CN103948614A - Novel application of aescin and salt thereof in pharmacy - Google Patents
Novel application of aescin and salt thereof in pharmacy Download PDFInfo
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- CN103948614A CN103948614A CN201410156293.2A CN201410156293A CN103948614A CN 103948614 A CN103948614 A CN 103948614A CN 201410156293 A CN201410156293 A CN 201410156293A CN 103948614 A CN103948614 A CN 103948614A
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Abstract
The invention discloses a novel application of aescin and salt thereof in pharmacy, in particular relates to the novel application of aescin and salt thereof in preparing alpha-blocker medicaments and medicaments for treating chronic abacterial prostatitis. Pharmacodynamic experiment results indicate that aescin and salt thereof can be used for reducing the prostate organ coefficient of a rat model with chronic abacterial prostatitis caused by an estradiol benzoate injection, reducing the number of leukocytes in the prostate of the rat model with chronic abacterial prostatitis, and improving the density of the lecithin body in the prostate of the rat model. Clinical testing results indicate that the aescin and salt thereof can be used for relaxing prostate and bladder smooth muscle and have effects similar to alpha-blocker (bensylyt), the total effective rate of the aescin and salt thereof for treating chronic abacterial prostatitis is 88.33 percent, which is superior to that of the alpha-blocker bensylyt, and no remarkable adverse response is found.
Description
Technical field
The present invention relates generally to the new medicine use of aescine and salt thereof, specifically relates to aescine and salt thereof in the new purposes of preparing in alpha-blocking agent medicine and treatment chronic nonbacterial prostatitis medicine.
Background technology
Aescine claims again aescine acid, for extract the general name of total saponins, β-aescine or the different aescine etc. that obtain from Hippocastanaceae buckeye seed.Be applied at present clinically mainly with total aescine, mainly contain 4 kinds of compositions.China's national standard goes out before and after peak by liquid chromatograph, called after aescine A, aescine B, aescine C and aescine D successively.Wherein aescine A and B are β-type aescine, and its structure is basic identical, thereby aescine A and B can merge and represent with structural formula (1); And also isomer each other of aescine C and D belongs to different in nature aescine, claim again different aescine, can combinatorial construction formula (2) represent.
Aescine and salt thereof are oral or be injected at and be usually used in clinically treating the cerebral edema that a variety of causes causes and the brain function imbalance occurring together, inflammation that a variety of causes (as wound, burn, operation) causes and swelling, venous return obstacle disease etc., there is very strong antiinflammatory, exudation effect, can obviously reduce acutely inflamed oozing out, but whether aescine and salt thereof have the effect for the treatment of chronic nonbacterial prostatitis, at present there are no bibliographical information.
Chronic nonbacterial prostatitis is adult male diseases of urinary system, is mainly in 20-40 year person between twenty and fifty, and chronic nonbacterial prostatitis sickness rate is high, accounts for 64% of prostatitis sickness rate.The cardinal symptom of chronic nonbacterial prostatitis is pelvis area pain for a long time, repeatedly and paruria and sexual dysfunction in various degree, and wherein the main manifestations of paruria is that urgent micturition, frequent micturition, dysurea and nocturia increase etc.The cause of disease of chronic nonbacterial prostatitis is still unclear at present, may be main relevant with following factor: (1) pathogenic infection; (2) urinary function imbalance, causes urine to be backflowed; (3) pelvic diaphragm muscle spasm; (4) psychologic factors; (5) neuroendocrine factor; (6) physical chemical factor stimulates; (7) immunoreaction abnormity; (8) oxidative stress effect strengthens; (9) lower urinary tract epithelium dysfunction etc.Due to pathogenetic indefinite property, the complexity of the cause of disease and the multiformity of interference factor, determine that chronic nonbacterial prostatitis becomes a kind of refractory disease.
The clinical medicine that is usually used at present treating chronic nonbacterial prostatitis has several classes such as antibiotics, antiinflammatory class, alpha receptor blocking agent, M-receptor blocking agent, plant amedica, immunosuppressant.Existing medicine majority is symptomatic treatment, if the Main Function of anti-inflammatory agent is alleviating pain, can not alleviate the parurias such as urgent micturition, frequent micturition, dysurea and nocturia increase; M-receptor blocking agent is used for alleviating urgent micturition, frequent micturition and nocturia, but can not cure pain; And antibiotic is mainly for struvite chronic prostatitis, but 5% the patients with chronic prostatitis of only having an appointment has clear and definite antibacterial to infect; By contrast, alpha-blocking agent example hydrochloric acid phenoxybenzamine, naftopidil be because the smooth muscle at the positions such as prostate and bladder that can relax improves lower urinary tract symptom and pain, thereby become the essential drugs for the treatment of chronic nonbacterial prostatitis.
Summary of the invention
The object of this invention is to provide a kind of aescine and salt thereof and preparing alpha-blocking agent medicine, especially treat the new purposes in chronic nonbacterial prostatitis medicine.
Aescine and salt thereof are free aescine or the salt for aescine, in the time being aescine salt, be preferably aescine or lysine aescin saponin, it can certainly be other pharmaceutical salts, wherein lysine aescin saponin can obtain by disclosed method in patent CN100357312C, also can obtain by other conventional preparation method.
Aescine and salt thereof are being prepared alpha-blocking agent medicine, especially treat in the medicinal application of chronic nonbacterial prostatitis, described medicine is the compositions of aescine and salt and the pharmaceutically acceptable carrier composition of effective dose, and said composition can be any dosage form of clinical acceptable.
The preferred administering mode of the present invention is intravenously administrable (being mainly intravenous injection), and preferred dosage form is powder pin or injection, is 1-30mg/ day (in aescine) with respect to adult's injection volume, and preferred dose is 5-20mg/ day.
Can be according to the product that needs clinically powder pin or injection to make different size, the preferred specification of the present invention is every 5mg or 10mg.
Pharmacodynamic experiment result shows, aescine and salt thereof can alleviate the prostate organ coefficient of the rat chronic nonbacterial prostatitis model due to estradiol benzoate injection, reduce the intraprostatic leukocyte number of chronic nonbacterial prostatitis rat model, improve the density of lecithin in rat model prostate.
Clinical test results shows, aescine and salt thereof can relax prostate and smooth muscle of bladder, have the effect similar to alpha-blocking agent (Phenoxybenzamine).The total effective rate for the treatment of chronic nonbacterial prostatitis, up to 88.33%, is better than alpha-blocking agent Phenoxybenzamine, and without significantly untoward reaction.
Detailed description of the invention
Below by embodiment, the present invention is described in detail.
The non-Study on clinical pharmacodynamics of embodiment 1 aescine
1. experiment material
1.1 Experimental agents
Medicine: aescine, the white lyophilizing block that loosens, is made into aescine respectively the solution of 2.0mg/ml, 1.5mg/ml and 1.0mg/ml with 0.9% sodium chloride injection when experiment.
Positive control medicine: Phenoxybenzamine (phenoxybenzamine hydrochloride sheet), tablet, 5mg/ sheet, is produced by Yu Zhong pharmaceutical factory of Tailong Pharmaceutical Co., Ltd., Henan.Authentication code: the accurate word H10910024 of traditional Chinese medicines.
Modeling medicine: estradiol benzoate injection, animal drug factory produces by Hangzhou.Authentication code: veterinary drug word (2008) 110202511.Specification: 2ml:4mg.
Benzylpenicillin sodium for injection: prevention of inflammation after rat castration, by Huabei Pharmaceutic Co., Ltd.Specification: 800,000 units (0.48g).
1.2 laboratory animal
SD rat, male, 200 ± 20 grams of body weight.Credit number: SCXK(Hubei Province) 2008-0004, provided by Wuhan University's zoopery center.For subsequent use after quarantine.
2. experimental technique
2.1 chronic nonbacterial prostatitis rat modelings
60 of SD rats choosing about 200-230g, are equally divided into 50 of 10 of Normal groups and model group at random.Normal group normal nursing that be left intact, model group adopts Wei Shi modeling method: adopt 4% chloral hydrate intraperitoneal injection of anesthesia (0.5mL/100g), anaesthetize successfully after by animal dorsal position, limbs and head are fixed on performs the operation on platen.With 75% alcohol swab sterilization.In the middle of scrotum, a kerf is cut in stringer, about 1cm is long, bilateral testes is extruded respectively to scrotum, (making sure to keep in mind necessarily by clean to testis and epididymis excision) cut off in root ligation at testis and epididymis, after hemostasis, use triangle medical suture needle and 3-0 suture to sew up subcutaneous tissue and skin, in postoperative 2 days, apply benzylpenicillin sodium for injection (800,000 units/kg, 800,000 units/ml, 0.1ml/100g) prevention infection, lumbar injection.Every daily estradiol benzoate 0.25mg/kg subcutaneous injection after model group castration, continuous 28 days.
2.2 grouping of chronic nonbacterial prostatitis rat model and administrations
60 successful SD rats of modeling are divided into model control group (10), Phenoxybenzamine medicine group (5mg/kg, 10), 3 groups of the high, normal, basic dosage (2.0mg/kg, 1.5mg/kg, 1.0mg/kg, every group each 10) of aescine.There is no 10 SD rats of castration as blank group.Blank group tail vein injection saline every day 1ml, feeds and puts to death together with administration group after 1 month.Phenoxybenzamine medicine group every day is to rat oral gavage administration, the administration of aescine group tail vein injection every day, and model control group gives isodose normal saline.Every day 1 time, continuously 28d.Within after last administration 2 hours, put to death rat.
The collection of 2.3 samples
Under aseptic condition, dissect, take off median abdominal incision, through abdominal cavity, takes out prostata tissue.Weigh prostate weight in wet base.
2.4 sample processing method
2.4.1 prostate morphological is observed
By each group of experimental mouse same area prostata tissue through 10% formaldehyde fix, paraffin embedding, 4 μ m serial section, conventional hematoxylin-eosin (HE) dyeing, light Microscopic observation prostate lymphocytic infiltration and fibroblast proliferation degree; Application SPSS13.0 software carries out statistical analysis, respectively organizes data and uses
represent, ranked data statistics adopts Wilcoxon rank test to analyze, and between measurement data group, relatively with t inspection, has statistical significance taking P<0.05 as difference.
2.4.2 leukocyte count and lecithin density measurement in prostate
Add normal saline 4 μ l by every 1mg prostata tissue, shred, fully mix.Get 1, test tube, add leukocyte diluent 0.38ml, accurately draw the above-mentioned specimen preparing 20 μ l with pipettor, emit gently in test tube diluent bottom, blow and beat and mix for 3 times, fill pond, count four jiaos of total white blood cellses in 4 large grids with low power lens.Leukocyte count/4 × 20 × 107 in leukocyte count/L=4 large grid; Lecithin density is divided into 4 grades by Clinical Laboratory standard, and completely the visual field is ++++, 3/4 visual field is +++, 1/2 visual field is ++, 1/4 visual field is+.Application SPSS13.0 software carries out statistical analysis, respectively organizes data and uses
represent, ranked data statistics adopts Wilcoxon rank test to analyze, and between measurement data group, relatively with t inspection, has statistical significance taking P<0.05 as difference.
3. experimental result
Prostatic cell morphologic observation result under 3.1 light microscopics
The affect table of table 1 aescine on rat model prostate organ coefficient
Illustrate: t inspection, and model control group comparison: * represents p<0.05, and * * represents p<0.01, and * * * represents p<0.001; Press down swollen rate=(model group matched group organ coefficient average-administration group organ coefficient average)/model group matched group organ coefficient average × 100%.
Show from table 1 result, model control group rat prostate organ coefficient increases, and compares with the organ coefficient of Normal group, has significant difference (P<0.01).Compare with model control group rat prostate organ coefficient, positive control medicine Phenoxybenzamine group significance reduces, and has significant difference (t assay is respectively P<0.001).Aescine can reduce the prostate organ coefficient of rat model, with model control group comparison, aescine 2.0mg/kg dosage group and 1.5mg/kg dosage group all have significant difference (t assay is respectively P<0.001 and P<0.05).Prompting aescine 2.0mg/kg dosage group and 1.5mg/kg dosage group have the effect of the chronic nonbacterial prostatitis that opposing estradiol benzoate injection causes.Aescine 1.0mg/kg dosage group also has the trend of the chronic nonbacterial prostatitis that causes of opposing estradiol benzoate injection.From table, also can find out effect and positive control medicine Phenoxybenzamine 5.0mg/kg quite (the P equal <0.001) of aescine 2.0mg/kg dosage group to rat prostate organ coefficient.
Leukocytic variation in 3.2 rat prostates
Leukocytic variation (N=10) in table 2 rat prostate
Illustrate: t inspection, and model control group comparison: * represents p<0.05, and * * represents p<0.01, and * * * represents p<0.001.
Show from table 2 result, compared with Normal group, leukocyte count showed increased (P<0.001) in chronic nonbacterial prostatitis model group prostate, difference has statistical significance; Compare with chronic nonbacterial prostatitis model group, the leukocyte count in positive control medicine Phenoxybenzamine group prostate obviously reduces, and has significant difference.Simultaneously compared with chronic nonbacterial prostatitis model group, in aescine 2.0mg/kg dosage group and 1.5mg/kg dosage group prostate, leukocyte count obviously reduces (t inspection, be respectively P<0.001 and P " 0.01), difference has statistical significance; And aescine 1.0mg/kg dosage group is compared with chronic nonbacterial prostatitis model group, in prostate, leukocyte count difference does not have statistical significance (P=0.0651).From interpretation of result, can find out, aescine 2.0mg/kg dosage group is to leukocytic effect in rat prostate and quite (the equal <0.001 of P) of positive control medicine Phenoxybenzamine 5.0mg/kg.
The variation of lecithin density in 3.3 rat prostates
The variation (N=10) of lecithin density in table 3 rat prostate
Illustrate: chronic nonbacterial prostatitis model group compared with Normal group, ★: p<0.05; Positive control medicine Phenoxybenzamine group and aescine 2.0mg/kg with 1.5mg/kg dosage group compared with chronic nonbacterial prostatitis model group, ▲: the equal <0.05 of p.
Show from table 3 result, compared with Normal group, the intraprostatic phospholipid corpusculum of chronic nonbacterial prostatitis model group density reduces (P<0.05), and difference has statistical significance; Compared with chronic nonbacterial prostatitis model group, in positive control medicine Phenoxybenzamine group and aescine 2.0mg/kg dosage group and 1.5mg/kg dosage group prostate, lecithin density increases (P<0.05), and difference has statistical significance; And aescine 1.0mg/kg dosage group is compared with chronic nonbacterial prostatitis model group, in prostate, lecithin density there is not difference, difference not statistically significant.From result, show effect and positive control medicine Phenoxybenzamine 5.0mg/kg quite (the P equal <0.001) of aescine 2.0mg/kg dosage group to the little body density of phospholipid in rat prostate.
Conclusion: be by the routine examination of leukocytic number in prostatic fluid and lecithin cell number clinically, if leukocyte is greater than 10/high power lens, lecithin is less than 50%, and prostatic fluid is negative, with regard to diagnosable be chronic nonbacterial prostatitis.We can sum up from nonclinical test, prostate organ coefficient obviously the reducing compared with model group of aescine group and positive drug Phenoxybenzamine group; Leukocyte number in the prostate of aescine 2.0mg/kg, 1.5mg/kg dosage group and positive drug Phenoxybenzamine group is starkly lower than model group simultaneously, and has statistical significance; In the prostate of aescine 2.0mg/kg, 1.5mg/kg dosage group and positive drug Phenoxybenzamine group, lecithin density is obviously greater than model group, has significant difference.Therefore can illustrate that the chronic nonbacterial prostatitis rat due to aescine 2.0mg/kg dosage group and 1.5mg/kg dosage group para Toluic Acid estradiol suspension,sterile has certain therapeutical effect.
The clinical research of embodiment 2 aescine
1. case basic condition
Enter to have organized altogether 60 III type prostatitis out-patients, the age, the elder of the course of disease reached 25 years from 20 to 55 years old, and the shortest 1 year, some patients were once used other medicine, but curative effect is not good enough.All cases all meet the inclusion criteria of research approach.
2. patient's inclusion criteria
(1) there is lower urinary tract symptom to increase as frequent micturition, urgent micturition, dysurea, smooth, the vesical tenesmus of urinating, nocturia, lower limb and inguinal region, lumbosacral region, scrotum testis and perineum pain discomfort, even chronic prostatitis (III type) symptom such as hyposexuality, premature ejaculation, painful ejaculation, and continuing 8 weeks male out-patients above, the age is between 20-55 year;
(2) NIH's Symptom of Chronic Prostatitis (NIH-CPSI) >=10;
(3) prostatic fluid antibacterial culturing is aobvious negative;
In (4) 2 weeks, do not take the medicine that other treatment chronic nonbacterial prostatitis and impact are urinated.
3. Therapeutic Method
Aescine is dissolved in 0.9% sodium chloride injection 250ml iv drip.One daily amount is 10mg, continuous drip 4 weeks.Using Phenoxybenzamine as positive control medicine, 2 times on the one, each 10mg.Aescine group patient 30 examples in 60 tested patients, Phenoxybenzamine group patient 30 examples.In process of the test, stop using other medicine.Follow up a case by regular visits to the weekend of the 2nd week and the 4th week (follow up a case by regular visits to check and need carry out after 24 hours at proxima luce (prox. luc) injectable drug, and follow up a case by regular visits at every turn every inspection that the medicine on the same day follows up a case by regular visits at this finish after start injection).
4. examination criteria
Parameters for observation on effect: (1) subjective index: NIH-CPSI, comprises pain and discomfort, the symptom of urinating, quality of life, the scoring of symptom yardstick and total score 5 parts.(2) objective indicator: prostatic fluid WBC counts checks tested patient's the inspection of prostatic fluid antibacterial culturing, liver function, renal function, routine blood test simultaneously.Respectively at before treatment, within 2 weeks and 4 weeks, detect and evaluate indices after treatment.
5. therapeutic evaluation
Cure: prostatitis disappears;
Effective: NIH's Symptom of Chronic Prostatitis (NIH-CPSI) reduces more than 50%;
Effective: NIH-CPSI reduces 25-50%;
Invalid: NIH-CPSI reduces below 25%.
6. therapeutic outcome
The comparison of every curative effect index before and after the routine patient of table 460 Drug therapy of the present invention (respectively organize patient and count N=30,
)
Before 60 routine patient treatments, after treatment in 2 weeks, 4 weeks pain and uncomfortable, the symptom of urinating and prostatic fluid the index such as WBC counting in table 4, before and after administration and after administration 2 weeks compared with indices between 4 weeks, the equal <0.0001 of P value, difference has significant.Wherein latter 2 weeks of positive control medicine Phenoxybenzamine group treatment, the NIH-CPSI total score of 4 weeks is treated front difference and is on average reduced 9.6(28.7%) and 18.1(54.0%), the scoring of symptom yardstick on average reduces 9.0(36.3% before treatment respectively) and 14.6(58.9%), pain has on average reduced 5.2(30.1% before treatment respectively with uncomfortable scoring) and 10.8(62.4%), the symptom score of urinating on average reduces 2.6(31.0% before treatment respectively) and 4.5(53.6%), quality of life scoring on average reduces 2.8(28.3% before treatment respectively) and 5.5(55.6%), in prostatic fluid, WBC counting on average reduces by 9.4/HP(38.8% before treatment) and 11.8/HP(48.8%).And aescine group is treated latter 2 weeks, 4 weeks NIH-CPSI total scores are treated front difference and are on average reduced 14.5(44.9%) and 20.6(63.8%), the scoring of symptom yardstick on average reduces 6.8(38.6% before treatment respectively) and 9.9(56.3%), pain has on average reduced 5.9(41.3% before treatment respectively with uncomfortable scoring) and 8.3(58.0%), the symptom score of urinating on average reduces 2.6(34.2% before treatment respectively) and 4.2(55.3%), quality of life scoring on average reduces 3.5(32.4% before treatment respectively) and 5.1(49.1%), in prostatic fluid, WBC counting on average reduces by 8.9/HP(37.1% before treatment) and 13.9/HP(57.9%).
After medication 4 weeks, positive control Phenoxybenzamine medicine group was cured (prostatitis disappearance) 6 examples; Effective (NIH's Symptom of Chronic Prostatitis (NIH-CPSI) reduces more than 50%) 7 examples; Effectively (NIH-CPSI reduces 25-50%) 11 examples; Invalid (NIH-CPSI reduces below 25%) 6 examples.And aescine group is cured 6 examples; Effective 8 examples; Effective 12 examples; Invalid 4 examples.Effective patient's 24 examples of positive control Phenoxybenzamine medicine group, total effective rate is 80.0%; Effective patient's 26 examples of aescine group, thereby patient's total effective rate is 86.7%.
In therapeutic process and after treatment, 60 routine experimenter's routine blood tests, routine urinalysis, liver function, renal function are all without abnormal, without other obvious adverse reaction.
Conclusion: clinical test results shows, compare with model group, aescine possesses good curative effect to chronic nonbacterial prostatitis, because it can alleviating pain, can alleviate again the paruria symptoms such as urgent micturition, frequent micturition, dysurea and nocturia increase, infer aescine can relax prostate and smooth muscle of bladder, there is the effect similar to alpha-blocking agent (Phenoxybenzamine).
Claims (6)
1. aescine and salt thereof are in the application of preparing in alpha-blocking agent medicine.
2. aescine and salt thereof the application in preparation treatment chronic nonbacterial prostatitis medicine.
3. application according to claim 1 and 2, is characterized in that described aescine salt is aescine or lysine aescine.
4. application according to claim 1 and 2, is characterized in that described medicine is the compositions of aescine and salt and the pharmaceutically acceptable carrier composition of effective dose.
5. application according to claim 4, is characterized in that described compositions is powder pin or injection.
6. application according to claim 5, is characterized in that containing in described powder pin or injection 5mg or 10mg aescine.
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| CN201410156293.2A CN103948614B (en) | 2014-04-18 | 2014-04-18 | The pharmaceutical applications of otoginsenoside and salt thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106236764A (en) * | 2016-07-12 | 2016-12-21 | 中国人民解放军第二军医大学 | The application in preparation prevention or treatment decompression sickness medicine of the β aescine element |
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2014
- 2014-04-18 CN CN201410156293.2A patent/CN103948614B/en active Active
Non-Patent Citations (1)
| Title |
|---|
| 薛云丽 等: "七叶树属药用植物化学成分、生物活性及临床应用研究进展", 《中草药》, vol. 43, no. 11, 30 November 2012 (2012-11-30), pages 2305 - 2310 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106236764A (en) * | 2016-07-12 | 2016-12-21 | 中国人民解放军第二军医大学 | The application in preparation prevention or treatment decompression sickness medicine of the β aescine element |
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