CN103961608B - Medicinal composition for treating chronic prostatitis and preparation method thereof - Google Patents

Medicinal composition for treating chronic prostatitis and preparation method thereof Download PDF

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CN103961608B
CN103961608B CN201410224405.3A CN201410224405A CN103961608B CN 103961608 B CN103961608 B CN 103961608B CN 201410224405 A CN201410224405 A CN 201410224405A CN 103961608 B CN103961608 B CN 103961608B
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blood
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CN103961608A (en
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高学敏
包侠萍
张建军
墙世发
李伟
南淑华
王景霞
关斌
王淳
郑珊珊
阳丽华
赖志成
王春凤
王杰
杨惠婉
肖顺彪
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XIAMEN TRADITIONAL CHINESE MEDICINE CO Ltd
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XIAMEN TRADITIONAL CHINESE MEDICINE CO Ltd
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Abstract

The invention discloses a medicinal composition for treating chronic prostatitis and a preparation method thereof. The medicinal composition is prepared from radix sophorae flavescentis, salviae miltiorrhizae, clerodendranthus spicatus, corydalis tuber, dandelion, rhizoma smilacis glabrae, medicinal cyathula root and cowherb seed. The preparation method comprises the following steps: (1) performing reflux extraction on salviae miltiorrhizae with ethanol, filtering, combining filtrates, reducing pressure to recycle ethanol, drying at reduced pressure, and crushing; (2) crushing the corydalis tuber, performing reflux extraction on the crushed corydalis tuber and salviae miltiorrhizae with ethanol, filtering to obtain an alcohol extract; (3) soaking the clerodendranthus spicatus, rhizoma smilacis glabrae, dandelion, medicinal cyathula root and cowherb seed with water, decocting, filtering, combining filtrates, and concentrating at reduced pressure to obtain aqueous extract concentrate; (4) combining the alcohol extract and the aqueous extract concentrate, concentrating at reduced pressure, drying at reduced pressure, and crushing; and (5) adding the extract powder into conventional auxiliaries, and preparing clinically acceptable preparations according to a conventional process. The invention also provides an application of the medicinal composition in preparing medicaments for treating chronic prostatitis.

Description

A kind of pharmaceutical composition for the treatment of chronic prostatitis and preparation method thereof
the application is the applying date is on 04 17th, 2013, the application number divisional application that to be 201310134119.3 denominations of invention be " a kind of pharmaceutical composition for the treatment of chronic prostatitis and preparation method thereof ".
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation technology thereof, particularly a kind of pharmaceutical composition and preparation technology thereof treating chronic prostatitis.
Background technology
Chronic prostatitis is male adult common disease, be apt to occur in 20-40 year male between twenty and fifty, sickness rate is very high, and main manifestations is the aspects such as pain, urinary tract symptom, reproductive system symptom, spirit depressing, is usually difficult to radical cure.Chronic prostatitis is generally divided into bacillary, non-bacterial and pelvic cavity perineal pain three class.The Literature Discussions such as " analysis of chronic prostatitis etiology and pathogenesis " (" Nanjing University of Traditional Chinese Medicine's journal " 03 phase in 2005 once celebrated fine jade) etiology and pathogenesis of chronic prostatitis, thinks that the damp and hot stagnant smart room of the turbid malicious stasis of blood is the main pathogenesis of chronic prostatitis.The chronic prostatitis initial stage, damp and hot heresy, can by invading outward, also can by interior life, and not invading outward person because of the damp and hot fire-toxin of diseases caused by exogenous pathogenic factor, or can experience the heresy of cold-damp, strongly fragrant heat-transformation of a specified duration, and damp-heat accumulation does not fall apart, pyrogene room under multiple abscess based on the damp and hot stagnant smart room of the turbid malicious stasis of blood; Interior survivor can by addicted to food delicious food wine cheese and pungent product, and taste are impaired, or feelings will is smooth, the liver failing to maintain the normal flow of QI, liver wood subjugates earth, transporting mistake department, and long-pending humidogene is warm, the multiple abscess part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels; Or lung spleen virtual loss, water channel blocks, priming damp-heat in lower-JIAO; Or phase hyperactivity of fire is contained, and bears essence and does not let out, retention of corruptive essence essence room, heat-transformation is lit a fire.Damp and hot for a long time must not profit clearly, with the passing of time make poison, pent up the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, cause hot and humid ecchymosis to block smart room, therefore the diseases such as frequent micturition, urgent micturition, urethra scorching hot be uncomfortable can be occurred.
The therapeutic goal of chronic prostatitis mainly alleviating pain, improve the symptom and improving the quality of living of urinating, therapeutic evaluation should be improved as master with symptom.The most frequently used medicine is antibiotic, alpha-blocking agent, galenical and non_steroidal anti_inflammatory drug, and other drug also has curative effect in various degree to relief of symptoms.
(1) antibiotic: at present, in the clinical practice of row adenitis before the treatment, the most frequently used first-line drug is antibiotic, but only have an appointment 5% patients with chronic prostatitis have clear and definite bacteriological infection.
(2) alpha-blocking agent: alpha-blocking agent can relax the position such as prostate and bladder smooth muscle and improve lower urinary tract symptom and pain, can select different alpha-blocking agents according to the situation of patient, the alpha-blocking agent of clinical recommendation mainly contains: doxazosin (doxazosin), naftopidil (naftopidil), Tamsulosin (tamsulosin) and terazosin (terazosin) etc.;
(3) galenical: galenical mainly refers to pollen class preparation and plant extract, the effects such as its pharmacological action is comparatively extensive, as lax in non-specific antiinflammatory, edema, the contraction of promotion detrusor of bladder and urethral smooth muscle.The galenical of clinical recommendation has: pervasive Thailand, sabal and extractum thereof etc.
(4) non_steroidal anti_inflammatory drug: non_steroidal anti_inflammatory drug is the related indication empirical medication for the treatment of III type prostatitis.Its main purpose is alleviating pain and discomfort.
(5) M-receptor blocking agent: without the prostatitis patient of urinary tract obstruction, M-receptor blocking agent (as tolterodine etc.) can be used as urgent micturition, frequent micturition and nocturia to treat to performance.
Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition, and another object of the present invention is the preparation method and its usage providing this pharmaceutical composition.
the present invention seeks to be achieved through the following technical solutions:
Pharmaceutical composition of the present invention is made by the crude drug of following weight portion:
Radix Sophorae Flavescentis 150-450 weight portion, kidney tea 100-300 weight portion, Rhizoma Smilacis Glabrae 150-450 weight portion, Radix Cyathulae 100-300 weight portion, Radix Salviae Miltiorrhizae 100-300 weight portion, Rhizoma Corydalis 100-300 weight portion, Herba Taraxaci 100-300 weight portion, Semen Vaccariae 100-300 weight portion
The preferred weight proportioning of above-mentioned raw materials medicine is as follows:
Radix Sophorae Flavescentis 300 weight portion, kidney tea, 200 weight portions, Rhizoma Smilacis Glabrae 300 weight portion, Radix Cyathulae 200 weight portion, Radix Salviae Miltiorrhizae 200 weight portion, Rhizoma Corydalis 200 weight portion, Herba Taraxaci 200 weight portion, Semen Vaccariae 200 weight portion;
Or
Radix Sophorae Flavescentis 260 weight portion, kidney tea 240 weight portion, Rhizoma Smilacis Glabrae 270 weight portion, Radix Cyathulae 230 weight portion, Radix Salviae Miltiorrhizae 160 weight portion, Rhizoma Corydalis 240 weight portion, Herba Taraxaci 170 weight portion, Semen Vaccariae 230 weight portion;
Or
Radix Sophorae Flavescentis 340 weight portion, kidney tea 160 weight portion, Rhizoma Smilacis Glabrae 330 weight portion, Radix Cyathulae 170 weight portion, Radix Salviae Miltiorrhizae 230 weight portion, Rhizoma Corydalis 170 weight portion, Herba Taraxaci 240 weight portion, Semen Vaccariae 160 weight portion;
Or
Radix Sophorae Flavescentis 260 weight portion, kidney tea 160 weight portion, Rhizoma Smilacis Glabrae 340 weight portion, Radix Cyathulae 240 weight portion, Radix Salviae Miltiorrhizae 170 weight portion, Rhizoma Corydalis 160 weight portion, Herba Taraxaci 230 weight portion, Semen Vaccariae 240 weight portion;
Or
Radix Sophorae Flavescentis 340 weight portion, kidney tea 240 weight portion, Rhizoma Smilacis Glabrae 260 weight portion, Radix Cyathulae 160 weight portion, Radix Salviae Miltiorrhizae 230 weight portion, Rhizoma Corydalis 240 weight portion, Herba Taraxaci 170 weight portion, Semen Vaccariae 160 weight portion.
Above-mentioned Radix Sophorae Flavescentis, kidney tea, Rhizoma Smilacis Glabrae, Radix Cyathulae, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Herba Taraxaci and Semen Vaccariae, be common in prior art and the Chinese crude drug known.
In pharmaceutical composition crude drug of the present invention, add customary adjuvant, conveniently technique, make clinical acceptable any dosage form, as powder, tablet, granule, capsule, solution, pill, injection or drop pill.
the concrete preparation technology of drug combination preparation of the present invention is as follows:
Step one: by Radix Salviae Miltiorrhizae alcohol reflux, filters, decompression recycling ethanol, drying under reduced pressure, pulverizes;
Step 2: pulverized by Rhizoma Corydalis, add alcohol reflux with Radix Sophorae Flavescentis, filters, obtains alcohol extract;
Step 3: the five tastes such as kidney tea, Rhizoma Smilacis Glabrae, Herba Taraxaci, Radix Cyathulae, Semen Vaccariae, soaks, and decocts, and filter, concentrating under reduced pressure obtains water extraction concentrated solution;
Step 4: merge above-mentioned alcohol extract and water extraction concentrated solution, concentrating under reduced pressure, drying under reduced pressure, pulverizes;
Step 5: said extracted thing powder is added customary adjuvant, conveniently technique, makes clinical acceptable any dosage form, as powder, tablet, granule, capsule, solution, pill, injection or drop pill.
the preferred preparation technology of drug combination preparation of the present invention is as follows:
In step one, in Radix Salviae Miltiorrhizae, add 95% ethanol of 7 times of weight portions, reflux, extract, 0.5 hour, filter, then add 70% ethanol, reflux, extract, 2 times, each 9 times of weight portions, each 0.5 hour, filter, merging filtrate, decompression recycling ethanol (temperature≤70 DEG C), with Baume hydrometer measure to Baume degrees for 23-25 degree (50-60 DEG C) time, drying under reduced pressure (temperature≤70 DEG C), is ground into fine powder;
In step 2, Rhizoma Corydalis is ground into most coarse powder, and add 80% soak with ethanol 2 hours with Radix Sophorae Flavescentis, reflux, extract, 2 times, each 1 hour, alcohol adding amount is respectively 9 times of weight portions, 7 times of weight portions, and filter, merging filtrate, obtains alcohol extract for subsequent use.
In step 3, the five tastes such as kidney tea, Rhizoma Smilacis Glabrae, Herba Taraxaci, Radix Cyathulae, Semen Vaccariae, soak 2 hours, decoct 3 times, each 0.5 hour, add water be respectively 10 weight portions doubly, 7 times of weight portions and 7 times of weight portions, filter, merging filtrate, concentrating under reduced pressure (temperature≤70 DEG C) to Baume degrees is 15-17 degree (55-65 DEG C), obtains water extraction concentrated solution for subsequent use.
In step 4, merge above-mentioned alcohol extract and water extraction concentrated solution, concentrating under reduced pressure (temperature≤70 DEG C), measure to Baume degrees for 19-22 degree (40-50 DEG C) with Baume hydrometer, drying under reduced pressure (temperature≤70 DEG C), is ground into fine powder.
In pharmaceutical composition of the present invention:
Radix Sophorae Flavescentis bitter in the mouth is cold in nature.GUIXIN, liver, stomach, large intestine, urinary bladder channel, function heat clearing and damp drying, parasite killing, diuresis.Compendium of Material Medica claims: " the bitter cold energy the kidney invigorating of Radix Sophorae Flavescentis, lid gets its bitter dampness, cold heat extraction also.Hot air wind producing, humidogene worm, therefore wind parasite killing can be controlled again.Only the weak and mutually fiery victor of kidney water, suitable with it.”
Radix Salviae Miltiorrhizae bitter in the mouth, cold nature.GUIXIN, pericardium, Liver Channel.Function blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, clearing away heart-fire for tranquillization." book on Chinese herbal medicine justice " cloud: " Radix Salviae Miltiorrhizae, specially enters blood system, and its merit is promoting the circulation of blood of invigorating blood circulation, and interior reaches internal organs and blood stasis dispelling is stagnant, thus gather Xiao Er mass in the abdomen breaks." we reuse Radix Salviae Miltiorrhizae, blood circulation promoting and blood stasis dispelling ，ization Disorder eliminating stagnation, reducing swelling and alleviating pain.
Radix Sophorae Flavescentis, the same use of Radix Salviae Miltiorrhizae in side, both can clearing heat, detoxicating, dispelling dampness treating stranguria, again can blood circulation promoting and blood stasis dispelling reducing swelling and alleviating pain, make damp and hot going, blood stasis falls apart, and poison fire is clear, and link closely pathogenesis, is monarch drug altogether.
Sweet, light, the micro-hardship of kidney tea flavour, cool in nature, return kidney, urinary bladder channel.Sweet light the oozing of this product is let out with dampness removing, and bitter cool heat clearing away is with pathogenic fire purging, and eliminating stagnation softening the hard mass, with calculus, has good clearing away heat-damp and promoting diuresis, the merit that calculus is treating stranguria.Modern age is clinical multiplexly controls damp invasion of lower energizer, the puckery pain of the frequent micturition caused by pyretic stranguria stranguria caused by urinary stone, urgent micturition, dribbling urination, is the common medicine of folk therapy pyretic stranguria stranguria caused by urinary stone.
Rhizoma Corydalis acrid in the mouth, hardship, warm in nature.GUIXIN, liver, spleen channel.Function is invigorated blood circulation, circulation of qi promoting, pain relieving, Compendium of Material Medica is recorded " Rhizoma Corydalis, the stagnation of QI in energy promoting the circulation of blood, stasis in gas, therefore specially control upper and lower all pains all over the body, among using, simply fantastic.Lid Rhizoma Corydalis is invigorated blood circulation activating QI, and the first product medicine is also ", " book on Chinese herbal medicine is looked for the truth " cloud: " Rhizoma Corydalis, no matter being gas is blood, long-pending and loose person.Taking this power can be sensible, warm in nature with it, then can manage it in QI and blood can be smooth, and acrid in the mouth then can moisten can fall apart in QI and blood, so reason upper and lower all pains all over the body." " book on Chinese herbal medicine justice " meaning: " and Rhizoma Corydalis, though the product for breaking stagnant promoting the circulation of blood, right disposition still belongs to gentle, very not fierce ... the circulation of qi promoting of double energy, is not specially good in removing blood stasis with potent drugs, therefore the disease that inside and outside controlling, upper and lower QI and blood is not declared, logical stagnant eliminating stagnation, all pains of all liver stomach breast abdomens of master." the pungent loose temperature of Rhizoma Corydalis leads to, be the gas medicine in blood, have promoting flow of QI and blood, effect of blood-activating analgetic, lasting medicine is eased up, blood stasis dispelling and just not hindering.
Kidney tea removing damp-heat, inducing diuresis for treating stranguria syndrome, removing obstruction for relieving pain; Rhizoma Corydalis blood circulation promoting and blood stasis dispelling, regulating QI to relieve pain, the same use of two medicines, strengthen monarch drug clearing away heat-damp and promoting diuresis, promoting flow of QI and blood, the effect of reducing swelling and alleviating pain is ministerial drug altogether.
Herba Taraxaci bitter in the mouth, sweet, cold in nature.Return liver, stomach warp.Function heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, inducing diuresis for treating stranguria syndrome." Amplification on Materia Medica addendum " is recorded: " enter bright, the Taiyin channels of sun.Heat-transformation poison." " the southern regions of the Yunnan Province book on Chinese herbal medicine " cloud: " diuresis ... control the five types of stranguria difficulty in urination, sharp bladder.”
Rhizoma Smilacis Glabrae sweet in the mouth, light, property is put down.Return liver,kidney,spleen, stomach warp.Function dehumidifies, removing toxic substances." the southern regions of the Yunnan Province book on Chinese herbal medicine " is recorded: " bitter in the mouth is micro-puckery, and property is put down ... control five types of stranguria nebulousurine "." book on Chinese herbal medicine justice " speech: " Rhizoma Smilacis Glabrae, dampness removing reduces phlegm and internal heat, and can enter network, searches to pick and damp and hot accumulates poison.”
Semen Vaccariae bitter in the mouth, property is put down.Return liver, stomach warp.Function promoting the circulation of blood is stimulated the menstrual flow, dissipating blood stasis for subsidence of swelling, inducing diuresis for treating stranguria syndrome.Compendium of Material Medica is recorded: " diuresis." " property of medicine opinion " cloud " promoting blood circulation ", " book on Chinese herbal medicine asks former " meaning " treating stranguria sharp key ".
Radix Cyathulae sweet in the mouth, micro-hardship, property is put down.Return liver, kidney channel.Function promoting blood circulation to restore menstrual flow, sharp joint, treating stranguria." Traditional Chinese Medicine in Sichuan will " is recorded: " expelling wind and removing dampness, stimulate the menstrual flow loose blood.Control ... ... mass in the abdomen, gonorrhea, hematuria.”
Herba Taraxaci heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, inducing diuresis for treating stranguria syndrome; Rhizoma Smilacis Glabrae removing dampness and detoxicating, kind in the turbid poison of damp-heat in lower-JIAO; Semen Vaccariae is walked and does not keep, and property is apt to sensible, is longer than promoting blood circulation to restore menstrual flow, dissipating blood stasis for subsidence of swelling, inducing diuresis for treating stranguria syndrome; Radix Cyathulae blood circulation promoting and blood stasis dispelling, relieving stranguria by diuresis are to get rid of evils, and liver and kidney tonifying, strengthening the tendons and bones are with righting, and priming is descending, and through sick institute is adjuvant altogether.
Pharmaceutical composition of the present invention is the compound Chinese medicinal preparation be made up of Radix Sophorae Flavescentis, Radix Salviae Miltiorrhizae, kidney tea, Rhizoma Corydalis, Herba Taraxaci, Rhizoma Smilacis Glabrae, Semen Vaccariae and Radix Cyathulae eight taste Chinese medicine, in side, Radix Sophorae Flavescentis, Radix Salviae Miltiorrhizae are with using, both can clearing heat, detoxicating, dispelling dampness treating stranguria, again can blood circulation promoting and blood stasis dispelling reducing swelling and alleviating pain, make damp and hot going, blood stasis falls apart, and poison fire is clear, closely interlocking with the main pathogenesis of the damp and hot stagnant smart room of the turbid malicious stasis of blood of chronic prostatitis, is monarch drug altogether.Kidney tea removing damp-heat, inducing diuresis for treating stranguria syndrome, removing obstruction for relieving pain; Rhizoma Corydalis blood circulation promoting and blood stasis dispelling, regulating QI to relieve pain, the same use of two medicines, strengthen monarch drug clearing away heat-damp and promoting diuresis, promoting flow of QI and blood, the effect of reducing swelling and alleviating pain is ministerial drug altogether.Herba Taraxaci heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, inducing diuresis for treating stranguria syndrome; Rhizoma Smilacis Glabrae removing dampness and detoxicating, kind in the turbid poison of damp-heat in lower-JIAO; Semen Vaccariae is walked and does not keep, and property is apt to sensible, is longer than promoting blood circulation to restore menstrual flow, dissipating blood stasis for subsidence of swelling, inducing diuresis for treating stranguria syndrome; Radix Cyathulae blood circulation promoting and blood stasis dispelling, relieving stranguria by diuresis are to get rid of evils, and liver and kidney tonifying, strengthening the tendons and bones are with righting, and priming is descending, and through sick institute is adjuvant altogether.The same use of all medicines above, can make turbid damp go, and pyretic toxicity is clear, and blood stasis falls apart, and swells and ache and disappears, and gasification row, plays the merit of clearing away heat-damp and promoting diuresis, promoting blood circulation and detoxication, treating stranguria pain relieving altogether.With only processed compared with the single medicinal material preparation QIANLIEKANG extracting and make by the Pollen Brassicae campestris with reinforcing kidney and strengthening resistance effect, the effect distinguishing kidney sifting tea treatment chronic prostatitis is more comprehensive.
From modern pharmacology Effect study, the treatment of pharmaceutical composition of the present invention to chronic prostatitis may be summarized to be the mechanism of action such as antiinflammatory, analgesia, blood circulation promoting and blood stasis dispelling, immunomodulating, antibacterial, diuresis.Having antiinflammatory action key agents in pharmaceutical composition of the present invention is Radix Sophorae Flavescentis, kidney tea, Rhizoma Smilacis Glabrae, Radix Cyathulae.Wherein monarch drug Radix Sophorae Flavescentis, bitter in the mouth is cold in nature, have heat clearing and damp drying effect, pharmacological research shows: the exudative inflammation that kurarinone on Carrageenan, Oleum Tiglii and glacial acetic acid bring out has obvious inhibitory action, and its mechanism of action may produce relevant with its suppression inflammatory cytokine; Ministerial drug kidney tea, bitter in the mouth, cool in nature, function removing damp-heat, removing obstruction for relieving pain, pharmacological research shows: the mice auricular concha swelling that kidney tea can obviously suppress Oleum Tiglii to bring out, and its antiinflammatory action may be relevant with its chemical composition Herba Rosmarini Officinalis and ursolic acid; The sweet light property of adjuvant Rhizoma Smilacis Glabrae is put down, function heat-clearing and toxic substances removing, pharmacological research shows: the rat paw edema that Rhizoma Smilacis Glabrae injection can obviously suppress subcutaneous injection dextran to cause, and this product obviously can also suppress the mice auricular concha swelling caused by dimethylbenzene and the mice toes inflammatory reaction caused by Ovum Gallus domesticus album.Radix Cyathulae is bitter, sweet, sour, flat, returns liver, kidney channel, and can let out under heat conduction, ignite descending, pharmacological research shows: Radix Cyathulae can obviously suppress rat paw swelling induced by egg, has obvious antiinflammatory action.
The medicine in pharmaceutical composition of the present invention with analgesic activity mainly contains Rhizoma Corydalis, Rhizoma Smilacis Glabrae, Radix Cyathulae.The pungent loose temperature of Rhizoma Corydalis is led to, and is the good medicine of blood-activating and qi-promoting pain relieving, is described as " morphine " in Chinese medicine, and forefathers call its energy " stagnation of QI in promoting the circulation of blood, the stasis of gas China, admittedly can control upper and lower all pains all over the body ".Wherein the main analgesic composition of Rhizoma Corydalis is alkaloid, and wherein tetrahydropalmatine is the strongest, and A prime and Chou prime also have strong analgesic activity.Rhizoma Smilacis Glabrae injection obviously can reduce the mouse writhing number of times that glacial acetic acid causes, and onset composition may be its main chemical compositions astilbin.Radix Cyathulae can blood circulation promoting and blood stasis dispelling, again can invigorating the liver and kidney, bone and muscle strengthening, can with controlling lumbago and skelalgia caused by caused by liver and kidney deficiency, pharmacological research shows [26]: Radix Cyathulae main chemical compositions radix achyranthis bidentatae saponin Dichlorodiphenyl Acetate causes pain model in mice, thermostimulation causes pain model in mice obvious analgesic activity, and its analgesic activity and dosage present certain dose-effect relationship.
In pharmaceutical composition of the present invention, Radix Sophorae Flavescentis, kidney tea are mainly contained to the influential medicine of immune system.Matrine and oxymatrine have certain immunoregulation effect, and oxymatrine can strengthen the human tonsil lymphocytes multiplication capacity of hypoergia, suppress human tonsil lymphocytes and and the mouse spleen cell proliferation of high response.Clinical pharmacology research shows: clerodendranthus spicatus extract can improve mice specificity and non-specific immunity comprehensively, there is immunoloregulation function, its primary chemical becomes rosmarinic acid to be its immunoregulatory principle active component, and think closely related between inflammation and immunity, immunomodulating can be explained as the one of antiinflammatory action.
The medicine in pharmaceutical composition of the present invention with function of promoting blood circulation to disperse blood clots mainly contains Radix Salviae Miltiorrhizae, Radix Cyathulae, Rhizoma Corydalis, Semen Vaccariae.Radix Salviae Miltiorrhizae bitter in the mouth cold nature, GUIXIN, pericardium, Liver Channel, be clinical in conventional activating blood and removing stasis drug, Compendium of Material Medica calls it " can break stagnated blood, benefit fresh blood ", and " the sensible opinion of gynecological " has again saying of " Radix Salviae Miltiorrhizae simply, the same SIWU TANG of merit ".Pharmacological research shows: the danshensu in Radix Salviae Miltiorrhizae can improve hemorheological property, anticoagulant, platelet fluidity is significantly increased, improves body anticoagulant and fibrinolytic with Radix Salviae Miltiorrhizae, suppress the contracting blood vessel class materials such as thromboxane A2 (TXA2), prostaglandin relevant.Radix Salviae Miltiorrhizae can also improve micro-ring, and intravenous injection Radix Salviae Miltiorrhizae Injection can obviously raise at mouse brain microcell blood flow during microcirculation disturbance caused by physiological status and macromolecule dextrose.Radix Cyathulae promoting blood circulation to restore menstrual flow, be usually used in the card for the treatment of stagnation of blood stasis, pharmacological research shows, Radix Cyathulae can improve mice Mesentery microcirculation, reduces blood stasis type rat whole blood viscosity.Rhizoma Corydalis, pungent loose temperature is led to, activating QI of invigorating blood circulation, and modern pharmacological research is thought, Rhizoma Corydalis has coronary artery dilator, increases the effect such as coronary flow, anticoagulant.Semen Vaccariae, bitter in the mouth is put down, and return liver, stomach warp, walk blood system, be good at promoting blood circulation, modern pharmacological research shows: Semen Vaccariae obviously can improve blood stasis model guinea pig blood fluid viscosity, is improved hemorheological effect.
The medicine in pharmaceutical composition of the present invention with antioxidation mainly contains Radix Salviae Miltiorrhizae, kidney tea, Rhizoma Corydalis.The aqueous soluble active constituent salvianolic acid of Radix Salviae Miltiorrhizae has very strong antioxidation, and pharmacological evaluation shows: Salvia miltiorrhiza Bge water solution obviously can suppress the lipid peroxidation of the heart of animal, liver, kidney, testis.The principle active component rosmarinic acid of kidney tea can suppress the generation of neutrophilic granulocyte superoxide anion and hydrogen peroxide and lipid peroxidation product malonaldehyde, and rosmarinic acid scavenging free radicals and antioxidation may be one of its main mechanisms of anti-inflammatories.Rhizoma Corydalis total alkaloids can suppress AChE vigor, maintains cholinergic nerve system normal function, strengthens superoxide dismutase and catalatic vigor, recovers antioxidant ability of organism, the ability of enhancing body scavenging free radicals.
The key agents in pharmaceutical composition of the present invention with bacteriostasis is Radix Sophorae Flavescentis, kidney tea, Herba Taraxaci, Rhizoma Smilacis Glabrae.Fang Zhongsi medicine all can detoxification and promoting urination, and sum up antibacterial action and show, each medicine all has wider scope of restraining fungi, and stronger bacteriostatic activity, all has inhibitory action to escherichia coli, staphylococcus aureus, streptococcus, Bacillus proteus etc.
The medicine in pharmaceutical composition of the present invention with diuresis is mainly Radix Sophorae Flavescentis, kidney tea.Radix Sophorae Flavescentis can heat clearing away, again can diuresis, availablely controls damp and hot dysuria, and pharmacological experiment study finds that matrine has remarkable diuresis to rabbit.Kidney tea flavour is bitter, cool in nature, kidney tea diuresis Detoxication determined curative effect, multiplexly controls in acute and chronic nephritis, cystitis, lithangiuria and the frequent micturition, the lumbago that are caused by calculus among the people.
By analyzing the Fang Yi of pharmaceutical composition of the present invention, pharmacological action is summed up, every experimental result is known, by the compound Chinese medicinal preparation of kinds of traditional Chinese medicines compatible combination with different efficacies, compared with being processed the single medicinal material preparation-QIANLIEKANG extracted and make by Pollen Brassicae campestris, pharmaceutical composition of the present invention is more comprehensive to the therapeutic efficiency of chronic prostatitis, the composition played a role is more various, and curative effect is more remarkable.
Pharmaceutical composition of the present invention can make turbid damp go, and pyretic toxicity is clear, and blood stasis falls apart, and swells and ache and disappears, and gasification row, plays the merit of clearing away heat-damp and promoting diuresis, promoting blood circulation and detoxication, treating stranguria pain relieving altogether.Heat-clearing and toxic substances removing damp eliminating simultaneously, regulating QI and promoting blood circulation to remove blood stasis.For chronic prostatitis, the damp and hot turbid malicious stasis of blood stagnant smart room card, disease sees frequent micturition, urgent micturition, and urethra scorching hot is uncomfortable, drips white after urine; Hypogastric region, lumbosacral region, perineal position falling inflation pain, dimly red tongue or have ecchymosis, yellow and greasy fur, slippery and rapid pulse, has obvious antiinflammatory, analgesia, blood circulation promoting and blood stasis dispelling, antioxidation, can play certain prevention to chronic prostatitis acute attack, long-term taking has therapeutical effect to chronic prostatitis.
Following experimental example and embodiment are used for further illustrating but are not limited to the present invention.
experimental example 1: antiinflammatory is tested
Probably be divided into three different phases according to inflammatory development process, acute stage, increases based on vascular permeability, and mid-term take leukoplania as feature, and granulation tissue hyperplasia appears in late period.Proinflammatory agent is applied in mice auricular concha, vascular permeability can be made to increase, and blood vessel is oozed out in tissue fluid, causes auricular concha edema, can simulate the change producing similar acute phase inflammatory.Sterilizing cotton balls is imbedded animal local subcutaneous, the granulation hyperplasia similar to some inflammation later stage pathological change clinical can be produced.In this experimental study, first-selected mice caused by dimethylbenzene xylene auricular concha swelling model and mice subcutaneous implantation cotton balls cause granulomatous model, observe the inhibitory action of compositions of the present invention to acute stage and late phase inflammation respectively.
the pharmaceutical composition xylol prepared by embodiment 1 causes the impact of mice auricular concha swelling
Adopt the method for mice caused by dimethylbenzene xylene auricular concha swelling, observe the influence that pharmaceutical composition (hereinafter referred to as this product) xylol prepared by embodiment 1 causes the swelling of mice auricular concha.
Get Kunming mouse 70 (KM kind mice, body weight 18-22g, male and female half and half, tie up company limited of tonneau China by Beijing to provide, licence is numbered: SCXK(capital) 2006-0009), after adaptability raises 3 days, be divided into model control group at random, (Bayer HealthCare Co provides Aspirin Enteric-coated Tablets group, authentication code: the accurate word J20080078 of traditional Chinese medicines), this product high dose group, middle dosage group, low dose group, totally 5 groups, often organize 14, gavage solvent (0.5%CMCNa solvent) respectively, Aspirin Enteric-coated Tablets aqueous solution 0.2g/kg(is equivalent to 10 times of 60kg adult clinical dosage), this product 1.65g/kg, 0.825g/kg, 0.4125 g/kg(is equivalent to 20 of 60kg adult's clinical dosage respectively, 10, 5 times), each group all by 0.2ml/10g body weight gavage, every day 1 time, continuous 7 days.After last administration 1h, with micropipettor, dimethylbenzene is dripped in mouse right ear, 20 μ l/ only, after 30min, mice is taken off vertebra to put to death, cut two ears along auricle baseline, lay round auricle at same position respectively with 7mm card punch, scales/electronic balance weighing, with the difference of left and right auricle weight for auricular concha swelling value, calculate the inhibitory rate of intumesce of this medicine group.
Auricular concha swelling value (mg)=auris dextra weight-left ear weight;
Auricular concha swelling rate (%)=(auris dextra weight-left ear weight)/auris dextra weight × 100%;
Inhibitory rate of intumesce (%)=(blank group auricular concha swelling value-treatment group auricular concha swelling value)/blank group auricular concha swelling value × 100%;
Gavage administration after 7 days, this product 1.65g/Kg dosage obviously can suppress the mice auricular concha swelling rate caused by dimethylbenzene, has significant difference (P < 0.01), the results are shown in Table 1 with model control group ratio.
This product of table 1 xylol cause the swelling of mice auricular concha impact ( )
Note: compare with model control group, *p < 0.05 *p < 0.01
Result shows that the pharmaceutical composition 1.650g/Kg dosage prepared by embodiment 1 obviously can suppress the mice ear caused by dimethylbenzene, and auricular concha swelling rate and model control group ratio have significant difference (P < 0.01); Pharmaceutical composition 0.825g/Kg, 0.4125g/Kg dosage prepared by embodiment 1 also has the effect suppressing mice ear, but with model control group than there was no significant difference (P > 0.05).
the pharmaceutical composition prepared by embodiment 1 is on the impact of mice granuloma induced by implantation of cotton pellets
Adopt in the method for mice oxter heeling-in sterilized cotton ball, observe the pharmaceutical composition prepared by embodiment 1 influence to granuloma weight caused by cotton balls.
Get Kunming mouse 70 (the same), male and female half and half, after adaptability raises 3 days, that 0.15mL/10g body weight of lumbar injection 0.05% pentobarbital is anaesthetized, after iodophor disinfection, a 1.0cm otch is respectively cut in oxter, left and right, implants subcutaneous with ophthalmic tweezers respectively by the autoclaving cotton balls of 2 each 5mg from incision, skin suture immediately, a small amount of penicillin prevention infection of lumbar injection.Postoperative mice is divided into model control group at random, Aspirin Enteric-coated Tablets group (the same), this product high dose group, middle dosage group, low dose group, totally 5 groups, often organize 14, gavage solvent (0.5%CMCNa solvent) respectively, Aspirin Enteric-coated Tablets aqueous solution 0.2g/kg(is equivalent to 10 times of 60kg adult clinical dosage), this product 1.65g/kg, 0.825g/kg, 0.4125 g/kg(is equivalent to 20 of 60kg adult's clinical dosage respectively, 10, 5 times), medicine is all mixed with respective concentration with 0.5%CMCNa, perform the operation and started gastric infusion the same day, each group all by 0.2ml/10g body weight gavage, once a day, successive administration 7 days.After last administration 1h, de-cervical vertebra puts to death mice, open otch, cotton balls is taken out together with surrounding connective tissue, rejects fatty tissue, drying 16 hours in constant temperature 60 DEG C of baking ovens, weigh with analytical balance, the weight claimed is deducted cotton balls weight (10mg), obtain granuloma weight, calculate every 10g body weight granuloma weight.
Suppression ratio (%)=(blank group granuloma dry weight-experimental group granuloma dry weight)/blank group granuloma dry weight × 100%.
Gavage administration after seven days, this product 1.65 g/Kg, 0.825g/Kg, 0.4125g/Kg all obviously can suppress the formation of mice granuloma induced by implantation of cotton pellets, granuloma dry weight has significant difference (P < 0.001 with model control group ratio, P < 0.001, P < 0.05), the results are shown in Table 2.
This product of table 2 on the impact of mice granuloma induced by implantation of cotton pellets weight ( )
Group Dosage n Granuloma dry weight Suppression ratio (%)
（g/Kg） (only) （mg/10g）
Model control group - 14 13.62±1.98 --
Aspirin Enteric-coated Tablets group 0.2 14 11.73±1.96 ** 13.88
This product group 1.650 14 8.80±0.92 *** 35.39
0.825 14 10.96±1.65 *** 19.53
0.4125 14 11.84±2.33 * 13.07
Note: compare with model control group, *p < 0.05 *p < 0.01 * *p < 0.001
In above-mentioned antiinflammatory experimentation, pharmaceutical composition of the present invention can significantly suppress mice caused by dimethylbenzene xylene auricular concha swelling rate and cotton balls to cause the granulomatous weight of mice, show no matter be the inflammatory reaction of chemical stimulation generation or the inflammatory reaction of physical property stimulation generation, pharmaceutical composition of the present invention all has obvious inhibitory action.
experimental example 2: analgesic experiment
Pain is the most common and topmost symptom of prostatitis, is also the main cause affecting patients ' life quality and patient assessment.Writhing method is the analgesic activity method of drugs to chemical stimulation, mouse peritoneal injects the chemical irritants of a constant volume and concentration, visceral layer and parietal peritoneum can be stimulated, cause the inflammatory pain of deep larger area long period, the behavior reactions such as abdominal part indent, trunk and hind leg are upheld, hips up that cause mice to occur, are called writhing response.This kind of test method is classical reliable, is easy to operation, and more fully can reflects the analgesic activity of medicine.In the present invention, first-selected acetic acid writhing test is as the experiment research of research pharmaceutical composition analgesic activity of the present invention.
the impact of the pharmaceutical composition Dichlorodiphenyl Acetate induced mice writhing response prepared by embodiment 1
Adopt the method for mouse peritoneal injection acetic acid, observe the pharmaceutical composition prepared by embodiment 1 to mice because acetic acid stimulates the impact of writhing response latent time and the writhing number of times produced.
Get kunming mice 80 (to tie up company limited of tonneau China by Beijing to provide, licence is numbered: SCXK(capital) 2012-0001), body weight 18-22g, male and female half and half, random is model control group, Aspirin Enteric-coated Tablets (the same) group, this product high dose group, middle dosage group, low dose group, totally 5 groups, often organize 16, gavage solvent (0.5%CMCNa solvent) respectively, Aspirin Enteric-coated Tablets aqueous solution 0.2g/kg(is equivalent to 10 times of 60kg adult clinical dosage), this product extract 1.65g/kg, 0.825g/kg, 0.4125 g/kg(is equivalent to 20 of 60kg adult's clinical dosage respectively, 10, 5 times), medicine is all mixed with respective concentration with 0.5%CMCNa, each group all by 0.2ml/10g body weight gavage, once a day, continuous 6 days.After last administration 60min, acetic acid (used time the is made into concentration 0.6%) 0.2ml of every lumbar injection 0.6%, observes the writhing response of 15min, abdominal cavity indent, and stretch hind leg, buttocks is raised and is calculated as a number, record number of times.
Analgesia percentage rate (%)=(blank group writhing number of times-medication group writhing number of times)/blank group writhing number of times * 100%
Result shows, and embodiment 1 Chinese medicine compositions 1.65g/Kg, 0.825g/Kg, 0.4125g/kg dosage can increase mouse writhing latent time, but no significant difference (P < 0.05), the results are shown in Table 3.
The preclinical impact of this product of table 3 Dichlorodiphenyl Acetate induced mice writhing ( )
Note: compare with model control group, *p < 0.05 *p < 0.01
Embodiment 1 Chinese medicine compositions 1.65 g/Kg, 0.825g/Kg, 0.4125/kg dosage can obviously reduce mouse writhing number of times, compare with model control group and have significant difference (P < 0.001, P < 0.01, P < 0.05), the results are shown in Table 4.
The impact of this product of table 4 Dichlorodiphenyl Acetate induced mice writhing number of times ( )
Note: compare with model control group, *p < 0.05 *p < 0.01 * *p < 0.001
In above-mentioned analgesic experiment research, pharmaceutical composition of the present invention obviously can reduce acetic acid and cause mouse writhing number of times and the incubation period extending mouse writhing, shows that this preparation has obvious inhibitory action to the pain reaction that chemical stimulation produces.
experimental example 3: blood circulation promoting and blood stasis dispelling is tested
The chronic prostatitis cause of disease is complicated, and wherein prostate local blood circulation is not freely cause its recurrent exerbation, the one of the main reasons that touching difficulty heals.This experiment prepares caused by qi and cold stagnation animal model with blood stasis by giving the heavy dose of adrenalin hydrochloride of rat skin lower injection with the method that frozen water stimulates, and studies the pharmaceutical composition function of promoting blood circulation to disperse blood clots prepared by embodiment 1.
After adopting rat skin lower injection adrenalin hydrochloride, frozen water stimulus method prepares rat blood stasis models, observes pharmaceutical composition that various dose prepared by embodiment 1 to the high, medium and low impact of cutting whole blood viscosity under rate of rat.
Animal (the healthy male Wistar rat of cleaning grade, body weight 180-200g, tie up company limited of tonneau China by Beijing to provide, licence is numbered: SCXK(capital) 2012-0001) after adaptability raises 3 days, 7 groups are divided at random by body weight, be respectively blank group, model control group, tanshinone capsule group, QIANLIEKANG group, the high, medium and low dosage group of embodiment pharmaceutical composition, often organize each 9.Animal gastric infusion, blank group and model control group all gavage solvent (0.5%CMCNa solvent), (the prosperous Xi Li company limited in effluent north provides tanshinone capsule, authentication code: the accurate word Z13020110 of traditional Chinese medicines) group gavages tanshinone capsule aqueous solution 0.075g/kg, QIANLIEKANG group (is provided by Kang Enbei Zhejiang Pharmaceutical Co, batch number: 110841) gavage 8 times that QIANLIEKANG aqueous solution 0.912g/kg(is equivalent to 60kg adult clinical dosage), this product solution of extract 1.32g/kg, 0.66g/kg, 0.33 g/kg(is equivalent to 16 of 60kg adult's clinical dosage respectively, 8, 4 times), medicine is all mixed with respective concentration with 0.5%CMCNa solvent, each group all by 1ml/100g body weight gavage, once a day, continuous 6 days.
Modeling after last administration 30min, (is provided by Tianjin KingYork Amino Acid Co., Ltd., lot number: 1110071) carry out subcutaneous injection to the rat except blank group by 0.85mL/kg adrenalin hydrochloride.After drug administration by injection 2h, each group rat is put into after frozen water soaks 5min respectively, is pulled out, towel wiping, again injects same dose adrenalin hydrochloride after 2h.Water is can't help in fasting, after 20h, open abdomen after 10% chloral hydrate solution (3ml/kg body weight) anesthesia, blood is got in ventral aorta puncture, 8%EDTA-2Na(is mixed with 8% solution for later use) anticoagulant, the whole blood viscosity under adopting blood rheological instrument to detect high, medium and low shear rate.
Result shows, this product 1.32g/Kg, 0.66g/Kg, 0.33g/Kg dosage all can significantly reduce high, medium and lowly cuts rate drag rat whole blood viscosity number: under (1) height cuts rate, whole blood viscosity has significant difference (P < 0.001 with model control group ratio, P < 0.01, P < 0.05); (2) under cutting rate in, whole blood viscosity has significant difference (P < 0.001, P < 0.001, P < 0.01) with model control group ratio; (3) low cut rate under whole blood viscosity have significant difference (P < 0.001, P < 0.001, P < 0.001) with model control group ratio, the results are shown in Table 5.
This product of table 5 on the impact of rat model of syndrome of blood stasis whole blood viscosity ( )
Note: compare with model control group, *p < 0.05 *p < 0.01 * *p < 0.001
Result shows: pharmaceutical composition 1.32g/Kg, 0.66g/Kg, 0.33g/Kg dosage that (1) is prepared by embodiment 1 all significantly can reduce that rat is high cuts whole blood viscosity under rate, significant difference (P < 0.001 is had with model control group ratio, P < 0.01, P < 0.05); (2) pharmaceutical composition 1.32g/Kg, 0.66g/Kg, 0.33g/Kg dosage prepared by embodiment 1 all significantly can reduce in rat whole blood viscosity under rate of cutting, significant difference (P < 0.001 is had with model control group ratio, P < 0.001, P < 0.01); (3) pharmaceutical composition 1.32g/Kg, 0.66g/Kg, 0.33g/Kg dosage prepared by embodiment 1 all significantly can reduce that rat model is low cuts whole blood viscosity under rate, significant difference (P < 0.001 is had with model control group ratio, P < 0.001, P < 0.001).
In blood circulation promoting and blood stasis dispelling experimentation, pharmaceutical composition of the present invention each dosage group obviously can reduce that blood stasis model rat is high, medium and low cuts whole blood viscosity under rate, shows that distinguishing kidney sifting tea can improve blood circulation to a certain extent.
experimental example 4: the pharmaceutical composition on Carrageenan prepared by embodiment 1 causes the therapeutical effect research of prostatitis rat model
The prostatitic cause of disease of aseptic is not yet illustrated, and wherein prostatic mucosa can protect the tissue below it, and therefore the destruction of mucosal barrier may play an important role in prostatitic pathogenesis.This damage effect may be the factor of chemistry or physics, may be even that the immunity deriving from self stimulates, make inflammation sustainable existence.According to above principle, chemical irritant (1% carrageenin normal saline solution) is used to make chronic prostatitis acute attack rat model [12], with nonbacterial prostatitis disease clinically, there is certain similarity.
Adopt rat prostate injection carrageenin to prepare rat chronic prostatitis acute attack model, detect WBC content, SPL classification in rat prostate; SOD in serum content, MDA content; Prostate Pathological morphologic change, studies the pharmaceutical composition prepared by embodiment 1 to the preventive effect of chronic prostatitis acute attack.
(tieing up company limited of tonneau China by Beijing provides, and licence is numbered: SCXK (capital) 2006-0009), adaptability feeds 7 days for the healthy male Wistar rat 60 of cleaning grade, body weight 260-280g to get 60 male rats.Then blank group matched group is divided at random by body weight, model control group, QIANLIEKANG group, this product high dose group, middle dosage group and low dose group, totally 6 groups, often organize 10, blank group and model control group all gavage solvent (0.5%CMCNa solvent), other each components gavage QIANLIEKANG (paracetamol, thered is provided by Kang Enbei Zhejiang Pharmaceutical Co, batch number: 110841) aqueous solution 0.912g/kg(is equivalent to 8 times of 60kg adult clinical dosage), this product 1.32g/kg, 0.66g/kg, 0.33 g/kg(is equivalent to 16 of 60kg adult's clinical dosage respectively, 8, 4 times), medicine is all mixed with respective concentration with 0.5%CMCNa solvent, each group all by 1ml/100g body weight gavage, once a day, continuous 7 days.
After last administration 1h, rat 10% chloral hydrate (3.5ml/kg) intraperitoneal injection of anesthesia, after 75% alcohol disinfecting rat abdomen skin, the otch of an about 0.5-1.0cm is cut at rat Ventral Midline, open abdomen and peritoneum, expose prostate, model group matched group, QIANLIEKANG group, this product high dose, middle dosage, low dose group only respectively injects 1% carrageenin normal saline solution 0.1ml/ in prostate left and right leaf, reset after injection prostate, last suturing them muscle layer and skin, wound spreads dual anti-solution prevention of postoperative infection, put back to Mus cage, free diet.Blank group rat same area injection Isodose physiological saline solution.Postoperative continuation gastric infusion 2 days, after last administration 1h, draws materials.
Sample preparation and detection method
(1) abdominal aortic blood after rat anesthesia, centrifuging and taking serum ,-70 DEG C of Refrigerator stores, indices to be measured; (2) each group rat peels off prostate, cuts prostate same area portion of tissue, fixes by 10% formalin, send pathology to make section and HE dyeing, remainder cryopreservation tube sealing-70 DEG C of cryopreservation.(3) numeration of leukocyte in each group rat prostate: the fritter prostate taking every rat same area with electronic balance, puts into manual glass homogenizer, adds physiological saline solution grinding by 4ul/mg, make homogenate and preserve.Separately get small test tube 1, add leukocyte diluent 0.78ml, the above-mentioned specimen 0.02ml prepared accurately is drawn with micropipettor, wipe the outside specimen of tip, suction pipe is inserted the bottom of diluent in small test tube, gently specimen is released, and draw the supernatant, gargle and wash suction pipe 2 times, finally with hand dynamic test tube mixing; Draw 10 μ L mixed liquors with micropipettor and fill pond, leave standstill 2-3min, treat that leukocyte sinks, with the total white blood cells (can experimentally situation increase extension rate) in low power lens counting 4, corner block plaid.Leukocyte count/4 × extension rate × 10 × 10 in leukocyte count/L=tetra-block plaid 6(÷ 4 represents leukocyte mean in 0.1 cubic millimeter, leukocyte mean in × 10 expressions one cubic millimeter, × 10 6represent and be scaled iu); (4) each group rat prostate lecithin density is observed: get 10 μ L homogenate smears, check lecithin density under mirror, by lecithin density by clinical criteria classification: 4 grades: the full visual field of lecithin; 3 grades: lecithin 3/4 visual field; 2 grades: lecithin 1/2 visual field; 1 grade: lecithin 1/4 visual field.
Pathological grading and standards of grading
HE colored light sem observation prostata tissue, pathological observation project is: prostata tissue body of gland tube chamber form, tube chamber content, epithelium degeneration necrosis, cell infiltration, proliferation of fibrous tissue and PTS 6.Classification and standards of grading following (note: because cell infiltration is the of paramount importance pathological manifestations of prostatitis, therefore give double weight):
(1) tube chamber form
Normal: body of gland arrangement is loose, have no tortuous, expand and extruding (0 point); Slight: body of gland is slightly expanded, see extruding (1 point) between body of gland; Moderate: body of gland moderate distension, extrudes comparatively obviously (2 points) between body of gland; Severe: body of gland severe is expanded, most Glandular Dilatation is circular, extrudes extremely obviously (3 points) between body of gland.
(2) tube chamber content
Normal: all visible secretions of intracavity, homogeneous powder dye (0 point); Slight: luminal sectetion thing slightly reduces, reduce about 1/3-1/2(1 and divide); Moderate: luminal sectetion thing moderate reduces, and reduces about 1/2-2/3(2 and divides); Severe luminal sectetion thing severe reduces, and reduces by about more than 2/3 (3 points).
(3) epithelium degeneration necrosis
Normal: glandular epithelium is simple cuboidal or monolayer Gao Zhu, have no degeneration and necrosis (0 point); Slight: glandular epithelium is slight papillary hyperplasia, topical epithelial degeneration (1 point); Moderate: large portion's glandular epithelium degeneration, visible apoptosis and necrosis (2 points); Severe: large portion glandular epithelium comes off, and remaining glandular epithelium is shown in apoptosis and necrosis (3 points).
(4) cell infiltration
Normal: in lumen of gland, to have no cell infiltration, a small amount of cell infiltration of interstitial (0 point); Slight: a small amount of cell infiltration in lumen of gland, interstitial moderate cell infiltration (2 points); Moderate: moderate cell infiltration in lumen of gland, interstitial moderate cell infiltration (4 points); Severe: a large amount of cell infiltration in lumen of gland, a large amount of cell infiltration of interstitial (6 points).
(5) proliferation of fibrous tissue
Normal: around body of gland, have no proliferation of fibrous tissue (0 point) in interstitial; Slight: around body of gland, a small amount of proliferation of fibrous tissue (1 point) in interstitial; Moderate: around body of gland, moderate proliferation of fibrous tissue in interstitial (2 points); Severe: around body of gland, a large amount of proliferation of fibrous tissue in interstitial, holds (3 points).
(6) total score is above-mentioned 5 score sums.
Experimental result
(1) this product 1.32 g/Kg, 0.66g/Kg dosage can significantly reduce leukocyte count in rat prostate, with model control group ratio, difference has statistical significance (P < 0.05, P < 0.001), wherein distinguish kidney tea 0.66g/Kg dosage group number of white blood cells minimum, effect is best, the results are shown in Table 6.
numeration of leukocyte in rat prostate of respectively organizing table 6 compares ( )
Note: compare with model group, *p < 0.05 *p < 0.01 * *p < 0.001
(2) between each group, in rat prostate, SPL density classification has notable difference, difference has statistical significance (P < 0.01), this product 1.32 g/Kg, 0.66g/Kg, 0.33g/Kg dosage all can increase rat prostate SPL content, and wherein this product 1.32g/Kg dosage curative effect is best.The results are shown in Table 7.
Table 7 is group rat prostate liquid lecithin density analysis (MeanRanks) respectively
(3) this product 1.32g/kg dosage obviously can reduce rat blood serum MDA content, compares with model control group, and difference has statistical significance (P < 0.05), the results are shown in Table 8.
This product of table 8 on Carrageenan cause prostatitis rat model serum MDA impact ( )
Note: compare with model control group *p < 0.05 (wherein QIANLIEKANG group sample blood is polluted)
(4) this product 1.32g/kg significantly can increase rat blood serum SOD content, compares with model group, and difference has statistical significance (P < 0.05), the results are shown in Table 9.
This product of table 9 on Carrageenan cause prostatitis rat model SOD in serum impact ( )
Note: compare with model control group *p < 0.05 *p < 0.01
(5) pathomorphism scoring detection shows that between each group, each item rating statistics of rat all has significant difference (P < 0.01), this product 1.32 g/Kg, 0.66g/Kg, 0.33g/Kg dosage can improvement rat prostate tube chamber form in various degree, tube chamber content, epithelium degeneration necrosis, cell infiltration, proliferation of fibrous tissue pathomorphism, in TOP SCORES statistics, this product 0.66g/Kg dosage curative effect is best, the results are shown in Table 10.
Pathomorphism is described below:
The loose distribution of blank group rat prostate body of gland, there is a lot of pleat on glandular epithelium surface, outstanding in lumen of gland in mamillary, and visible a large amount of powder dye secretions in lumen of gland, interstitial is loosened, and fibre weight is few.Model control group rat body of gland is expansion extremely, and a large amount of cell infiltration in lumen of gland, glandular epithelium comes off, necrosis, and interstitial congestion and edema, a large amount of cell infiltration, proliferation of fibrous tissue is obvious.QIANLIEKANG group rat body of gland is slightly expanded, a small amount of cell infiltration in lumen of gland, the visible degeneration of glandular epithelium, interstitial mild hyperaemia edema, a small amount of cell infiltration, hypertrophy that fibrous tissue is slight.This product 1.32 g/Kg dosage group rat body of gland is slightly expanded, and extruding is comparatively obvious, and a small amount of cell infiltration in lumen of gland, glandular epithelium partial denaturization is downright bad, interstitial mild hyperaemia edema, a small amount of cell infiltration, proliferation of fibrous tissue.This product 0.66 g/Kg dosage group rat body of gland is slightly expanded, and a small amount of cell infiltration in lumen of gland, glandular epithelium is shown in degeneration, interstitial mild hyperaemia edema, a small amount of cell infiltration, hypertrophy that fibrous tissue is slight.This product 0.33 g/Kg dosage group rat body of gland moderate distension, moderate cell infiltration in lumen of gland, local glandular epithelium degeneration necrosis comes off, interstitial moderate congestion and edema, moderate cell infiltration, and proliferation of fibrous tissue is more obvious).
This product of table 10 causes prostatitis rat model prostate pathomorphism impact (Mean Ranks) on Carrageenan
Result shows: pharmaceutical composition 1.32 g/Kg, 0.66g/Kg dosage that (1) is prepared by embodiment 1 significantly can reduce the quantity of leucocyte in rat prostate, compare with model control group and have significant difference (P < 0.05, P < 0.001); (2) between each group, in rat prostate, SPL density classification has notable difference, difference has statistical significance (P < 0.01), pharmaceutical composition 1.32g/Kg, 0.66g/Kg, 0.33g/Kg dosage prepared by embodiment 1 all can increase rat prostate SPL content, and the pharmaceutical composition 1.32g/Kg dosage curative effect wherein prepared by embodiment 1 is best.(3) the pharmaceutical composition 1.32g/Kg dosage prepared by embodiment 1 significantly can increase rat blood serum SOD content, has significant difference (P < 0.05) with model control group ratio.(4) the pharmaceutical composition 1.32g/Kg dosage prepared by embodiment 1 significantly can reduce rat blood serum MDA content, has significant difference (P < 0.05) with model control group ratio.(5) in pathomorphism scoring detection, between each group, each item rating statistics of rat all has significant difference (P < 0.01), and the pharmaceutical composition 1.32g/Kg dosage prepared by embodiment 1 curative effect in tube chamber form and tube chamber content scoring statistics is best; The pharmaceutical composition 0.66g/Kg dosage prepared by embodiment 1 curative effect in epithelium degeneration necrosis, cell infiltration, proliferation of fibrous tissue and TOP SCORES statistics is best.
Above-mentioned on Carrageenan causes in the Effect study of rat prostate inflammation model and shows:
(1) pharmaceutical composition of the present invention can obviously improve rat prostate pathomorphism.Normal prostatic lumen of gland pleat is flourishing, and tube chamber is irregular, and have a large amount of wind rose dye secretions in lumen of gland, interstitial inflammatory cell is rare, accidental a small amount of proliferation of fibrous tissue.Compared with model control group, pharmaceutical composition of the present invention can improve prostate gland tube chamber form, and body of gland pleat quantity is increased, and tube chamber endocrine increases, alleviate gland epithelial cells degeneration necrosis degree simultaneously, suppress infiltration and the proliferation of fibrous tissue situation of inflammatory cell;
(2) pharmaceutical composition of the present invention significantly can reduce quantity of leucocyte and increase lecithin content in rat prostate.In chronic prostatitis, the quantity of leucocyte in prostatic fluid routine examination and lecithin have close relationship.Without leukocyte or little in normal prostatic, during prostate light inflammation, have a small amount of leukocyte to exist, during hyperphlogosis, leukocyte occurs in a large number, even intensive agglomerating.Lecithin is one of composition of prostatic fluid; produced by prostate epithelial cell and secrete; there is protection always to use to sperm and promote the liquefaction of seminal fluid; under normal condition mirror, lecithin almost spreads all over the full visual field; when chronic prostatitis; affect prostatic secretions function, lecithin minimizing even disappears.Although the order of severity of leukocyte and lecithin quantity and patients symptomatic is inconsistent in prostatic fluid to have report to think, can not as the index of the sick order of severity of measurement.But in clinic diagnosis, most of doctor still raises according to WBC counting in EPS and (or) the minimizing of SPL content judges whether prostate exists the order of severity of inflammation and inflammation, and as one of standard judging curative effect.This experiment also proves that the curative effect being evaluated pharmaceutical composition of the present invention by WBC quantity and SPL content before and after counting treatment is feasible;
(3) pathogenesis of chronic prostatitis is not yet clear and definite, and influence factor is numerous, and response to oxidative stress is likely one of its Etiologic Mechanism extremely to have scholar to think.Cause in the Effect study of rat prostate inflammation model in pharmaceutical composition on Carrageenan of the present invention, pharmaceutical composition of the present invention can reduce rat blood serum MDA content, enhance SOD vigor.MDA is the polyunsaturated fatty acid that body oxygen-derived free radicals attacks in biomembrane, cause lipid peroxidation and a kind of lipid peroxide of producing, MDA can amplify the effect of active oxygen, cause cellular metabolism and dysfunction, even dead, participate in the generation evolution of chronic prostatitis, bring out the pathological reactions such as edema, congestion, cytopathy, fibrosis.SOD is a kind of important anti-oxidation metal enzyme be extensively present in organism, can catalysis superoxide radical generation dismutation reaction, finally generates nontoxic H 2o, thus the lipid peroxidation injury that protection biological cell membrane produces from free radical.Result shows, by strengthening serum activity of SOD, to reduce MDA level, is likely that pharmaceutical composition of the present invention reduces inflammation reaction to one of mechanism of injury of prostate.Overall experimental result shows, by prevention administration, the symptom improvement that the carrageenin of pharmaceutical composition of the present invention to the acute attack of simulation chronic prostatitis causes rat prostate inflammation model has obvious effect.
experimental example 5: the pharmaceutical composition prepared by embodiment 1 causes the therapeutical effect research of rat chronic prostatitis model to antibacterial
The method for building animal model of chronic bacterial prostatitis is still immature, at present the experimental technique adopting Escherichia Coli Injection in rat prostate more.This experiment opens abdomen in prostate local injection escherichia coli method establishment chronic prostatitis model under adopting aseptic condition.After two weeks, partial rat is peeled off prostate and is made pathology section examination blank group and model control group rat pathomorphism, and whether verification model is successful.Pathomorphism result shows, and blank group rat prostate lumen of gland pleat is flourishing, and tube chamber is irregular, and have a large amount of wind rose dye secretions in lumen of gland, interstitial inflammatory cell is rare, accidental a small amount of proliferation of fibrous tissue.Compare with blank group, model group rats prostate pathomorphism obviously changes, lumen of gland pleat smoothly even disappears, there is capillary hemorrhage phenomenon, in lumen of gland, pink secretions obviously reduces and even disappears, visible a large amount of blue engrain cell infiltration in interstitial, and fibroblast proliferation is remarkable, there is inflammatory cell agglomerate sample clustering phenomena in department pattern group rat prostate, even occurs body of gland consolidation.It is successful that experimental result shows that this experimentation takes injection of prostate escherichia coli to prepare chronic prostatitis model.
Adopt rat prostate Escherichia Coli Injection to prepare rat chronic prostatitis model, detect WBC content, SPL classification in rat prostate; Serum NO levels; The change of prostate pathomorphism, studies the pharmaceutical composition prepared by embodiment 1 to the therapeutical effect of chronic prostatitis.
Adaptability feeds healthy male Wistar rat (the body weight 180-200g of cleaning grade, tie up company limited of tonneau China by Beijing to provide, licence is numbered: SCXK(capital) 2012-0001) 7 days be divided into blank group and model group at random afterwards, blank group 13, model group 65, within two weeks, after modelling verification success, model control group is divided into 5 groups again by body weight in operation modeling, i.e. model control group, QIANLIEKANG group, this product high dose group, middle dosage group, low dose group, often organizes 13.
After rat raises and train one week, 10% chloral hydrate (3.5ml/kg) intraperitoneal injection of anesthesia, after 75% alcohol disinfecting rat abdomen skin, the otch of an about 0.5-1cm is cut at rat Ventral Midline, open abdomen and peritoneum, expose prostate, model control group respectively injects 1.5 × 10 in prostate notopodium both sides 7the escherichia coli ATCC25922 0.1ml(of cfu/ml concentration adopts turbidimetry, is made into 1.5 × 10 with physiological saline solution 7cfu/ml concentration bacterium liquid is stand-by, prepared by microorganism teaching and research room of Beijing University of Chinese Medicine and provide), reset after injection prostate, last suturing them muscle layer and skin, wound spreads a little dual anti-solution prevention of postoperative infection, put back to mouse cage, free diet, blank group rat method same area injection Isodose normal saline of the same race.
Operation modeling is after two weeks, randomly draw blank group 3, model group 15, totally 18 rats, peel off prostate after anesthesia (to be provided by Kang Enbei Zhejiang Pharmaceutical Co, batch number: 110841), makes pathological section and HE dyeing by 10% formalin after fixing, whether checking chronic prostatitis syndrome model is successful.
Administration
If model success, animal starts gastric infusion, blank group and model control group all gavage solvent (0.5%CMCNa solvent), other each components gavage QIANLIEKANG aqueous solution 0.912g/kg(and are equivalent to 60kg and are grown up 8 times of clinical dosage), this product extract 1.32g/kg, 0.66g/kg, 0.33 g/kg(be equivalent to 16,8,4 times of 60kg adult's clinical dosage respectively), medicine is all mixed with respective concentration with 0.5%CMCNa solvent, each group all by 1ml/100g body weight gavage, once a day, treat 4 weeks continuously.
Draw materials
(1) abdominal aortic blood after rat anesthesia, centrifuging and taking serum ,-70 DEG C of Refrigerator stores, indices to be measured.
(2) peel off prostate, cut prostate same area portion of tissue, fix by 10% formalin, send pathology to make section and HE dyeing, remainder cryopreservation tube sealing-70 DEG C of cryopreservation.
(3) each group rat prostate leukocyte (WBC) counting: the fritter prostate taking every rats with left notopodium same area with electronic balance, put into manual glass homogenizer, add physiological saline solution grinding by 4ul/mg, make homogenate and preserve.Separately get small test tube 1, add leukocyte diluent 0.78ml, the above-mentioned specimen 0.02ml prepared accurately is drawn with micropipettor, wipe the outside specimen of tip, suction pipe is inserted the bottom of diluent in small test tube, gently specimen is released, and draw the supernatant, gargle and wash suction pipe 2 times, finally with hand dynamic test tube mixing; Draw 10 μ L mixed liquors with micropipettor and fill pond, leave standstill 2-3min, treat that leukocyte sinks, with the total white blood cells (can experimentally situation increase extension rate) in low power lens counting 4, corner block plaid.Leukocyte count/4 × extension rate × 10 × 10 in leukocyte count/L=tetra-block plaid 6(÷ 4 represents leukocyte mean in 0.1 cubic millimeter, leukocyte mean in × 10 expressions one cubic millimeter, × 10 6represent and be scaled iu).
(4) each group rat prostate lecithin density is observed: get 10 μ L homogenate smears, check lecithin under mirror, by lecithin density by clinical criteria classification: 4 grades: the full visual field of lecithin; 3 grades: lecithin 3/4 visual field; 2 grades: lecithin 1/2 visual field; 1 grade: lecithin 1/4 visual field.
Pathological grading and standards of grading
HE colored light sem observation prostata tissue, pathological observation project is: prostata tissue body of gland tube chamber form, tube chamber content, epithelium degeneration necrosis, cell infiltration, proliferation of fibrous tissue and PTS 6.Classification and standards of grading as follows:
(1) tube chamber form
Normal: body of gland arrangement is loose, have no tortuous, expand and extruding (0 point); Slight: body of gland is slightly expanded, see extruding (1 point) between body of gland; Moderate: body of gland moderate distension, extrudes comparatively obviously (2 points) between body of gland; Severe: body of gland severe is expanded, most Glandular Dilatation is circular, extrudes extremely obviously (3 points) between body of gland.
(2) tube chamber content
Normal: all visible secretions of intracavity, homogeneous powder dye (0 point); Slight: luminal sectetion thing slightly reduces, reduce about 1/3-1/2(1 and divide); Moderate: luminal sectetion thing moderate reduces, and reduces about 1/2-2/3(2 and divides); Severe luminal sectetion thing severe reduces, and reduces by about more than 2/3 (3 points).
(3) epithelium degeneration necrosis
Normal: glandular epithelium is simple cuboidal or monolayer Gao Zhu, have no degeneration and necrosis (0 point); Slight: glandular epithelium is slight papillary hyperplasia, topical epithelial degeneration (1 point); Moderate: large portion's glandular epithelium degeneration, visible apoptosis and necrosis (2 points); Severe: large portion glandular epithelium comes off, and remaining glandular epithelium is shown in apoptosis and necrosis (3 points).
(4) cell infiltration
Normal: in lumen of gland, to have no cell infiltration, a small amount of cell infiltration of interstitial (0 point); Slight: a small amount of cell infiltration in lumen of gland, interstitial moderate cell infiltration (2 points); Moderate: moderate cell infiltration in lumen of gland, interstitial moderate cell infiltration (4 points); Severe: a large amount of cell infiltration in lumen of gland, a large amount of cell infiltration of interstitial (6 points).
(5) proliferation of fibrous tissue
Normal: around body of gland, have no proliferation of fibrous tissue (0 point) in interstitial; Slight: around body of gland, a small amount of proliferation of fibrous tissue (1 point) in interstitial; Moderate: around body of gland, moderate proliferation of fibrous tissue in interstitial (2 points); Severe: around body of gland, a large amount of proliferation of fibrous tissue in interstitial, holds (3 points).
(6) total score is above-mentioned 5 score sums.
Experimental result
(1) modelling verification result
After pathological section and HE dye, carry out Pathomorphologic observation to 18 rats (3 blank groups, 15 model group), result is as follows:
Blank group rat prostate lumen of gland pleat is flourishing, and tube chamber is irregular, and have a large amount of wind rose dye secretions in lumen of gland, interstitial inflammatory cell is rare, accidental a small amount of proliferation of fibrous tissue.Compare with blank group, model group rats prostate pathomorphism obviously changes, lumen of gland pleat smoothly even disappears, there is capillary hemorrhage phenomenon, in lumen of gland, pink secretions obviously reduces and even disappears, visible a large amount of blue engrain cell infiltration in interstitial, and fibroblast proliferation is remarkable, there is inflammatory cell agglomerate sample clustering phenomena in department pattern group rat prostate, even occurs body of gland consolidation.Experimental result shows, operation modeling is after two weeks, and antibacterial causes the success of rat chronic prostatitis model.
(2) pharmaceutical composition 1.32 g/Kg, 0.66g/Kg dosage can significantly reduce leukocyte count in rat prostate, with model control group ratio, difference has statistical significance (P<0.05, P<0.01), wherein pharmaceutical composition 0.66g/Kg group number of white blood cells is minimum, and effect is best.The results are shown in Table 11.
Numeration of leukocyte in rat prostate of respectively organizing table 11 compares ( )
Note: compare with model control group *p<0.05 *represent P<0.01
(3) between each group, in rat prostate, SPL density classification has notable difference, and difference has statistics to anticipate (p<0.05).Compare with model control group, pharmaceutical composition sheet 1.32 g/Kg, 0.66g/Kg, 0.33g/Kg dosage all can raise the SPL content in rat prostate, and wherein pharmaceutical composition 0.66 g/Kg dosage curative effect is best.The results are shown in Table 12.
Table 12 prostatic fluid lecithin density analysis (MeanRanks)
(4) pharmaceutical composition 1.32 g/kg, 0.66g/kg dosage group obviously can reduce rat blood serum NO content, with model control group ratio, difference has statistical significance (P < 0.01), wherein 0.66g/kg dosage group curative effect is best, the results are shown in Table 13(note: blank group serum sample is contaminated).
Table 13 each group rat blood serum NO content ( )
Note: compare with model group, *p < 0.01
(5) pharmaceutical composition 1.32g/kg, 0.66g/kg dosage obviously can reduce rat blood serum MDA content, with model control group ratio, difference has statistical significance (P < 0.05, P < 0.01), wherein 0.66g/kg dosage group curative effect is best, the results are shown in Table 14.
Table 14 each group rat blood serum MDA content ( )
Note: compare with model group, *p < 0.05 *p < 0.01
(6) pharmaceutical composition 1.32g/kg, 0.66g/kg dosage obviously can strengthen rat blood serum SOD vigor, and with model control group ratio, difference has statistical significance (P < 0.01), and wherein 0.66g/kg dosage group curative effect is best, the results are shown in Table 15.
Table 15 each group rat blood serum SOD vigor ( )
Note: compare with model group, *p < 0.01
(7) in pathomorphism scoring detection, between each group, each item rating statistics of rat all has significant difference (P < 0.01), this product 1.32 g/Kg, 0.66g/Kg, 0.33g/Kg dosage can improvement rat prostate tube chamber form in various degree, tube chamber content, epithelium degeneration necrosis, cell infiltration, proliferation of fibrous tissue pathomorphism, in TOP SCORES statistics, this product 0.66g/Kg dosage curative effect is best, the results are shown in Table 14.Pathomorphism is described below:
The loose distribution of blank group rat prostate body of gland, visible a large amount of powder dye secretions in lumen of gland, interstitial is loosened, and fibre weight is few.The extruding of model control group rat Glandular Dilatation obviously, a large amount of cell infiltration in lumen of gland, glandular epithelium degeneration, apoptosis, come off, necrosis is all visible, interstitial congestion and edema obviously, cell infiltration, volume proliferation of fibrous tissue.QIANLIEKANG group rat body of gland is slightly expanded, and a small amount of cell infiltration in lumen of gland, glandular epithelium Mild edema, degeneration, interstitial congestion and edema, a small amount of cell infiltration, proliferation of fibrous tissue is not obvious.This product 1.32g/kg dosage group rat body of gland is slightly expanded, and a small amount of cell infiltration in lumen of gland, glandular epithelium partial denaturization is downright bad, interstitial mild hyperaemia edema, a small amount of cell infiltration, hypertrophy that fibrous tissue is slight.This product 0.66g/kg dosage group rat body of gland is slightly expanded, a small amount of cell infiltration in lumen of gland, degeneration that glandular epithelium is slight, focal necrosis, interstitial congestion and edema, a small amount of cell infiltration, hypertrophy that fibrous tissue is slight.This product 0.33g/kg dosage group rat body of gland moderate distension, body of gland is shown in extruding, moderate cell infiltration in lumen of gland, and local glandular epithelium degeneration necrosis comes off, and interstitial moderate congestion and edema, moderate cell infiltration, proliferation of fibrous tissue is more obvious.
Table 16 antibacterial causes rat chronic prostatitis model prostate pathomorphism impact (Mean Ranks)
Result shows: pharmaceutical composition 1.32 g/Kg, 0.66g/Kg dosage that (1) is prepared by embodiment 1 significantly can reduce the quantity of leucocyte in rat prostate, significant difference (P < 0.05, P < 0.01) is had with model control group ratio; (2) between each group, in rat prostate, SPL density classification has notable difference, difference has statistical significance (P < 0.05), pharmaceutical composition 1.32g/Kg, 0.66g/Kg, 0.33g/Kg dosage prepared by embodiment 1 all can increase rat prostate SPL content, and the pharmaceutical composition 0.66g/Kg dosage curative effect wherein prepared by embodiment 1 is best.(3) pharmaceutical composition 1.32g/Kg, 0.66g/Kg dosage prepared by embodiment 1 can significantly reduce NO content in rat blood serum, has significant difference (P < 0.01, P < 0.01) with model control group ratio.(4) in pathomorphism scoring detection, between each group, each item rating statistics of rat all has significant difference (P < 0.01), and the pharmaceutical composition 1.32 g/Kg dosage prepared by embodiment 1 curative effect in tube chamber form, epithelium degeneration necrosis, proliferation of fibrous tissue scoring statistics is best; The pharmaceutical composition 0.66g/Kg dosage prepared by embodiment 1 curative effect in tube chamber content, cell infiltration and TOP SCORES statistics is best.
Above-mentioned the Effect study that antibacterial causes rat chronic prostatitis model to be shown:
(1) pharmaceutical composition of the present invention can obviously improve rat prostate pathomorphism;
(2) pharmaceutical composition of the present invention obviously can reduce quantity of leucocyte and increase lecithin content in rat prostate;
(3) pharmaceutical composition of the present invention distinguishes the content that kidney sifting tea obviously can reduce rat blood serum NO.NO, in vivo as the free radical that a kind of reactivity is extremely strong, has second message,second messenger and neurotransmitter effect concurrently, is again a kind of effector molecule simultaneously, has physiological and pathological effect widely in vivo.Endogenous NO has the effect of inflammation-inhibiting reaction under normal circumstances, but under pathologic condition, induction type NO synzyme synthesizes a large amount of NO, has cellulotoxic effect, and exacerbate inflammation is reacted.Clinical experimental study [18] shows that patients with chronic prostatitis serum NO content obviously raises, may with endotoxin and cytokine profiles induce stimulate impaired relevant with cellular immune function, and after the treatment serum NO levels reduce.In this experiment, pharmaceutical composition of the present invention is distinguished kidney sifting tea and significantly can be reduced rat blood serum NO content, proves that distinguishing kidney sifting tea treatment chronic prostatitis has certain curative effect.Overall experimental result shows, the antibacterial of pharmaceutical composition of the present invention to simulation chronic prostatitis causes rat chronic prostatitis model and have obvious therapeutical effect;
4) pharmaceutical composition of the present invention obviously can strengthen model rat blood serum SOD vigor, reduces Content of MDA.
Overall experimental result shows, after rat chronic prostatitis model is successfully established, by 4 weeks therapeutic administratp, distinguishes the antibacterial of kidney sifting tea to the clinical chronic prostatitis of simulation and causes rat chronic prostatitis model and have therapeutical effect.
Above-mentioned on Carrageenan causes the Effect study of prostatitis rat model, with antibacterial is caused in the Effect study of rat chronic prostatitis model, the each dosage group of pharmaceutical composition of the present invention and QIANLIEKANG all can improve rat model prostate pathomorphism in various degree, reduce rat model prostate quantity of leucocyte, improve lecithin content, illustrate pharmaceutical composition of the present invention and QIANLIEKANG all effective in cure to the prevention and therapy of chronic prostatitis.In blood circulation promoting and blood stasis dispelling experimentation, compared with QIANLIEKANG, pharmaceutical composition 1.32 g/Kg, 0.66g/Kg dosage group of the present invention cuts whole blood viscosity under rate all lower than QIANLIEKANG high, medium and low, points out pharmaceutical composition blood circulation invigorating efficacies of the present invention to be better than QIANLIEKANG to a certain extent, prostatitis rat model SOD in serum is caused in detection pharmaceutical composition on Carrageenan of the present invention, in MDA influence, pharmaceutical composition 1.32 g/Kg dosage of the present invention obviously can strengthen rat blood serum SOD vigor, reduce MDA content in serum, significant difference (P < 0.05) is more all had with model control group, at detection pharmaceutical composition of the present invention, rat chronic prostatitis model SOD in serum is caused to antibacterial, in MDA influence, pharmaceutical composition 1.32 g/Kg of the present invention, 0.66g/Kg obviously can strengthen rat blood serum SOD vigor, significant difference (P < 0.01 is had with model group ratio, P < 0.01), obvious reduction rat blood serum MDA content has significant difference (P < 0.05 with model group ratio, P < 0.01), although QIANLIEKANG also can strengthen rat blood serum SOD vigor to a certain extent, reduce MDA content in serum, but the difference that compares with model control group that there are no significant, cause in the Effect study of rat chronic prostatitis model serum NO level at pharmaceutical composition of the present invention to antibacterial, pharmaceutical composition 1.32g/Kg of the present invention, 0.66g/Kg dosage obviously can reduce rat blood serum NO content, compare with model control group and have significant difference (P < 0.01, P < 0.01), although QIANLIEKANG can reduce rat blood serum NO content, but compare there was no significant difference with model control group, experimental result all points out pharmaceutical composition of the present invention to have stronger opposing response to oxidative stress to body damage effect compared with QIANLIEKANG.
Detailed description of the invention
embodiment 1: the preparation of tablet
Radix Sophorae Flavescentis 300g, kidney tea 200g, Rhizoma Smilacis Glabrae 300g, Radix Cyathulae 200g, Radix Salviae Miltiorrhizae 200g, Rhizoma Corydalis 200g, Herba Taraxaci 200g, Semen Vaccariae 200g;
In above listed pharmaceutical composition crude drug of the present invention, add customary adjuvant, conveniently technique, make tablet, specifically comprise:
Step one: 95% ethanol adding 7 times of weight portions in Radix Salviae Miltiorrhizae, reflux, extract, 0.5 hour, filters, add 70% ethanol again, reflux, extract, 2 times, each 9 times of weight portions, each 0.5 hour, filter, merging filtrate, decompression recycling ethanol (temperature≤70 DEG C), measures to Baume degrees as 23-25 degree (50-60 DEG C) with Baume hydrometer, drying under reduced pressure (temperature≤70 DEG C), is ground into fine powder;
Step 2: Rhizoma Corydalis is ground into most coarse powder, and add 80% soak with ethanol 2 hours with Radix Sophorae Flavescentis, reflux, extract, 2 times, each 1 hour, alcohol adding amount is respectively 9 times of weight portions, 7 times of weight portions, filter, merging filtrate, obtains alcohol extract for subsequent use;
Step 3: the five tastes such as kidney tea, Rhizoma Smilacis Glabrae, Herba Taraxaci, Radix Cyathulae, Semen Vaccariae, soak 2 hours, decoct 3 times, each 0.5 hour, add water be respectively 10 weight portions doubly, 7 times of weight portions and 7 times of weight portions, filter, merging filtrate, concentrating under reduced pressure (temperature≤70 DEG C) to Baume degrees is 15-17 degree (55-65 DEG C), obtains water extraction concentrated solution for subsequent use;
Step 4: merge above-mentioned alcohol extract and water extraction concentrated solution, concentrating under reduced pressure (temperature≤70 DEG C), measure to Baume degrees for 19-22 degree (40-50 DEG C) with Baume hydrometer, drying under reduced pressure (temperature≤70 DEG C), is ground into fine powder;
Step 5: said extracted thing powder adds carboxymethylstach sodium, silicon dioxide mix homogeneously, makes granule, adds magnesium stearate mix homogeneously, tabletting, film coating, to obtain final product.
embodiment 2: the preparation of tablet
Radix Sophorae Flavescentis 160 weight portion, kidney tea 290 weight portion, Rhizoma Smilacis Glabrae 155 weight portion, Radix Cyathulae 295 weight portion, Radix Salviae Miltiorrhizae 105 weight portion, Rhizoma Corydalis 295 weight portion, Herba Taraxaci 110 weight portion, Semen Vaccariae 290 weight portion;
Step one: by Radix Salviae Miltiorrhizae alcohol reflux, filters, decompression recycling ethanol, drying under reduced pressure, pulverizes;
Step 2: pulverized by Rhizoma Corydalis, add alcohol reflux with Radix Sophorae Flavescentis, filters, obtains alcohol extract;
Step 3: the five tastes such as kidney tea, Rhizoma Smilacis Glabrae, Herba Taraxaci, Radix Cyathulae, Semen Vaccariae, soaks, and decocts, and filter, concentrating under reduced pressure obtains water extraction concentrated solution;
Step 4: merge above-mentioned alcohol extract and water extraction concentrated solution, concentrating under reduced pressure, drying under reduced pressure, pulverizes;
Step 5: said extracted thing powder adds carboxymethylstach sodium, silicon dioxide mix homogeneously, makes granule, adds magnesium stearate mix homogeneously, tabletting, film coating, to obtain final product.
embodiment 3: the preparation of powder
Radix Sophorae Flavescentis 440 weight portion, kidney tea 110 weight portion, Rhizoma Smilacis Glabrae 445 weight portion, Radix Cyathulae 105 weight portion, Radix Salviae Miltiorrhizae 290 weight portion, Rhizoma Corydalis 110 weight portion, Herba Taraxaci 290 weight portion, Semen Vaccariae 110 weight portion;
In above listed invention pharmaceutical composition crude drug, add customary adjuvant according to preceding method, conveniently technique, make powder.
embodiment 4: the preparation of granule
Radix Sophorae Flavescentis 440 weight portion, kidney tea 290 weight portion, Rhizoma Smilacis Glabrae 160 weight portion, Radix Cyathulae 110 weight portion, Radix Salviae Miltiorrhizae 280 weight portion, Rhizoma Corydalis 290 weight portion, Herba Taraxaci 120 weight portion, Semen Vaccariae 110 weight portion;
In above listed pharmaceutical composition crude drug of the present invention, add customary adjuvant according to preceding method, conveniently technique, make granule.
embodiment 5: the preparation of granule
Radix Sophorae Flavescentis 165 weight portion, kidney tea 120 weight portion, Rhizoma Smilacis Glabrae 435 weight portion, Radix Cyathulae 280 weight portion, Radix Salviae Miltiorrhizae 125 weight portion, Rhizoma Corydalis 150 weight portion, Herba Taraxaci 275 weight portion, Semen Vaccariae 250 weight portion;
Step one: by Radix Salviae Miltiorrhizae alcohol reflux, filters, decompression recycling ethanol, drying under reduced pressure, pulverizes;
Step 2: pulverized by Rhizoma Corydalis, add alcohol reflux with Radix Sophorae Flavescentis, filters, obtains alcohol extract;
Step 3: the five tastes such as kidney tea, Rhizoma Smilacis Glabrae, Herba Taraxaci, Radix Cyathulae, Semen Vaccariae, soaks, and decocts, and filter, concentrating under reduced pressure obtains water extraction concentrated solution;
Step 4: merge above-mentioned alcohol extract and water extraction concentrated solution, concentrating under reduced pressure, drying under reduced pressure, pulverizes;
Step 5: said extracted thing powder is added customary adjuvant, conveniently technique, shaping, makes granule.
embodiment 6: the preparation of pill
Radix Sophorae Flavescentis 430g, kidney tea 200g, Rhizoma Smilacis Glabrae 170g, Radix Cyathulae 280g, Radix Salviae Miltiorrhizae 200g, Rhizoma Corydalis 120g, Herba Taraxaci 270g, Semen Vaccariae 130g;
In above listed pharmaceutical composition crude drug of the present invention, add customary adjuvant, conveniently technique, make pill.
embodiment 7: the preparation of injection
Radix Sophorae Flavescentis 175g, kidney tea 200g, Rhizoma Smilacis Glabrae 425g, Radix Cyathulae 115g, Radix Salviae Miltiorrhizae 200g, Rhizoma Corydalis 285g, Herba Taraxaci 130g, Semen Vaccariae 270g;
In above listed pharmaceutical composition crude drug of the present invention, add customary adjuvant, conveniently technique, make injection, specifically comprise:
Step one: 95% ethanol adding 7 times of weight portions in Radix Salviae Miltiorrhizae, reflux, extract, 0.5 hour, filters, add 70% ethanol again, reflux, extract, 2 times, each 9 times of weight portions, each 0.5 hour, filter, merging filtrate, decompression recycling ethanol (temperature≤70 DEG C), measures to Baume degrees as 23-25 degree (50-60 DEG C) with Baume hydrometer, drying under reduced pressure (temperature≤70 DEG C), is ground into fine powder;
Step 2: Rhizoma Corydalis is ground into most coarse powder, and add 80% soak with ethanol 2 hours with Radix Sophorae Flavescentis, reflux, extract, 2 times, each 1 hour, alcohol adding amount is respectively 9 times of weight portions, 7 times of weight portions, filter, merging filtrate, obtains alcohol extract for subsequent use;
Step 3: the five tastes such as kidney tea, Rhizoma Smilacis Glabrae, Herba Taraxaci, Radix Cyathulae, Semen Vaccariae, soak 2 hours, decoct 3 times, each 0.5 hour, add water be respectively 10 weight portions doubly, 7 times of weight portions and 7 times of weight portions, filter, merging filtrate, concentrating under reduced pressure (temperature≤70 DEG C) to Baume degrees is 15-17 degree (55-65 DEG C), obtains water extraction concentrated solution for subsequent use;
Step 4: merge above-mentioned alcohol extract and water extraction concentrated solution, concentrating under reduced pressure (temperature≤70 DEG C), measure to Baume degrees for 19-22 degree (40-50 DEG C) with Baume hydrometer, drying under reduced pressure (temperature≤70 DEG C), is ground into fine powder;
Step 5: said extracted thing powder adds customary adjuvant, and conveniently technique, makes injection.
embodiment 8: the preparation of injection
Radix Sophorae Flavescentis 300g, kidney tea 125g, Rhizoma Smilacis Glabrae 375g, Radix Cyathulae 200g, Radix Salviae Miltiorrhizae 115g, Rhizoma Corydalis 285g, Herba Taraxaci 135g, Semen Vaccariae 265g;
In above listed pharmaceutical composition of the present invention, add customary adjuvant according to preceding method, conveniently technique, make injection.
embodiment 9: the preparation of solution
Radix Sophorae Flavescentis 300g, kidney tea 285g, Rhizoma Smilacis Glabrae 165g, Radix Cyathulae 200g, Radix Salviae Miltiorrhizae 280g, Rhizoma Corydalis 120g, Herba Taraxaci 150g, Semen Vaccariae 250g;
In above listed pharmaceutical composition of the present invention, add customary adjuvant according to preceding method, conveniently technique, make solution.
embodiment 10: the preparation of capsule
Radix Sophorae Flavescentis 425g, kidney tea 125g, Rhizoma Smilacis Glabrae 440g, Radix Cyathulae 280g, Radix Salviae Miltiorrhizae 110g, Rhizoma Corydalis 120g, Herba Taraxaci 280g, Semen Vaccariae 120g;
In above listed pharmaceutical composition crude drug of the present invention, add customary adjuvant according to preceding method, conveniently technique, make capsule.
embodiment 11: the preparation of capsule
Radix Sophorae Flavescentis 175g, kidney tea 275g, Rhizoma Smilacis Glabrae 180g, Radix Cyathulae 120g, Radix Salviae Miltiorrhizae 270g, Rhizoma Corydalis 280g, Herba Taraxaci 135g, Semen Vaccariae 265g;
Step one: by Radix Salviae Miltiorrhizae alcohol reflux, filters, decompression recycling ethanol, drying under reduced pressure, pulverizes;
Step 2: pulverized by Rhizoma Corydalis, add alcohol reflux with Radix Sophorae Flavescentis, filters, obtains alcohol extract;
Step 3: the five tastes such as kidney tea, Rhizoma Smilacis Glabrae, Herba Taraxaci, Radix Cyathulae, Semen Vaccariae, soaks, and decocts, and filter, concentrating under reduced pressure obtains water extraction concentrated solution;
Step 4: merge above-mentioned alcohol extract and water extraction concentrated solution, concentrating under reduced pressure, drying under reduced pressure, pulverizes;
Step 5: said extracted thing powder adds customary adjuvant, and conveniently technique, makes capsule.
embodiment 12: the preparation of tablet
Radix Sophorae Flavescentis 300g, kidney tea 200g, Rhizoma Smilacis Glabrae 300g, Radix Cyathulae 200g, Radix Salviae Miltiorrhizae 200g, Rhizoma Corydalis 200g, Herba Taraxaci 200g, Semen Vaccariae 200g;
Step one: 95% ethanol adding 7 times of weight portions in Radix Salviae Miltiorrhizae, reflux, extract, 0.5 hour, filters, add 70% ethanol again, reflux, extract, 2 times, each 9 times of weight portions, each 0.5 hour, filter, merging filtrate, decompression recycling ethanol (temperature≤70 DEG C), measures to Baume degrees as 23-25 degree (50-60 DEG C) with Baume hydrometer, drying under reduced pressure (temperature≤70 DEG C), is ground into fine powder;
Step 2: Rhizoma Corydalis is ground into most coarse powder, and add 80% soak with ethanol 2 hours with Radix Sophorae Flavescentis, reflux, extract, 2 times, each 1 hour, alcohol adding amount is respectively 9 times of weight portions, 7 times of weight portions, filter, merging filtrate, obtains alcohol extract for subsequent use;
Step 3: the five tastes such as kidney tea, Rhizoma Smilacis Glabrae, Herba Taraxaci, Radix Cyathulae, Semen Vaccariae, soak 2 hours, decoct 3 times, each 0.5 hour, add water be respectively 10 weight portions doubly, 7 times of weight portions and 7 times of weight portions, filter, merging filtrate, concentrating under reduced pressure (temperature≤70 DEG C) to Baume degrees is 15-17 degree (55-65 DEG C), obtains water extraction concentrated solution for subsequent use;
Step 4: merge above-mentioned alcohol extract and water extraction concentrated solution, concentrating under reduced pressure (temperature≤70 DEG C), measure to Baume degrees for 19-22 degree (40-50 DEG C) with Baume hydrometer, drying under reduced pressure (temperature≤70 DEG C), is ground into fine powder;
Step 5: said extracted thing powder adds carboxymethylstach sodium, silicon dioxide mix homogeneously, makes granule, adds magnesium stearate mix homogeneously, tabletting, film coating, to obtain final product.
Obviously, above-described embodiment is only for clearly example being described, and the restriction not to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here exhaustive without the need to also giving all embodiments.And thus the apparent change of extending out or variation be still among the protection domain of the invention.

Claims (3)

1. be used for the treatment of a preparation method for the pharmaceutical composition of chronic prostatitis, it is characterized in that, the crude drug of said composition consists of:
Radix Sophorae Flavescentis 300g, kidney tea 200g, Rhizoma Smilacis Glabrae 300g, Radix Cyathulae 200g, Radix Salviae Miltiorrhizae 200g, Rhizoma Corydalis 200g, Herba Taraxaci 200g, Semen Vaccariae 200g;
Described pharmaceutical composition is prepared by the following method:
Step one: 95% ethanol adding 7 times of weight portions in Radix Salviae Miltiorrhizae, reflux, extract, 0.5 hour, filters, add 70% ethanol again, reflux, extract, 2 times, each 9 times of weight portions, each 0.5 hour, filter, merging filtrate, decompression recycling ethanol, temperature≤70 DEG C, measure to Baume degrees as 23-25 degree with Baume hydrometer, temperature is 50-60 DEG C, drying under reduced pressure, temperature≤70 DEG C, are ground into fine powder;
Step 2: Rhizoma Corydalis is ground into coarse powder, adds 80% soak with ethanol 2 hours with Radix Sophorae Flavescentis, reflux, extract, 2 times, each 1 hour, and alcohol adding amount is respectively 9 times of weight portions, 7 times of weight portions, and filter, merging filtrate, obtains alcohol extract for subsequent use;
Step 3: the five tastes such as kidney tea, Rhizoma Smilacis Glabrae, Herba Taraxaci, Radix Cyathulae, Semen Vaccariae, soak 2 hours, decoct 3 times, each 0.5 hour, add water be respectively 10 weight portions doubly, 7 times of weight portions and 7 times of weight portions, filter, merging filtrate, concentrating under reduced pressure, temperature≤70 DEG C, be 15-17 degree to Baume degrees, temperature is 55-65 DEG C, obtains water extraction concentrated solution for subsequent use;
Step 4: merge above-mentioned alcohol extract and water extraction concentrated solution, concentrating under reduced pressure, temperature≤70 DEG C, measure to Baume degrees for 19-22 degree with Baume hydrometer, temperature is 40-50 DEG C, drying under reduced pressure, and temperature≤70 DEG C, are ground into fine powder;
Step 5: said extracted thing powder adds carboxymethylstach sodium, silicon dioxide mix homogeneously, makes granule, adds magnesium stearate mix homogeneously, tabletting, film coating, to obtain final product.
2. preparation method as claimed in claim 1, the application of described pharmaceutical composition in preparation treatment chronic prostatitis medicine.
3. the application of the pharmaceutical composition prepared by preparation method as claimed in claim 1 in preparation treatment chronic prostatitis medicine.
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