CN103120727B - Traditional Chinese medicine composition for treating gynecological inflammation and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating gynecological inflammation and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating gynecological inflammation and a preparation method thereof. The traditional Chinese medicine composition for treating gynecological inflammation is prepared by the following components in parts by weight: 7.69 parts of picria felterrae, 11.54 parts of elephantopus scaber, 7.69 parts of Chinese angelica, 11.54 parts of suberect spatholobus stem, 11.54 parts of shinyleaf pricklyash root, 11.54 parts of membranaceous beautyleaf root, 11.54 parts of persimmon leaf, 11.54 parts of thlaspi arvense mustard herb and 15.38 parts of ficus hirta vahl; the traditional Chinese medicine composition is prepared by extracting the nine traditional Chinese medicines by alcohol, and aqueous extracting the medicine residues after alcohol extraction. A rat model with gynecological inflammation caused by mixed infection of staphylococcus aureus, escherichia coli and Pseudomonas aeruginosa is used for test; and the inventor finds that the traditional Chinese medicine composition provided by the invention has the effect of treating gynecological inflammation, is especially effective in treatment of vaginitis, in particular to bacterial vaginitis, and is superior to the prior art.
Description
Technical field
The present invention relates to treat the Chinese medicine composition 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 (be mainly insufficiency of the spleen, suffer from a deficiency of the kidney, stagnation of liver-QI), disorder of QI and blood, Yi Jichong, appoint, superintend and direct, be with damage three aspects.Due to the special physiological feature of women, as through row, pregnancy, production, easily cause vessels of the uterus inanition, evil poison is invaded in taking advantage of a weak point in opponent's defence, turbid damp, the long-pending part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels of pyretic toxicity poultry, visitor, in born of the same parents, fights mutually with QI and blood, thereby produces gynecological's various diseases disease.Good and evil are handed over and are striven, disharmony of nutrient QI with defensive QI, evil poison are stopped up and contained, therefore disease is seen fever with aversion to cold, headache; Insufficiency of the spleen leading to overabundance of dampness, phlegm-damp bet, damp-stagnancy heat-transformation, instability of kidney QI, and disease is seen 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, is detained for suffering from, and in the long-pending born of the same parents of the stasis of blood, the evil poison of multiple sense, fights mutually with QI and blood, so that patient's condition prolongs silk floss, forms chronic gynaecological inflammation disease.
FUYANJING is the Pharmacopoeia of the People's Republic of China disclosed compound recipe of version in 2010, discloses the following information of FUYANJING JIAONANG in pharmacopeia:
1) composition: 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, get part Radix Picriae felterrae, be ground into fine powder; Eight tastes such as residue Radix Picriae felterrae and all the other Elephantopus scaber L. decoct with water secondary, and 3 hours for the first time, 2 hours for the second time, decocting liquid filtered, and filtrate merges, and is concentrated in right amount, mixes with above-mentioned fine powder, dry, pulverize, and incapsulates, and makes 1000.
3) function with cure mainly: clearing heat and expelling damp, adjusting meridian and stopping leukorrhea.For the leukorrheal diseases due to damp-heat accumulation, menoxenia, dysmenorrhea; Chronic pelvic inflammatory disease, adnexitis, endometritis etc. are shown in above-mentioned patient.
There is following report about the extracting method of FUYANJING:
In the preparation method of FUYANJING that Chinese patent application 200510200230.3 is clear and definite: 50% Radix Picriae felterrae is pulverized, and all the other decoctings boil the preparation method of twice.
Chinese patent application 200410060988.7 discloses the compound Chinese medicinal preparation of being 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, the disclosed preparation method of this patent adopts whole Chinese medicine water extractions, or precipitate with ethanol after water extraction.
Because the character of active component in nine taste medicines is different, as the method for above-mentioned two patents or patent application adopts water extraction, can cause some active component to propose, or extraction ratio is low, affect 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 that is 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, composition by following weight portion is made: 7.69 parts of Radix Picriae felterrae, 11.54 parts of Elephantopus scaber L., 7.69 parts of Radix Angelicae Sinensis, 11.54 parts of Caulis Spatholobis, 11.54 parts of Radix Zanthoxylis, 11.54 parts of Radix calophylli membranacei, 11.54 parts of 11.54 parts of, Herba Thlaspiss of Folium Kaki, 15.38 parts of Herba Fici Simplicissimae, it is prepared by following methods: nine taste Chinese medicine alcohol extractions, the medicinal residues water extraction after alcohol extraction.
Concrete, described Chinese medicine composition is prepared by following methods:
1) take nine taste Chinese medicines according to proportioning, then by medicinal ethanol extraction in nine tastes 2-3 time, add the 30-80% ethanol that nine taste Chinese medicine gross weight 6-12 doubly measure, each extraction time is 2-5 hour, reclaims medicinal residues at every turn, merge extractive liquid,, extracting solution filters, and the clear paste that when filtrate is concentrated into 50-70 DEG C, relative density is 1.10-1.20 is dry, obtain ethanol extract, for subsequent use;
2) water extraction 2-3 time of the medicinal residues after alcohol extraction adds the water that nine taste Chinese medicine gross weight 6-12 doubly measure at every turn, and each decocting time is 2-3 hour, collecting decoction, filter, the clear paste that when filtrate is concentrated into 50-70 DEG C, relative density is 1.10-1.20, adds ethanol and makes to reach 40-80% containing alcohol amount, leave standstill 6-24 hour, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10-1.20, dry, obtain water extract, for subsequent use;
3) combining step 1) ethanol extract and the step 2 of gained) water extract of gained, stir.
Preferably, described nine taste Chinese medicine alcohol mention that the method for medicinal residues water extraction comprises the following steps:
1) take nine taste Chinese medicines according to proportioning, then by medicinal ethanol extraction in nine tastes 2 times, add nine taste Chinese medicine gross weight 8-10 at every turn and doubly measure 70-80% ethanol, each extraction time is 3 hours, reclaims medicinal residues, merge extractive liquid,, extracting solution filters, and the clear paste that when filtrate is concentrated into 60 DEG C, relative density is 1.12-1.15 is dry, obtain ethanol extract, for subsequent use;
2) water extraction 2-3 time of the medicinal residues after alcohol extraction adds the water that nine taste Chinese medicine gross weight 8-12 doubly measure at every turn, and each decocting time is 3 hours, collecting decoction, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10-1.12, adds ethanol and makes to reach 70-80% containing alcohol amount, leave standstill 6-12 hour, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.12-1.20, dry, obtain water extract, for subsequent use.
Further preferably, described nine taste Chinese medicine alcohol mention that the method for the medicinal residues water extraction after alcohol extraction comprises the following steps:
1) take nine taste Chinese medicines according to proportioning, then by medicinal ethanol extraction in nine tastes 2 times, add 10 times of amount 80% ethanol of nine taste Chinese medicine gross weights, each extraction time is 3 hours, reclaims medicinal residues at every turn, merge extractive liquid,, extracting solution filters, and the clear paste that when filtrate is concentrated into 60 DEG C, relative density is 1.15 is dry, obtain ethanol extract, for subsequent use;
2) water extraction 2 times for the medicinal residues after alcohol extraction adds the water of 12 times of amounts of nine taste Chinese medicine gross weights at every turn, and each decocting time is 3 hours, collecting decoction, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10-, adds ethanol and makes to reach 80% containing alcohol amount, leave standstill 6 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.20, dry, obtain water extract, for subsequent use;
3) combining step 1) ethanol extract and the step 2 of gained) water extract of gained, stir.
Further preferably, nine taste Chinese medicine alcohol mention that the method for the medicinal residues water extraction after alcohol extraction comprises the following steps:
1) take nine taste Chinese medicines according to proportioning, then by medicinal ethanol extraction in nine tastes 2 times, add 8 times of amount 70% ethanol of nine taste Chinese medicine weight, each extraction time is 3 hours, reclaims medicinal residues at every turn, merge extractive liquid,, extracting solution filters, and the clear paste that when filtrate is concentrated into 60 DEG C, relative density is 1.12 is dry, obtain ethanol extract, for subsequent use;
2) water extraction 3 times for the medicinal residues after alcohol extraction adds the water of 8 times of amounts of nine taste Chinese medicine gross weights at every turn, and each decocting time is 3 hours, collecting decoction, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.12, adds ethanol and makes to reach 70% containing alcohol amount, leave standstill 12 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.12, dry, obtain water extract, for subsequent use;
3) combining step 1) ethanol extract and the step 2 of gained) water extract of gained, stir.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, specifically comprises the following steps:
1) take nine taste Chinese medicines according to proportioning, then use ethanol extraction 2-3 time, add the 30-80% ethanol that nine taste Chinese medicine gross weight 6-12 doubly measure, each extraction time is 2-5 hour, reclaims medicinal residues at every turn, merge extractive liquid,, extracting solution filters, and the clear paste that when filtrate is concentrated into 50-70 DEG C, relative density is 1.10-1.20 is dry, obtain ethanol extract, for subsequent use;
2) water extraction 2-3 time of the medicinal residues after alcohol extraction adds the water that nine taste Chinese medicine gross weight 6-12 doubly measure at every turn, and each decocting time is 2-3 hour, collecting decoction, filter, the clear paste that when filtrate is concentrated into 50-70 DEG C, relative density is 1.10-1.20, adds ethanol and makes to reach 40-80% containing alcohol amount, leave standstill 6-24 hour, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10-1.20, dry, obtain water extract, for subsequent use;
3) combining step 1) ethanol extract and the step 2 of gained) water extract of gained, stir.
Above-mentioned steps 2) described in when precipitate with ethanol, add ethanol to make it contain alcohol amount and reach 40-80%, concentration of alcohol is wherein 95-99%.
The present invention also provides the preparation containing above-mentioned Chinese medicine composition, and 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;
The present invention also provides a kind of method of preparing above-mentioned preparation, and the method can adopt the preparation of conventional formulation technique.
The present invention also provides above-mentioned Chinese medicine composition or the application of preparation in the medicine of preparation chronic pelvic inflammatory disease or treatment gynecological inflammation, and described gynaecopathia is preferably 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, Herba Fici Simplicissimae etc.Cure mainly clearing heat and expelling damp, circulation of qi promoting leukorrhagia stopping.See above-mentioned patient for leukorrheal diseases, menoxenia, dysmenorrhea, chronic pelvic inflammatory disease, adnexitis, endometritis due to damp-heat accumulation.
2, because the character of active component in nine taste medical materials is different, fail at present clearly all Chinese medicine and in treatment various diseases, really play the composition of curative effect effect, there is very multicomponent character also to fail clearly, therefore adopt after ethanol extraction, reclaim medicinal residues, extracting in water again, can all extract alcohol dissolubility and water-soluble active ingredient in medical material by different level, has improved the effectiveness of medicine.
3, the rat model that adopts staphylococcus aureus, escherichia coli and bacillus pyocyaneus mixed infection to cause is tested, inventor finds: Chinese medicine composition provided by the invention has the effect for the treatment of treatment gynecological inflammation, especially at treatment vaginitis, particularly bacterial vaginitis aspect is evident in efficacy, and is better than prior art.
Detailed description of the invention
Following examples are used for illustrating 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) take nine taste Chinese medicines according to proportioning, for subsequent use;
2) medicinal ethanol extraction 2 times in nine tastes adds 8 times of amount 70% ethanol of nine taste Chinese medicine gross weights at every turn, and each extraction time is 3 hours, reclaims medicinal residues, merge extractive liquid,, extracting solution filters, the clear paste that when filtrate is concentrated into 60 DEG C, relative density is 1.12, be dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) water extraction 3 times of the medicinal residues after alcohol extraction, add the water of 8 times of amounts of nine taste Chinese medicine gross weights, each decocting time is 3 hours, collecting decoction at every turn, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.12, adds 95% ethanol and makes to reach 70% containing alcohol amount, leaves standstill 12 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.12, is dried to dried cream powder, obtains water extract;
4) combining step 2) water extract described in described ethanol extract and step 3), mix homogeneously, obtains described Chinese medicine composition 21.8kg(yield 21.8%).
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) take each nine taste Chinese medicines according to proportioning, for subsequent use;
2) medicinal ethanol extraction 2 times in nine tastes adds 6 times of amount 30% ethanol of nine taste Chinese medicine gross weights at every turn, and each extraction time is 5 hours, reclaims medicinal residues, merge extractive liquid,, extracting solution filters, the clear paste that when filtrate is concentrated into 50 DEG C, relative density is 1.20, be dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) water extraction 2 times for the medicinal residues after alcohol extraction adds the water of 10 times of amounts of nine taste Chinese medicine gross weights at every turn, and each decocting time is 2 hours, collecting decoction, filter, the clear paste that when filtrate is concentrated into 60 DEG C, relative density is 1.15, adds 90% ethanol and makes to reach 40% containing alcohol amount, leave standstill 20 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 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), mix homogeneously, obtains described Chinese medicine composition 18.2kg(yield 18.2%).
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) take nine taste Chinese medicines according to proportioning, for subsequent use;
2) medicinal ethanol extraction 3 times in nine tastes adds 12 times of amount 50% ethanol of nine taste Chinese medicine gross weights at every turn, and each extraction time is 2 hours, reclaims medicinal residues, merge extractive liquid,, extracting solution filters, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10, be dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) water extraction 3 times for the medicinal residues after alcohol extraction adds the water of 6 times of amounts of nine taste Chinese medicine gross weights at every turn, and each decocting time is 3 hours, collecting decoction, filter, the clear paste that when filtrate is concentrated into 50 DEG C, relative density is 1.20, adds 95% ethanol and makes to reach 50% containing alcohol amount, leave standstill 24 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 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), mix homogeneously, obtains described Chinese medicine composition 20.7kg(yield 20.7%).
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) take each composition according to proportioning, for subsequent use;
2) medicinal ethanol extraction 2 times in nine tastes adds 10 times of amount 80% ethanol of nine taste Chinese medicine gross weights at every turn, and each extraction time is 3 hours, reclaims medicinal residues, merge extractive liquid,, extracting solution filters, the clear paste that when filtrate is concentrated into 60 DEG C, relative density is 1.15, be dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) water extraction 2 times for the medicinal residues after alcohol extraction adds the water of 12 times of amounts of nine taste Chinese medicine gross weights at every turn, and each decocting time is 3 hours, collecting decoction, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10, adds 90% ethanol and makes to reach 80% containing alcohol amount, leave standstill 6 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 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), mix homogeneously, obtains described Chinese medicine composition 22.6kg(yield 22.6%).
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) take nine taste Chinese medicines according to proportioning, for subsequent use;
2) medicinal ethanol extraction 3 times in nine tastes adds 9 times of amount 60% ethanol of nine taste Chinese medicine gross weights at every turn, and each extraction time is 4 hours, reclaims medicinal residues, merge extractive liquid,, extracting solution filters, the clear paste that when filtrate is concentrated into 55 DEG C, relative density is 1.17, be dried to dried cream powder, obtain ethanol extract, for subsequent use;
3) extracting in water 2 times for the medicinal residues after alcohol extraction adds the water of 7 times of amounts of nine taste Chinese medicine gross weights at every turn, and each decocting time is 2 hours, collecting decoction, filter, the clear paste that when filtrate is concentrated into 55 DEG C, relative density is 1.16, adds 95% ethanol and makes to reach 60% containing alcohol amount, leave standstill 18 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 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), mix homogeneously, obtains described Chinese medicine composition 21.3kg(yield 21.3%).
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) take nine taste Chinese medicines according to proportioning, for subsequent use;
2) medicinal ethanol extraction 2 times in nine tastes, add 7 times of amount 40% ethanol of nine taste Chinese medicine gross weights at every turn, each extraction time is 3 hours, reclaim medicinal residues, merge extractive liquid,, extracting solution filters, the clear paste that when filtrate is concentrated into 65 DEG C, relative density is 1.13, be dried to dried cream powder, obtain Caulis Spatholobi and Radix Zanthoxyli ethanol extract, for subsequent use;
3) water extraction 3 times for the medicinal residues after alcohol extraction adds the water of 9 times of amounts of nine taste Chinese medicine gross weights at every turn, and each decocting time is 3 hours, collecting decoction, filter, the clear paste that when filtrate is concentrated into 65 DEG C, relative density is 1.16, adds 90% ethanol and makes to reach 50% containing alcohol amount, leave standstill 16 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 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), mix homogeneously, obtains described Chinese medicine composition 19.5kg(yield 19.5%).
Embodiment 7: the capsule for the treatment of gynecological inflammation
1, composition: embodiment 1 gained dried cream powder 21.8kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation is made capsule.
Embodiment 8: the capsule for the treatment of gynecological inflammation
1, composition: embodiment 1 gained dried cream powder 21.8kg, micropowder silica gel 0.3kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation is made capsule.
Embodiment 9: the tablet for the treatment of gynecological inflammation
1, composition: embodiment 2 gained dried cream powder 18.2kg, lactose 7.3kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation is made tablet.
Embodiment 10: the tablet for the treatment of gynecological inflammation
1, composition: embodiment 2 gained dried cream powder 18.2kg, Pulvis Talci 0.3kg.
2, preparation method: the method according to conventional Chinese medicine preparation is made tablet.
Embodiment 11: the tablet for the treatment of gynecological inflammation
1, composition: embodiment 2 gained dried cream powder 18.2kg, magnesium stearate 0.45kg;
2, preparation method: the method with reference to conventional Chinese medicine preparation is made tablet.
Embodiment 12: the granule for the treatment of gynecological inflammation
1, composition: embodiment 3 gained dried cream powder 20.7kg, lactose 11.7kg, dextrin 2.9kg.
2, preparation method: with reference to the method granulation agent of conventional Chinese medicine preparation.
Embodiment 13: the granule for the treatment of gynecological inflammation
1, composition: embodiment 3 gained dried cream powder 20.7kg, starch 1.4kg.
2, preparation method: with reference to the method granulation agent of conventional Chinese medicine preparation.
Embodiment 14: the oral liquid for the treatment of gynecological inflammation
1, composition: embodiment 4 gained dried cream powder 22.6kg, water 209kg, sucrose 14.8kg and potassium sorbate 0.11kg.
2, preparation method: by dried cream powder water dissolution, then add sucrose and potassium sorbate, embedding, sterilizing, makes oral liquid.
Embodiment 15: the capsule for the treatment of gynecological inflammation
1, composition: embodiment 5 gained dried cream powder 21.3kg, lactose 115kg.
2, preparation method: the method with reference to conventional Chinese medicine preparation is made capsule.
Embodiment 16: the granule for the treatment of gynecological inflammation
1, composition: embodiment 6 gained dried cream powder 19.5kg, mannitol 4.4kg.
2, preparation method: with reference to the method granulation agent of conventional Chinese medicine preparation.
Comparative example 1: Chinese medicine composition
With reference to the embodiment of CN200510200230.3, its composition and preparation method are 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) be 250g by 50% Radix Picriae felterrae, 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 to twice, add water for the first time 10 times and measure, decoct 3 hours, 8 times of amounts for the second time add water, decoct 2 hours, collecting decoction, filters, and filtrate is condensed into thick paste shape, add Radix Picriae felterrae fine powder, mix, 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:
By nine taste Chinese medicines, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction, filtered, and filtrate is condensed into clear paste, dry, to obtain final product.
Experimental example: on the impact of Experimental vaginitis
1, the clean level of laboratory animal: SPF Wistar rat, female, body weight 200-300g, provides (credit number: SCXK osmanthus 2009-0002) by Guangxi Medical University's Experimental Animal Center;
2, experiment material:
Embodiment 1-6, comparative example 1-2: according to the method preparation of 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:
Getting 220 rats is divided at random: Normal group, model group, positive controls and embodiment 1-6 group, 1,2 groups of comparative examples, 20 every group.Wherein:
Positive controls is with ofloxacin gastric infusion, and dosage is 0.06g/kg; Each group of embodiment 1-6,1,2 groups of gastric infusions of comparative example, dosage is all by crude drug amount 2.93g/kg, the medication that positive controls, each group of embodiment 1-6,1,2 groups of comparative examples etc. are nine groups is: weigh respectively rat body weight, calculate corresponding dosage, then dilute gastric infusion with the water for injection of 0.2ml;
Normal group and model group be gavage 0.2ml water for injection respectively.
3.2 bacterial vaginitis model preparations:
Be that staphylococcus aureus (ATCC 25923), escherichia coli (ATCC25922) and bacillus pyocyaneus (ATTC 27853) recover, go down to posterity by conventional method respectively by 3 kinds of bacterial strains, 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, the processing of other each group rats: first use aseptic PBS liquid (phosphate buffer of pH8.5) to rinse rat vagina 3 times (every minor tick 5min), then be coated with aseptic paraffin oil with 5 number sword-shaped needle silica gel tubes, slowly insert the about 1.0cm-1.5cm of rat vagina, 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 during with a large amount of purulent secretion, get secretions smear, except Normal group, model group and each administration group rat are injected after antibacterial 5d, under mirror, visible a large amount of infectious bacteria and non-viable non-apoptotic cells, shows that rat bacterial vaginitis model is successfully prepared.
After there is typical vaginitis symptom.Model group and each administration group give respectively Drug therapy.Normal group gives gavage normal saline, successive administration 14d.
2h after last administration, the local film making of vagina, 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, complete, the mucosa undertissue normal of mucosa in vagina tissue section.
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 damaged, telangiectasis in mucosa undertissue, erythrocytosis, have a small amount of neutrophil infiltration in tissue.
Invalid: the hyperemia of vagina outward appearance, redness, have a large amount of pus Sui secretions, vaginal swab smear for microscopic examination is shown in a large amount of infectious bacterias and non-viable non-apoptotic cell, and the visible mucosa of vagina tissue section microscopy has damaged, a large amount of telangiectasis, erythrocytosis in mucosa undertissue, has 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 comparison
| Group | Number of animals | Invalid | Take a turn for the better | Recovery from illness | Effective percentage (%) |
| Normal group | 20 - - - - | ||||
| Model group | 20 | 20 ** | 0 | 0 | 0 |
| Positive controls | 20 | 0 | 2 | 18 | 100 * |
| 1 group of embodiment | 20 | 0 | 3 | 17 | 100 **#△ |
| 2 groups of embodiment | 20 | 1 | 4 | 15 | 95 **#△ |
| 3 groups of embodiment | 20 | 1 | 2 | 17 | 95 **#△ |
| 4 groups of embodiment | 20 | 0 | 3 | 17 | 100 **#△ |
| 5 groups of embodiment | 20 | 0 | 4 | 16 | 95 **#△ |
| 6 groups of embodiment | 20 | 1 | 3 | 16 | 95 **#△ |
| 1 group of comparative example | 20 | 7 | 5 | 8 | 65 * |
| 2 groups of comparative examples | 20 | 7 | 5 | 8 | 65 * |
With model group comparison,
*p<0.05,
*p<0.05; With 1 group of comparison of comparative example,
#p<0.05; With 1 group of comparison of comparative example,
△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 utmost point significant difference (P<0.01); The vaginitis effective percentage that comparative example is 1,2 groups is 60%, compared with model group, has significant difference (P<0.05);
Compared with 1,2 groups of comparative examples, the colpitic total effective rate that embodiment 1-6 respectively organizes rat obviously increases respectively, 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 change and vagina immunologic function unbalance, or the pathogen of Infective, easily there is multiple colpitis in vagina.Vaginitis is women's common frdquently encountered disease, and staphylococcus aureus and the escherichia coli common pathogen that is vaginitis.
The rat model that adopts staphylococcus aureus, escherichia coli and bacillus pyocyaneus mixed infection to cause is tested, inventor finds: Chinese medicine composition provided by the invention has the effect for the treatment of gynecological inflammation, especially at treatment vaginitis, particularly bacterial vaginitis aspect is evident in efficacy, and is better than prior art.
Although, above use general explanation, detailed description of the invention and test, the present invention is described in detail, on basis of the present invention, can make some modifications or improvements it, and 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 (11)
1. treat the Chinese medicine composition of bacterial vaginitis for one kind, composition by following weight portion is made: 7.69 parts of Radix Picriae felterrae, 11.54 parts of Elephantopus scaber L., 7.69 parts of Radix Angelicae Sinensis, 11.54 parts of Caulis Spatholobis, 11.54 parts of Radix Zanthoxylis, 11.54 parts of Radix calophylli membranacei, 11.54 parts of 11.54 parts of, Herba Thlaspiss of Folium Kaki, 15.38 parts of Herba Fici Simplicissimae, it is characterized in that, described Chinese medicine composition is prepared by following methods:
1) take nine taste Chinese medicines according to proportioning, then by medicinal ethanol extraction in nine tastes 2-3 time, add the 30-80% ethanol that nine taste Chinese medicine gross weight 6-12 doubly measure, each extraction time is 2-5 hour, reclaims medicinal residues at every turn, merge extractive liquid,, extracting solution filters, and the clear paste that when filtrate is concentrated into 50-70 DEG C, relative density is 1.10-1.20 is dry, obtain ethanol extract, for subsequent use;
2) water extraction 2-3 time of the medicinal residues after alcohol extraction adds the water that nine taste Chinese medicine gross weight 6-12 doubly measure at every turn, and each decocting time is 2-3 hour, collecting decoction, filter, the clear paste that when filtrate is concentrated into 50-70 DEG C, relative density is 1.10-1.20, adds ethanol and makes to reach 40-80% containing alcohol amount, leave standstill 6-24 hour, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10-1.20, dry, obtain water extract, for subsequent use;
3) combining step 1) ethanol extract and the step 2 of gained) water extract of gained, stir.
2. Chinese medicine composition according to claim 1, is characterized in that, described step 1) be:
Take nine taste Chinese medicines according to proportioning, then by medicinal ethanol extraction in nine tastes 2 times, add nine taste Chinese medicine gross weight 8-10 at every turn and doubly measure 70-80% ethanol, each extraction time is 3 hours, reclaims medicinal residues, merge extractive liquid,, extracting solution filters, the clear paste that when filtrate is concentrated into 60 DEG C, relative density is 1.12-1.15, dry, obtain ethanol extract.
3. Chinese medicine composition according to claim 2, is characterized in that, described step 1) be:
Take nine taste Chinese medicines according to proportioning, then by medicinal ethanol extraction in nine tastes 2 times, add 10 times of amount 80% ethanol of nine taste Chinese medicine gross weights at every turn, each extraction time is 3 hours, reclaims medicinal residues, merge extractive liquid,, extracting solution filters, the clear paste that when filtrate is concentrated into 60 DEG C, relative density is 1.15, dry, obtain ethanol extract.
4. Chinese medicine composition according to claim 2, is characterized in that, described step 1) be:
Take nine taste Chinese medicines according to proportioning, then by medicinal ethanol extraction in nine tastes 2 times, add 8 times of amount 70% ethanol of nine taste Chinese medicine weight at every turn, each extraction time is 3 hours, reclaims medicinal residues, merge extractive liquid,, filter, the clear paste that when filtrate is concentrated into 60 DEG C, relative density is 1.12, dry, obtain ethanol extract.
5. Chinese medicine composition according to claim 1, is characterized in that, described step 2) be:
Water extraction 2-3 time of medicinal residues after alcohol extraction, add the water that nine taste Chinese medicine gross weight 7-12 doubly measure, each decocting time is 2-3 hour, collecting decoction at every turn, filter, the clear paste that when filtrate is concentrated into 55-70 DEG C, relative density is 1.10-1.16, adds ethanol and makes to reach 60-80% containing alcohol amount, leaves standstill 6-18 hour, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.12-1.20, dry, obtain water extract.
6. Chinese medicine composition according to claim 5, it is characterized in that, described step 2) be: the water extraction of the medicinal residues after alcohol extraction 2-3 time, add the water that nine taste Chinese medicine gross weight 8-12 doubly measure at every turn, each decocting time is 3 hours, collecting decoction, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10-1.12, adds ethanol and makes to reach 70-80% containing alcohol amount, leaves standstill 6-12 hour, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.12-1.20, dry, obtain water extract.
7. Chinese medicine composition according to claim 6, is characterized in that, described step 2) be: the water extraction of the medicinal residues after alcohol extraction 2 times, add the water of 12 times of amounts of nine taste Chinese medicine gross weights, each decocting time is 3 hours, collecting decoction at every turn, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10, adds ethanol and makes to reach 80% containing alcohol amount, leaves standstill 6 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.20, dry, obtain water extract.
8. Chinese medicine composition according to claim 6, is characterized in that, described step 2) be: the water extraction of the medicinal residues after alcohol extraction 3 times, add the water of 8 times of amounts of nine taste Chinese medicine gross weights, each decocting time is 3 hours, collecting decoction at every turn, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.12, adds ethanol and makes to reach 70% containing alcohol amount, leaves standstill 12 hours, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.12, dry, obtain water extract.
9. a method of preparing Chinese medicine composition claimed in claim 1, is characterized in that, the method comprises the following steps:
1) take nine taste Chinese medicines according to proportioning, then use ethanol extraction 2-3 time, add the 30-80% ethanol that nine taste Chinese medicine gross weight 6-12 doubly measure, each extraction time is 2-5 hour, reclaims medicinal residues at every turn, merge extractive liquid,, extracting solution filters, and the clear paste that when filtrate is concentrated into 50-70 DEG C, relative density is 1.10-1.20 is dry, obtain ethanol extract, for subsequent use;
2) water extraction 2-3 time of the medicinal residues after alcohol extraction adds the water that nine taste Chinese medicine gross weight 6-12 doubly measure at every turn, and each decocting time is 2-3 hour, collecting decoction, filter, the clear paste that when filtrate is concentrated into 50-70 DEG C, relative density is 1.10-1.20, adds ethanol and makes to reach 40-80% containing alcohol amount, leave standstill 6-24 hour, filter, the clear paste that when filtrate is concentrated into 70 DEG C, relative density is 1.10-1.20, dry, obtain water extract, for subsequent use;
3) combining step 1) ethanol extract and the step 2 of gained) water extract of gained, stir.
10. containing the preparation of Chinese medicine composition described in claim 1-8 any one, 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.
The application in the medicine of preparation treatment bacterial vaginitis of Chinese medicine composition described in 11. claim 1-8 any one or preparation claimed in claim 10.
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