CN1895361A - Chinese-medicinal composition for treating gynecological inflammation and its preparation - Google Patents

Chinese-medicinal composition for treating gynecological inflammation and its preparation Download PDF

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CN1895361A
CN1895361A CN 200610027752 CN200610027752A CN1895361A CN 1895361 A CN1895361 A CN 1895361A CN 200610027752 CN200610027752 CN 200610027752 CN 200610027752 A CN200610027752 A CN 200610027752A CN 1895361 A CN1895361 A CN 1895361A
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add
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water
pharmaceutical composition
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CN1895361B (en
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金幸�
汤磊
方积年
王琰
朱益锋
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Shanghai Cirui Pharmaceutical Sci & Tech Co Ltd
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Shanghai Cirui Pharmaceutical Sci & Tech Co Ltd
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Abstract

A Chinese medicine in the form of tablet, capsule, dripping pill, injection, suppository, effervescent tablet, etc for treating pelvic inflammation, cervicitis, salpingitis, vulvitis and vaginitis is prepared from prunella spike, eucalyptus leaf and honeysuckle flower. Its preparing process is also disclosed.

Description

Pharmaceutical composition of a kind of treatment by Chinese herbs gynecological inflammation and preparation method thereof
Technical field
The present invention relates to pharmaceutical composition of a kind of treatment by Chinese herbs gynecological inflammation and preparation method thereof, belong to technical field of Chinese medicines.
Background technology
Gynecological inflammation occupies very big ratio in gynaecopathia, especially cervicitis, pelvic inflammatory disease, salpingitis, vulvitis and vaginitis.At present, treat gynecological inflammation clinically and mainly adopt heavy dose of antibiotic, also need multiple antibiotic to share sometimes, make that antibiotic side effects such as drug resistance, complication are obvious day by day.
Summary of the invention
The purpose of this invention is to provide a kind of good effect, pharmaceutical composition of the treatment by Chinese herbs gynecological inflammation that side effect is little and preparation method thereof.
For realizing above purpose, technical scheme of the present invention provides a kind of pharmaceutical composition of the treatment by Chinese herbs gynecological inflammation of being made for raw material by Herba Ajugae (HerbaAjugae), Folium eucalypti globueli (Eucalyptus globulus Labill.) (Folium Eucalypti) and Flos Lonicerae (Flos Lonicerae Japonicae), it is characterized in that, can treat pelvic inflammatory disease, cervicitis, salpingitis, vulvitis and vaginitis.
A kind of pharmaceutical composition of treatment by Chinese herbs gynecological inflammation is characterized in that, is made by the raw material of following weight portion: Herba Ajugae 1-5 part, Folium eucalypti globueli (Eucalyptus globulus Labill.) 2-6 part, Flos Lonicerae 1-4 part; Dosage form has tablet, capsule, drop pill, mixture, granule, injection, suppository, effervescent tablet, subcutaneous administration preparation.
A kind of preparation of drug combination method of treatment by Chinese herbs gynecological inflammation the steps include:
Step 1: Herba Ajugae and the preparation of Folium eucalypti globueli (Eucalyptus globulus Labill.) volatile oil
A) get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) material, merge and pulverize, in the supercritical fluid extraction jar of packing into, carbon dioxide is the supercritical extraction fluid, flow 2.0-3.0 liter/minute, pressure 20-30MPa, temperature 35-40 ℃, time 60-80 minute, get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) volatile oil A;
B) or get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) medical material, merge and pulverize, in the volatile oil extractor of packing into, adds 8-10 times of water gaging, fed steam distillation 4-5 hour, collect distillate just, redistillation 3-4 hour again, get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) volatile oil B;
Step 2: Flos Lonicerae extract preparation
A) extracting honeysuckle medical material, the water decoction adds water 7-9 twice, the 1 time and doubly measures, decocted 1 hour, pour out extracting solution, add water 6-8 the 2nd time doubly to measure, decocted 1 hour, merge extractive liquid,, centrifugal, get the supernatant concentrating under reduced pressure, pressure is-0.2--0.9Mpa, spray drying or vacuum drying get Flos Lonicerae extract C;
B) or the extracting honeysuckle medical material, with 60-80% alcohol reflux 2 times, add ethanol 7-9 and doubly measure for the 1st time, refluxed 2 hours, pour out extracting solution, add ethanol 6-8 the 2nd time doubly to measure, refluxed 1 hour, merge extractive liquid,, filter, decompression filtrate recycling ethanol also concentrates, and pressure is-0.2--0.9Mpa, spray drying or vacuum drying get Flos Lonicerae extract D;
Step 3: extract mixes and the dosage form preparation
A) extract A or B are mixed with extract C or D, get extract E;
B) press extract E and drop pill substrate polyethylene glycol 6000 weight ratio 1: 2-5 mixes, and is heated to 85-95 ℃ of fusion, drips system with dimethicone as coolant, collects drop pill, absorbs coolant, promptly gets oral administration dripping pill;
C) in the extract E of step a), add 1-5 and doubly measure water for injection, stir cold preservation, centrifugal, get supernatant, add the injection water to the recipe quantity volume, add 9g sodium chloride and 1-5ml Tween 80 by every 1000ml, stir, cold preservation, centrifugal, the supernatant filtering with microporous membrane, embedding, sterilization promptly gets injection;
D) in the extract E of step a), add with extract E weight ratio be 1: 1-1: 2 Tween 80 and with extract E weight ratio 1: 1-1: 20 semi-synthetic fatty acid glyceride, heating in water bath dissolves, mix homogeneously, pour molding in the bolt mould while hot into, cooling, remove after treating to solidify fully and overflow part, promptly get suppository;
E) in the extract E of step a), add weight ratio 1: 1-1: 4 medical starch, 1: 0.1-1: 0.8 sodium carboxymethyl cellulose and 1: 0.01-1: 0.05 beta-schardinger dextrin-, mix homogeneously is granulated, tabletting promptly gets the oral tablet of pharmaceutical composition of the present invention;
F) in the extract E of step a), add weight ratio 1: 0.5-1: 3 carboxymethyl starch sodium, mixing granulation, filled capsules promptly gets medicament composition capsule agent of the present invention.
Advantage of the present invention is a good effect, and side effect is little.
The specific embodiment
The invention will be further described for following examples.
Embodiment 1: the preparation of drop pill
Get 1 part of Herba Ajugae, 2 parts of Folium eucalypti globueli (Eucalyptus globulus Labill.)s merge and pulverize, and in the supercritical fluid extraction jar of packing into, carbon dioxide is the supercritical extraction fluid, 2.5 liters/minute of flows, and pressure 25MPa, 35 ℃ of temperature, get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) extractive of volatile oil A at 80 minutes time;
1 part of extracting honeysuckle with 70% alcohol reflux 2 times, adds 8 times of amounts of ethanol the 1st time, refluxes 2 hours, pours out extracting solution, add 6 times of amounts of ethanol for the 2nd time, refluxed 1 hour, merge extractive liquid, filters filtrate decompression, pressure is-0.8Mpa, reclaim ethanol and concentrate, spray drying, Flos Lonicerae extract D;
Extract A is mixed with extract D, get extract E, press extract E and mix at 1: 2 with drop pill substrate polyethylene glycol 6000 weight ratio, be heated to 85 ℃ of fusions, drip system as coolant, collect drop pill with dimethicone, absorb coolant, promptly get the drop pill of pharmaceutical composition of the present invention.
Embodiment 2: the preparation of tablet
Get the extract E1 part among the embodiment 1, add 3 parts of medical starches, 0.5 part of sodium carboxymethyl cellulose, 0.3 part of beta-schardinger dextrin-, mix homogeneously is granulated, and tabletting promptly gets the tablet of pharmaceutical composition of the present invention.
Embodiment 3: the preparation of capsule
Get the extract E1 part among the embodiment 1, add 2 parts of carboxymethyl starch sodium, mix homogeneously is granulated, and filled capsules promptly gets the capsule of pharmaceutical composition of the present invention.
Embodiment 4: the preparation of injection
Get 5 parts of Herba Ajugaes, 2 parts of Folium eucalypti globueli (Eucalyptus globulus Labill.)s, merging is pulverized, and in the volatile oil extractor of packing into, adds 10 times of water gagings, feeds steam distillation 5 hours, collects distillate just, and redistillation is 3 hours again, gets Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) extractive of volatile oil B;
2 parts of extracting honeysuckles, water decoct twice, the 1 time and add 9 times of amounts of water, decoct 1 hour, add 7 times of amounts of water the 2nd time, decocted 1 hour, and merge extractive liquid,, centrifugal, get the supernatant concentrating under reduced pressure, pressure is-0.9Mpa, spray drying must Flos Lonicerae extract C;
Extract B is mixed with extract C, add 2 times of amount waters for injection, stir, cold preservation, centrifugal, get supernatant, add the injection water to the recipe quantity volume, add 9g sodium chloride and 3ml Tween 80, stir by every 1000ml, cold preservation, centrifugal, supernatant filtering with microporous membrane, embedding, sterilization promptly gets medicine composition injection of the present invention.
Embodiment 5: the preparation of suppository
Get 3 parts of Herba Ajugaes, 4 parts of Folium eucalypti globueli (Eucalyptus globulus Labill.)s merge and pulverize, and in the supercritical fluid extraction jar of packing into, carbon dioxide is the supercritical extraction fluid, 2.5 liters/minute of flows, and pressure 25MPa, 35 ℃ of temperature, get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) extractive of volatile oil A at 80 minutes time;
1 part of extracting honeysuckle, water decoct twice, the 1 time and add 9 times of amounts of water, decoct 1 hour, pour out extracting solution, add 7 times of amounts of water the 2nd time, decocted 1 hour, and merge extractive liquid,, centrifugal, get the supernatant concentrating under reduced pressure, pressure is-0.8Mpa, spray drying must Flos Lonicerae extract C;
Extract A is mixed with extract C, get extract F, go into and equiponderant Tween 80 of F and the semi-synthetic fatty acid glyceride that is equivalent to 15 times of F weight, heating in water bath dissolves, and mix homogeneously is poured molding in the bolt mould while hot into, cooling, remove after treating to solidify fully and overflow part, release suppository, promptly get pharmaceutical composition suppository of the present invention.
Pharmaceutical composition of the present invention proves the effectiveness of its treatment gynecological inflammation by pharmacological testing and clinical practice.
One, pharmacological testing
1, bacteriostatic test
Method: agar dilution
Pharmaceutical composition of the present invention is made serial dilution with the agar culture medium that has melted, pour into the plating medium that becomes to contain different pharmaceutical concentration.Establish each one of the plating medium that do not add medicinal liquid and contain penicillin, streptomycin simultaneously, make antibacterial normal growth contrast and positive drug respectively and contrast.The flat board of inoculation test bacterium liquid put in 37 ℃ of incubators cultivated 24 hours, each bacterial strain of observed and recorded is at the growing state of different pharmaceutical concentration culture medium.The least concentration of pharmaceutical composition bacteria growing inhibiting of the present invention is minimal inhibitory concentration (MIC), represents the external antibacterial intensity of medicine with it.The results are shown in Table 1.
Table 1, pharmaceutical composition extracorporeal bacteria inhibitor test result of the present invention
Strain name The bacterial strain number Pharmaceutical composition minimal inhibitory concentration MIC of the present invention (mg/ml) Penicillin 1000u/ml Streptomycin 1000u/ml The antibacterial contrast
Staphylococcus aureus 4 25.31±8.26 - - +
Bacillus pyocyaneus 5 13.52±11.35 + - +
B family streptococcus 3 32.63±13.62 - - +
Escherichia coli 3 35.17±9.87 - - +
Klebsiella pneumoniae 2 63.25±15.32 - - +
Annotate: "-" is no bacterial growth, and "+" is for there being bacterial growth
The result shows that pharmaceutical composition of the present invention all has inhibitory action in various degree to the examination bacterial strain, especially to bacillus pyocyaneus, staphylococcus aureus, B family streptococcus and escherichia coli.
2, antiinflammatory test
Method: Ovum Gallus domesticus album causes the rat paw edema model
The SD rat is divided 4 groups at random, 10 every group: matched group; High, medium and low three the dosage groups of pharmaceutical composition of the present invention.It is long-pending to survey the Mus corpus unguis with drainage earlier, the difference oral administration, and matched group is given with the volume distilled water.It is subcutaneous with syringe Ovum Gallus domesticus album to be injected the left back foot sole of the foot of rat after 1 hour, every 0.05ml, and it is long-pending to measure the Mus corpus unguis respectively at 0.5,1,2,3,4,5,6 hour then, calculates Mus pawl swelling percentage rate.The results are shown in Table 2.
Table 2 pharmaceutical composition of the present invention causes the effect of rat paw edema to Ovum Gallus domesticus album
The result shows that the middle dosage of pharmaceutical composition of the present invention and high dose group cause rat paw edema to Ovum Gallus domesticus album and have remarkable inhibitory action, shows that it has tangible antiinflammatory action.
Two, clinical practice
The suppository of pharmaceutical composition of the present invention used for 3 weeks through 89 routine pelvic inflammatory disease, cervicitis, salpingitis and vaginitis patient, observed clinical symptoms and laboratory indexes, and total effective rate is 85%, and 11 examples of wherein fully recovering account for 12.3%; Produce effects 50 examples account for 55.9%; 15 examples that take a turn for the better account for 16.8%; 9 examples that midway come off account for 8.6%; Invalid 7 examples account for 6.7%.Do not see that toxic and side effects takes place.
Above pharmacological testing and clinical practice result show that pharmaceutical composition of the present invention has significant curative effect to gynecological inflammation such as pelvic inflammatory disease, cervicitis, salpingitis, vulvitis and vaginitis etc.

Claims (3)

1. the pharmaceutical composition of a treatment by Chinese herbs gynecological inflammation is characterized in that, can treat pelvic inflammatory disease, cervicitis, salpingitis, vulvitis and vaginitis.
2. the pharmaceutical composition of a treatment by Chinese herbs gynecological inflammation, it is characterized in that, raw material by following weight portion is made: Herba Ajugae 1-5 part, Folium eucalypti globueli (Eucalyptus globulus Labill.) 2-6 part, Flos Lonicerae 1-4 part, dosage form have tablet, capsule, drop pill, mixture, granule, injection, suppository, effervescent tablet, subcutaneous administration preparation.
3. the preparation of drug combination method of a kind of treatment by Chinese herbs gynecological inflammation according to claim 2 the steps include:
Step 1: Herba Ajugae and the preparation of Folium eucalypti globueli (Eucalyptus globulus Labill.) volatile oil
A) get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) material, merge and pulverize, in the supercritical fluid extraction jar of packing into, carbon dioxide is the supercritical extraction fluid, flow 2.0-3.0 liter/minute, pressure 20-30MPa, temperature 35-40 ℃, time 60-80 minute, get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) volatile oil A;
B) or get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) medical material, merge and pulverize, in the volatile oil extractor of packing into, adds 8-10 times of water gaging, fed steam distillation 4-5 hour, collect distillate just, redistillation 3-4 hour again, get Herba Ajugae and Folium eucalypti globueli (Eucalyptus globulus Labill.) volatile oil B;
Step 2: Flos Lonicerae extract preparation
A) extracting honeysuckle medical material, the water decoction adds water 7-9 twice, the 1 time and doubly measures, decocted 1 hour, pour out extracting solution, add water 6-8 the 2nd time doubly to measure, decocted 1 hour, merge extractive liquid,, centrifugal, get the supernatant concentrating under reduced pressure, pressure is-0.2--0.9Mpa, spray drying or vacuum drying get Flos Lonicerae extract C;
B) or the extracting honeysuckle medical material, with 60-80% alcohol reflux 2 times, add ethanol 7-9 and doubly measure for the 1st time, refluxed 2 hours, pour out extracting solution, add ethanol 6-8 the 2nd time doubly to measure, refluxed 1 hour, merge extractive liquid,, filter, decompression filtrate recycling ethanol also concentrates, and pressure is-0.2--0.9Mpa, spray drying or vacuum drying get Flos Lonicerae extract D;
Step 3: extract mixes and the dosage form preparation
A) extract A or B are mixed with extract C or D, get extract E;
B) press extract E and drop pill substrate polyethylene glycol 6000 weight ratio 1: 2-5 mixes, and is heated to 85-95 ℃ of fusion, drips system with dimethicone as coolant, collects drop pill, absorbs coolant, promptly gets drop pill;
C) in the extract E of step a), add 1-5 and doubly measure water for injection, stir cold preservation, centrifugal, get supernatant, add the injection water to the recipe quantity volume, add 9g sodium chloride and 3ml Tween 80 by every 1000ml, stir, cold preservation, centrifugal, the supernatant filtering with microporous membrane, embedding, sterilization promptly gets injection;
D) in the extract E of step a), add and extract E weight ratio 1: 1-1: 2 Tween 80 and with extract E weight ratio 1: 1-1: 20 semi-synthetic fatty acid glyceride, heating in water bath dissolves, mix homogeneously, pour molding in the bolt mould while hot into, cooling, remove after treating to solidify fully and overflow part, promptly get suppository;
E) in the extract E of step a), add weight ratio 1: 1-1: 4 medical starch, 1: 0.1-1: 0.8 sodium carboxymethyl cellulose and 1: 0.01-1: 0.05 beta-schardinger dextrin-, mix homogeneously is granulated, and tabletting promptly gets the tablet of pharmaceutical composition of the present invention;
F) in the extract E of step a), add weight ratio 1: 0.5-1: 3 carboxymethyl starch sodium, mixing granulation, filled capsules promptly gets the capsule of pharmaceutical composition of the present invention.
CN2006100277522A 2006-06-19 2006-06-19 Chinese-medicinal composition for treating gynecological inflammation and its preparation Expired - Fee Related CN1895361B (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104606284A (en) * 2013-11-05 2015-05-13 北京康辰药业有限公司 New uses of Ajuga ciliata Bunge extract
CN108576542A (en) * 2018-05-24 2018-09-28 杨进成 A kind of mixed type draft solid beverage and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104606284A (en) * 2013-11-05 2015-05-13 北京康辰药业有限公司 New uses of Ajuga ciliata Bunge extract
CN108576542A (en) * 2018-05-24 2018-09-28 杨进成 A kind of mixed type draft solid beverage and preparation method thereof

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