CN100409859C - 'Fu Yan Jing' film for treating gynecological inflammation and preparation method thereof - Google Patents
'Fu Yan Jing' film for treating gynecological inflammation and preparation method thereof Download PDFInfo
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Abstract
The present invention provides a gynecological inflammation removal membrane for treating gynecological inflammation and a preparation method thereof. The gynecological inflammation removal membrane of the present invention is prepared from flavescent sophora root, common cnidium fruit, climbing groundsel herb, polyvinyl alcohol PVA17-88 glycerol, sorbic acid, poly crataegus fat-80, tinidazole, lactic acid and purified water. Compared with the prior art, the preparation of the present invention has the advantages of outstanding curative effect, no toxic or side effect, rapid dissolving and medicine release, formation of a medicine contained layer with high concentration, achievement of the action of fast killing of pathogenic microorganism, stabilization of the acid-base equilibrium of the woman vagina, rehabilitation and health care action on the vagina, stable quality, asepsis and no stimulation to the mucous membrane of the vagina, safety, reliability, no medicine tolerance, small volume, light weight, portability and convenient use.
Description
Technical field:
The present invention relates to a kind of FUYANJING film for the treatment of gynecological inflammation and preparation method thereof, belong to the pharmaceutical technology field
Background technology:
Gynecologic miscellaneous diseases is commonly encountered diseases, the frequently-occurring disease in the daily life, has the sickness rate height, hazardness is big, and except bringing to the patient the misery of painful topic, severe patient also can influence female reproductive system, causes the loss that can't retrieve all the life.Vaginitis is the general name of the multiple vaginal mucosa inflammatory of the women disease that caused by the different causes of disease, generally is the common recurrent infection disease of gynecological.Mainly be because the woman vagina defense function when low, is subjected to pathogenic microorganism invasion institute causes.Cause the common pathogenic microorganism of vaginitis and mainly contain (as: trichomonas vaginitis, white vagina candida mycoderma and Hemophilus vaginalis(Hemophilus vaginalis)s) such as antibacterial, virus, protozoon, mycete, candidiasis, chlamydia.It mainly is divided into: bacterial vaginitis, colpitis mycotica, trichomonal vaginitis, read coccus property vaginitis, the vagina normal flora caused nonspecific vaginitis etc. of lacking of proper care.Its symptom shows as the special pruritus of affected part, leucorrhoea grow in quantity, abnormal flavour, causalgia etc. is arranged; If untimely treatment, pathogenic microorganism is further invaded infection, causes multiple gynecological accompanying infections such as adnexa, uterus, pelvic cavity, and consequence is hardly imaginable.
The scorching embolism extinguishing agent of existing woman is obvious to the curative effect of gynecological inflammation, but its bioavailability is poor, and need melt in tract looses could discharge the efficacy of a drug.And have quick-acting, efficient, characteristics such as volume is little, safe, good stability in conjunction with the middle medicine film of modern advanced pharmaceutical technology, it is very convenient to portably use.
Summary of the invention:
The objective of the invention is to: a kind of FUYANJING film for the treatment of gynecological inflammation and preparation method thereof is provided, the present invention is on the basis of the scorching embolism extinguishing agent of existing woman, it is changed agent is the water solublity sheet film, with high molecular polymer PVA as basic framework, medicine there is bigger pardon, with vaginal secretions good intermiscibility is arranged, make the membrane dissolving rapidly, release is rapid, and form the medicated layer of high concentration at the woman vagina wall, reach that quick pathogenic microbe killing, the clean the moon of performance are antipruritic, the effect of anti-inflammation and sterilization, elimination abnormal flavour; This membrane can also be stablized the woman vagina acid-base balance, and vagina is played the rehabilitation effect.
The present invention constitutes like this: it is made with Radix Sophorae Flavescentis 190～210g, Fructus Cnidii 190～210g, Herba Senecionis Scandentis 170～190g, PVAC polyvinylalcohol 17-88450～470g, glycerol 190～210g, sorbic acid 0.5～4g, poly-Pyrusussuriensis fat-8015～25g, tinidazole 25～35g, lactic acid 35～45g and purified water 3800ml.
Specifically, it is made with Radix Sophorae Flavescentis 200g, Fructus Cnidii 200g, Herba Senecionis Scandentis 180g, PVAC polyvinylalcohol 17-88460g, glycerol 200g, sorbic acid 2g, poly-Pyrusussuriensis fat-8020g, tinidazole 30g, lactic acid 40g and purified water 3800ml.
The preparation method of FUYANJING film is: Radix Sophorae Flavescentis, Fructus Cnidii, Herba Senecionis Scandentis are through cleaning processing; Fructus Cnidii soaks after 48 hours reflux, extract, 3 times with 6 times of amount 70% alcohol at normal temperature, and reflux, extract, is 2 hours for the first time, and second and third time be reflux, extract, 1.5 hours respectively; Merge three times extracting solution, filter filtrate for later use; Radix Sophorae Flavescentis and Herba Senecionis Scandentis decoct with water three times, and the decocting that adds 8 times of amounts for the first time boiled 2 hours, and the decocting that second and third time adds 6 times of amounts boiled 1.5 hours, collecting decoction, filter, it is 1.20 clear paste that filtrate is concentrated into 60 ℃ of relative densities, adds 95% ethanol and makes and contain the alcohol amount and reach 70%, alcohol extract with Fructus Cnidii merges again, fully stir evenly, leave standstill precipitate with ethanol more than 48 hours, filter with 150 order steel-wire screens, reclaiming ethanol and being concentrated into 60 ℃ of relative densities is 1.40 thick paste, standby; Other gets PVAC polyvinylalcohol 17-88, adds the 3000ml purified water, leaves standstill to place to send out in 12-24 hour to rise softeningly, and heated and stirred is dissolved into even rubber cement in 80-90 ℃ of water-bath; Starch mixing with above-mentioned hot glue behind reuse 800ml purified water heating for dissolving tinidazole, sorbic acid, the lactic acid; Glycerol adding, poly-Pyrusussuriensis fat-80, mix homogeneously adds above-mentioned Chinese medicine extraction thick paste, stirs evenly to make even medicine film rubber cement, then 90-95 ℃ of following high temperature sterilize 30 minutes, place certain hour and remove bubble, film for 50 ℃-60 ℃, 40 ℃-60 ℃ heat up dry gradually, divided dose is cut film, the uviol lamp sterilization, packing, promptly.
Trichomonal vaginitis, colpitis mycotica, acute and chronic cervicitis belong to categories such as the traditional Chinese medical science " leukorrheal diseases ", " pudendal pruritus ", are the common gynecological disease card.How because of deficiency of vital QI, evil poison is invaded in taking advantage of a weak point in opponent's defence, and turbid damp is made a bet, and accumulates the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, and damage is appointed and is with two arteries and veins, and it is dirty to cause dirty liquid; Or infect the disease worm because of ignoring health, in worm-eaten the moon, and cause the pudendal pruritus discomfort, etc. all cards." the secret section of married woman " cloud: " disease of leukorrhagia, the women has it more.Red person belongs to heat, and the empty fire of holding concurrently of holding concurrently is controlled it." " Yizong Jinjian gynecological heart method knack ": " and married woman's pudendal pruritus, how because of parasite caused by accumulation of damp-heat in the body, limbs asthenia very then, dribbling urination ... " so the suitable heat-clearing and toxic substances removing of external treatment, removing dampness and killing parasites, dispelling wind for relieving itching.
Radix Sophorae Flavescentis hardship, cold among the present invention, heat clearing and damp drying, wind dispelling insecticide; Fructus Cnidii suffering, hardship, temperature, cold expelling dispels the wind, removing dampness and killing parasites; More join Herba Senecionis Scandentis and help Radix Sophorae Flavescentis, Fructus Cnidii removing dampness and killing parasites antipruritic, have the effect of heat-clearing and toxic substances removing again.Side's Chinese medicine and western medicine component tinidazole is nitro glyoxaline protozoacide, antianaerobic-microbacterial drug, and antibacterial action is better than metronidazole, and side effect is low, is one of active drug for the treatment of at present anaerobic infection.Add in the Chinese medicine extract performance Chinese medicine and western medicine dual function.Said preparation is that adjuvant is made the external membrane from the pharmaceutics angle analysis with PVA, Polysorbate, glycerol etc., vagina administration, but the through sick institute of messenger drug brings into play heat-clearing and toxic substances removing, removing dampness and killing parasites, the effect of dispelling wind for relieving itching jointly.Be used for leukorrheal diseases (trichomonal vaginitis, colpitis mycotica, acute and chronic cervicitis) etc., drug effect rapidly and lastingly.
Compared with prior art, preparation of the present invention is antalgesic-antipruritic effectively, suppresses the mucus secretion, promotes tissue regeneration etc., determined curative effect, has no side effect; With high molecular weight water soluble polymer PVA as basic framework, medicine there is bigger pardon, with vaginal secretions good intermiscibility is arranged, make the membrane dissolving rapidly, release is rapid, and form the medicated layer of high concentration at the woman vagina wall, reach that quick pathogenic microbe killing, the clean the moon of performance are antipruritic, the effect of anti-inflammation and sterilization, elimination abnormal flavour; Can also stablize the woman vagina acid-base balance, vagina is played the rehabilitation effect, recover vagina normal physiological state; Steady quality,, nonirritant nontoxic to vaginal mucosa, safe and reliable, have no drug resistance; Volume is little, and is in light weight, and it is very convenient to portably use.
In order to ensure the effect of preparation of the present invention, the applicant has carried out following experimental study:
One, Study on Preparation
1. Chinese crude drug of the present invention extracts, characteristics according to the contained effective ingredient of used each Chinese crude drug, adopt water to carry and two kinds of technologies of alcohol immersion back reflux, extract,, water extraction method such as the kurarinone in Radix Sophorae Flavescentis, the Herba Senecionis Scandentis, and the osthole in the Fructus Cnidii can fully extract used Chinese crude drug effective ingredient with 70% soak with ethanol after heat reflux, extract.Determined that water is carried and alcohol soaks after heat reflux, extract, number of times and time, determined preparation technology parameters such as alcohol precipitation concentration, time and fluid extract density; Wherein the pure liquid behind the precipitate with ethanol will filter with 150 order steel-wire screens, otherwise is mingled with thicker granule in the last gained fluid extract, directly influences the pliability and the smoothness of medicine film.
2. the present invention adopts Chinese medicine membrane prescription, and (PVA17-88) makes filmogen with polyvinyl alcohol, and glycerol is made plasticising and wetting agent, and sorbic acid is made antiseptic, and Pyrusussuriensis fat-80 is done solubilizing agent; Formula proportion and processing parameter have been determined by experiment; In development and trial-manufacturing process, combine with tinidazole with lactic acid, increased the dissolubility of tinidazole in membrane, solved the tinidazole problem that easy crystallization is separated out in film-forming process, the medicine film surface of making is complete bright and clean, and color and luster is even, consistency of thickness, there is not obvious bubble, no mouldy, denaturalization phenomenon, and also water solublity is fabulous.
3. the present invention adopts water retting technology, helps the leaching of composition and shortens dip time; Chinese medicine extraction extractum, tinidazole, glycerol, sorbic acid, poly-Pyrusussuriensis fat-80, lactic acid, water-soluble high-molecular compound (PVA), homogenate casting films preparation process through uniqueness, the water solublity sheet film that processes not only keeps its effective ingredient but also do not waste medical material.Adopt this preparation technology,, adapt to industrialized great production, produce stable, quality controllable through the long-term production evidence.Because the water solublity of tinidazole is bad, easily crystallization is separated out in the film preparation process, influences the preparation presentation quality, can increase the water solublity of tinidazole in development process with lactic acid, suppresses the crystallization of tinidazole and separates out.
Two, preliminarily stabilised investigation
Since in November, 2003,, investigate according to three batches of preparations of the present invention that fixed preparation technology produces according to pilot-scale according to the index of intending the quality standard draft certainly and method, the result shows the present invention's steady quality under the room temperature natural conditions.
Three, pharmacological toxicology research
The acute toxicity test of rat skin single administration, rat skin administration subacute toxicity test, the test of rabbit single administration skin irritation, multiple dosing is to the irritation test of damaged skin, the guinea pig skin hypersensitive test, and the result all shows: when the FUYANJING film adopts percutaneous drug delivery approach, used dosage, the used course of treatment, toxicity is little, non-stimulated, non-sensitization, safety range is big.
Rat long term toxicity test: FUYANJING film high dose (be equivalent to clinical Coming-of-Age Day consumption 200 times), middle dosage (be equivalent to clinical Coming-of-Age Day consumption 195 times), low dosage (be equivalent to clinical Coming-of-Age Day consumption 100 times) continuous 4 all skin administrations, the general situation of animal, body weight, appetite, hematological indices no abnormality seen; The above-mentioned observation in 2 weeks of drug withdrawal is no abnormality seen also.Administration group result of the test and vehicle group compare, difference that there are no significant.Long-term toxicity test for animals shows that when the clinical employing percutaneous drug delivery of FUYANJING film approach, used dosage, the used course of treatment, toxicity is little, and safety range is big.In view of the above result of the test as can be seen the present invention do not have the toxicology meaning, thereby provide the drug safety foundation for clinical verification.
Four, pharmacodynamic study
1, anti-damage test: the result shows that the FUYANJING film obviously improves soft tissue injury place healing score value, obviously alleviates the animal injury place and organizes blood stasis, edema and myofibrillar degeneration and necrosis.
2, analgesic test: mouse writhing method analgesic test, mice formaldehyde method analgesic test.Result of the test: obvious analgesic activity is all arranged.
3, antiinflammatory test: anti-mice ear swelling test, the swollen test of Chinese People's Anti-Japanese Military and Political College's Mus chondrus ocellatus Holmes colloidality foot, the swollen test of Chinese People's Anti-Japanese Military and Political College's Mus bud.Result of the test: the FUYANJING film all has the obvious suppression effect to inflammation.
4, anti-mouse peritoneal capillary permeability test: the result shows that the FUYANJING film can reduce the optical density of mouse peritoneal, and the mouse peritoneal capillary permeability is had tangible reduction effect.
5, the experiment of invigorating blood circulation: the result shows that the FUYANJING film can reduce whole blood viscosity RBC hematocrit and the RBC electrophoresis index of rat, and rat Blood stasis hemorheology is had the improvement effect.
Conclusion: the FUYANJING film has anti-damage, antiinflammatory, eases pain and the effect of invigorating blood circulation.Thereby, provide experimental basis for determining function of the present invention, curing mainly and the clinical application scope.
In a word, by to main result of study of the present invention, preparation of the present invention is safe in utilization, and determined curative effect is quality controllable, and each production link carries out in strict accordance with operation SOP, thereby has reached controlled, even, the stable purpose of process.
The specific embodiment:
Embodiments of the invention: Radix Sophorae Flavescentis 200g, Fructus Cnidii 200g, Herba Senecionis Scandentis 180g, PVAC polyvinylalcohol 17-88460g, glycerol 200g, sorbic acid 2g, poly-Pyrusussuriensis fat-8020g, tinidazole 30g, lactic acid 40g, purified water 3800ml
Radix Sophorae Flavescentis, Fructus Cnidii, Herba Senecionis Scandentis are through cleaning processing; Fructus Cnidii soaks after 48 hours reflux, extract, 3 times with 6 times of amount 70% alcohol at normal temperature, and reflux, extract, is 2 hours for the first time, and second and third time be reflux, extract, 1.5 hours respectively; Merge three times extracting solution, filter filtrate for later use; Radix Sophorae Flavescentis and Herba Senecionis Scandentis decoct with water three times, and the decocting that adds 8 times of amounts for the first time boiled 2 hours, and the decocting that second and third time adds 6 times of amounts boiled 1.5 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.20 (60 ℃), adds 95% ethanol and makes and contain the alcohol amount and reach 70%, alcohol extract with Fructus Cnidii merges again, fully stir evenly, leave standstill precipitate with ethanol more than 48 hours, filter with 150 order steel-wire screens, reclaim ethanol and be concentrated into the thick paste that relative density is 1.40 (60 ℃), standby; Other gets polyvinyl alcohol (PVA17-88), add Total Water 3/4 (3000ml) purified water, leaving standstill 12-24 hour of placement rises softening, heated and stirred is dissolved into even rubber cement in 80-90 ℃ of water-bath, starches mixing with above-mentioned hot glue behind reuse Total Water 1/4 (800ml) purified water heating for dissolving tinidazole, sorbic acid, the lactic acid; Glycerol adding, poly-Pyrusussuriensis fat-80, mix homogeneously adds above-mentioned Chinese medicine extraction thick paste (d=1.4), stir evenly and make even medicine film rubber cement, 90-95 ℃ of following high temperature sterilize 30 minutes, place certain hour and remove bubble then, film for 50 ℃-60 ℃, 40 ℃-60 ℃ heat up dry gradually, divided dose is cut film, uviol lamp sterilization, packing, make 2000, promptly.
Claims (3)
1. FUYANJING film for the treatment of gynecological inflammation is characterized in that: it is made with Radix Sophorae Flavescentis 190～210g, Fructus Cnidii 190～210g, Herba Senecionis Scandentis 170～190g, PVAC polyvinylalcohol 17-88 450～470g, glycerol 190～210g, sorbic acid 0.5～4g, poly-Pyrusussuriensis fat-80 15～25g, tinidazole 25～35g, lactic acid 35～45g and purified water 3800ml.
2. according to the FUYANJING film of the described treatment gynecological inflammation of claim 1, it is characterized in that: it is made with Radix Sophorae Flavescentis 200g, Fructus Cnidii 200g, Herba Senecionis Scandentis 180g, PVAC polyvinylalcohol 17-88 460g, glycerol 200g, sorbic acid 2g, poly-Pyrusussuriensis fat-80 20g, tinidazole 30g, lactic acid 40g and purified water 3800ml.
3. treat the preparation method of the FUYANJING film of gynecological inflammation as claimed in claim 1 or 2, it is characterized in that: Radix Sophorae Flavescentis, Fructus Cnidii, Herba Senecionis Scandentis are through cleaning processing; Fructus Cnidii soaks after 48 hours reflux, extract, 3 times with 6 times of amount 70% alcohol at normal temperature, and reflux, extract, is 2 hours for the first time, and second and third time be reflux, extract, 1.5 hours respectively; Merge three times extracting solution, filter filtrate for later use; Radix Sophorae Flavescentis and Herba Senecionis Scandentis decoct with water three times, and the decocting that adds 8 times of amounts for the first time boiled 2 hours, and the decocting that second and third time adds 6 times of amounts boiled 1.5 hours, collecting decoction, filter, it is 1.20 clear paste that filtrate is concentrated into 60 ℃ of relative densities, adds 95% ethanol and just contains the alcohol amount and reach 70%, alcohol extract with Fructus Cnidii merges again, fully stir evenly, leave standstill precipitate with ethanol more than 48 hours, filter with 150 order steel-wire screens, reclaiming ethanol and being concentrated into 60 ℃ of relative densities is 1.40 thick paste, standby; Other gets PVAC polyvinylalcohol 17-88, adds the 3000ml purified water, leaves standstill to place to send out in 12-24 hour to rise softeningly, and heated and stirred is dissolved into even rubber cement in 80-90 ℃ of water-bath; Starch mixing with above-mentioned hot glue behind reuse 800ml purified water heating for dissolving tinidazole, sorbic acid, the lactic acid; Glycerol adding, poly-Pyrusussuriensis fat-80, mix homogeneously adds above-mentioned Chinese medicine extraction thick paste, stirs evenly to make even medicine film rubber cement, then 90-95 ℃ of following high temperature sterilize 30 minutes, place certain hour and remove bubble, film for 50 ℃-60 ℃, 40 ℃-60 ℃ heat up dry gradually, divided dose is cut film, the uviol lamp sterilization, packing, promptly.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2006102004498A CN100409859C (en) | 2006-05-15 | 2006-05-15 | 'Fu Yan Jing' film for treating gynecological inflammation and preparation method thereof |
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| CNB2006102004498A CN100409859C (en) | 2006-05-15 | 2006-05-15 | 'Fu Yan Jing' film for treating gynecological inflammation and preparation method thereof |
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| CN100409859C true CN100409859C (en) | 2008-08-13 |
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| CN103301373B (en) * | 2013-07-01 | 2015-04-08 | 朱月英 | Pharmaceutical composition for treating postpartum perineal mucosal lesions |
| CN105616294B (en) * | 2016-02-05 | 2018-07-03 | 株洲千金药业股份有限公司 | It is a kind of that there is antibacterial, disinfection liquid and its application |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1245708A (en) * | 1999-08-12 | 2000-03-01 | 湖南正清制药集团股份有限公司 | Medicine for external application for curing gynecopathy |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1245708A (en) * | 1999-08-12 | 2000-03-01 | 湖南正清制药集团股份有限公司 | Medicine for external application for curing gynecopathy |
Non-Patent Citations (2)
| Title |
|---|
| 三种妇科外用药的体外抗菌活性比较. 王娟，梁健健.广州医药，第33卷第5期. 2002 |
| 三种妇科外用药的体外抗菌活性比较. 王娟，梁健健.广州医药，第33卷第5期. 2002 * |
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Address after: 6 floor, No. 85 Zhonghua Road, Guiyang, Guizhou 550001, China Patentee after: Guizhou Baiqiang Pharmaceutical Co., Ltd. Address before: 6 floor, No. 85 Zhonghua Road, Guiyang, Guizhou 550001, China Patentee before: Guizhou Baiqiang Pharmaceutical Co., Ltd. |
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