CN103110734B - Traditional Chinese medicine composition for treating gynecologic inflammation and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating gynecologic inflammation and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating gynecologic inflammation, which is prepared from the following components in parts by weight: 7.69 parts of picria fel-terrae, 11.54 parts of herba elephantopi, 7.69 parts of angelica, 11.54 parts of spatholobus stem, 11.54 parts of radix zanthoxyli, 11.54 parts of membranaceous beautyleaf root, 11.54 parts of persimmon leaf, 11.54 parts of Thlaspi arvense and 15.38 parts of radix fici simplicissimae. The traditional Chinese medicine composition is prepared through the following steps: performing alcohol extraction on six traditional Chinese medicines of picria fel-terrae, herba elephantopi, angelica, spatholobus stem, radix zanthoxyli and persimmon leaf; and performing water extraction on the other three traditional Chinese medicines. The traditional Chinese medicine composition provided by the invention can treat various gynecologic inflammation diseases, especially colpitis; and above all, the traditional Chinese medicine composition has remarkable treatment effect on bacterial colpitis caused by mixed infection of Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa, and the treatment effect is superior to the prior art.
Description
Technical field
The present invention relates to the Chinese medicine composition for the treatment of gynaecopathia, be specifically related to a kind of Chinese medicine composition for the treatment of gynecological inflammation and preparation method thereof.
Background technology
Motherland's medical science is thought, the pathogeny of gynecological, may be summarized to be function not normal (mainly insufficiency of the spleen, suffer from a deficiency of the kidney, stagnation of liver-QI), disorder of QI and blood, Yi Jichong, appoints, superintends and directs, is with four arteries and veins to damage three aspects.Due to the physiological feature that women is special, as through row, pregnancy, production, easily cause vessels of the uterus hollow, evil poison is invaded in taking advantage of a weak point in opponent's defence, and the long-pending part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels of turbid damp, pyretic toxicity poultry, visitor, in born of the same parents, fights mutually with QI and blood, thus produces the various disorder of gynecological.Good and evil friendship is striven, Sheng stopped up by disharmony of nutrient QI with defensive QI, evil poison, therefore disease sees fever with aversion to cold, headache; The bet of insufficiency of the spleen leading to overabundance of dampness, phlegm-damp, damp-stagnancy heat-transformation, instability of kidney QI, and disease sees menoxenia, red white fulminant leucorrhagia with yellowish discharge, profuse leukorrhea, dysmenorrhea, abdominal distention, spirit and inappetence, stop up and hold back not all right and see stomachache, knot for a long time and in ecchymosis, knot Er Cheng Disorder.As because for the treatment of or malpractice not in time, remaining heresy not to the greatest extent, be detained for suffering from, amass in born of the same parents by the stasis of blood, and the evil poison of multiple sense, fight mutually, so that patient's condition prolongs silk floss, form chronic gynaecological inflammation disease with QI and blood.
FUYANJING is compound recipe disclosed in Pharmacopoeia of the People's Republic of China version in 2010, discloses the following information of FUYANJING JIAONANG in pharmacopeia:
1) form: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli, Radix calophylli membranacei, Folium Kaki, Herba Thlaspis, Herba Fici Simplicissimae;
2) method for making: above nine tastes, gets part Radix Picriae felterrae, is ground into fine powder; Eight tastes such as residue Radix Picriae felterrae and all the other Elephantopus scaber L. etc. decoct with water secondary, 3 hours first times, second time 2 hours, and decocting liquid filters, and filtrate merges, and are concentrated into appropriate, mix, dry, pulverize, incapsulate, make 1000 with above-mentioned fine powder.
3) function with cure mainly: clearing heat and expelling damp, adjusting meridian and stopping leukorrhea, for the leukorrheal diseases caused by damp-heat accumulation, menoxenia, dysmenorrhea; Chronic pelvic inflammatory disease, adnexitis, endometritis etc. are shown in above-mentioned patient.
But the amount of the Radix Picriae felterrae clearly do not pulverized in described pharmacopeia is definitely how many.
Extracting method about FUYANJING has following report:
Chinese patent application 200510200230.3 specify that in the preparation method of FUYANJING: the Radix Picriae felterrae of 50% is pulverized, the preparation method that all the other soak by water are twice.
Chinese patent application 200410060988.7 discloses the compound Chinese medicinal preparation be made up of Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Radix calophylli membranacei, Folium Kaki, Herba Thlaspis, Herba Fici Simplicissimae, Caulis Spatholobi, Radix Zanthoxyli, preparation method disclosed in this patent adopts whole medical material water extraction, or precipitate with ethanol after water extraction.
Because in nine taste Chinese medicines, the character of active component is different, the method as above-mentioned two patents or patent application adopts water extraction, some active component can be caused to propose, or extraction ratio is low, affects the performance of drug effect.
Therefore, need to provide a kind of extraction ratio that can improve FUYANJING active component, to improve the preparation method of pharmaceutical effectiveness.
Summary of the invention
The object of this invention is to provide a kind of Chinese medicine composition being used for the treatment of gynecological inflammation of determined curative effect.
A kind of Chinese medicine composition for the treatment of gynecological inflammation provided by the invention, be made up of the composition of following weight portion: Radix Picriae felterrae 7.69 parts, Elephantopus scaber L. 11.54 parts, Radix Angelicae Sinensis 7.69 parts, Caulis Spatholobi 11.54 parts, Radix Zanthoxyli 11.54 parts, Radix calophylli membranacei 11.54 parts, Folium Kaki 11.54 parts of, Herba Thlaspiss 11.54 parts, Herba Fici Simplicissimae 15.38 parts, it is prepared by following methods: the Six-element Chinese medicine alcohol extractions such as Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki, its excess-three taste Chinese medicine water extraction.
Above in described Chinese medicine composition:
The Six-element Chinese medicine alcohol extractions such as described Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki comprise the following steps: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2-3 time, add Six-element Chinese medicine gross weight 6-12 times amount 30-80% ethanol at every turn, each extraction time is 2-5 hour, merge extractive liquid, filter, when filtrate is concentrated into 50-70 DEG C, relative density is the clear paste of 1.10-1.20, dry;
Preferably, the Six-element Chinese medicine alcohol extracting methods such as described Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki comprise the following steps: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Six-element Chinese medicine gross weight 8-10 times amount 70-80% ethanol at every turn, each extraction time is 3 hours, merge extractive liquid, filter, when filtrate is concentrated into 60 DEG C, relative density is the clear paste of 1.12-1.15, dry;
Further preferably, the Six-element Chinese medicine alcohol extractions such as described Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki comprise the following steps: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Six-element Chinese medicine gross weight 8 times amount 70% ethanol at every turn, each extraction time is 3 hours, merge extractive liquid, filter, when filtrate is concentrated into 60 DEG C, relative density is the clear paste of 1.12, dry;
Further preferably, the Six-element Chinese medicine alcohol extractions such as described Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki comprise the following steps: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli, Folium Kaki weight 10 times amount 80% ethanol at every turn, each extraction time is 3 hours, merge extractive liquid, filter, when filtrate is concentrated into 60 DEG C, relative density is the clear paste of 1.15, dry.
Its excess-three taste Chinese medicine water extraction described comprises the following steps: Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2-3 time, add the water of three taste Chinese medicine gross weight 6-12 times amount at every turn, each decocting time is 2-3 hour, collecting decoction, filters, when filtrate is concentrated into 50-70 DEG C, relative density is the clear paste of 1.10-1.20, adding ethanol makes alcohol content reach 40-80%, leaves standstill 6-24 hour, filters, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10-1.20, dry;
Preferably, its excess-three taste Chinese medicine water extraction described comprises the following steps: Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2-3 time, and add the water of three taste Chinese medicine gross weight 8-12 times amount, each decocting time is 3 hours at every turn, collecting decoction, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10-1.12, adds ethanol and makes alcohol content reach 70-80%, leave standstill 6-12 hour, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.12-1.20, dry;
Further preferably, its excess-three taste Chinese medicine water extraction described comprises the following steps: Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 3 times, and add the water of three taste Chinese medicine gross weight 8 times amount, each decocting time is 3 hours at every turn, collecting decoction, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.12, adds ethanol and makes alcohol content reach 70%, leave standstill 12 hours, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.12, dry;
Further preferably, its excess-three taste Chinese medicine water extraction described comprises the following steps:
Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2 times, add the water of three taste Chinese medicine gross weight 12 times amount at every turn, each decocting time is 3 hours, collecting decoction, filters, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10, adding ethanol makes alcohol content reach 80%, leaves standstill 6 hours, filters, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.20, dry.
Present invention also offers a kind of method preparing above-mentioned Chinese medicine composition, specifically comprise the following steps:
1) Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2-3 time, add Six-element Chinese medicine gross weight 6-12 times amount 30-80% ethanol at every turn, extract 2-3 hour, merge extractive liquid, filter, when filtrate is concentrated into 50-70 DEG C, relative density is the clear paste of 1.10-1.20, is dried to dried cream powder, for subsequent use;
2) Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2-3 time, add the water of three taste Chinese medicine gross weight 6-12 times amount at every turn, decoct 2-3 hour, collecting decoction, filter, when filtrate is concentrated into 50-70 DEG C, relative density is the clear paste of 1.10-1.20, adds ethanol and makes alcohol content reach 40-80%, leaves standstill 6-24 hour, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10-1.20, is dried to dried cream powder, for subsequent use;
3) combining step 1) and step 2) in dried cream powder, mixing, to obtain final product.
Above-mentioned steps 2) described in add ethanol and make its alcohol content reach 40-80%, concentration of alcohol is wherein 95-99%.
Present invention also offers the preparation containing above-mentioned Chinese medicine composition, said preparation is made up separately of Chinese medicine composition or is made up of Chinese medicine composition and pharmaceutically acceptable carrier.
Described preparation is solid preparation or liquid preparation, and solid preparation is tablet, capsule or granule; Liquid preparation is mixture or oral liquid.
Described pharmaceutically acceptable carrier is one or more in lactose, starch, dextrin, mannitol, sucrose, hydroxypropyl methylcellulose, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, micropowder silica gel, pregelatinized Starch, sorbitol, magnesium stearate, Pulvis Talci, hydroxypropyl methylcellulose, low-substituted hydroxypropyl cellulose, sodium benzoate, potassium sorbate, sucrose or aspartame.
Present invention also offers a kind of method preparing the above-mentioned preparation containing Chinese medicine composition, the method can adopt conventional formulation technique to prepare.
Present invention also offers above-mentioned Chinese medicine composition or the application of preparation in the medicine of preparation treatment gynecological inflammation, described gynecological inflammation is vaginitis, described gynecological inflammation more preferably bacterial vaginitis.
A kind of Chinese medicine composition for the treatment of gynecological inflammation provided by the invention has the following advantages:
1, main component of the present invention is Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli, Radix calophylli membranacei, Folium Kaki and Herba Fici Simplicissimae etc.Cure mainly clearing heat and expelling damp, circulation of qi promoting leukorrhagia stopping.Above-mentioned patient is seen for the leukorrheal diseases caused by damp-heat accumulation, menoxenia, dysmenorrhea, chronic pelvic inflammatory disease, inflammation of uterus, adnexitis.
2, because the character of active component in nine taste medical materials is different, fail clearly all Chinese medicine at present in the various disease for the treatment of, really play the composition of curative effect effect, very multicomponent character is had also to fail clearly, result of study shows, the Six-element Chinese medicine alcohol extractions such as Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki, the method of its excess-three taste Chinese medicine water extraction, can extract the effective Alcohol soluble composition and water soluble ingredient for the treatment of gynaecopathia in medical material to greatest extent.
3, the rat bacterial vaginitis caused with staphylococcus aureus, escherichia coli and bacillus pyocyaneus mixed infection is for model, investigate effect of the present invention, result shows: Chinese medicine composition provided by the invention can treat various gynecological inflammation, especially at treatment vaginitis, Be very effective in the bacterial vaginitis particularly caused in treatment staphylococcus aureus, escherichia coli and bacillus pyocyaneus mixed infection, and be better than prior art.
Detailed description of the invention
Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.
If no special instructions, the concentration of alcohol in the present invention is percent by volume.
Embodiment 1: the Chinese medicine composition for the treatment of gynecological inflammation
1, raw material: Radix Picriae felterrae 7.69kg, Elephantopus scaber L. 11.54kg, Radix Angelicae Sinensis 7.69kg, Caulis Spatholobi 11.54kg, Radix Zanthoxyli 11.54kg, Radix calophylli membranacei 11.54kg, Folium Kaki 11.54kg, Herba Thlaspis 11.54kg, Herba Fici Simplicissimae 15.38kg.
2, preparation method:
1) each composition is taken according to proportioning, for subsequent use;
2) Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Six-element Chinese medicine gross weight 8 times amount 70% ethanol at every turn, each extraction time is 3 hours, merge extractive liquid, filter, when filtrate is concentrated into 60 DEG C, relative density is the clear paste of 1.12, is dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 3 times, add the water of three taste Chinese medicine gross weight 8 times amount, each decocting time is 3 hours at every turn, collecting decoction, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.12, adds 95% ethanol and makes alcohol content reach 70%, leave standstill 12 hours, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.12, is dried to dried cream powder, obtain water extract, for subsequent use;
4) combining step 2) water extract described in described ethanol extract and step 3), obtain described Chinese medicine composition 15.8kg(yield 15.8%).
Embodiment 2: the Chinese medicine composition for the treatment of gynecological inflammation
1, raw material: Radix Picriae felterrae 7.69kg, Elephantopus scaber L. 11.54kg, Radix Angelicae Sinensis 7.69kg, Caulis Spatholobi 11.54kg, Radix Zanthoxyli 11.54kg, Radix calophylli membranacei 11.54kg, Folium Kaki 11.54kg, Herba Thlaspis 11.54kg, Herba Fici Simplicissimae 15.38kg.
2, preparation method:
1) each composition is taken according to proportioning, for subsequent use;
2) Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Six-element Chinese medicine gross weight 6 times amount 30% ethanol at every turn, each extraction time is 5 hours, merge extractive liquid, filter, when filtrate is concentrated into 50 DEG C, relative density is the clear paste of 1.20, is dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2 times, add the water of three taste Chinese medicine gross weight 10 times amount, each decocting time is 2 hours at every turn, collecting decoction, filter, when filtrate is concentrated into 60 DEG C, relative density is the clear paste of 1.15, adds 90% ethanol and makes alcohol content reach 40%, leave standstill 20 hours, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.15, is dried to dried cream powder, obtain water extract, for subsequent use;
4) combining step 2) water extract described in described ethanol extract and step 3), obtain described Chinese medicine composition 14.2kg(yield 14.2%).
Embodiment 3: the Chinese medicine composition for the treatment of gynecological inflammation
1, raw material: Radix Picriae felterrae 7.69kg, Elephantopus scaber L. 11.54kg, Radix Angelicae Sinensis 7.69kg, Caulis Spatholobi 11.54kg, Radix Zanthoxyli 11.54kg, Radix calophylli membranacei 11.54kg, Folium Kaki 11.54kg, Herba Thlaspis 11.54kg, Herba Fici Simplicissimae 15.38kg.
2, preparation method:
1) each composition is taken according to proportioning, for subsequent use;
2) Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 3 times, add Six-element Chinese medicine gross weight 12 times amount 50% ethanol at every turn, each extraction time is 2 hours, merge extractive liquid, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10, is dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 3 times, add the water of three taste Chinese medicine gross weight 6 times amount, each decocting time is 3 hours at every turn, collecting decoction, filter, when filtrate is concentrated into 50 DEG C, relative density is the clear paste of 1.20, adds 95% ethanol and makes alcohol content reach 50%, leave standstill 24 hours, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10, is dried to dried cream powder, obtain water extract, for subsequent use;
4) combining step 2) water extract described in described ethanol extract and step 3), obtain described Chinese medicine composition 15.1kg(yield 15.1%).
Embodiment 4: the Chinese medicine composition for the treatment of gynecological inflammation
1, raw material: Radix Picriae felterrae 7.69kg, Elephantopus scaber L. 11.54kg, Radix Angelicae Sinensis 7.69kg, Caulis Spatholobi 11.54kg, Radix Zanthoxyli 11.54kg, Radix calophylli membranacei 11.54kg, Folium Kaki 11.54kg, Herba Thlaspis 11.54kg, Herba Fici Simplicissimae 15.38kg.
2, preparation method:
1) each composition is taken according to proportioning, for subsequent use;
2) Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Six-element Chinese medicine gross weight 10 times amount 80% ethanol at every turn, each extraction time is 3 hours, merge extractive liquid, filter, when filtrate is concentrated into 60 DEG C, relative density is the clear paste of 1.15, is dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2 times, add the water of three taste Chinese medicine gross weight 12 times amount, each decocting time is 3 hours at every turn, collecting decoction, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10, adds 90% ethanol and makes alcohol content reach 80%, leave standstill 6 hours, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.20, is dried to dried cream powder, obtain water extract, for subsequent use;
4) combining step 2) water extract described in described ethanol extract and step 3), obtain described Chinese medicine composition 16.5kg(yield 16.5%).
Embodiment 5: the Chinese medicine composition for the treatment of gynecological inflammation
1, raw material: Radix Picriae felterrae 7.69kg, Elephantopus scaber L. 11.54kg, Radix Angelicae Sinensis 7.69kg, Caulis Spatholobi 11.54kg, Radix Zanthoxyli 11.54kg, Radix calophylli membranacei 11.54kg, Folium Kaki 11.54kg, Herba Thlaspis 11.54kg, Herba Fici Simplicissimae 15.38kg.
2, preparation method:
1) each composition is taken according to proportioning, for subsequent use;
2) Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 3 times, add Six-element Chinese medicine gross weight 9 times amount 60% ethanol at every turn, each extraction time is 4 hours, merge extractive liquid, filter, when filtrate is concentrated into 55 DEG C, relative density is the clear paste of 1.17, is dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2 times, add the water of three taste Chinese medicine gross weight 7 times amount, each decocting time is 2 hours at every turn, collecting decoction, filter, when filtrate is concentrated into 55 DEG C, relative density is the clear paste of 1.16, adds 95% ethanol and makes alcohol content reach 60%, leave standstill 18 hours, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.17, is dried to dried cream powder, obtain water extract, for subsequent use;
4) combining step 2) water extract described in described ethanol extract and step 3), obtain described Chinese medicine composition 15.5kg(yield 15.5%).
Embodiment 6: the Chinese medicine composition for the treatment of gynecological inflammation
1, raw material: Radix Picriae felterrae 7.69kg, Elephantopus scaber L. 11.54kg, Radix Angelicae Sinensis 7.69kg, Caulis Spatholobi 11.54kg, Radix Zanthoxyli 11.54kg, Radix calophylli membranacei 11.54kg, Folium Kaki 11.54kg, Herba Thlaspis 11.54kg, Herba Fici Simplicissimae 15.38kg.
2, preparation method:
1) each composition is taken according to proportioning, for subsequent use;
2) Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Six-element Chinese medicine gross weight 7 times amount 40% ethanol at every turn, each extraction time is 3 hours, merge extractive liquid, filter, when filtrate is concentrated into 65 DEG C, relative density is the clear paste of 1.13, is dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 3 times, add the water of three taste Chinese medicine gross weight 9 times amount, each decocting time is 3 hours at every turn, collecting decoction, filter, when filtrate is concentrated into 65 DEG C, relative density is the clear paste of 1.16, adds 90% ethanol and makes alcohol content reach 50%, leave standstill 16 hours, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.13, is dried to dried cream powder, obtain water extract, for subsequent use;
4) combining step 2) water extract described in described ethanol extract and step 3), obtain described Chinese medicine composition 14.6kg(yield 14.6%).
Embodiment 7: the capsule for the treatment of gynecological inflammation
1, form: embodiment 1 gained dried cream powder 15.8kg;
2, preparation method: the method with reference to conventional Chinese medicine preparation makes capsule.
Embodiment 8: the capsule for the treatment of gynecological inflammation
1, form: embodiment 1 gained dried cream powder 15.8kg, micropowder silica gel 0.20kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation makes capsule.
Embodiment 9: the tablet for the treatment of gynecological inflammation
1, form: embodiment 2 gained dried cream powder 14.2kg, lactose 5.8kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation makes tablet.
Embodiment 10: the tablet for the treatment of gynecological inflammation
1, form: embodiment 2 gained dried cream powder 14.2kg, Pulvis Talci 0.22kg.
2, preparation method: conveniently the method for Chinese medicine preparation makes tablet.
Embodiment 11: the tablet for the treatment of gynecological inflammation
1, form: embodiment 2 gained dried cream powder 14.2kg, magnesium stearate 0.4kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation makes tablet.
Embodiment 12: the granule for the treatment of gynecological inflammation
1, form: embodiment 3 gained dried cream powder 15.1kg, lactose 10.1kg, dextrin 1.8kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation makes granule.
Embodiment 13: the granule for the treatment of gynecological inflammation
1, form: embodiment 3 gained dried cream powder 15.1kg, starch 1.9kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation makes granule.
Embodiment 14: the oral liquid for the treatment of gynecological inflammation
1, form: embodiment 4 gained dried cream powder 16.5kg, water 151kg, sucrose 10.5kg and potassium sorbate 0.08kg.
2, preparation method: by dried cream powder water dissolution, then adds sucrose and potassium sorbate, embedding, sterilizing, makes oral liquid.
Embodiment 15: the capsule for the treatment of gynecological inflammation
1, form: embodiment 5 gained dried cream powder 15.5kg, lactose 84kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation makes capsule.
Embodiment 16: the granule for the treatment of gynecological inflammation
1, form: embodiment 6 gained dried cream powder 14.6kg, mannitol 3.2kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation makes granule.
Comparative example 1: Chinese medicine composition
With reference to the embodiment of CN200510200230.3, its composition and preparation method as follows:
1, raw material: Radix Picriae felterrae 250g, Elephantopus scaber L. 375g, Radix Angelicae Sinensis 250g, Caulis Spatholobi 375g, Radix Zanthoxyli 375g, Herba Fici Simplicissimae 500g, Radix calophylli membranacei 375g, Folium Kaki 375g, Herba Thlaspis 375g.
2, preparation method:
1) by 50% Radix Picriae felterrae and 250g, be ground into fine powder, cross 60 mesh sieves, for subsequent use;
2) the eight taste Chinese medicines such as remaining Radix Picriae felterrae and Radix Angelicae Sinensis are decocted with water twice, add water 10 times amount for the first time, decocts 3 hours, and add water 8 times amount for the second time, decocts 2 hours, collecting decoction, and filter, filtrate is condensed into paste, for subsequent use;
3) Radix Picriae felterrae fine powder and step 2 described in step 1)) described thick paste mixing, dry, to obtain final product.Comparative example 2: Chinese medicine composition
With reference to the preparation method of the embodiment of CN200410060988.7, be specially:
1, raw material: Radix Picriae felterrae 250g, Elephantopus scaber L. 375g, Radix Angelicae Sinensis 250g, Caulis Spatholobi 375g, Radix Zanthoxyli 375g, Herba Fici Simplicissimae 500g, Radix calophylli membranacei 375g, Folium Kaki 375g, Herba Thlaspis 375g.
2, preparation method:
Take nine taste Chinese medicines, decoct with water secondary, 3 hours first times, second time 2 hours, collecting decoction, filter, filtrate is condensed into clear paste, dry, to obtain final product.
Experimental example: on the impact of Rat Experimental inflammation of uterus
1, laboratory animal: SPF cleaning grade Wistar rat, female, body weight 200-300g, is provided (credit number: SCXK osmanthus 2009-0002) by Guangxi Medical University's Experimental Animal Center;
2, experiment material:
Embodiment 1-6, comparative example 1-2: prepare according to the method for embodiment;
Paraffin oil, purchased from Hengshui Jia Run lubricating oil company limited;
Ofloxacin, purchased from Jiangsu Huang He Pharmaceutical Co., Ltd;
Staphylococcus aureus (ATCC 25923), escherichia coli (ATCC 25922), bacillus pyocyaneus (ATTC 27853), purchased from disease prevention and control center of Zhongshan city.
3, experimental technique and grouping
3.1 experiment groupings:
Get 110 rats to be divided at random: Normal group, model group, positive controls and embodiment 1-6 group, comparative example 1,2 groups, often organize 10.Wherein:
Positive controls is with ofloxacin gastric infusion, and dosage is 0.06g/kg; Each group of embodiment 1-6, comparative example 1,2 groups of gastric infusions, dosage is all by crude drug amount 2.93g/kg, the medication of each group of positive controls, embodiment 1-6, comparative example 1,2 groups etc. nine groups is: weigh rat body weight respectively, calculate corresponding dosage, then dilute with the water for injection of 0.2ml, gastric infusion;
Normal group and model group gavage 0.2ml water for injection respectively.
3.2 bacterial vaginitis model preparations:
3 kinds of bacterial strains and staphylococcus aureus (ATCC 25923), escherichia coli (ATCC25922) and bacillus pyocyaneus (ATTC 27853) are recovered by conventional method, gone down to posterity respectively, and being mixed with concentration with physiological saline solution is 1.8 × l0
9the bacterium liquid of/mL, is mixed into infectious bacteria liquid in the ratio of 1:1:1.
Except rats in normal control group, other respectively organize the process of rat: first rinse rat vagina 3 times (every minor tick 5min) with aseptic PBS liquid (phosphate buffer of pH8.5), then aseptic paraffin oil is coated with 5 number sword-shaped needle silica gel tubes, slow insertion rat vagina is about 1.0cm-1.5cm, every rat is injected amount of bacteria and is 0.025mL/100g, every day 1 time.
After inoculated bacteria, observe rat vagina pathological changes situation every day, and get vaginal secretions smear staining microscopy.
When rat vagina obviously congested, red and swollen and with a large amount of purulent secretion time, get secretions smear, except Normal group, after model group and each administration group rat inject antibacterial 5d, infectious bacterias a large amount of as seen under mirror and non-viable non-apoptotic cell, show that rat bacterial vaginitis model is successfully prepared.
After typical vaginitis symptom to appear.Model group and each administration group give Drug therapy respectively.Normal group gives gavage normal saline, successive administration 14d.
2h after last administration, the film making of vagina local, gets vaginal swab smear staining microscopy, then puts to death rat, gets vagina tissue 10% neutral formalin with fixed, and pathological examination is done in paraffin embedding, section, HE dyeing.
3.3 criterions of therapeutical effect:
Recovery from illness: vagina outward appearance is without congested, red and swollen, and without purulent secretion, vaginal swab smear for microscopic examination loses infectious bacteria and non-viable non-apoptotic cell, in vagina tissue section, mucosa is complete, sub-mucosal tissues is normal.
Take a turn for the better: vagina outward appearance has mild hyperaemia, redness, there is a small amount of purulent secretion, the visible a small amount of infectious bacteria of vaginal swab smear for microscopic examination and a small amount of non-viable non-apoptotic cell, the visible vaginal mucosa of tissue slice microscopy has slight defect, telangiectasis in sub-mucosal tissues, erythrocytosis, have a small amount of neutrophil infiltration in tissue.
Invalid: vagina outward appearance is congested, red and swollen, have a large amount of pus Sui secretions, vaginal swab smear for microscopic examination is shown in a large amount of infectious bacteria and non-viable non-apoptotic cell, and the visible mucosa of vagina tissue section microscopy has defect, telangiectasis a large amount of in sub-mucosal tissues, erythrocytosis, have a large amount of neutrophil infiltration.
4, statistical method: adopt statistical method to add up experimental data.
5, experimental result: in table 1
Table 1: Chinese People's Anti-Japanese Military and Political College's Mus bacterial vaginitis effective percentage compares
| Group | Number of animals | Invalid | Take a turn for the better | Recovery from illness | Effective percentage (%) |
| Normal group | 10 | - | - | - | - |
| Model group | 10 | 10 | 0 | 0 | 0 |
| Positive controls | 10 | 0 | 2 | 8 | 100 * |
| Embodiment 1 group | 10 | 0 | 4 | 6 | 100 **#△ |
| Embodiment 2 groups | 10 | 1 | 4 | 5 | 95 **#△ |
| Embodiment 3 groups | 10 | 1 | 2 | 7 | 95 **#△ |
| Embodiment 4 groups | 10 | 0 | 3 | 7 | 100 **#△ |
| Embodiment 5 groups | 10 | 1 | 2 | 7 | 95 **#△ |
| Embodiment 6 groups | 10 | 1 | 3 | 6 | 95 **#△ |
| Comparative example 1 group | 10 | 4 | 2 | 4 | 60 * |
| Comparative example 2 groups | 10 | 4 | 3 | 3 | 60 * |
Compare with model group,
*p<0.05,
*p<0.05; Compare with comparative example 1 group,
#p<0.05; Compare with comparative example 1 group,
△p<0.05.
Table 1 result shows:
Model group has all infected vaginitis;
Compared with model group, the colpitic total effective rate that embodiment 1-6 respectively organizes rat is 95-100%, compared with model group, has pole significant difference (P<0.01); The colpitic total effective rate that comparative example is 1,2 groups is 60%, compared with model group, has significant difference (P<0.05);
Respectively compared with comparative example 1,2 groups, the colpitic total effective rate that embodiment 1-6 respectively organizes rat obviously increases, and has significant difference (P<0.05).
Result shows: Chinese medicine composition provided by the invention has the effect for the treatment of bacterial vaginitis, and effect is better than comparative example group.
6, discuss
Vaginitis is the inflammation of connective tissue under vaginal mucosa and mucosa, whenever vagina ecological-environment differention and vagina immunologic function unbalance, or the pathogen of Infective, then easily there is multiple colpitis in vagina.Vaginitis is the common frdquently encountered disease of women, and staphylococcus aureus and the escherichia coli pathogen that to be vaginitis common.
The rat bacterial vaginitis caused with staphylococcus aureus, escherichia coli and bacillus pyocyaneus mixed infection is for model, investigate effect of the present invention, result shows: Chinese medicine composition provided by the invention can treat various gynecological inflammation, especially at treatment vaginitis, Be very effective in the bacterial vaginitis particularly caused in treatment staphylococcus aureus, escherichia coli and bacillus pyocyaneus mixed infection, and be better than prior art.
Although above with general explanation, detailed description of the invention and test, the present invention is described in detail, and on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (10)
1. treat the Chinese medicine composition of bacterial vaginitis for one kind, be made up of the composition of following weight portion: Radix Picriae felterrae 7.69 parts, Elephantopus scaber L. 11.54 parts, Radix Angelicae Sinensis 7.69 parts, Caulis Spatholobi 11.54 parts, Radix Zanthoxyli 11.54 parts, Radix calophylli membranacei 11.54 parts, Folium Kaki 11.54 parts, Herba Thlaspis 11.54 parts, Herba Fici Simplicissimae 15.38 parts, it is characterized in that, this Chinese medicine composition is prepared by following methods: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki alcohol extraction, its excess-three taste Chinese medicine water extraction, described Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki alcohol extraction comprise the following steps: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2-3 time, add Six-element Chinese medicine gross weight 6-12 times amount 30-80% ethanol at every turn, each extraction time is 2-5 hour, merge extractive liquid, filter, when filtrate is concentrated into 50-70 DEG C, relative density is the clear paste of 1.10-1.20, dry, its excess-three taste Chinese medicine water extraction described comprises the following steps: Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2-3 time, add the water of three taste Chinese medicine gross weight 6-12 times amount at every turn, each decocting time is 2-3 hour, collecting decoction, filters, when filtrate is concentrated into 50-70 DEG C, relative density is the clear paste of 1.10-1.20, adding ethanol makes alcohol content reach 40-80%, leaves standstill 6-24 hour, filters, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10-1.20, dry.
2. Chinese medicine composition according to claim 1, it is characterized in that, described Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki alcohol extracting method comprise the following steps: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Six-element Chinese medicine gross weight 8-10 times amount 70-80% ethanol at every turn, each extraction time is 3 hours, merge extractive liquid, filters, when filtrate is concentrated into 60 DEG C, relative density is the clear paste of 1.12-1.15, dry.
3. Chinese medicine composition according to claim 1, it is characterized in that, described Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki alcohol extraction comprise the following steps: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Six-element Chinese medicine gross weight 8 times amount 70% ethanol at every turn, each extraction time is 3 hours, merge extractive liquid, filters, when filtrate is concentrated into 60 DEG C, relative density is the clear paste of 1.12, dry.
4. Chinese medicine composition according to claim 1, it is characterized in that, described Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki alcohol extraction comprise the following steps: Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2 times, add Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli, Folium Kaki weight 10 times amount 80% ethanol at every turn, each extraction time is 3 hours, merge extractive liquid, filter, when filtrate is concentrated into 60 DEG C, relative density is the clear paste of 1.15, dry.
5. Chinese medicine composition according to claim 1, it is characterized in that, its excess-three taste Chinese medicine water extraction described comprises the following steps: Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2-3 time, add the water of three taste Chinese medicine gross weight 8-12 times amount at every turn, each decocting time is 3 hours, collecting decoction, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10-1.12, adding ethanol makes alcohol content reach 70-80%, leaves standstill 6-12 hour, filters, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.12-1.20, dry.
6. Chinese medicine composition according to claim 1, is characterized in that, its excess-three taste Chinese medicine water extraction described comprises the following steps: Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 3 times, add the water of three taste Chinese medicine gross weight 8 times amount at every turn, each decocting time is 3 hours, collecting decoction, filters, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.12, adding ethanol makes alcohol content reach 70%, leaves standstill 12 hours, filters, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.12, dry.
7. Chinese medicine composition according to claim 1, is characterized in that, its excess-three taste Chinese medicine water extraction described comprises the following steps: Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae water extraction 2 times, add the water of three taste Chinese medicine gross weight 12 times amount at every turn, each decocting time is 3 hours, collecting decoction, filters, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10, adding ethanol makes alcohol content reach 80%, leaves standstill 6 hours, filters, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.20, dry.
8. prepare a method for Chinese medicine composition described in claim 1, it is characterized in that, the method comprises the following steps:
1) Radix Picriae felterrae, Elephantopus scaber L., Radix Angelicae Sinensis, Caulis Spatholobi, Radix Zanthoxyli and Folium Kaki ethanol extraction 2-3 time, add Six-element Chinese medicine gross weight 6-12 times amount 30-80% ethanol at every turn, extract 2-3 hour, merge extractive liquid, filter, when filtrate is concentrated into 50-70 DEG C, relative density is the clear paste of 1.10-1.20, is dried to dried cream powder, for subsequent use;
2) Radix calophylli membranacei, Herba Thlaspis and Herba Fici Simplicissimae, with water extraction 2-3 time, adds the water of three taste Chinese medicine gross weight 6-12 times amount at every turn, decoct 2-3 hour, collecting decoction, filters, and when filtrate is concentrated into 50-70 DEG C, relative density is the clear paste of 1.10-1.20, adding ethanol makes alcohol content reach 40-80%, leave standstill 6-24 hour, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.10-1.20, be dried to dried cream powder, for subsequent use;
3) combining step 1) and step 2) in dried cream powder, mixing, to obtain final product.
9., containing the preparation of Chinese medicine composition described in any one of claim 1-7, it is characterized in that, said preparation is made up separately of Chinese medicine composition or is made up of Chinese medicine composition and pharmaceutically acceptable carrier.
10. the application in the medicine of preparation treatment bacterial vaginitis of the Chinese medicine composition described in any one of claim 1-7 or preparation according to claim 9.
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