the eluent reclaiming after ethanol is dried, obtain Nidus Vespae extract.
(3) said extracted thing is mixed, be dissolved in 1000mL water for injection, adopt existing preparation of injection, make injectable powder.
Embodiment 3
The pharmaceutical composition of the treatment prostatic hyperplasia that the present embodiment is enumerated, is made up of the medicinal raw material of following weight: Rhizoma Chuanxiong 15g, Nidus Vespae 15g.
Above-mentioned medicinal raw material is prepared into capsule, and preparation method is as follows:
(1) get Ligusticum chuanxiong Hort by formula proportion, with 95% alcohol reflux of 10 times of volumes 3 times, each 1.5h, extracting liquid filtering, merging filtrate, concentrating under reduced pressure, obtain extractum, be dissolved in water, sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:20), first washes with water, and this water elution liquid is discarded, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying, obtains Rhizoma Chuanxiong extract.
(2) get Nidus Vespae medical material by formula proportion, with 695% ethanol percolation of 10 times of volumes 2 times, collect and merge percolate, gained percolate is condensed into rare extractum; Above-mentioned rare extractum is crossed to macroporous adsorbent resin, first wash with water, remove the impurity that is dissolved in polar solvent, water elution liquid is discarded; Use again 60% high concentration ethanol eluting, collect this high concentration ethanol eluent, the eluent reclaiming after ethanol is dried, obtain Nidus Vespae extract.
(3) said extracted thing is mixed, 120g is mixed homogeneously with starch, adopts capsules preparation technique, makes the pharmaceutical composition of capsule.
For showing clinical effectiveness of the present invention, with reference to " new Chinese medicine guideline of clinical investigations " (1997), select 50 years old above, to be diagnosed as prostatic hyperplasia patient's 30 example, carry out the objective clinical observation of system.One month observation period.Instructions of taking: take the obtained medicament of embodiment 1,10g/ day, points 3 times oral.Respectively at before taking medicine and take observation post administration:
(1) safety indexes: blood pressure, pulse, blood, urine, the large routine of excrement three and electrocardiogram, liver, kidney brake check.
(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 abnormal etc.
Before and after treatment, indices changes as shown in table 1~4
The international prostate gland symptoms scoring of table 1 (I-PSS) and quality of life index (QOL) change
Note: * represents self cross-reference p>0.05, * * represent and treatment before p<0.05 relatively, * * * represent with treatment before relatively under p<0.01(with).
Table 2 Qmax (MFR), AFR (AFR) are relatively
Note: p value representation is the same.
Table 3 residual urine volume (PVR) relatively
Note: p value representation is the same.
Table 4 prostate volume (ml) relatively
Note: p value representation is the same.
Above-mentioned clinical observation result shows, pharmaceutical composition of the present invention can be alleviated the clinical symptoms of prostatic hyperplasia, dwindles prostate volume, improves patient's quality of life.
In drug administration process, have no obvious adverse reaction, electrocardiogram before and after taking medicine, liver, renal function, blood, routine urinalysis are without significant change.