CN1210050C - Medicine for treating bacterial vaginal disease - Google Patents
Medicine for treating bacterial vaginal disease Download PDFInfo
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- CN1210050C CN1210050C CN 03104544 CN03104544A CN1210050C CN 1210050 C CN1210050 C CN 1210050C CN 03104544 CN03104544 CN 03104544 CN 03104544 A CN03104544 A CN 03104544A CN 1210050 C CN1210050 C CN 1210050C
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Abstract
The present invention relates to a drug for treating bacterial vaginosis, particularly to a medicinal composition for treating the bacterial vaginosis. The bacterial vaginosis is one of common gynecological vaginal infectious diseases, which accounts for 40 to 50% of vulva infections, and the ages of patients with the bacterial vaginosis are from 15 to 44 or so; the bacterial vaginosis is relevant to cervical atypical hyperplasia, and the women with the cervical atypical hyperplasia has twice the morbidity of normal women. Besides, the bacterial vaginosis can cause other gynecological syndromes. At present, antibiotics are usually used for treating the bacterial vaginosis, but the effect of the antibiotics is not good, and the relapse rate of the bacterial vaginosis is high; the treatment of the bacterial vaginosis is a problem which is clinically not solved for many years. The drug of the present invention is prepared from components of the following proportion by weight: 100 to 120 of astragalus extract, 80 to 120 of licorice extract and 70 to 100 of flavescent sophora extract. The present invention has the advantages of pain and itch elimination at high efficiency and a high speed, vagina dysbacteriosis adjustment, no relapse during the treatment of the bacterial vaginosis and little side effect.
Description
Technical field: the present invention relates to a kind of compositions for the treatment of the bacterial vaginosis medicine.
Background technology: bacterial vaginosis is that the common gynaecologic vaginal of women one of catches, and accounts for the 40-50% that outer vagina infects, and patient age is about 15-44 year, and is and relevant with cervical atypical hyperplasia, is 2 times of normal women.In addition, often can cause other gynecological's syndromes.At present, the treatment bacterial vaginosis adopts antibiotic more, but poor effect, the relapse rate height, the treatment of this disease is clinical unsolved for many years problem.
Summary of the invention: the object of the present invention is to provide a kind of medicine for the treatment of bacterial vaginosis, it should have efficiently removes painful itching fast, adjusts vaginal dysbacteriosis, and the treatment bacterial vaginosis does not recur the characteristics that side effect is little.Medicine of the present invention is formulated by following parts by weight by Radix Astragali extract, Radix Glycyrrhizae extract, Radix Sophorae Flavescentis extract: Radix Astragali extract 100-120, Radix Glycyrrhizae extract 80-120, Radix Sophorae Flavescentis extract 70-100; The extraction of medicine of the present invention and preparation method: (1) gets the Radix Astragali, the Radix Sophorae Flavescentis decoction pieces decocts 3 times, and each 90 minutes, concentrated extracting solution, the ethanol that cooling back adds 95% concentration makes and contains the alcohol amount and reach 75%, leave standstill 24 hours after, filter, reclaim alcohol, it is standby to be condensed into extractum cold drying in baking oven.(2) the extracting liquorice coarse powder add 0.1% concentration ammonia in the percolation bucket, soak after 24 hours, the beginning percolation, 1 droplet/second of the speed of filtering, the liquid of filtering transfers pH value to 3-4 with the sulfuric acid solution of 1% concentration, leaves standstill 24 hours, filters to such an extent that precipitate, 60 ℃ of dry glycyrrhizic acid inclusion compounds that get.(3) take by weighing three flavor Chinese medicine extract by ratio of weight and the number of copies, mix homogeneously, be sub-packed in No. 1 Capsules, also can be pressed into tablet, suppository, in three flavor Chinese medicine extract, add an amount of tartaric acid, sodium bicarbonate and sodium lauryl sulphate, be sub-packed in behind the mix homogeneously in No. 1 Capsules and can be made into the effervescent capsule.
Medicine of the present invention be according to ancient times prescriptions and modern age pharmacology of Chinese materia medica principle design form.Main with reference to the treatment married woman damp invasion of lower energizer in " Waike Zhengzong, Orthodox Manual of External Diseases ", pruritus vulvae, and in collapsing of external skin ulcer itch in prescription such as soup and the recent studies achievement, utilize microecology principle and method about the etiology of bacterial vaginosis, adopt the drug effect tracking method to filter out this medicine, be specifically designed to the treatment bacterial vaginosis, based on classic prescription, with modern age the Chinese medicine research achievement be auxilliary, emphasis is a core with the effective Chinese herbal medicine in the clinical observation, Chinese medicine thinks that " married woman's erosion of vulva is seven emotions stagnated fire trauma liver spleen, due to the damp invasion of lower energizer.The person of itching, worm also, swollen person, pyretic toxicity also, it is damp and hot that to accumulate poison infested, for swollen for itching." so in treatment with strengthening the body resistance, the human body immunity improving ability, it is main adjusting vaginal dysbacteriosis, is the Therapeutic Method of assisting with the killing parasites for relieving itching heat-clearing and toxic substances removing.
The analysis of the contained composition of this medicine and incompatibility: the Radix Astragali, Radix Glycyrrhizae has the raise immunity effect, Radix Sophorae Flavescentis has heat clearing and damp drying, killing parasites for relieving itching, the antineoplastic pharmacological action, all have dual function and synergism in the three flavor Chinese medicines, studies show that from modern pharmacology, the medicine that improves immunity function in the prescription can improve cellular immunization, humoral immunization, the complement immunity, the complement level, complement-mediated immune complex lytic activity, make immune organ and tissue hyper-microstructure recover normal, therefore, in the treatment of bacterial vaginosis, reach the purpose of colony balance by fostering the vagina normal flora, the vaginal dysbacteriosis phenomenon is improved, thereby primary disease has been played therapeutical effect, this is a new discovery of the present invention, start with from etiology, by strengthening the body resistance, the human body immunity improving function, foster the growth of normal flora, improve the state of vaginal microbial flora.Add heat clearing and damp drying, the synergy of killing parasites for relieving itching medicine has efficiently the present invention, and characteristics can reach therapeutic purposes rapidly fast.
Medicine of the present invention had both had the raising immunologic function, regulated the effect of dysbacteriosis, can make damp and hot getting clearly again, and the pain of itching can be separated, and reaches colony balance, the therapeutical effect of removing itching and pain.Instant effect, there is not recurrence, easy to use, and said preparation is a pure Chinese medicinal preparation, have no side effect, safe and reliable, prove that through the pharmacology irritation test rabbit vagina administration is after 7 days, check vagina histopathologic slide, do not have any change, preparation stability test, sample three batches all qualified by the every index of stability inspection, the quality standard inspection all meets every index under the Chinese Pharmacopoeia capsule item, the pharmacokinetics test confirms that said preparation absorbs metabolism in the rabbit body slow, and its biological half-life was above 8 hours.
The present invention treats the bacterial vaginosis clinical analysis:
One, the standard of case selection:
Test group: 32 examples, age 21-47 year, 32.4 years old mean age.
The normal control group: 32 examples, in age 20-40 year, 28.5 years old mean age, for the healthy women that gynecological's outpatient service checks UP the same period, got rid of gynaecopathia, no sexual life and vagina lavation history in 3 days, not whole body or topical application antibiotic therapy in 2 weeks.
Two, the diagnostic criteria of disease:
Press document diagnostic criteria Amsel standard: (1) vagina PH 〉=4.7, (2) vaginal secretions increases, and is homogenizing, and the canescence emulsus having stench flavor, (3) vaginal smear Gram chromoscopy clues cell feminine gender, (4) ammonia test positive.More than meet 3 in 4 conditions and both can confirm as bacterial vaginitis, wherein the clues cell positive is an essential condition.
Three, medication ingredient:
Include the Radix Astragali, Radix Glycyrrhizae, Radix Sophorae Flavescentis extract.
Four, administrated method:
After doctor's advice patient cleans pudendum every night just before going to bed, place 2 (0.5g/ grain) capsules in intravaginal, once a day, 10 days is a course of treatment.
Five, the criterion of curative effect:
Cure: symptom, Signs complete obiteration, vagina microorganism is normal distribution, and cleannes reach the I degree, and drug withdrawal was not recurred after 1 month.
Effectively: symptom, Signs takes a turn for the better fully, and vagina microorganism is near normal distribution, and cleannes are the II degree.
Invalid: symptom, Signs no change, vagina microorganism distribute and are abnormality, cleannes III-IV degree.
Six, efficacy result analysis:
(1), the variation of Clinical symptoms before and after normal control group and test group are treated with this medicine:
All compare then no significant difference (P＞0.005) with the normal control group with medicine treatment of the present invention back each clinical symptoms of bacterial vaginosis patient, Signs than improve significantly before the treatment (P＜0.001).
(2) vaginal secretions Gram feature:
Before the treatment, epithelial cell is smudgy, be partly dissolved necrosis, cell edges reaches on every side even cell surface is covered the karyopycnosis of part epithelial cell by amyloid granule, free of lactic acid bacteria and leukocyte in the background, after the treatment, lactobacillus reappears in the background, and amyloid granule disappears, but epithelial cell dyeing is owed evenly, and the part cell still has disappearance.
(3) measurement result of vagina cleanness degree before and after normal group and test group are treated with this medicine:
Vagina cleanness degree I-II degree is a normal condition, there is patient's vagina cleanness degree mile abnormality of 65.63% to be the III degree when suffering from bacterial vaginitis, 3.12% patient IV degree, the patient who treats back 84.38% with this medicine has recovered normally, but still has 15.62% patient to be in abnormality (III degree).
(4) normal group and test group change with vaginal microbial flora before and after the treatment of this medicine and compare:
The patient who suffers from bacterial vaginosis, significant change has taken place in the vagina normal flora, the quantity of lactobacillus sharply descend (P＜0.01) wherein, the quantity sharp increase (P＜0.01) of bacteroid, enterobacteria, staphylococcic quantity growth is especially significantly (P＜0.001) especially, bacteroid, enterobacteria, staphylococcic positive rate also have significance in various degree to increase, and after this medicine is treated the average logarithm value of four kinds of vagina dominant bacterias and recall rate and normal control group there was no significant difference (P＞0.05).The present invention has efficiently and to remove painful itching fast, adjusts vaginal dysbacteriosis, and the treatment bacterial vaginosis does not recur the advantage that side effect is little.
The specific embodiment one: the medicine of present embodiment is formulated by following parts by weight by Radix Astragali extract, Radix Glycyrrhizae extract, Radix Sophorae Flavescentis extract: Radix Astragali extract 100-120, Radix Glycyrrhizae extract 80-120, Radix Sophorae Flavescentis extract 70-100; The extraction of medicine of the present invention and preparation method: (1) gets the Radix Astragali, the Radix Sophorae Flavescentis decoction pieces decocts 3 times, and each 90 minutes, concentrated extracting solution, the ethanol that cooling back adds 95% concentration makes and contains the alcohol amount and reach 75%, leave standstill 24 hours after, filter, reclaim alcohol, it is standby to be condensed into extractum cold drying in baking oven.(2) the extracting liquorice coarse powder add 0.1% concentration ammonia in the percolation bucket, soak after 24 hours, the beginning percolation, 1 droplet/second of the speed of filtering, the liquid of filtering transfers pH value to 3-4 with the sulphuric acid of 1% concentration, leaves standstill 24 hours, filters to such an extent that precipitate, 60 ℃ of dry glycyrrhizic acid inclusion compounds that get.(3) take by weighing three flavor Chinese medicine extract by ratio of weight and the number of copies, mix homogeneously, be sub-packed in No. 1 Capsules, also can be pressed into tablet, suppository, in three flavor Chinese medicine extract, add an amount of tartaric acid, sodium bicarbonate and sodium lauryl sulphate, be sub-packed in behind the mix homogeneously in No. 1 Capsules and can be made into the effervescent capsule.
The specific embodiment two: the medicine of present embodiment is formulated by following parts by weight: Radix Astragali extract 110, Radix Glycyrrhizae extract 100, Radix Sophorae Flavescentis extract 85.
The specific embodiment three: the medicine of present embodiment is formulated by following parts by weight: Radix Astragali extract 100, Radix Glycyrrhizae extract 100, Radix Sophorae Flavescentis extract 100.
The specific embodiment four: the medicine of present embodiment is formulated by following parts by weight: Radix Astragali extract 120, Radix Glycyrrhizae extract 80, Radix Sophorae Flavescentis extract 100.
Claims (4)
1, a kind of medicine for the treatment of bacterial vaginosis is characterized in that it is formulated by following parts by weight by Radix Astragali extract, Radix Glycyrrhizae extract, Radix Sophorae Flavescentis extract: Radix Astragali extract 100-120, Radix Glycyrrhizae extract 80-120, Radix Sophorae Flavescentis extract 70-100; The extracting method of medicine: (1) gets the Radix Astragali, the Radix Sophorae Flavescentis decoction pieces decocts 3 times, each 90 minutes, concentrated extracting solution, the ethanol that cooling back adds 95% concentration makes and contains the alcohol amount and reach 75%, after leaving standstill 24 hours, filter, reclaim alcohol, it is standby to be condensed into extractum cold drying in baking oven, (2) the extracting liquorice coarse powder adds the ammonia of 0.1% concentration in the percolation bucket, soak after 24 hours beginning percolation, 1 droplet/second of the speed of filtering, the liquid of filtering transfers pH value to 3-4 with the sulfuric acid solution of 1% concentration, left standstill 24 hours, and filtered to such an extent that precipitate, 60 ℃ of dry glycyrrhizic acid inclusion compounds that get.
2, a kind of medicine for the treatment of bacterial vaginosis according to claim 1 is characterized in that it is formulated by following parts by weight: Radix Astragali extract 110, Radix Glycyrrhizae extract 100, Radix Sophorae Flavescentis extract 85.
3, a kind of medicine for the treatment of bacterial vaginosis according to claim 1 is characterized in that it is formulated by following parts by weight: Radix Astragali extract 100, Radix Glycyrrhizae extract 100, Radix Sophorae Flavescentis extract 100.
4, a kind of medicine for the treatment of bacterial vaginosis according to claim 1 is characterized in that it is formulated by following parts by weight: Radix Astragali extract 120, Radix Glycyrrhizae extract 80, Radix Sophorae Flavescentis extract 100.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03104544 CN1210050C (en) | 2003-02-18 | 2003-02-18 | Medicine for treating bacterial vaginal disease |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03104544 CN1210050C (en) | 2003-02-18 | 2003-02-18 | Medicine for treating bacterial vaginal disease |
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| CN1437991A CN1437991A (en) | 2003-08-27 |
| CN1210050C true CN1210050C (en) | 2005-07-13 |
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| CN 03104544 Expired - Fee Related CN1210050C (en) | 2003-02-18 | 2003-02-18 | Medicine for treating bacterial vaginal disease |
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