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 more than 60 years old elderly men population 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 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 Quality of Life.
The treatment means of BPH is a lot, but the domestic and international various means of existing treatment BPH run into following thorny problem: operative treatment is with certain traumatic, and complication is many, and the old people is poor to the toleration of operation and anesthesia.Naturopathy such as microwave, radio frequency, high-energy focusing etc. are relief of symptoms in a short time, also has the complication such as urethral stricture.Dwindle 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 the side effect such as hyposexuality, sexual impotence.
Though at present research 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 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:
A kind of pharmaceutical composition for the treatment of prostatic hyperplasia, it is to be the medicament that medicinal raw material is made by Rhizoma Chuanxiong and Nidus Vespae.
The weight proportion of the used medicine material of pharmaceutical composition of the present invention can be Rhizoma Chuanxiong 3-15 part, Nidus Vespae 3-15 part.
The more preferably proportioning of the used medicine material of pharmaceutical composition of the present invention is: Rhizoma Chuanxiong 6-12 part, Nidus Vespae 6-12 part.
The best proportioning of the used medicine material of pharmaceutical composition of the present invention is: 9 parts of Rhizoma Chuanxiongs, 9 parts in 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, the 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, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:15-1:20), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(2) get the Nidus Vespae medical material, with the ethanol percolation of the 60%-95% of 8-10 times of volume 2 times, collect and merge percolate, the gained percolate is condensed into rare extractum; Above-mentioned rare extractum is crossed macroporous adsorbent resin, and the low-concentration ethanol eluting of first water or 1-20% is removed the impurity that is dissolved in polar solvent, and the eluent of this water or low-concentration ethanol is discarded need not; Use again the high concentration ethanol eluting of 60-95%, collect this high concentration ethanol eluent, the eluent behind the Recycled ethanol is dry, obtain Nidus Vespae extract.
(3) the said extracted thing is mixed, make acceptable various pharmaceutical dosage form.
In the above preparation process, if necessary, can add adjuvant commonly used in an amount of pharmaceutics, such as starch, dextrin, microcrystalline cellulose, amylum pregelatinisatum, magnesium stearate, micropowder silica gel, sucrose, carboxymethyl starch sodium etc.
Solution of the present invention is based on motherland's medical science to pathogenetic understanding of BPH, according to oneself clinical experience for many years, determines first the effective Chinese medicine of a series for the treatment of BPH from numerous Chinese medicines, repeatedly verifies through clinical again, screens.In the pharmaceutical composition of the present invention, the 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; The amenorrhea dysmenorrhea; Puerperal, the stasis of blood stagnated raw meat bitterly; The mass in the abdomen lump; Pain in chest and hypochondrium; It is dizzy to have a headache; Anemofrigid-damp arthralgia; Traumatic injury; Ulcer sores.Modern pharmacological research shows that Rhizoma Chuanxiong can increase coronary flow, improves the myocardial ischemia situation, prolongs in the platelet aggregation time that external ADP induces, and the platelet of having assembled is had depolymerisation.The Nidus Vespae sweet in the mouth, property is flat.Return the stomach warp.Detoxicating and killing parasites, wind-expelling pain-stopping.Be used 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 be alleviated BPH controlled micturition difficulty symptom and removes its misery, can dwindle prostate volume again and delays its disease progression, and low price, have no side effect.
The used various raw medicinal materials of the present invention 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 the result to show that following advantage is arranged:
(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 the urine flow rate.
(3) obviously reduce residual urine volume.
(4) have no side effect.
(5) stable curative effect.
The specific embodiment
The present invention is described in further detail below in conjunction with the specific embodiment.
Embodiment 1
The pharmaceutical composition of the treatment prostatic hyperplasia that present embodiment is enumerated is comprised 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, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:20), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(2) get the Nidus Vespae medical material by formula proportion, with 85% ethanol percolation of 10 times of volumes 2 times, collect and merge percolate, the gained percolate is condensed into rare extractum; Above-mentioned rare extractum is crossed macroporous adsorbent resin, wash with water first, remove the impurity that is dissolved in polar solvent, this water elution liquid is discarded need not; Use again 95% high concentration ethanol eluting, collect this high concentration ethanol eluent, the eluent behind the Recycled ethanol is dry, obtain Nidus Vespae extract.
(3) the said extracted thing is mixed, add vegetable oil 15g, mixing is made capsule casing material with gelatin, is pressed into soft capsule.
Embodiment 2
The pharmaceutical composition of the treatment prostatic hyperplasia that present embodiment is enumerated is comprised 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, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:15), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(2) get the Nidus Vespae medical material by formula proportion, with 60% ethanol percolation of 8 times of volumes 2 times, collect and merge percolate, the gained percolate is condensed into rare extractum; Above-mentioned rare extractum is crossed macroporous adsorbent resin, use first 20% low-concentration ethanol eluting, remove the impurity that is dissolved in polar solvent, the eluent of this low-concentration ethanol is discarded need not; Use again 95% high concentration ethanol eluting, collect this high concentration ethanol eluent, the eluent behind the Recycled ethanol is dry, obtain Nidus Vespae extract.
(3) the said extracted thing is mixed, be dissolved in the 1000mL water for injection, adopt existing preparation of injection, make injectable powder.
Embodiment 3
The pharmaceutical composition of the treatment prostatic hyperplasia that present embodiment is enumerated is comprised 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, get extractum, be dissolved in water sucking filtration, filtrate is crossed macroporous resin column (volume ratio of extractum and resin is 1:20), washes with water first, and this water elution liquid is discarded need not, then use 30% ethanol elution, merge 30% ethanol elution, decompression recycling ethanol, vacuum drying gets Rhizoma Chuanxiong extract.
(2) get the Nidus Vespae medical material by formula proportion, with 695% ethanol percolation of 10 times of volumes 2 times, collect and merge percolate, the gained percolate is condensed into rare extractum; Above-mentioned rare extractum is crossed macroporous adsorbent resin, wash with water first, remove the impurity that is dissolved in polar solvent, water elution liquid is discarded need not; Use again 60% high concentration ethanol eluting, collect this high concentration ethanol eluent, the eluent behind the Recycled ethanol is dry, obtain Nidus Vespae extract.
(3) the said extracted thing is mixed, with starch 120g mix homogeneously, adopt capsules preparation technique, make 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 more than 50 years old, be diagnosed as patient's 30 examples of prostatic hyperplasia, carry out the objective clinical observation of system.One month observation period.Instructions of taking: take embodiment 1 obtained medicament, 10g/ day, minutes 3 times oral.Respectively at taking medicine front and taking medicine rear observation:
(1) safety indexes: blood pressure, pulse, blood, urine, excrement three large routines 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 unusual etc.
Indices changes shown in table 1~4 before and after the treatment
The international prostate gland symptoms scoring of table 1 (I-PSS) and quality of life index (QOL) change
Annotate: * 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
Annotate: the p value representation is the same.
Table 3 residual urine volume (PVR) relatively
Annotate: the p value representation is the same.
Table 4 prostate volume (ml) relatively
Annotate: the p value representation is the same.
Above-mentioned clinical observation result shows that pharmaceutical composition of the present invention can be alleviated the clinical symptoms of prostatic hyperplasia, dwindles prostate volume, improves Quality of Life.
Have no obvious adverse reaction in the drug administration process, electrocardiogram before and after taking medicine, liver, renal function, blood, routine urinalysis are without significant change.