CN101879237A - Chinese medicinal composition for external use and preparation method thereof - Google Patents
Chinese medicinal composition for external use and preparation method thereof Download PDFInfo
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- CN101879237A CN101879237A CN2009100619171A CN200910061917A CN101879237A CN 101879237 A CN101879237 A CN 101879237A CN 2009100619171 A CN2009100619171 A CN 2009100619171A CN 200910061917 A CN200910061917 A CN 200910061917A CN 101879237 A CN101879237 A CN 101879237A
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Abstract
The invention discloses a Chinese medicinal composition for external use and a preparation method and application thereof. The composition consists of amur corktree bark, herba agrimoniae, common cnidium fruit, climbing groundsel herb, dried alum and borneol according to certain proportion; and according to a pharmaceutical conventional method, the composition is prepared into clinical acceptable formulae for external use, such as suppositories, capsules for external use, gelata, ointments, vaginal tablets, vaginal effervescent tablets, vaginal pellicles, washing liquor, aerosols, forming agents and the like. The composition has a better therapeutic effect of treating gynecologic diseases, such as cervical erosion, gynecologic inflammations and urinary tract infection; the composition is prepared into an external preparation and is not orally taken to avoid a liver first-pass effect and a gastrointestinal tract physiological checkpoint effect and reduce adverse reactions; the external preparation can directly act on sick parts, has strong pertinence, can act on a whole body through skins or mucous membranes, can be absorbed quickly, has small interference on the internal environment of an organism, is a non-invasive treatment mode, is simple and convenient to operate, has high safety and high curative ratio in clinical application, is a Chinese medicament for enhancing the body resistance, has small side effects, can effectively and thoroughly eradicate causes of diseases, can be used for performing safe and effective treatments under the guidance of doctors, and is favorable for popularization.
Description
Technical field
The present invention relates to a kind of external medicine composition and method for making, particularly a kind of external medicine composition that is used for the treatment of female pelvic inflammation, vaginitis, cervicitis, cervical erosion, urinary tract infection and its production and use.
Background technology
Cervical erosion is the modal genitals's inflammation of women, is more common in the married woman.China medical worker had once carried out EPDML investigation in the Hubei city, found that the sickness rate of the married woman's cervical erosion of being employed is up to 43.89%, its mild or moderate cervical erosion person accounts for 70.12%, moderate cervical erosion person accounts for 27.86%, and moderate and severe cervical person accounts for 2.02%.In classification, simple type is in the great majority, and is 56.69%, and mastoid process type and granular pattern account for 43.31% altogether; Rural women's sickness rate is higher.According to another report, the age group that the primary disease sickness rate is the highest is to account for 51.71% in 20～30 years old, is 30～40 years old secondly, accounts for 44.20%.
Though cervical erosion is local patholoic change, it directly influences women's physical and mental health, and cervical erosion is not only brought misery to the patient, and the danger that causes infertility and cervical cancer is arranged.Have data to show that patients of cervical ruin cervical cancer incidence rate is higher than 4.4 times of normal persons, rotten to the corn area is big more, and danger coefficient is also just big more.Therefore, active treatment and prevention cervical erosion are significant.Cervical erosion belongs to traditional Chinese medical science leukorrhagia category, mainly is because insufficiency of the spleen leading to overabundance of dampness, strongly fragrant heat-transformation of a specified duration, or pathogenic fire derived from stagnation of liver-QI, become damp and hot or bacterial infection due to.And cervical erosion has the trend of canceration, so it is significant to improve the cure rate of cervical erosion.Treatment cervical erosion has several different methods at present, and common methods has naturopathy and Drug therapy.Wherein, clinical physiotherapy commonly used has infrared light, microwave, laser and Thermocauterization etc., makes rotten to the corn tissue coagulation, freezing, vaporization, and the reparation of the hypertrophy of process fibrous tissue and epithelium reaches the effect of healing again.Though therapeutic effect is relatively good, the postoperative vagina flowing water time is longer, and often has hemorrhagely, and the amount of bleeding that has is greater than menstrual blood volume.Have following problem when treating for cervical erosion and intrauterine device and the patient that deposits: intrauterine device has metal mostly, and the electric conductivity of metal is difficult to carry out Therapeutic Method.And some physiotherapy all exists the crowd who is not suitable for using.The patient of various vaginitis patients, acute pelvic inflammatory disease patient, menorrhagia overfrequency all avoids and uses laser therapy.The effect of physiotherapy treatment cervical erosion is remarkable, shortcoming be when treatment relatively more painful, the wound healing phase is long, misoperation or treated and to destroy the partial body of gland of cervix uteri deeply, influence the normal secretion of cervical mucus, thereby cause infertile, and can form scar tissue after the treatment, lack ductility, symptoms such as laceration of cervix, postpartum hemorrhage when causing vagina to be produced easily.
At drug treatment, 1. interferon clinical observation and research are thought, interferon therapy cervical erosion has determined curative effect, and is easy to use.But interferon costs an arm and a leg, and side reaction is more, is a big bottleneck that limits its extensive use.2. its main component of Albothyl Albothyl is a policresulen, but the Albothyl cure rate is low, and the course of treatment is longer.
Gynecological inflammation and urinary tract infection equally also are women's a kind of commonly encountered diseases, frequently-occurring diseases, and gynecological inflammation comprises pelvic inflammatory disease, vaginitis, cervicitis etc.Therapeutic Method commonly used at present has liquid medicine vaginadouche, part to put medicine, oral medication etc., and used medicine is also varied, but clinical efficacy is unsatisfactory, and cure rate is about 50～85% not to be waited.Antibiotic therapy is especially used in chemical medicine treatment, and instant effect but easily produce drug resistance is often because of thoroughly outbreak repeatedly of treatment.
From the therapeutic effect of present this type of gynaecopathia, doctor trained in Western medicine does not still have ideal Therapeutic Method and medicine; The traditional Chinese medical science is with a long history to the treatment of this disease, has accumulated abundant clinical experience, and is evident in efficacy.Chinese medicine has good effect, few side effects, advantages such as easy prolonged application.But also exist the clinical shortcoming of taking medicine and mostly being decoct, taking inconvenience.
Summary of the invention
Purpose of the present invention aims to provide a kind of external medicine composition that is used for the treatment of gynaecopathia, the present invention also aims to provide this preparation of drug combination method and purposes.
The present invention is achieved through the following technical solutions.
Chinese medicine composition of the present invention mainly is made up of following bulk drugs:
Cortex Phellodendri 2～5 weight portions, Herba Agrimoniae 2～5 weight portions, Fructus Cnidii 2～5 weight portions, Herba Senecionis Scandentis 2～5 weight portions, dried Alumen 1～4 weight portion, Borneolum Syntheticum 0.5～2 weight portion.
Crude drug preferred weight part of the above-mentioned Chinese medicine composition of the present invention is:
Cortex Phellodendri 4 weight portions, Herba Agrimoniae 4 weight portions, Fructus Cnidii 4 weight portions, Herba Senecionis Scandentis 4 weight portions, dried Alumen 3 weight portions, Borneolum Syntheticum 1 weight portion.
Crude drug preferred weight part of the above-mentioned Chinese medicine composition of the present invention is:
Cortex Phellodendri 7 weight portions, Herba Agrimoniae 2.5 weight portions, Fructus Cnidii 2 weight portions, Herba Senecionis Scandentis 6 weight portions, dried Alumen 2 weight portions, Borneolum Syntheticum 0.5 weight portion.
Crude drug with the invention described above compositions, handle according to the pharmaceutics conventional method, add adjuvant, excipient, be prepared into the dosage form of accepting clinically, as suppository, external-applied capsules agent, gel, ointment, vaginal tablet, vagina effervescence, vagina membrane, washing liquid, aerosol, foam etc.
The preparation method of Chinese medicine composition of the present invention is:
Get Cortex Phellodendri 2～5 weight portions, Herba Agrimoniae 2～5 weight portions, Fructus Cnidii 2～5 weight portions, Herba Senecionis Scandentis 2～5 weight portions, dried Alumen 1～4 weight portion, Borneolum Syntheticum 0.5～2 weight portion; Alumen powder is broken into fine powder, Cortex Phellodendri, Herba Agrimoniae, Fructus Cnidii, Herba Senecionis Scandentis add 8～12 times of decoctings and boil 2～3 times, 2～3 hours for the first time, 1～2 hour for the second time, 0～1.5 hour for the third time, collecting decoction, filter, filtrate is concentrated in right amount, adds ethanol and makes that to contain alcohol amount in the solution be 65～80%, stirs, left standstill 24 hours, get supernatant and reclaim ethanol, being condensed into relative density is the extractum thick paste of 1.2～1.35 (25～30 ℃), drying, pulverize, mix with dried Alumen, excipient, additives, the Borneolum Syntheticum behind the adding dissolve with ethanol is made the solid preparation of clinical acceptance.
Also can after supernatant reclaims ethanol, add dried Alumen fine powder, Borneolum Syntheticum, excipient, additives, make the liquid preparation for external application of clinical acceptance.
The research situation of the stype that Chinese medicine composition of the present invention is made in clinical practice is as follows:
Treatment cervical erosion
Object of study is the 160 routine patients of cervical ruin of accepting for medical treatment the same period, does not all have acute genital inflammation, and canceration, 20～48 years old age are got rid of in the cervical scraping smear cytolgical examination.Clinical manifestation is that leucorrhea is increased for a long time, and lumbosacral region is ached, I～II ° of cervical erosion 124 examples wherein, III ° of cervical erosion 36 examples.160 routine patients are divided into first group 30 example and second group 130 examples at random.Two groups are all given the microwave electricity and press treatment: the clean back of menstruation 3～7d, get lithotomy position after the controlled micturition, sterilization pudendum, vagina, last specula, fully expose the cervix uteri and the cervix uteri of sterilizing, wipe away clean vagina and cervix uteri 2 mucus, press by the mobile gradually from inside to outside electricity in nearly cervical canal place with aseptic dry cotton ball, I～II ° of patients of cervical ruin popped one's head in circular solidification treatment, and III ° of patients of cervical ruin popped one's head in oval solidification treatment.If any Naboth's cysts, it is broken, flow clean mucus, make to be pressed and organize substrate to be evenly faint yellow, with smooth and do not have active hemorrhage degree of being, do not press to cervical canal, in case the cervical canal adhesion takes place, will be pressed tissue surface and be coated with iodine glycerol.Stype of the present invention is placed to 1 piece of cervix uteri, totally 5～10 times after late Qing Dynasty is washed pudendum next day of 1 week voluntarily in second group 6～10d and treatment back before micro-wave therapeutic.Prohibit bath in a tub, sexual intercourse and vaginadouche with treating in back 1 month during the medication before the treatment, take in sail after the local application, in case the downward slippage of stype affects the treatment.Curative effect determinate standard: transference cure, rotten to the corn face disappears, and the cervix uteri smooth surface is a produce effects; Sx, rotten to the corn face are reduced into effectively; Symptom and rotten to the corn face do not have change into invalid.The result: first group produce effects 24 examples (80%), effective 6 examples (20%), second group produce effects 129 examples (99.23%), effective 1 example (0.77%), second group obvious effective rate is significantly higher than first group (P＜0.05); Sanguinous leukorrhea 10 examples (33.3%) appear in first group postoperative, and second group 5 examples (3.85%), second group incidence rate significantly are lower than first group (P＜0.05).
Micro-wave therapeutic can destroy cervical erosion face epithelium, makes it that necrosis comes off and for newborn squamous epithelial cancer covers, in about 3～4 weeks in cycle, the dark person of pathological changes needed for 6～8 weeks approximately.Stype of the present invention is a Chinese medicine suppository, and local application is simple and convenient, and whole body is had no side effect.This result shows, uses stype of the present invention before and after the cervical erosion micro-wave therapeutic and can improve curative effect, and can prevent and treat infection, and softening wound surface reduces hemorrhage that incrustation comes off and causes, accelerates healing rate, is worthy of popularization.
The treatment vaginitis
Use stype of the present invention treatment vaginitis 40 examples, nonspecific vaginitis 17 examples wherein, colpitis mycotica 13 examples, trichomonal vaginitis 10 examples.20～54 years old age, average 28.3 years old, the course of disease 2～70 days, average 30.3 days.Above-mentioned case is the married woman, and all MethodsThe cases enrolled are not accepted other intravaginal medication in 3 months.
40 routine vaginitis patients all follow the doctor's advice and are cleaning pudendum with clear water just before going to bed, and control Mi Ling with 1 piece then and fill in the vagina depths, above-mentioned treatment per 2 days 1 time, 5 times is a course of treatment, continuous 20 days, drug withdrawal was checked after 2～7 days, the menstrual phase forbidding.Therapeutic outcome shows: controlling Mi Ling all has good efficacy to various vaginitis patients.28 examples of fully recovering (70%), effective 11 examples (27.5%), invalid 1 example (2.5%), total effective rate reaches 97.5%.It is better to colpitis mycotica and trichomonal vaginitis curative effect to control Mi Ling, and symptom, sign all have clear improvement, and negative conversion rate reaches 100%.And former bulk-growth 15 examples of molten urea urea, cloudy 14 examples of changeing in treatment back, negative conversion rate is 93.3%.
Clinical observation result shows that stype treatment vaginitis curative effect of the present invention is comparatively satisfied; And have the cloudy commentaries on classics of the molten urea urea substance of the growth of can making, and therapeutic effect is good, and molten urea urea pathogen infection vaginitis and cervicitis are more clinically at present sees, and treatment means is satisfied than difficult, negative conversion rate is higher after treating with stype of the present invention, and method is easy, is worth using for reference.This medicine can be used for clinical various vaginitis, has avoided limitation of clinical commonly used drug indication, to the strong drawback of specific aim religion of pathogen.Do not find the report of allergy and Drug resistance in the treatment as yet, drug side effect is little, and safety is good, is a kind of efficient, and the colpitic medicine of safe in utilization, easy treatment is worth clinical expansion to use.
As seen, the present invention has reasonable therapeutical effect to gynaecopathia such as cervical erosion, gynecological inflammation, urinary tract infection.Be prepared into external preparation, without oral administration, thereby avoided liver first-pass effect stomach function regulating intestinal physiology outpost of the tax office effect, reduced the generation of untoward reaction, external preparation can directly act on disease sites, and is with strong points, can play general action through skin or mucosa, drug absorption is rapid, little to the organismic internal environment interference, be a kind of non-invasive treatment mode, easy and simple to handle, clinical safety in utilization is good, cure rate is high, Chinese medicine consolidates, and side effect is little, can effectively thoroughly eradicate old complaint, can under physician guidance, treat safely and effectively, be beneficial to popularization.
Specific embodiments
The invention will be further described but be not limited to the present invention below by concrete experimental example and embodiment.
Embodiment 1
Cortex Phellodendri 400g, Herba Agrimoniae 400g, Fructus Cnidii 400g, Herba Senecionis Scandentis 400g, dried Alumen 300g, Borneolum Syntheticum 100g; Alumen powder is broken into fine powder, and Cortex Phellodendri, Herba Agrimoniae, Fructus Cnidii, Herba Senecionis Scandentis add 10 times of decoctings and boil 3 times, 2 hours for the first time, 1 hour for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is concentrated in right amount, adds ethanol and makes that to contain in the solution that alcohol measures be 75%, stir, left standstill 24 hours, get supernatant and reclaim ethanol, being condensed into relative density is the thick paste of 1.3～1.35 (25～30 ℃), vacuum drying, dried cream powder is broken into fine powder, with dried Alumen fine powder, polyvinylpolypyrrolidone mixing; With 60% ethanol system soft material, granulate drying, granulate with 20 mesh sieves; Dried granule sprays into the dehydrated alcohol that is dissolved with Borneolum Syntheticum, mixes thoroughly, and is airtight, and the adding polyvinylpolypyrrolidone is an amount of, and tabletting is made 1000 vaginal tablets.
Embodiment 2
Cortex Phellodendri 250, Herba Agrimoniae 450, Fructus Cnidii 450, Herba Senecionis Scandentis 600, dried Alumen 150, Borneolum Syntheticum 100; Step 1: Cortex Phellodendri, Herba Agrimoniae, Fructus Cnidii, Herba Senecionis Scandentis add 10 times of decoctings and boil 3 times, and 2 hours for the first time, 1 hour for the second time, 1 hour for the third time, collecting decoction filtered, filtrate is concentrated in right amount, adds ethanol and makes that to contain alcohol amount in the solution be 75%, stirs, left standstill 24 hours, get supernatant and reclaim ethanol, being condensed into relative density is the thick paste of 1.3～1.35 (25～30 ℃), and thick paste adds the xylitol stirring and evenly mixing, 60 degree drying under reduced pressure, standby;
Step 2: it is standby that alumen powder is broken into fine powder;
Step 3: boric acid and effervescent are spent drying for standby down respectively at 105;
Step 4:, standby with an amount of anhydrous alcohol solution of Borneolum Syntheticum;
Step 5: step 1,2,3 spares are ground into the segmentation of 120 orders, add part hydroxypropyl cellulose mixing, spray into an amount of dehydrated alcohol, mixing is granulated, dry 1 hour of 60 degree, granulate.Add the solution in the step 4, mix thoroughly, airtight 24 hours, add hydroxypropyl cellulose and magnesium stearate, be pressed into 1000 vagina effervescences.
Embodiment 3
Cortex Phellodendri 700, Herba Agrimoniae 250, Fructus Cnidii 200, Herba Senecionis Scandentis 600, dried Alumen 200, Borneolum Syntheticum 50; Alumen powder is broken into fine powder, Cortex Phellodendri, Herba Agrimoniae, Fructus Cnidii, Herba Senecionis Scandentis add 10 times of decoctings and boil 3 times, and 2 hours for the first time, 1 hour for the second time, 1 hour for the third time, collecting decoction filters, and filtrate is concentrated in right amount, add ethanol and make that to contain alcohol amount in the solution be 75%, stir, left standstill 24 hours, get supernatant and reclaim ethanol, being condensed into relative density is the thick paste of 1.3～1.35 (25～30 ℃), with dried Alumen fine powder mixing, in the substrate that adding polyoxyethylene monoester acid esters and glycerol are made, mixing, moulding, cooling, 1000 pieces of suppositorys are made in the demoulding.
Embodiment 4
Cortex Phellodendri 500, Herba Agrimoniae 300, Fructus Cnidii 300, Herba Senecionis Scandentis 450, dried Alumen 360, Borneolum Syntheticum 80; Alumen powder is broken into fine powder, and Cortex Phellodendri, Herba Agrimoniae, Fructus Cnidii, Herba Senecionis Scandentis add 10 times of decoctings and boil 3 times, and 2 hours for the first time, 1 hour for the second time, 1 hour for the third time, collecting decoction filtered, merging filtrate also is concentrated into the clear paste that relative density is 1.13～1.15 (70～80 ℃), puts coldly, adds ethanol and makes that to contain alcohol amount in the solution be 90%, stir, left standstill 24 hours, filter, filtrate recycling ethanol adds polyoxyethylene sorbitan monoleate to there not being the alcohol flavor, adds water to ormal weight again, stir evenly, filter, fill becomes washing liquid.
Claims (7)
1. external medicine composition is characterized in that the crude drug of said composition consists of:
Cortex Phellodendri 2～10 weight portion Herba Agrimoniaes 2～8 weight portion Fructus Cnidiis 2～8 weight portions
Herba Senecionis Scandentis 2～10 weight portion dried Alumens 1～6 weight portion Borneolum Syntheticum 0.5～2 weight portion.
2. external medicine composition as claimed in claim 1 is characterized in that the crude drug of said composition consists of:
Cortex Phellodendri 4 weight portion Herba Agrimoniaes 4 weight portion Fructus Cnidiis 4 weight portions
Herba Senecionis Scandentis 4 weight portion dried Alumens 3 weight portion Borneolum Syntheticums 1 weight portion.
3. external medicine composition as claimed in claim 1 is characterized in that the crude drug of said composition consists of:
Cortex Phellodendri 7 weight portion Herba Agrimoniaes 2.5 weight portion Fructus Cnidiis 2 weight portions
Herba Senecionis Scandentis 6 weight portion dried Alumens 2 weight portion Borneolum Syntheticums 0.5 weight portion.
4. as claim 1,2 or 3 described external medicine compositions, it is characterized in that said composition according to the pharmaceutics conventional method directly or add excipient, additives are made the external preparation of clinical acceptance, as suppository, external-applied capsules agent, gel, ointment, vaginal tablet, vagina effervescence, vagina membrane, washing liquid, aerosol, foam.
5. as the preparation method of claim 1,2 or 3 described external medicine compositions, it is characterized in that this method is: get Cortex Phellodendri 2～10 weight portions, Herba Agrimoniae 2～8 weight portions, Fructus Cnidii 2～8 weight portions, Herba Senecionis Scandentis 2～10 weight portions, dried Alumen 1～6 weight portion, Borneolum Syntheticum 0.5～2 weight portion; Alumen powder is broken into fine powder, Cortex Phellodendri, Herba Agrimoniae, Fructus Cnidii, Herba Senecionis Scandentis add 8～12 times of decoctings and boil 2～3 times, 2～3 hours for the first time, 1～2 hour for the second time, 0～1.5 hour for the third time, collecting decoction, filter, filtrate is concentrated in right amount, adds ethanol and makes that to contain alcohol amount in the solution be 65～80%, stirs, left standstill 24 hours, get supernatant and reclaim ethanol, being condensed into relative density is the thick paste of 1.2～1.35 (25～30 ℃), drying, pulverize, mix with dried Alumen, excipient, additives, the Borneolum Syntheticum behind the adding dissolve with ethanol is made the solid preparation of clinical acceptance.
6. as the method for making of claim 1,2 or 3 described external medicine compositions, it is characterized in that this method is: get Cortex Phellodendri 2～10 weight portions, Herba Agrimoniae 2～8 weight portions, Fructus Cnidii 2～8 weight portions, Herba Senecionis Scandentis 2～10 weight portions, dried Alumen 1～6 weight portion, Borneolum Syntheticum 0.5～2 weight portion; Alumen powder is broken into fine powder, and Cortex Phellodendri, Herba Agrimoniae, Fructus Cnidii, Herba Senecionis Scandentis add 8～12 times of decoctings and boil 2～3 times, 2～3 hours for the first time, 1～2 hour for the second time, 0～1.5 hour for the third time, collecting decoction, filter, filtrate is concentrated in right amount, adds ethanol and makes that to contain alcohol amount in the solution be 65～80%, stirs, left standstill 24 hours, get supernatant and reclaim ethanol, add dried Alumen fine powder, Borneolum Syntheticum, excipient, additives, make the liquid preparation of clinical acceptance.
7. external medicine composition as claimed in claim 1 or 2 is used for the treatment of cervical erosion, gynecological inflammation, urinary tract infection.
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| CN2009100619171A CN101879237A (en) | 2009-05-06 | 2009-05-06 | Chinese medicinal composition for external use and preparation method thereof |
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| CN2009100619171A CN101879237A (en) | 2009-05-06 | 2009-05-06 | Chinese medicinal composition for external use and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488776A (en) * | 2011-12-31 | 2012-06-13 | 杨彦玲 | Medicine used for treating gynecological inflammation, and preparation method thereof |
| CN104288266A (en) * | 2014-11-06 | 2015-01-21 | 田思媛 | Medicine for treating female cervicitis and preparation method thereof |
-
2009
- 2009-05-06 CN CN2009100619171A patent/CN101879237A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488776A (en) * | 2011-12-31 | 2012-06-13 | 杨彦玲 | Medicine used for treating gynecological inflammation, and preparation method thereof |
| CN102488776B (en) * | 2011-12-31 | 2013-11-13 | 杨彦玲 | Medicine used for treating gynecological inflammation, and preparation method thereof |
| CN104288266A (en) * | 2014-11-06 | 2015-01-21 | 田思媛 | Medicine for treating female cervicitis and preparation method thereof |
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Application publication date: 20101110 |