CN101797325A - Medicament composition for treating gynecologic inflammation and preparation method and application thereof - Google Patents
Medicament composition for treating gynecologic inflammation and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a medicament composition for treating gynecologic inflammation, which is prepared by using cockscomb flower, tree-of-heaven ailanthus bark, pomegranate rind, raidx astragali, largehead atractylodes rhizome, common yam rhizome, Chinese angelica, cuttle bone and India madder root as the raw materials. The invention provides a preparation method and application for the medicinal composition. The medicinal composition of the invention has reasonable formula, corresponds to the traditional Chinese medical theory, has effects of clearing away heat and eliminating dampness, replenishing qi and strengthening the spleen and stopping leukorrhea, can be used for treating gynecologic inflammation, such as colpitis, cervicitis, pelvic inflammation, endometritis, adnexitis, episioitis, bartholinitis and the like and provides a novel use selection.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of gynecological inflammation and its production and use, belong to drug world.
Background technology
Gynecological inflammation is meant that female genital system infects caused disease.Mainly be divided into vaginitis, cervicitis and pelvic inflammatory disease, endometritis, adnexitis, vulvitis, bartholinitis.Because gynecological inflammation be adult female's common, frequently-occurring disease, its clinical manifestation is also varied, and cause of disease complexity and often with multiple severe complication has a significant impact women's live and work.The sickness rate of gynaecological inflammation disease is quite high, in recent years, though the prevalence of gynecological inflammation changes not quite, remains high always.Prevalence height, relapse rate height are the main features of gynaecological inflammation disease, reflect that simultaneously the gynecological inflammation medicine market demand is huge.South medication economics institute calculates that according to the Epidemiological study result in some areas China married woman's gynaecopathia prevalence is 46.10%, and wherein, rural women's gynecological inflammation prevalence reaches 48.85%, is higher than the prevalence in city 41.26%.
The western medical treatment of gynecological inflammation is at present still with antibiotic, and antiinflammatory is main.Antibiotic infects comparatively effective to gynecological inflammation acute stage sensitive bacterial in the Western medicine, but owing to tissue adhesionization, local circulation obstacle, antibiotic is difficult to infiltrate the part and plays a role, relatively poor to fibrous tissue and the connective tissue effect of eliminating inflammatory infiltration, and antibiotic does not possess the adhesion of alleviation and analgesic effect, so gynecological inflammation is used antibiotic therapy merely, curative effect is not fully up to expectations.In recent years, Chinese medicine is being obtained very big progress aspect the control gynecological inflammation, under the guidance of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs principle, give corresponding decoction for the treatment according to different pattern of syndrome, clinical effectiveness is remarkable, therefore actively develop the experimentation of Chinese medicine of the various gynecological inflammations of control, utilization modernism and means are developed and are utilized Chinese medicine, clinical research and basic research being combined closely develop more efficiently Chinese medicine patent medicine and preparation, is the key subjects that we vast pharmacy worker faces.As: number of patent application: 02127914.4, denomination of invention: the FUKE ZAIZAO WAN of treatment gynaecopathia, the invention discloses a kind of FUKE ZAIZAO WAN for the treatment of gynaecopathia, it is characterized in that: it is by Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Colla Corii Asini, Poria, Radix Codonopsis, the Radix Astragali, Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Fructus Ligustri Lucidi, Carapax Et Plastrum Testudinis, Fructus Corni, Radix Dipsaci, the Cortex Eucommiae, Herba Cistanches, Fructus Rubi, Cornu Cervi Degelatinatum, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Achyranthis Bidentatae, Herba Leonuri, Rhizoma Corydalis, Radix Notoginseng, Folium Artemisiae Argyi, Fructus Foeniculi, Rhizoma Ligustici, Endoconcha Sepiae, Radix Sanguisorbae, Fructus Alpiniae Oxyphyllae, Rhizoma Alismatis, Folium Nelumbinis, Radix Gentianae Macrophyllae, Cortex Lycii, Radix Cynanchi Atrati, Cortex Ailanthi, succinum, Radix Scutellariae, Semen Ziziphi Spinosae, Radix Polygalae, Pericarpium Citri Reticulatae, Radix Glycyrrhizae 42 flavor herbal raw materials are made.The present invention has that therapeutic domain is extensive, curative effect better, treating both the principal and secondary aspects of a disease, cost of manufacture be cheap, have no side effect, take advantages such as safe and reliable.It has nourishing blood for regulating menstruation, liver and kidney tonifying, warm palace analgesic effect, can be used for menstruation irregularly successively, the treatment of gynaecopathias such as menostaxis, dripping hemorrhage, dysmenorrhea, leukorrhagia.
Summary of the invention
Technical scheme of the present invention has provided a kind of pharmaceutical composition for the treatment of gynecological inflammation, and another technical scheme of its invention has provided this preparation of drug combination method and purposes.
The invention provides a kind of pharmaceutical composition for the treatment of gynecological inflammation, it is the medicament that is prepared from by following raw materials by weight proportions:
Flos Celosiae Cristatae 50-1500 part, Cortex Ailanthi 50-1500 part, Pericarpium Granati 40-1200 part, Radix Astragali 15-300 part, Rhizoma Atractylodis Macrocephalae 20-400 part, Rhizoma Dioscoreae 15-350 part, Radix Angelicae Sinensis 3-60 part, Os Sepiae 5-150 part, Radix Rubiae 5-150 part.
Further preferably, it is the medicament that is prepared from by following raw materials by weight proportions:
Flos Celosiae Cristatae 150-1200 part, Cortex Ailanthi 150-1200 part, Pericarpium Granati 100-800 part, Radix Astragali 25-200 part, Rhizoma Atractylodis Macrocephalae 35-300 part, Rhizoma Dioscoreae 25-250 part, Radix Angelicae Sinensis 5-40 part, Os Sepiae 15-120 part, Radix Rubiae 15-120 part.
Still more preferably, it is the medicament that is prepared from by following raw materials by weight proportions:
833.4 parts of Flos Celosiae Cristataes, 833.4 parts of Cortex Ailanthis, 558.3 parts of Pericarpium Granatis, 125.0 parts of the Radixs Astragali, 208.3 parts of the Rhizoma Atractylodis Macrocephalaes, 150.0 parts of Rhizoma Dioscoreaes, 25.0 parts of Radix Angelicae Sinensis, 83.3 parts of Os Sepiae, 83.3 parts in Radix Rubiae.
It is to be active component by water of Flos Celosiae Cristatae, Cortex Ailanthi, Pericarpium Granati, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Os Sepiae, Radix Rubiae or extractive with organic solvent, adds the medicament that acceptable accessories or complementary composition are prepared from.
Wherein, described medicament is tablet, capsule, pill, oral liquid or granule.
The present invention also provides a kind of method for preparing the pharmaceutical composition of described treatment gynecological inflammation, and it comprises the steps:
A, take by weighing each materials of weight proportions:
B, above nine flavors, decoct with water twice, adding for the first time 4-12 times of water gaging decocted 0.5-3 hour, adding for the second time 4-10 times of water gaging decocted 0.5-2.5 hour, merge decocting liquid twice, filter, be concentrated into the clear paste of relative density 1.10-1.15 (60 ℃), add acceptable accessories or complementary composition and make preparation pharmaceutically commonly used.
The present invention also provides the purposes of this pharmaceutical composition in the medicine of preparation treatment gynecological inflammation.
Wherein, described gynecological inflammation comprises: vaginitis, cervicitis, pelvic inflammatory disease, endometritis, adnexitis, vulvitis, bartholinitis.
The described Rhizoma Atractylodis Macrocephalae can be with the product of giving birth to or processed product, as Rhizoma Atractylodis Macrocephalae preparata; Rhizoma Dioscoreae is a Rhizoma dioscoreae; Radix Angelicae Sinensis can be used Radix Angelicae Sinensis; Radix Rubiae is wide Radix Rubiae.
Pharmaceutical composition of the present invention has the function of heat clearing and damp drying, replenishing QI to invigorate the spleen, leukorrhagia stopping, can be used for treating damp-heat accumulation, women's leukorrhagia due to deficiency of vital energy spleen is weak, disease is seen: profuse leukorrhea, HUANGBAI(sic) is alternate or yellow, matter thickness or as the bean curd scoriform, abnormal smells from the patient is big or smelly, pudendum discomfort or pruritus, pain, lower abdomen, lumbus sacrum pain, bitter taste in the mouth and dry throat, oliguria with reddish urine, red tongue with yellowish and greasy fur; Vaginitis, cervicitis, pelvic inflammatory disease, endometritis, adnexitis, vulvitis, bartholinitis are seen above-mentioned sign person.
Material combination is precise and appropriate in the pharmaceutical composition of the present invention, and monarch is with Cortex Ailanthi heat clearing and damp drying, convergence leukorrhagia stopping; Minister is with Flos Celosiae Cristatae, Pericarpium Granati convergence leukorrhagia stopping; Minister is with the Radix Astragali, Radix Angelicae Sinensis QI invigorating and blood producing again, human body immunity improving, and the Rhizoma Atractylodis Macrocephalae, Rhizoma dioscoreae strengthening spleen, tonifying kidney are opened day the source of vital function successively; Assistant is with Radix Rubiae, Os Sepiae cooling blood and removing stasis leukorrhagia stopping; Heat clearing and damp drying is played, replenishing QI to invigorate the spleen, the merit of leukorrhagia stopping altogether by full side.
Observe through pharmacodynamic experiment, mouse vagina inflammation, rat uterus inflammation, rat salpingitis, mice ear, mice granuloma induced by implantation of cotton pellets are had the obvious anti-inflammatory and anti effect after taking pharmaceutical composition of the present invention; Can reduce the mice capillary permeability; The effect of the mice of enhancing body's immunity is arranged, standard bacterium escherichia coli, staphylococcus aureus, beta hemolytic streptococcus, Candida albicans are had inhibitory action; Experimental result shows that medicine of the present invention has the effect of multiple gynecological inflammations such as treatment vaginitis, cervicitis, pelvic inflammatory disease, endometritis, adnexitis, vulvitis, bartholinitis.Observe through toxicological experiment, experimental result shows that pharmaceutical composition toxicity of the present invention is extremely low, belongs to no overt toxicity pharmaceutical composition.
Pharmaceutical composition checking treatment gynecological inflammation (vulvitis, bartholinitis, vaginitis, cervicitis, pelvic inflammatory disease, endometritis, adnexitis) 600 examples of the present invention.The result: produce effects 100 examples that heal, effective 400 examples, invalid 100 examples, total effective rate is 83.33%, cure-remarkable-effectiveness rate 16.67%.Result of the test shows: pharmaceutical composition of the present invention has precise effects to the treatment of gynecological inflammation, and no obvious toxic-side effects is worth using at clinical expansion.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
The preparation of embodiment 1 medicine of the present invention
Flos Celosiae Cristatae 833.4g Cortex Ailanthi 833.4g Pericarpium Granati 558.3g
Radix Astragali 125.0g Rhizoma Atractylodis Macrocephalae 208.3g Rhizoma Dioscoreae 150.0g
QUANGUI 25.0g Os Sepiae 83.3g Radix Rubiae 83.3g
More than nine flavors, decoct with water twice, add for the first time 8 times of water gagings and decocted 2 hours, add for the second time 6 times of water gagings and decocted 1.5 hours, merge decocting liquid twice, filter, be concentrated into the clear paste of relative density 1.10-1.15 (60 ℃), get 2/3 medicine liquid spray drying, get the powdered extract powder; Get an amount of dextrin and powdered extract powder mixing, put in the fluid bed, do binding agent with remaining 1/3 medicinal liquid and granulate, make 1000g altogether, promptly.
Embodiment 2 medication preparation of the present invention
Get crude drug: Flos Celosiae Cristatae 50g, Cortex Ailanthi 50g, Pericarpium Granati 40g, Radix Astragali 300g, Rhizoma Atractylodis Macrocephalae 400g, Rhizoma Dioscoreae 350g, Radix Angelicae Sinensis 60g, Os Sepiae 150g, Radix Rubiae 150g, press the method for embodiment 1 and extract medical material, decoct with water twice, adding for the first time 4 times of water gagings decocted 0.5 hour, add for the second time 4 times of water gagings and decocted 0.5 hour, merge decocting liquid twice, filter, be concentrated into the clear paste of relative density 1.10-1.15 (60 ℃), granulate, the granule with preparation adds an amount of stearate acid, tabletting gets tablet.
The preparation of embodiment 3 medicines of the present invention
Get crude drug: Flos Celosiae Cristatae 150g, Cortex Ailanthi 150g, Pericarpium Granati 100g, Radix Astragali 200g, Rhizoma Atractylodis Macrocephalae 300g, Rhizoma Dioscoreae 250g, Radix Angelicae Sinensis 40g, Os Sepiae 120g, Radix Rubiae 120g, press the method for embodiment 1 and extract medical material, decoct with water twice, adding for the first time 12 times of water gagings decocted 3 hours, add for the second time 10 times of water gagings and decocted 2.5 hours, merge decocting liquid twice, filter, be concentrated into the clear paste of relative density 1.10-1.15 (60 ℃), add acceptable accessories and be prepared into oral liquid.
The preparation of embodiment 4 medicines of the present invention
Get crude drug: Flos Celosiae Cristatae 1500g, Cortex Ailanthi 1500g, Pericarpium Granati 1200g, Radix Astragali 15g, Rhizoma Atractylodis Macrocephalae 20g, Rhizoma Dioscoreae 15g, Radix Angelicae Sinensis 3g, Os Sepiae 5g, Radix Rubiae 5g, directly beat powder, encapsulated, be prepared into capsule.
The preparation of embodiment 5 medicines of the present invention
Get crude drug: Flos Celosiae Cristatae 1200g, Cortex Ailanthi 1200g, Pericarpium Granati 800g, Radix Astragali 25g, Rhizoma Atractylodis Macrocephalae 35g, Rhizoma Dioscoreae 25g, Radix Angelicae Sinensis 5g, Os Sepiae 15g, Radix Rubiae 15g, adopt 50% ethanol extraction, concentrate, get clear paste, add starch system granule, add the magnesium stearate tabletting, get tablet.
Below prove beneficial effect of the present invention by concrete pharmacodynamics test.
Experimental example 1: different proportioning prescriptions are to the therapeutical effect of mouse experiment bacterial vaginitis model
Adopt same dosage (18.10 (crude drug) g/kg) pharmaceutical composition A of the present invention (by embodiment 1 preparation), B (by embodiment 2 preparations), C (by embodiment 3 preparations), D (by embodiment 4 preparations), E (by embodiment 5 preparations) ig7 days, the animal model pathogen negative conversion rate of setting up the mixed infection of mice (NIH) vagina with staphylococcus aureus and escherichia coli and the healing degree of vaginal mucosa inflammation all are significantly improved, A, B, C, D, the E group is respectively 70.0% to the negative conversion rate of staphylococcus aureus, 45.0%, 50.0%, 60.0%, the negative conversion rate of escherichia coli is respectively 60.0%, 30.0%, 45.0%, 55.0%.Experimental result shows that pharmaceutical composition of the present invention has better curative effect to experimental staphylococcus aureus of mouse vagina mucosa and escherichia coli mixed infection, is the best with pharmaceutical composition A of the present invention (by embodiment 1 preparation).
The different proportioning prescriptions of table 1 are to the therapeutical effect of mouse experiment bacterial vaginitis model
Compare with model control group,
*P＜0.01,
*P＜0.05
Experimental example 2: antiinflammatory action
(1) to the therapeutical effect of mouse experiment bacterial vaginitis model
Medicament composition granule agent of the present invention (by embodiment 1 preparation) ig7 days, the animal model pathogen negative conversion rate of setting up the mixed infection of mice (NIH) vagina with staphylococcus aureus and escherichia coli and the healing degree of vaginal mucosa inflammation all are significantly improved, low (4.52 (crude drug) g/kg), in (9.05 (crude drug) g/kg), high (18.10 (crude drug) g/kg) dosage group the negative conversion rate of staphylococcus aureus is respectively 50.0%, 60.0%, 70.0%, the negative conversion rate of escherichia coli is respectively 30.0%, 50.0%, 60.0%.Experimental result shows that medicament composition granule agent of the present invention has better curative effect to experimental staphylococcus aureus of mouse vagina mucosa and escherichia coli mixed infection, for its clinical treatment bacterial vaginitis provides the pharmacodynamics basis.
The therapeutical effect of table 2 pair mouse vagina bacterial infection
Compare with model control group,
*P＜0.01,
*P＜0.05
(2) to the therapeutical effect of experimental metritis rat model
The continuous ig administration of medicament composition granule agent of the present invention 7 days, compare with model control group, high (12.53 (crude drug) g/kg), in (6.26 (crude drug) g/kg), low (3.13 (crude drug) g/kg) dosage medicament composition granule agent of the present invention group and FUKE QIANJIN PIAN group all can significantly suppress rat uterus swelling (P＜0.01).With the model control group ratio, high, middle dosage medicament composition granule agent of the present invention group can significantly alleviate inflammation of uterus pathological changes (P＜0.01), low dosage medicament composition granule agent of the present invention group and FUKE QIANJIN PIAN group can obviously alleviate inflammation of uterus reaction (P＜0.05), remarkable oozing out of inflammation-inhibiting cell, symptom reduces inflammation.
The influence of table 3 pair metritis model (x ± s)
Annotate: with the model control group ratio,
△ △P＜0.01
The influence that influences model of table 4 pair inflammation of uterus pathological change
(3) to the therapeutical effect of experimental salpingitis rat model
The continuous ig administration of medicament composition granule agent of the present invention 7 days, compare with model control group, high (12.53 (crude drug) g/kg), in (6.26 (crude drug) g/kg) dosage medicament composition granule agent of the present invention group can significantly alleviate salpingitis tubal pathological changes (P＜0.01), low (3.13 (crude drug) g/kg) dosage medicament composition granule agent of the present invention group and FUKE QIANJIN PIAN group can obviously alleviate salpingitis tubal pathological changes (P＜0.05).Certain dose-dependence is arranged.
The influence of table 5 pair rat salpingitis model
(4) influence of xylol mice ear
Medicament composition granule agent of the present invention (18.10 (crude drug) g/kg, 9.05 (crude drug) g/kg, 4.52 (crude drug) g/kg) ig7 days, the swelling of xylol induced mice can obviously press down (P＜0.05), and suppression ratio is respectively 39.2%, 33.0%, 29.0%.
The shadow of table 6 xylol mice ear
Annotate: compare with matched group
*P＜0.05
(5) to the influence of mice granuloma induced by implantation of cotton pellets
Medicament composition granule agent of the present invention (18.10 (crude drug) g/kg, 9.05 (crude drug) g/kg, 4.52 (crude drug) g/kg), prednisone (10mg/kg) ig7 days all have obvious reduction effect (P＜0.01) to mice granuloma induced by implantation of cotton pellets weight.
The table 7 pair granulomatous influence of mice cotton balls number (x ± s, mg)
Annotate: compare * P＜0.05, * * P＜0.01 with (NS) matched group.
Experimental example 3: reduce the effect of mice capillary permeability
Medicament composition granule agent of the present invention (18.10 (crude drug) g/kg, 9.05 (crude drug) g/kg, 4.52 (crude drug) g/kg), prednisone (10mg/kg) all had significant reduction (P＜0.05 or 0.01) to the increase of histamine induced mice vascular permeability in ig7 days.This experiment also shows the reduction of medicament composition granule agent of the present invention to vascular permeability, increases with dosage, shows dose-effect relationship.
The influence of table 8 pair mouse skin capillary permeability (x ± s)
Annotate: compare * P＜0.05, * * P＜0.01 with (NS) matched group.
Experimental example 4: strengthen the effect of mice body's immunity
(1) to the colibacillary protective effect of mouse infection
Medicament composition granule agent of the present invention (18.10 (crude drug) g/kg, 9.05 (crude drug) g/kg, 4.52 (crude drug) g/kg) gastric infusion 1 hour, every mouse peritoneal injection escherichia coli 0.5ml (106Fgu/ml), infectious bacteria 12 hours, 24 hours, administration is 2 times again, the result can prolong life cycle to the coli-infection mice, and each is organized rate elongation and is followed successively by 60.0%, 40.0%, 20.0%.
The protective effect of table 9 pair coli-infection mice
(2) influence that caused by cyclophosphamide immunologic hypofunction Mus serum hemolytic antibody is formed
Medicament composition granule agent of the present invention (18.10 (crude drug) g/kg, 9.05 (crude drug) g/kg, 4.52 (crude drug) g/kg) ig8 days, except that the normal control group, other each treated animal was in the 6th, 7,8 day difference ip cyclophosphamide 20mg/kg, 1h narrows clump and gets blood from mouse orbit is quiet after the last administration, separation of serum, the method of " pharmacological experimental methodology " of hitting etc. by uncle Xu is being surveyed hemolytic antibody in its serum in the 540nm place on 3210 ultraviolet spectrophotometers, and hemolytic antibody obviously increases (P＜0.01) in the serum.
The influence that table 10 pair caused by cyclophosphamide immunologic hypofunction Mus serum hemolytic antibody forms (X ± s, n=10)
Compare with model control group,
★P＜0.01.
(3) to the influence of caused by cyclophosphamide immunologic hypofunction mouse macrophage function
Medicament composition granule agent of the present invention (18.10 (crude drug) g/kg, 9.05 (crude drug) g/kg, 4.52 (crude drug) g/kg) ig9 days, except that the normal control group, other each treated animal was in the 7th, 8,9 day difference ip cyclophosphamide 20mg/kg, 1h after the last administration, every ip in mice 5 chicken erythrocyte 0.5ml, put to death mice behind the 4h, wash the abdominal cavity with the 1ml normal saline, collecting cell, smear, dyeing, every chicken red blood cell number that calculates 200 phagocyte and engulf calculates phagocytic percentage and phagocytic index under the oily mirror.Medicament composition granule agent of the present invention can obviously improve caused by cyclophosphamide immunologic hypofunction mice phagocytic percentage and phagocytic index (high, middle dosage (P＜0.01), low dosage (P＜0.05)), points out medicine of the present invention to have tangible immunological enhancement.
The influence of table 11 pair caused by cyclophosphamide immunologic hypofunction mouse macrophage function (X ± s, n=10)
Compare with model control group,
★P＞0.05,
★ ★P＜0.05,
△P＜0.01.
Experimental example 5: in-vitro antibacterial experiment
Adopt medicament composition granule agent liquid tube method of the present invention to measure minimum inhibitory concentration (MIC), standard bacterium escherichia coli, staphylococcus aureus, beta hemolytic streptococcus, Candida albicans are recorded MIC be respectively 12.5%, 6.25%, 25.0%, 12.5%.
The experiment of table 12 in-vitro antibacterial
Experimental example 6: acute toxicity test
The every gram of medicament composition granule agent of the present invention is equivalent to crude drug in whole 2.9g.Medicament composition granule agent Cmax of the present invention (0.82g/ml), maximum volume (0.4ml/10g) are given mice twice filling every day stomach, every day, dosage was: 190.24g (crude drug)/kg (clinical every day of the recommended dose that is equivalent to be grown up 328 times), appear as moving less, the perpendicular hair of statvolt after the administration, recover normal after one hour gradually.The quilt hair of animal, the colour of skin, nose, eye, oral cavity, urogenital tract secretions there is no unusually, and test back mice body weight increases to some extent, does not see animal dead.Performance judges that medicine of the present invention belongs to no overt toxicity medicine after the dosage that acute toxicity test is given of medicine of the present invention and the administration.
Experimental example 7: long term toxicity test
Medicament composition granule agent 50.12,25.06 of the present invention, 12.53g (crude drug in whole)/kg (high, medium and low three dosage), continuously give 6 weeks of rat oral gavage administration, 12 weeks and drug withdrawal observed for 2 weeks, the behavioral activity of animal, outward appearance sign, feed consumption, body weight gain amount etc. are not all had obviously to be influenced.
Blood cell is learned and is detected 17 of peripheral blood mensuration erythrocyte, hemoglobin, platelet count, erythrocyte, reticulocytes etc., and after 6 weeks of administration, whole blood is learned index administration group and the relatively more equal no difference of science of statistics (p＞0.05) of matched group; Administration is during 24 weeks, and high dose group RBC counting, HGB and CT reduce (p＜0.05), and high, medium and low dosage networking is knitted erythrocyte and obviously given birth to high (p＜0.01); In 2 weeks after the drug withdrawal, low dosage and middle dosage networking are knitted erythrocyte and are raise (p＜0.05), and all the other hematological indices administration groups and matched group be no difference of science of statistics (p＞0.05) relatively all.
Blood biochemical is learned and is detected 10 of aspartate aminotransferase, alanine aminotransferase, alkali phosphatase, total protein, albumin, T-CHOL, total bilirubin, blood urea nitrogen, glucose, creatinines etc., in 2 weeks after 6 weeks of administration and the drug withdrawal, all indexs of administration group and matched group be no difference of science of statistics (P＞0.05) relatively; After 12 weeks of administration, low dose group ALB reduces (p＜0.05), middle dosage group TP, ALB, TC all reduce (p＜0.05), all the other indexs and matched group be no difference of science of statistics (P＞0.05) relatively, all the other indexs and matched group be no difference of science of statistics (P＞0.05) relatively, above data all fluctuate in normal range, do not have remarkable biological significance.
Each treated animal of anatomic observation, each main organs does not all have the visible pathological changes of naked eyes, organize relatively no difference of science of statistics (P＞0.05) except that minority genitals organ coefficient of organ coefficient and matched group, histopathological examination, the pathological tissue morphological examination of each treated animal there is no toxicity damage.
6 weeks of rat oral gavage administration, 12 weeks and drug withdrawal observed for 2 weeks continuously for medicament composition granule agent 50.12,25.06 of the present invention, 12.53g (crude drug in whole)/kg dosage (be equivalent to clinical consumption 86.4,42.3,21.6 times), do not see that obvious abnormal response appears in animal, the clinical recommended dose of experimental result prompting medicament composition granule agent of the present invention is safe.
Below prove beneficial effect of the present invention by clinical trial.
Test example 1 clinical drug trial of the present invention
1 clinical data
1.1 clinical manifestation
The case object is the out-patient, all has profuse leukorrhea in various degree, and HUANGBAI(sic) is alternate or yellow, matter thickness or as the bean curd scoriform, abnormal smells from the patient is big or smelly, pudendum discomfort or pruritus, pain, lower abdomen, lumbus sacrum pain, bitter taste in the mouth and dry throat, oliguria with reddish urine, red tongue with yellowish and greasy fur, thready and stringy pulse or stringy and rolling pulse.Western medicine diagnose is vulvitis, bartholinitis, vaginitis, cervicitis, pelvic inflammatory disease, adnexitis, endometritis.Chinese medical discrimination belongs to damp-heat accumulation or the insufficiency of the spleen wet notes type of holding concurrently.
2 cases are selected and standards of grading
2.1 Western medicine diagnose standard
Clinical manifestation and diagnosis content with reference to " new Chinese medicine treatment female genital disease clinical research guideline " are formulated.
2.1.1 symptom: hypogastralgia, rectal tenesmus, lumbosacral region is ached, after the fatigue of being everlasting, the sexual intercourse, during defecation, increase the weight of before and after the menstruation.Can increase and leucorrhoea grow in quantity with menstruation.
2.1.2 gynecologial examination: the uterus often is the position, back, and active receiving restriction or adhesion are fixed.May touch streak thing in the one or both sides, uterus during salpingitis, and mild tenderness is arranged; During the inflammation of pelvic cavity connective tissue, the one or both sides, uterus have that lamellar thickens, tenderness; Or touch enclosed mass in the pelvic cavity one or both sides.
2.1.3 lab testing: B ultrasonic shows that pelvic cavity has hydrops or inflammatory mass.Leucorrhea routine examination or uterine secretions inspection amount increase or find pus cell.
2.1.4 state of an illness grade scale:
1. standards of grading: uterine activity is limited, tenderness 0-5 branch; Fallopian tube is streak, tenderness 0-5 branch; One or both sides, uterus lamellar thickens, tenderness 0-5 branch; The lower abdomen waist tenesmus 0-3 branch of aching; Leukorrhagia increases the 0-1 branch; The every increase of the course of disease added 0.5 fen in 1 year.
2. severity extent classification: above iterated integral is a severe 15 fens above persons; 10-14 is divided into moderate; 5-9 is divided into slightly.
2.2 tcm diagnosis standard
With reference to " the clinical research guideline of new Chinese medicine treatment female genital disease; vulvitis, vaginitis. syndrome of dampness-heat of liver channel; cervicitis. syndrome of spleen-deficiency, pelvic inflammatory disease. noxious dampness stop up contain and syndrome of qi stagnation and blood stasis " draft: 1. lower abdomen pain or few abdomen one or both sides pain; 2. profuse leukorrhea, yellow skin or white, or be purulence, water sample, or hold the blood streak under the arm, smelly oxious gas is arranged; 3. lumbosacral aching pain; 4. the Mental fatigue limb is soft; 5. anus weighs down pain; 6. menostaxis; 7. menorrhagia; 8. bitter taste in the mouth and dry throat; 9. pudendal pruritus or pain is arranged; 10. body of the tongue is light red, yellow fur or yellow greasy, rolling pulse or stringy and thready pulse.Disease is preceding 4 on the indispensability, 1 dialectical i.e. establishment of surplus disease tool.The level Four of primary symptom is kept the score and is+(gently)-have once in a while, and is slight; ++ (in)-have often, can tolerate; +++(is heavy)-continue to have tolerance reluctantly; ++ ++ (seriously)-continue to have, be difficult to stand."+" note 2 minutes.
2.3 the standard of including in
2.3.1 meet Western medicine diagnose standard and tcm diagnosis, dialectical standard person.
2.3.2 the women at 18～50 years old age.
2.3.3 not take above-mentioned disease be the Chinese and western drugs of principal indication and adopted other treatment method at above-mentioned disease to observe first half of the month.
2.3.4 voluntarily as study subject, accept to observe pharmaceutical dosage form, guarantee to finish the course of treatment.
2.4 exclusion standard:
2.4.1 the age, gestation or women breast-feeding their children were to this medicine allergy sufferers under-18s or person more than 50 years old.
2.4.2 be associated with serious recurrence sexually transmitted disease (STD) such as cardiovascular, liver, kidney and hemopoietic system and psychotic.
2.4.3 there is or merges the patient of hysteromyoma, endometriosis or other gynecological tumors.
2.4.4 not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment and safety judgement person.
3 Therapeutic Method
Oral medicament composition granule agent of the present invention (by embodiment 1 preparation), each 4g, every day 3 times.One week was a course of treatment.During the treatment, the experimenter can proceed the treatment of other protopathy, is the Chinese and western drugs of principal indication and adopts other treatment method at above-mentioned disease but must not take with the gynecological inflammation.
4 observation of curative effect
4.1 observation index
4.1.1 the variation of clinical each primary symptom: reach before the beginning of taking medicine and finish record in back 1 day the course of treatment.
4.1.2 untoward reaction:
Slightly: occur once in a while in the drug administration process, symptom is slight, and the persistent period is no more than half an hour;
Moderate: take medicine the back or ask one section the time after ask disconnected the appearance, symptom is lighter, asks when lasting to be no more than half a day;
Severe: promptly occur after taking medicine, severe symptoms and often generation are more than lasting half a day often.
4.1.3 detection index: general health check-up project; Blood, urine routine test; The heart, liver, kidney function test.Following up a case by regular visits to each phase after medication front and back and drug withdrawal respectively detects 1 time.
4.1.4B super observation the: size variation such as uterus, ovary, pelvic lump hydrops.
4.2 curative effect determinate standard
4.2.1 curative effect of disease criterion:
Recovery from illness: symptom, sign and gynecologial examination recover normal, and integration is 0;
Produce effects: symptom, sign and gynecologial examination have clear improvement, and integration reduces more than 2/3;
Effectively: symptom, sign and gynecologial examination have and alleviate, and integration reduces more than 1/3;
Invalid: symptom, sign and gynecologial examination do not have improvement, and integration reduces less than below 1/3;
4.2.2 tcm syndrome curative effect judging standard:
Recovery from illness: the primary symptom integration reduces more than 91% before the treatment;
Produce effects: the primary symptom integration reduces 70%～90% before the treatment;
Effectively: the primary symptom integration reduces 35%～69% before the treatment;
Invalid: the primary symptom integration reduces less than 35% before the treatment.
4.2.3B super inspection criterion
Recovery from illness: inflammatory mass, pelvic hydrops disappear;
Produce effects: inflammatory mass, pelvic hydrops are dwindled more than 1/2;
Effectively: inflammatory mass, pelvic hydrops are dwindled more than 1/3;
Invalid: inflammatory mass pelvic hydrops no change or anti-the increase.
4.3 therapeutic outcome
4.3.1 total effects (seeing Table 13)
Table 13 therapeutic outcome table
Treatment back total effective rate reaches 83.33%, and cure-remarkable-effectiveness rate is: 16.67%, show that medicament composition granule agent of the present invention has the good curing effect to the gynecological inflammation curative effect.
4.3.2 change of illness state (seeing Table 14) before and after the treatment
Change of illness state before and after table 14 treatment
By the table can, the treatment before and after see that the state of an illness has clear improvement.
4.3.3 primary symptom changes (see Table 15, table 16) before and after the treatment
The primary symptom integration changes before and after table 15 treatment
Primary symptom changes before and after table 16 treatment
By primary symptom and primary symptom integration before and after table 15, the 16 visible treatments improvement is in various degree arranged all.
4.3.4 pelvic lump changes (seeing Table 17) before and after the treatment
Change before and after the treatment of table 17 pelvic lump
By the visible medicament composition granule agent of the present invention of table 17 pelvic lump there is good therapeutical effect.
4.3.5 the comparison (seeing Table 18) of sick kind and therapeutic effect relationship
Table 18 is sick plants and therapeutic effect relationship
By table 18 as seen, curative effect no significant difference between each sick kind.
4.3.6 the relation of the course of disease and curative effect (seeing Table 19)
The relation of table 19 course of disease and curative effect
Become long certain downward trend that has by the visible medicament composition granule agent treatment gynecological inflammation of the present invention of table 19 with the course of disease.
4.4.7 the observation of untoward reaction
Not untoward reaction.
Through adopting medicament composition granule agent treatment gynecological inflammation (vulvitis, bartholinitis, vaginitis, cervicitis, pelvic inflammatory disease (comprising endometritis, adnexitis)) 600 examples of the present invention.The result: produce effects 100 examples that heal, effective 400 examples, invalid 100 examples, total effective rate is 83.33%, cure-remarkable-effectiveness rate 16.67%.Clinical verification shows: medicament composition granule agent of the present invention has certain effect to the treatment of gynecological inflammation, and no obvious toxic-side effects is worth using at clinical expansion.
Claims (8)
1. pharmaceutical composition for the treatment of gynecological inflammation, it is characterized in that: it is the medicament that is prepared from by following raw materials by weight proportions:
Flos Celosiae Cristatae 50-1500 part, Cortex Ailanthi 50-1500 part, Pericarpium Granati 40-1200 part, Radix Astragali 15-300 part, Rhizoma Atractylodis Macrocephalae 20-400 part, Rhizoma Dioscoreae 15-350 part, Radix Angelicae Sinensis 3-60 part, Os Sepiae 5-150 part, Radix Rubiae 5-150 part.
2. the pharmaceutical composition of treatment gynecological inflammation according to claim 1 is characterized in that: it is the medicament that is prepared from by following raw materials by weight proportions:
Flos Celosiae Cristatae 150-1200 part, Cortex Ailanthi 150-1200 part, Pericarpium Granati 100-800 part, Radix Astragali 25-200 part, Rhizoma Atractylodis Macrocephalae 35-300 part, Rhizoma Dioscoreae 25-250 part, Radix Angelicae Sinensis 5-40 part, Os Sepiae 15-120 part, Radix Rubiae 15-120 part.
3. the pharmaceutical composition of treatment gynecological inflammation according to claim 2 is characterized in that: it is the medicament that is prepared from by following raw materials by weight proportions:
833.4 parts of Flos Celosiae Cristataes, 833.4 parts of Cortex Ailanthis, 558.3 parts of Pericarpium Granatis, 125.0 parts of the Radixs Astragali, 208.3 parts of the Rhizoma Atractylodis Macrocephalaes, 150.0 parts of Rhizoma Dioscoreaes, 25.0 parts of Radix Angelicae Sinensis, 83.3 parts of Os Sepiae, 83.3 parts in Radix Rubiae.
4. according to the pharmaceutical composition of any described treatment gynecological inflammation of claim 1-3, it is characterized in that: it is to be active component by water of Flos Celosiae Cristatae, Cortex Ailanthi, Pericarpium Granati, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Os Sepiae, Radix Rubiae or extractive with organic solvent, adds the medicament that acceptable accessories or complementary composition are prepared from.
5. the pharmaceutical composition of treatment gynecological inflammation according to claim 4 is characterized in that: described medicament is tablet, capsule, pill, oral liquid or granule.
6. method for preparing the pharmaceutical composition of any described treatment gynecological inflammation of claim 1-5, it comprises the steps:
A, take by weighing each materials of weight proportions:
B, above nine flavors, decoct with water twice, adding for the first time 4-12 times of water gaging decocted 0.5-3 hour, adding for the second time 4-10 times of water gaging decocted 0.5-2.5 hour, merge decocting liquid twice, filter, be concentrated into the clear paste of relative density 1.10-1.15 (60 ℃), add acceptable accessories or complementary composition and make preparation pharmaceutically commonly used.
7. the purposes of any described pharmaceutical composition of claim 1-5 in the medicine of preparation treatment gynecological inflammation.
8. purposes according to claim 7 is characterized in that: described gynecological inflammation comprises vaginitis, cervicitis, pelvic inflammatory disease, endometritis, adnexitis, vulvitis or bartholinitis.
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| CN103071007A (en) * | 2011-10-25 | 2013-05-01 | 王丽萍 | Medicine for treating hysteromyoma |
| CN103638224A (en) * | 2013-12-17 | 2014-03-19 | 谢友文 | Traditional Chinese medicine composition for treating female leukorrhea |
| CN103719856A (en) * | 2013-12-31 | 2014-04-16 | 陈慧婷 | Cuttlefish bone-ginkgo dispersible tablets and preparation method thereof |
| CN104758627A (en) * | 2015-04-30 | 2015-07-08 | 青岛辰达生物科技有限公司 | Traditional Chinese preparation for treating nulliparity chronic cervicitis |
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| CN1089499A (en) * | 1993-01-13 | 1994-07-20 | 张振祥 | Skin-cleaning liquid and preparation method |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103071007A (en) * | 2011-10-25 | 2013-05-01 | 王丽萍 | Medicine for treating hysteromyoma |
| CN103071007B (en) * | 2011-10-25 | 2014-10-22 | 王丽萍 | Medicine for treating hysteromyoma |
| CN103638224A (en) * | 2013-12-17 | 2014-03-19 | 谢友文 | Traditional Chinese medicine composition for treating female leukorrhea |
| CN103719856A (en) * | 2013-12-31 | 2014-04-16 | 陈慧婷 | Cuttlefish bone-ginkgo dispersible tablets and preparation method thereof |
| CN103719856B (en) * | 2013-12-31 | 2015-09-09 | 陈慧婷 | A kind of cuttle bone gingko dispersing tablet and preparation method |
| CN104758627A (en) * | 2015-04-30 | 2015-07-08 | 青岛辰达生物科技有限公司 | Traditional Chinese preparation for treating nulliparity chronic cervicitis |
| CN104758627B (en) * | 2015-04-30 | 2018-03-16 | 李秀玲 | It is a kind of to treat the Chinese medicine preparation for not producing type chronic cervicitis |
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