CN101579432A - Vaginal gel for treating gynecologic diseases, and preparation method thereof - Google Patents

Vaginal gel for treating gynecologic diseases, and preparation method thereof Download PDF

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Publication number
CN101579432A
CN101579432A CNA2008101117303A CN200810111730A CN101579432A CN 101579432 A CN101579432 A CN 101579432A CN A2008101117303 A CNA2008101117303 A CN A2008101117303A CN 200810111730 A CN200810111730 A CN 200810111730A CN 101579432 A CN101579432 A CN 101579432A
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China
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flos lonicerae
gel
organic acids
total organic
herba houttuyniae
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CNA2008101117303A
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Chinese (zh)
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刘会臣
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BEIJING PHARMASECE Co Ltd
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BEIJING PHARMASECE Co Ltd
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Abstract

The invention discloses a vaginal gel for treating gynecological inflammation, and a preparation method thereof. The vaginal gel is prepared mainly by taking houttuynia volatile oil and honeysuckle total organic acids as effective components. Meanwhile, the invention also discloses a method for preparing the vaginal gel. The method ensures higher content of the effective components by extracting, enriching and purifying houttuynia and honeysuckle. The vaginal gel has the characteristics of convenient drug administration, good absorption and high efficacy.

Description

A kind of vaginal gel for the treatment of gynaecopathia and preparation method thereof
Technical field
The invention belongs to medical technical field, specifically relate to a kind of Herba Houttuyniae extract of gynaecopathia and gel of pharmaceutical composition, particularly this pharmaceutical composition that Flos Lonicerae extract is formed and preparation method thereof for the treatment of.
Background technology
Vaginitis, cervicitis are modal gynaecopathias.Vaginitis is the general name of the multiple vaginal mucosa disease that causes of the different causes of disease.At the normal physiological state, the histological anatomy biochemistry characteristics of vagina are enough to prevent the invasion and attack of external microbe.If the sour environment of vagina runs into destruction, then pathogen is taken advantage of the occasion and goes into, and causes colpitis.The female reproduction investigation of health conditions shows, once suffers from colpitic adult female and accounts for 53.86%, wherein has 9.48% people to show effect repeatedly and reaches more than 4 times; Cervicitis is modal a kind of in the female sex organ inflammation, and the sickness rate height accounts for the more than half of married woman, is staphylococcus, streptococcus, escherichia coli, candidiasis and anaerobe and cause the main pathogenic bacteria of these gynecological inflammations.
Medicine for gynecopathy such as treatment vaginitis and cervicitis are divided into oral medicine and medicine for external use at present.Oral medicine is based on Chinese patent medicine, and dosage form comprises capsule, drop pill etc.; Medicine for external use is then based on chemical drugs, and dosage form is in the majority with built-in suppository, tablet.Medicines such as metronidazole, clotrimazole are all contained in most of gynecological with chemical drugs, too much use the restricting relation that destroys easily between vaginal microbial flora, make pathogenic bacterium produce drug resistance simultaneously, cause treatment cycle to prolong, and make disease can not get effective treatment.Suppository and tablet use inconvenient, easily cause intravaginal that foreign body sensation and easy damaged vagina are arranged, and it is relatively slow to bring into play drug effect simultaneously; Become liquid after suppository dissolves and easily flow out vagina, pollution clothes, action time, short, medicine was difficult to whole releases like this.
Gel be a class contain two or more, by solid-liquid two phase compositions, have the macromolecular network system of semi-solid property.With medicine dissolution or be evenly distributed on and be gel in the gel, gel has good adhesive force and film forming characteristics, so it can keep long-time tight adhesion with site of action, biocompatibility is preferably arranged, method for making is simple, easy to use, comfortable, after making vaginal gel, long in the intravaginal holdup time, medicine can all discharge, the bioavailability height, and intravaginal does not have foreign body sensation, can not damage vagina, is difficult for pollution clothes, therefore, vaginal gel is a kind of ideal vagina medicinal pharmaceutical dosage form.
Herba Houttuyniae is the fresh herb or the dry aerial parts of saururaceae plant houttuynia cordata for Chinese medicine commonly used, has the effect of heat-clearing and toxic substances removing, eliminating carbuncle evacuation of pus, inducing diuresis for treating stranguria syndrome, cures mainly diseases such as lung abscess vomiting pus, expectorant dyspnea of heat type are coughed, hematodiarrhoea, pyretic stranguria, carbuncle sore tumefacting virus.Herba Houttuyniae mainly contain volatile oil, main chemical compositions is houttuynine sodium bisulfite, myrcene, methylnonanone etc., have multiple activity such as resisting pathogenic microbes, enhancing human body immunity function, analgesic, analgesia, antiinflammatory, antiallergic for modern pharmacology studies have shown that it, be used for the treatment of diseases of the five sense organies such as respiratory tract infection such as acute/chronic bronchitis, pneumonia and suppurative otitis media clinically.Flos Lonicerae is the dry flower of caprifoliaceae plant Radix Ophiopogonis, Flos Lonicerae, Flos Lonicerae or hair style Radix Ophiopogonis or the flower that band is just opened, the property sweet, cold, return lung, the heart, stomach warp, mainly contain multiple chlorogenic acid chemical compound, flavone and volatile oil etc., has heat-clearing and toxic substances removing, the effect of wind-heat dissipating is used for the carbuncle furuncle, sore throat, erysipelas, toxic-heat and blood stasis, anemopyretic cold, epidemic febrile disease heating.The two all has good antiinflammatory and antivirus action, and the two extract combination is used for gynaecopathia and does not see that bibliographical information is arranged.
Summary of the invention
The medicine of gynaecopathias such as quality is good, curative effect is fast, the little treatment cervicitis of side effect and vaginitis is still people's demand.The inventor creatively is applied to gynecological inflammation with fish gold preparation and combines with modern preparation technique, has overcome the shortcoming of traditional gynecological suppository, and in anti-bacteria and anti-virus, it is good to have a compatibility, and adhesion is strong, the advantage of no foreign body sensation.
Pharmaceutical composition of the present invention is mainly Flos Lonicerae extract and Herba Houttuyniae extract.Flos Lonicerae extract is mainly the Flos Lonicerae total organic acids, and Herba Houttuyniae extract is mainly Herba Houttuyniae volatile oil.
In the pharmaceutical composition Flos Lonicerae extract of the present invention total organic acids in chlorogenic acid greater than 50%.
The object of the present invention is to provide a kind of prescription to simplify, composition and effectiveness is clear and definite, determined curative effect, dosage form advanced person's Amino-Cerv.
Another purpose of the present invention provides the preparation method of this pharmaceutical composition gel.
The present invention can be achieved through the following technical solutions:
1, the preparation of Herba Houttuyniae volatile oil
Herba Houttuyniae volatile oil can adopt conventional steam distillation to extract, and also can adopt the co_2 supercritical fluid extraction method to extract.
Get the Herba Houttuyniae medical material of predetermined weight part, suitably chopping adds the water that 5-8 doubly measures, and steam distillation heating extraction volatile oil 4-6 hour gets Herba Houttuyniae volatile oil.
Perhaps: get the Herba Houttuyniae medical material of predetermined weight part, give as one thinks fit cataclasmly, be added in the supercritical extraction reactor, extracted 4-6 hour, Herba Houttuyniae volatile oil.
2, the extraction of Flos Lonicerae total organic acids preparation
Get the Chinese medicine honeysuckle of predetermined weight part, adding 6-10, doubly to measure warm water moistening, hot dipping 1-3 time, filter, immersion merges, and filters, concentrating under reduced pressure makes medicine liquid volume and medical material weight (ml: g) be 1: 1, high speed centrifugation, centrifugal liquid adds on the macroporous adsorbent resin of having handled well, first water flushing, the alcohol flushing of reuse 30%-60%, collect the ethanol elution of 30%-60%, decompression recycling ethanol is evaporated to driedly, promptly gets Flos Lonicerae total organic acids extract.
3, the preparation of fish gold vaginal gel
Carbomer with an amount of distilled water swelling, again with an amount of propylene glycol, distilled water mix homogeneously, is added triethanolamine then while stirring and makes into gel-type vehicle; Herba Houttuyniae volatile oil is dissolved in 95% ethanol, and the Flos Lonicerae total organic acids is dissolved in an amount of distilled water, and it adds in the gel-type vehicle with the two under constantly stirring, and adds suitable quantity of water again, regulates pH value to 4.0, and mix homogeneously is inserted in the vaginal administration device, promptly.
The present invention will be used for gynecological inflammation after will treating the extraction of the golden preparation process of the fish that catches a cold, purification, have effect preferably aspect resisting pathogenic microbes; The present invention combines novel pharmaceutical formulation with Chinese medicine, when strengthening drug effect, increased the comfortableness and the compliance of medication.
The present invention is further illustrated below by the pharmacodynamic experiment example
(1) anti-rabbit vagina mucosa fungal infection test:
Get 60 of Female rabbits, be divided into 6 groups at random, 10 every group, wherein inoculate (about 500,000,000/ml), and cause the vagina local failure of white beads ball (from colpitis mycotica patient vaginal secretions, separating) bacterium liquid 0.2ml in intravaginal for 5 groups.In inoculation beginning in back 24 hours, inject distilled water, 10%, 50%, 100% fish gold vagina with each 0.5ml of gel from vagina every day respectively, treated altogether 7 days.Each is organized in treatment execution in back second day animal and makes vaginal smear examination, and adopts vagina merocrine secretion thing and make fungal culture, at last vagina is done the pathology cut sections for microscopic examination.The result shows that fish gold vaginal gel has the artificial fungal infection effect of anti-preferably rabbit vagina mucosa, and its vaginal smear, mycology are cultivated, the check pathological section result compares there was no significant difference (P>0.05) with the JIEERYIN group.The results are shown in Table l.
Table l angle of the present invention can vagina with the artificial fungal infection curative effect of the anti-vaginal mucosa of gel
Figure A20081011173000061
(2) anti-mice caused by dimethylbenzene xylene ear swelling test
Get 72 of mices, be divided into 6 groups at random, 12 every group.Be applied to two sides, mouse right ear front and back with dimethylbenzene, every 0.02ml after half an hour, is coated with at the test position by above-mentioned dosage and administration and is subjected to reagent thing and tester.Put to death mice after 4 hours, lay auricle respectively in mice left and right sides ear same position, weigh with card punch.Deduct left auricle weight with the auris dextra sheet of every Mus and be the swelling degree.The results are shown in Table 2.
The influence that table 2 fish gold vagina is tested mice ear with gel (X ± S)
Figure A20081011173000071
Annotate: * * and model control group be P<0.01 relatively
The result shows, fish gold vagina of the present invention with 3 dosage groups of gel all can obviously suppress mice ear test in the ear thickness of mice, through variance analysis, compare with model control group, significant difference (P<0.01) is arranged, compare there was no significant difference (P>0.05) with the JIEERYIN group.
The specific embodiment:
Embodiment 1
Prescription: Herba Houttuyniae 4000g Flos Lonicerae 2000g
Get the Herba Houttuyniae medical material, add the distilled water of 8 times of amounts, after the moistening, water vapour distillation volatile oil 5 hours, it is standby to get volatilization fluid; The extracting honeysuckle medical material, it is moistening to add 8 times of calorimetric water, 80 ℃ of lixiviates 3 times, filter, filtrate merges, concentrating under reduced pressure, making medicine liquid volume and medical material weight is that (ml: g), high speed centrifugation joined on the macroporous adsorbent resin of having handled well in 1: 1, elder generation's water flushing, the alcohol flushing of reuse 30% is collected 30% ethanol elution, decompression recycling ethanol, be evaporated to driedly, promptly get Flos Lonicerae total organic acids extract.
Carbomer-934 usefulness dissolved in distilled water is become 4% aqueous solution,, add triethanolamine then while stirring and make into gel-type vehicle again with an amount of propylene glycol, distilled water mix homogeneously; Herba Houttuyniae volatile oil is dissolved in a small amount of 95% ethanol, the Flos Lonicerae total organic acids is dissolved in an amount of distilled water, slowly be added in the gel-type vehicle, stir, add an amount of distilled water again, regulate pH to 4.0, mix homogeneously with hydrochloric acid then, insert in the vaginal administration device, promptly get vaginal gel of the present invention.
Embodiment 2
Prescription: Herba Houttuyniae 4000g Flos Lonicerae 4000g
Get the Herba Houttuyniae medical material, add the distilled water of 10 times of amounts, after the moistening, water vapour distillation volatile oil 4 hours, it is standby to get volatilization fluid; The extracting honeysuckle medical material, it is moistening to add 10 times of calorimetric water, 80 ℃ of lixiviates 2 times, filter, filtrate merges, concentrating under reduced pressure, making medicine liquid volume and medical material weight is that (ml: g), high speed centrifugation joined on the AB-8 macroporous adsorbent resin of having handled well in 1: 1, water with 2 times of column volumes washes earlier, 60% alcohol flushing of 4 times of column volumes of reuse is collected 60% ethanol elution, decompression recycling ethanol, be evaporated to dried, Flos Lonicerae total organic acids extract.
Carbomer-934 usefulness dissolved in distilled water is become 4% aqueous solution,, add triethanolamine then while stirring and make into gel-type vehicle again with an amount of propylene glycol, distilled water mix homogeneously; Herba Houttuyniae volatile oil is dissolved in a small amount of 95% ethanol, the Flos Lonicerae total organic acids is dissolved in an amount of distilled water, slowly be added in the gel-type vehicle, stir, add an amount of distilled water again, regulate pH to 4.0, mix homogeneously with hydrochloric acid then, insert in the vaginal administration device, promptly get vaginal gel of the present invention.
Embodiment 3
Prescription: Herba Houttuyniae 4000g Flos Lonicerae 2000g
Get the Herba Houttuyniae medical material, add the distilled water of 8 times of amounts, after the moistening, water vapour distillation volatile oil 5 hours, it is standby to get volatilization fluid; The extracting honeysuckle medical material, it is moistening to add 10 times of calorimetric water, 80 ℃ of lixiviates 2 times, filter, filtrate merges, concentrating under reduced pressure, making medicine liquid volume and medical material weight is that (ml: g), high speed centrifugation joined on the AB-8 macroporous adsorbent resin of having handled well in 1: 1, water with 2 times of column volumes washes earlier, 40% alcohol flushing of 4 times of column volumes of reuse is collected 40% ethanol elution, decompression recycling ethanol, be evaporated to dried, Flos Lonicerae total organic acids extract.
Carbomer-934 usefulness dissolved in distilled water is become 4% aqueous solution,, add triethanolamine then while stirring and make into gel-type vehicle again with an amount of propylene glycol, distilled water mix homogeneously; Herba Houttuyniae volatile oil is dissolved in a small amount of 95% ethanol, the Flos Lonicerae total organic acids is dissolved in an amount of distilled water, slowly be added in the gel-type vehicle, stir, add an amount of distilled water again, regulate pH to 4.0, mix homogeneously with hydrochloric acid then, insert in the vaginal administration device, promptly get vaginal gel of the present invention.

Claims (4)

1, a kind of vaginal gel that is used for gynecological inflammation, it is characterized in that: used medicinal raw material is made up of Herba Houttuyniae and Flos Lonicerae, and main effective ingredient is Herba Houttuyniae volatile oil and Flos Lonicerae total organic acids extract.
2, the described vaginal gel of claim 1 is characterized in that described Flos Lonicerae exchange acid content is not less than 30%.
3, the described vaginal gel of claim 1 is characterized in that the content of total organic acids in the described Flos Lonicerae exchange acid extraction thing is not less than 50%.
4, a kind of preparation method that is used for the vaginal gel of gynecological inflammation comprises that the following step poly-:
(1), the preparation of Herba Houttuyniae volatile oil
Herba Houttuyniae volatile oil can adopt conventional steam distillation to extract, and also can adopt the co_2 supercritical fluid extraction method to extract.
(2), the preparation of Flos Lonicerae total organic acids
Get the Chinese medicine honeysuckle of predetermined weight part, adding 6-10, doubly to measure warm water moistening, hot dipping 1-3 time, filter, immersion merges, and filters, concentrating under reduced pressure makes medicine liquid volume and medical material weight (ml: g) be 1: 1, high speed centrifugation, centrifugal liquid adds on the macroporous adsorbent resin of having handled well, first water flushing, the alcohol flushing of reuse 30%-60%, collect the ethanol elution of 30%-60%, decompression recycling ethanol is evaporated to driedly, promptly gets Flos Lonicerae total organic acids extract.
(3), the preparation of vaginal gel
Carbomer with an amount of distilled water swelling, again with an amount of propylene glycol, distilled water mix homogeneously, is added triethanolamine then while stirring and makes into gel-type vehicle; Herba Houttuyniae volatile oil is dissolved in 95% ethanol, and the Flos Lonicerae total organic acids is dissolved in an amount of distilled water, and above-mentioned volatile oil and total organic acids are added in the gel-type vehicle, stir, add suitable quantity of water again, regulate pH value to 4.0, mix homogeneously is inserted in the vaginal administration device, promptly.
CNA2008101117303A 2008-05-15 2008-05-15 Vaginal gel for treating gynecologic diseases, and preparation method thereof Pending CN101579432A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106798915A (en) * 2017-03-21 2017-06-06 郭燕立 A kind of utilization rhEGF treatment cervical erosion and the gel of damage and preparation method thereof
CN110420235A (en) * 2019-08-09 2019-11-08 杭州清净和生物工程有限公司 It is a kind of for balancing the Chinese medicine preparation of microecology in vaginas
CN111617245A (en) * 2020-07-04 2020-09-04 福州弘海生物科技有限公司 Multi-purpose anti-inflammatory foam for female vagina
CN114652773A (en) * 2022-04-22 2022-06-24 湖南省中医药研究院 Gynecological gel and preparation method and application thereof

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106798915A (en) * 2017-03-21 2017-06-06 郭燕立 A kind of utilization rhEGF treatment cervical erosion and the gel of damage and preparation method thereof
CN110420235A (en) * 2019-08-09 2019-11-08 杭州清净和生物工程有限公司 It is a kind of for balancing the Chinese medicine preparation of microecology in vaginas
CN111617245A (en) * 2020-07-04 2020-09-04 福州弘海生物科技有限公司 Multi-purpose anti-inflammatory foam for female vagina
CN114652773A (en) * 2022-04-22 2022-06-24 湖南省中医药研究院 Gynecological gel and preparation method and application thereof

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Open date: 20091118