CN1212147C - Compound preparation of Chinese herbal medicine for treating chronic prostatitis and its preparing method - Google Patents

Abstract

The present invention relates to a Chinese medicine compound preparation for treating chronic prostatitis and a preparation method thereof. The Chinese medicine compound preparation is prepared from the components of the following weight ratio: 10 to 50 portions of leech, 4 to 20 portions of rhubarb, 6 to 30 portions of motherwort herb, 4 to 20 portions of dandelion, 1 to 5 portions of safflower, 1 to 5 portions of earthworm, 2 to 10 portions of milkvetch root, 2 to 10 portions of angelica, 2 to 10 portions of white peony alba, 1 to 5 portions of chicken's gizzard-membrane and 1.2 to 6 portions of bupleurum root. The finely selected components are mixed according to the weight ratio and decocted in water, and after medicinal liquid obtained when the components are decocted every time is filtered and mixed, the mixture is decompressed and condensed into thick paste; after the processes of vacuum drying or spray drying, granulation, sieving and redrying operation are carried out on the thick paste, the Chinese medicine compound preparation for treating chronic prostatitis is prepared. When the Chinese medicine compound preparation is used for clinical operation, the obvious effective rate can reach 58.8%, and the total effective rate is 86.2%.

Description

Treatment chronic prostatitis compound Chinese medicinal preparation and preparation method thereof

Technical field

The present invention relates to a kind of treatment chronic prostatitis compound Chinese medicinal preparation and preparation method thereof.

Background technology

Chronic prostatitis Chinese medicine belongs to sick categories such as " pouring " " turbid ", and existing many it is belonged to " smart turbid " are the clinical commonly encountered diseases of urology department, Andriatrics Dept..Male more than 35 years old particularly, its sickness rate is up to 31-40%, the cause of disease that at present should disease is unclear fully as yet, doctor trained in Western medicine is to this sick effective way that lacks both at home and abroad, its clinical psychology and spiritual healing and physiotherapys of adopting more, to improve prostate blood circulation, drain prostatic fluid, promote inflammation to absorb, reach the purpose of alleviating and eliminating symptom.Though the traditional Chinese medical science has its original advantage to treatment " smart turbid ", often can achieve good results, effective Chinese patent medicine for the treatment of this disease is less, and curative effect is also unsatisfactory.Be specifically designed to the similar of less types of chronic prostatitis in the market, mainly contain general Lean capsule, QIANLIEKANG PIAN, QIANLIEXIN JIAONANG etc., such medicine not only can not treating both the principal and secondary aspects of a disease, and its curative effect is not really satisfactory.The present invention can be extensive patients a kind of good effect, instant effect, good medicine that untoward reaction is few is provided.

Summary of the invention

The object of the present invention is to provide the compound Chinese medicinal preparation that is used for the treatment of chronic prostatitis and the preparation method of a kind of good effect, instant effect, treating both the principal and secondary aspects of a disease.

The object of the present invention is achieved like this: treatment chronic prostatitis compound Chinese medicinal preparation is to be made by the raw material of following ratio of weight and number, Hirudo 10-50 part, Radix Et Rhizoma Rhei 4-20 part, Herba Leonuri 6-30 part, Herba Taraxaci 4-20 part, Flos Carthami 1-5 part, Pheretima 1-5 part, Radix Astragali 2-10 part, Radix Angelicae Sinensis 2-10 part, Radix Paeoniae Alba 2-10 part, Endothelium Corneum Gigeriae Galli 1-5 part and Radix Bupleuri 1.2-6 part.

The compound Chinese medicinal preparation of described treatment chronic prostatitis can be made by following parts by weight proportion raw material, Hirudo 20-40 part, Radix Et Rhizoma Rhei 8-10 part, Herba Leonuri 10-20 part, Herba Taraxaci 8-10 part, Flos Carthami 2-4 part, Pheretima 2-4 part, Radix Astragali 4-6 part, Radix Angelicae Sinensis 4-6 part, Radix Paeoniae Alba 4-6 part, Endothelium Corneum Gigeriae Galli 2-4 part and Radix Bupleuri 2-4 part.

The compound Chinese medicinal preparation of treatment chronic prostatitis also can be made by following optimum weight umber proportion raw material, 3 parts of 25 parts of Hirudos, 10 parts of Radix Et Rhizoma Rhei, 15 parts of Herba Leonuris, 10 parts of Herba Taraxacis, 2.5 parts on Flos Carthami, 2.5 parts of Pheretimas, 5 parts of the Radixs Astragali, 5 parts of Radix Angelicae Sinensis, 5 parts of the Radix Paeoniae Albas, 2.5 parts of Endothelium Corneum Gigeriae Galli and Radix Bupleuri.

The preparation method for preparing above-mentioned treatment chronic prostatitis compound Chinese medicinal preparation is:

A, selected Hirudo is made the above fine powder of 100 orders, standby;

B, will be mixed with Herba Leonuri, Herba Taraxaci, Flos Carthami, Pheretima, the Radix Astragali, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Endothelium Corneum Gigeriae Galli and Radix Bupleuri behind the selected Radix Et Rhizoma Rhei processed with wine, decoct with water 1-3 time, each decocting time is 1-1.5 hour, to decoct the medical filtration of gained at every turn, carry out concentrating under reduced pressure after mixing and become thick paste, it is standby that vacuum drying or spray drying are made 60-100 purpose extract powder;

C, with above-mentioned A, B after standby fine powder and extract powder mix, granulate again, sieve, make treatment chronic prostatitis compound Chinese medicinal preparation after the drying.

Theory of Chinese medical science thinks, chronic prostatitis roughly belongs to sick category such as " stranguria ", " nebulousurine ", named to essence turbidly in recent years by national Chinese medicine industry standard, and smart turbid disease is urology department, andrology's common clinical.Chronic prostatitis sickness rate in male more than 35 years old reaches 31-40%, the height of visible smart turbid clinical onset rate." smart turbid " or " nebulousurine " sick origin cause of formation, the traditional Chinese medical science is thought and damp invasion of lower energizer, disturbance in functional activity of the urinary bladder, clear QI being mixed up with turbid QI; Or the stagnation of blood stasis passages through which vital energy circulates, discharge loses smart multiple abscess urethra; Or sinking of QI due to deficiency of the spleen, essence of water and grain is dirty; Or kidney qi loses emptyly, and fat liquid loses Shu Youguan, because primary disease pathogenic factor multiterminal, coldheat complex, deficiency and excess is double sees, brings certain difficulty to clinical treatment.The common clinical reflection of primary disease is frequent micturition, urgent micturition, dysurea, with having symptoms such as sexual impotence, premature ejaculation, nebulousurine, frequent micturition often concurrently, so clinical have the doctor generally to control from the opinion of suffering from a deficiency of the kidney more, common drug mostly is the product of kidney invigorating and YANG supporting, unsatisfactory curative effect, and the supporing yang anxiety of getting angry, missing the tonification disease is whenever arranged.Also have the people mostly to be inflammation greatly according to this class disease, during treatment generally based on heat-clearing and toxic substances removing, dampness removing is treating stranguria, curative effect is also not good, and the fraud of bitter cold impairment of YANG, bitter dry misfortune the moon is whenever arranged.Characteristics of incidence analysis at primary disease, the chronic prostatitis course of disease is longer, damp and hot delay, the resistance of the passages through which vital energy circulates stasis of blood, the long-term congested enlargement of prostate in addition, the blood flow circulation is not smooth, blood stasis is by interior and give birth to, the blood stasis damp-heat accumulation is the main pathomechanism that causes primary disease, thus the present invention with promoting blood circulation and detoxication, dampness removingization is turbid to be the Therapeutic Principle.Choose institute of the present invention medicament component by its Therapeutic Principle, the effect of its each drug component is as follows: Hirudo is a removing blood stasis, the key medicine of Tong Jing Xiao Disorder, and have the energy of tonneau water channel concurrently, it is to the effect of blood system: (1) blood coagulation resisting function, experiment in vitro shows that the Hirudo water decoction has strong blood coagulation resisting function, can the fibrinogenic pool time of significant prolongation.(2) antiplatelet aggregation and thrombosis effect, fibrin plate solubility test show that the water decoction-alcohol sedimentation liquid of Hirudo to fibrin very strong fibrinolytic effect takes place external.(3) to the influence of blood fat and hemorheological property, Hirudo can reduce whole blood contrast viscosity and the plasma viscosity of rat, shortens erythrocyte electrophoretic time.Radix Et Rhizoma Rhei is an eliminating blood stasis and inducing menstruation, removing pathogenic heat from blood and toxic substance from the body, eliminating damp-heat, the good merchantable brand of relieving constipation the turbid descending.Observe from rat experiment gastric ulcer model, give the hemorrhage of Radix Et Rhizoma Rhei treatment and prevention stress gastric ulcer.Rheum officinale and sorrel all have antibacterial action hemostasis and the effect of invigorating blood circulation to most gram-positive bacteriums and some gram negative bacteria in test tube.The function of Herba Leonuri for invigorate blood circulation, blood stasis dispelling.Herba Taraxaci has heat-clearing and toxic substances removing, the eliminating carbuncle eliminating stagnation, and the function that dampness removing is treating stranguria, external bacteriostatic experiment proves that TMP is to the antibacterial potentiation of Herba Taraxaci tool, the compound dandelion bacteriostatic activity strengthens.Dandelion Injectable Solution in vitro has stronger bactericidal action to staphylococcus aureus Resistant strain, Hemolytic streptococcus.Flos Carthami energy promoting blood circulation to restore menstrual flow, blood stasis removing pain relieving have anticoagulant and the effect of fortifying fibre protein dissolution.The heat clearing away of Pheretima function, suppressing the hyperactive liver, Zhichuan, collateral dredging, experimental studies results shows, the good refrigeration function of artificial fever rabbit tool that Pheretima water logging agent and lumbrifebrine cause colitoxin and warm stimulation.The invigorating the spleen and replenishing QI of Radix Astragali function, the Radix Astragali can make leukocyte and the multinuclear leucocyte number in the white mice blood obviously increase, and the antibody systematic function of normal body is had obvious facilitation.Radix Angelicae Sinensis function benefiting blood and regulating blood circulation, menstruction regulating and pain relieving is moisturized laxation, and the Radix Angelicae Sinensis decoct has antibacterial action to various bacteria such as dysentery bacterium, Hemolytic streptococcus in test tube.Radix Paeoniae Alba function is supported and is learned yin fluid astringing, easing the affected liver to relieve pain, and Radix Paeoniae Alba decoct has stronger bacteriostasis to dysentery bacterium in vitro, can also suppress staphylococcus in addition, and tincture can suppress bacillus pyocyaneus.Endothelium Corneum Gigeriae Galli function removing food stagnancy stagnates, strengthening the spleen and stomach, hard masses softening and resolving.Radix Bupleuri function reconciling superficies and interior, soothing the liver, yang invigorating has antiinflammatory action, and heavy dose of Radix Bupleuri decoct (5 gram crude drug/kilogram) or pure extractum (2.5 gram crude drug/kilogram) have refrigeration function to the rabbit of artificial fever.Be monarch drug with Hirudo, Radix Et Rhizoma Rhei among the present invention, with removing blood stasis blood, broken mass in the abdomen, dampness removing heat, it is turbid to rush down the stasis of blood; Be aided with Herba Leonuri, Herba Taraxaci, Flos Carthami, Pheretima, strengthen the monarch drug blood circulation promoting and blood stasis dispelling, mass dissipating and swelling eliminating, eliminating damp-heat, the effect of separating clear and excreting turbid; Assistant is with Radix Astragali benefiting qi and raising yang, and is dirty to end the spleen essence, and the row of enriching blood stagnates, unimpeded QI and blood, and the diuresis eliminating dampness by diuresis is turbid with removing dampness; Chinese angelica blood supplementing promoting blood circulation and stopping pain, the Radix Paeoniae Alba are fated and return, and the Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI is joined in the gentle muscle pain relieving of nourishing blood, and transfers smooth QI and blood.Be messenger drug with Radix Bupleuri in the side, the sick institute of the through cloudy Liver Channel of fainting of priming.The monarch and his subjects are orderly, complement each other, and the system of grasping " monarch's two ministers four " prescription with ingredients even in number also.

The specific embodiment

Below in conjunction with embodiment the present invention is described in further detail:

Component	Embodiment 1	Embodiment 2	Embodiment 3	Embodiment 4	Embodiment 5
						Hirudo	100g	200g	250g	400g	500g
Radix Et Rhizoma Rhei	40g	80g	100g	100g	200g
						Herba Leonuri	60g	100g	150g	200g	300g
Herba Taraxaci	40g	80g	100g	100g	200g
						Flos Carthami	10g	20g	25g	40g	50g
Pheretima	10g	20g	25g	40g	50g
						The Radix Astragali	20g	40g	50g	60g	100g
Radix Angelicae Sinensis	20g	40g	50g	60g	100g
						The Radix Paeoniae Alba	20g	40g	50g	60g	100g
Endothelium Corneum Gigeriae Galli	10g	20g	25g	40g	50g
						Radix Bupleuri	12g	20g	30g	40g	60g

The preparation method for preparing above-mentioned treatment chronic prostatitis compound Chinese medicinal preparation:

(1), at first above-mentioned selected Hirudo is made the above fine powder of 100 orders, standby;

(2), will be mixed with Herba Leonuri, Herba Taraxaci, Flos Carthami, Pheretima, the Radix Astragali, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Endothelium Corneum Gigeriae Galli and Radix Bupleuri behind the above-mentioned selected Radix Et Rhizoma Rhei processed with wine again, decoct with water 3 times, each decocting time is 1 hour, to decoct the medical filtration of gained at every turn, carry out concentrating under reduced pressure after mixing and become thick paste, it is standby that vacuum drying or spray drying are made 80 purpose extract powders;

(3), above-mentioned standby Hirudo fine powder and extract powder mixed after, granulate again, sieve, make treatment chronic prostatitis compound Chinese medicinal preparation after the drying.This compound preparation can be made into capsule, tablet, granule or pill.

Medicine of the present invention is set at pathogenesis, has the function of heat-clearing and toxic substances removing dampness removing, blood circulation promoting and blood stasis dispelling QI invigorating.That the chemical constituent that used Chinese medicine contains in the prescription has is antibiotic, antiviral, antiinflammatory, improvement are organized microcirculation, effects such as raise immunity, except that medicine at the pathogenesis, the active factor that can also transfer body is eliminated the various paathogenic factors of chronic prostatitis, thereby has curative effect preferably.For estimating the effectiveness and the safety of the chronic preceding adenitis of Drug therapy of the present invention, recommend the clinical using dosage and the course of treatment, with the positive contrast medicine of QIANLIETAI PIAN, according to " clinical drug trial management regulation ", worked out the clinical research scheme with reference to " new Chinese medicine clinical research guideline ", in Guang-amen Hospital, China Traditional Chinese Medicine Instl, No.2 Hospital, Hebei Medical Univ., the Shandong Prov. Hospital, Hospital Attached to Shandong Chinese Medical Univ., No.1 Hospital Attached to He'nan Traditional Chinese Medical College, five tame countries such as Attached Hospital, Changchun Chinese Medicinal College adopt at random clinical pharmacological centre, double blinding, dual analog, parallel control multicenter method is carried out clinical experiment.Be total to MethodsThe cases enrolled 618 examples, actual 599 examples of finishing are taken off blind through twice, actual case test group 404 examples of finishing, matched group 195 examples, test group Drug therapy chronic prostatitis of the present invention obvious effective rate 58.8% as a result, total effective rate 86.2% obviously is better than positive control drug.Medicine of the present invention is more rigorous rationally than existing treatment chronic prostatitis pharmaceutical formulation, and determined curative effect, short term therapy are not seen obvious toxic-side effects and untoward reaction.Details see Appendix 1,2,3.

Acute toxicity test: after giving mouse stomach at twice in medicine 97.7g/kg2 of the present invention hour, do not see that mice has unusual performance.Animal activity, look for food, breathing, hair color be all normal, body weight shows a rising trend.Defecation outward appearance no abnormality seen, the no abnormal secretions of mouth and nose is observed and was not seen animal dead on the 7th, all survival.

Conclusion: after giving mouse stomach at twice in medicine 97.7g/kg2 of the present invention hour, observe and do not see dead mouse on 7th, so its maximum tolerated dose is 97.7g/kg, this dosage is than high about 997 times of clinical consumption.Details see Appendix 4.

Long term toxicity test: medicine 9.12g/kg of the present invention gives rat oral gavage 90 days continuously, raises but rising of hyperamization platelet and cruor time extending and serum aspartate amino transferase are active, more than changes and all can recover after drug withdrawal.Three dosage medicines of the present invention do not have obvious influence to other index of rat, and histopathological examination is not seen obvious change yet.

Pharmacodynamics test:

1, medicine gastric infusion of the present invention has tangible antiinflammatory action to rat paw carrageenin inflammation, inhibited to the swollen growth of rat granuloma, the rat prostate inflammatory model is also had an antiinflammatory action, and according to these experimental results, medicine of the present invention has tangible antiinflammatory action.

2, medicine gastric infusion of the present invention has significant analgesia role to tenderness due to the rat inflammation.

3, medicine of the present invention has bacteriostasis at Plating and test tube method to escherichia coli and staphylococcus aureus.

Through drug effect and pharmacological evaluation, show that medicine of the present invention has antiinflammatory, analgesia, bacteriostasis, the scorching model of rat prostate there is antiinflammatory action, succeeding in developing of medicine of the present invention will make the chronic prostatitis patient obtain faster, better treatment.Details see Appendix 5.

Claims (4)

1, a kind of treatment chronic prostatitis compound Chinese medicinal preparation, it is characterized in that it can be made Hirudo 20-40 part, Radix Et Rhizoma Rhei 8-10 part, Herba Leonuri 10-20 part, Herba Taraxaci 8-10 part, Flos Carthami 2-4 part, Pheretima 2-4 part, Radix Astragali 4-6 part, Radix Angelicae Sinensis 4-6 part, Radix Paeoniae Alba 4-6 part, Endothelium Corneum Gigeriae Galli 2-4 part and Radix Bupleuri 2-4 part by following parts by weight proportion raw material.

2, treatment chronic prostatitis compound Chinese medicinal preparation according to claim 1, it is characterized in that it also can be made by following optimum weight umber proportion raw material, 3 parts of 25 parts of Hirudos, 10 parts of Radix Et Rhizoma Rhei, 15 parts of Herba Leonuris, 10 parts of Herba Taraxacis, 2.5 parts on Flos Carthami, 2.5 parts of Pheretimas, 5 parts of the Radixs Astragali, 5 parts of Radix Angelicae Sinensis, 5 parts of the Radix Paeoniae Albas, 2.5 parts of Endothelium Corneum Gigeriae Galli and Radix Bupleuri.

3, the preparation method of any one described treatment chronic prostatitis compound Chinese medicinal preparation in the preparation claim 1 or 2 is characterized in that:

A, selected Hirudo is made the above fine powder of 100 orders, standby;

B, will be mixed with Herba Leonuri, Herba Taraxaci, Flos Carthami, Pheretima, the Radix Astragali, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Endothelium Corneum Gigeriae Galli and Radix Bupleuri behind the selected Radix Et Rhizoma Rhei processed with wine, decoct with water 1-3 time, each decocting time is 1-1.5 hour, to decoct the medical filtration of gained at every turn, carry out concentrating under reduced pressure after mixing and become thick paste, it is standby that vacuum drying or spray drying are made 60-100 purpose extract powder;

C, with above-mentioned A, B after standby fine powder and extract powder mix, granulate again, sieve, make treatment chronic prostatitis compound Chinese medicinal preparation after the drying.

4, the preparation method of treatment chronic prostatitis compound Chinese medicinal preparation according to claim 3 is characterized in that described compound preparation can be made into capsule, tablet, granule or pill.