CN1679649A - Medicinal composition for cervical erosion and vaginitis and its preparation - Google Patents
Medicinal composition for cervical erosion and vaginitis and its preparation Download PDFInfo
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- CN1679649A CN1679649A CN 200410023106 CN200410023106A CN1679649A CN 1679649 A CN1679649 A CN 1679649A CN 200410023106 CN200410023106 CN 200410023106 CN 200410023106 A CN200410023106 A CN 200410023106A CN 1679649 A CN1679649 A CN 1679649A
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- 230000003628 erosive effect Effects 0.000 title claims abstract description 10
- 206010046914 Vaginal infection Diseases 0.000 title abstract description 4
- 201000008100 Vaginitis Diseases 0.000 title abstract description 3
- 238000002360 preparation method Methods 0.000 title description 8
- 239000000203 mixture Substances 0.000 title description 2
- 239000002775 capsule Substances 0.000 claims abstract description 18
- -1 softgel Substances 0.000 claims abstract description 17
- 239000000829 suppository Substances 0.000 claims abstract description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 108
- 239000000843 powder Substances 0.000 claims description 93
- 238000000034 method Methods 0.000 claims description 33
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 claims description 27
- 229940089161 ginsenoside Drugs 0.000 claims description 27
- 229930182494 ginsenoside Natural products 0.000 claims description 27
- PFTAWBLQPZVEMU-DZGCQCFKSA-N (+)-catechin Chemical compound C1([C@H]2OC3=CC(O)=CC(O)=C3C[C@@H]2O)=CC=C(O)C(O)=C1 PFTAWBLQPZVEMU-DZGCQCFKSA-N 0.000 claims description 24
- 235000006226 Areca catechu Nutrition 0.000 claims description 24
- 244000080767 Areca catechu Species 0.000 claims description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 22
- 238000001694 spray drying Methods 0.000 claims description 19
- 238000005516 engineering process Methods 0.000 claims description 17
- 239000002904 solvent Substances 0.000 claims description 17
- 239000007901 soft capsule Substances 0.000 claims description 16
- 238000000605 extraction Methods 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 14
- 238000005325 percolation Methods 0.000 claims description 13
- 229940099259 vaseline Drugs 0.000 claims description 11
- 239000008194 pharmaceutical composition Substances 0.000 claims description 10
- 238000010298 pulverizing process Methods 0.000 claims description 10
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 9
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 9
- 229940057995 liquid paraffin Drugs 0.000 claims description 9
- 239000000654 additive Substances 0.000 claims description 8
- 239000003921 oil Substances 0.000 claims description 8
- 235000019198 oils Nutrition 0.000 claims description 8
- 235000012424 soybean oil Nutrition 0.000 claims description 8
- 239000003549 soybean oil Substances 0.000 claims description 8
- 239000003826 tablet Substances 0.000 claims description 8
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims description 7
- 235000010445 lecithin Nutrition 0.000 claims description 7
- 239000000787 lecithin Substances 0.000 claims description 7
- 229940067606 lecithin Drugs 0.000 claims description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 6
- 239000011248 coating agent Substances 0.000 claims description 6
- 238000000576 coating method Methods 0.000 claims description 6
- 239000007938 effervescent tablet Substances 0.000 claims description 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 6
- 229920000053 polysorbate 80 Polymers 0.000 claims description 6
- 238000010992 reflux Methods 0.000 claims description 6
- 239000012141 concentrate Substances 0.000 claims description 4
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- 239000012528 membrane Substances 0.000 claims description 4
- 239000002674 ointment Substances 0.000 claims description 4
- 239000002244 precipitate Substances 0.000 claims description 4
- 210000000582 semen Anatomy 0.000 claims description 4
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- ARIWANIATODDMH-AWEZNQCLSA-N 1-lauroyl-sn-glycerol Chemical compound CCCCCCCCCCCC(=O)OC[C@@H](O)CO ARIWANIATODDMH-AWEZNQCLSA-N 0.000 claims description 3
- ARIWANIATODDMH-UHFFFAOYSA-N Lauric acid monoglyceride Natural products CCCCCCCCCCCC(=O)OCC(O)CO ARIWANIATODDMH-UHFFFAOYSA-N 0.000 claims description 3
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- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 3
- 239000007902 hard capsule Substances 0.000 claims description 3
- 229920000573 polyethylene Polymers 0.000 claims description 3
- AXTGDCSMTYGJND-UHFFFAOYSA-N 1-dodecylazepan-2-one Chemical compound CCCCCCCCCCCCN1CCCCCC1=O AXTGDCSMTYGJND-UHFFFAOYSA-N 0.000 claims description 2
- 244000235603 Acacia catechu Species 0.000 claims description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 2
- 108010010803 Gelatin Proteins 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 2
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 2
- 229920002125 Sokalan® Polymers 0.000 claims description 2
- 235000021355 Stearic acid Nutrition 0.000 claims description 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 2
- 229960001631 carbomer Drugs 0.000 claims description 2
- 238000005119 centrifugation Methods 0.000 claims description 2
- 235000015165 citric acid Nutrition 0.000 claims description 2
- 238000013270 controlled release Methods 0.000 claims description 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 2
- 229930195729 fatty acid Natural products 0.000 claims description 2
- 239000000194 fatty acid Substances 0.000 claims description 2
- 239000010408 film Substances 0.000 claims description 2
- 239000008394 flocculating agent Substances 0.000 claims description 2
- 238000004108 freeze drying Methods 0.000 claims description 2
- 229920000159 gelatin Polymers 0.000 claims description 2
- 239000008273 gelatin Substances 0.000 claims description 2
- 235000019322 gelatine Nutrition 0.000 claims description 2
- 235000011852 gelatine desserts Nutrition 0.000 claims description 2
- 238000010438 heat treatment Methods 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- 238000007654 immersion Methods 0.000 claims description 2
- 239000012567 medical material Substances 0.000 claims description 2
- 238000000465 moulding Methods 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 2
- 238000005457 optimization Methods 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 235000013772 propylene glycol Nutrition 0.000 claims description 2
- 238000004062 sedimentation Methods 0.000 claims description 2
- 239000011734 sodium Substances 0.000 claims description 2
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 2
- 239000008117 stearic acid Substances 0.000 claims description 2
- 239000011975 tartaric acid Substances 0.000 claims description 2
- 235000002906 tartaric acid Nutrition 0.000 claims description 2
- 239000010409 thin film Substances 0.000 claims description 2
- 239000010913 used oil Substances 0.000 claims description 2
- 239000000003 vaginal tablet Substances 0.000 claims description 2
- 229940044977 vaginal tablet Drugs 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 25
- 230000000694 effects Effects 0.000 abstract description 4
- 206010018612 Gonorrhoea Diseases 0.000 abstract description 2
- 206010028470 Mycoplasma infections Diseases 0.000 abstract description 2
- 208000001786 gonorrhea Diseases 0.000 abstract description 2
- 239000002131 composite material Substances 0.000 abstract 1
- 239000004088 foaming agent Substances 0.000 abstract 1
- 229960004756 ethanol Drugs 0.000 description 37
- 238000003756 stirring Methods 0.000 description 21
- 238000002156 mixing Methods 0.000 description 18
- 239000000796 flavoring agent Substances 0.000 description 17
- 235000019634 flavors Nutrition 0.000 description 17
- 239000006071 cream Substances 0.000 description 13
- 238000012856 packing Methods 0.000 description 12
- 238000006424 Flood reaction Methods 0.000 description 10
- 239000012530 fluid Substances 0.000 description 7
- 239000000243 solution Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 239000000706 filtrate Substances 0.000 description 3
- 239000000758 substrate Substances 0.000 description 3
- 229920002535 Polyethylene Glycol 1500 Polymers 0.000 description 2
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 229960000935 dehydrated alcohol Drugs 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 150000002148 esters Chemical class 0.000 description 2
- 238000001746 injection moulding Methods 0.000 description 2
- 229940093430 polyethylene glycol 1500 Drugs 0.000 description 2
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 2
- 208000004926 Bacterial Vaginosis Diseases 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- 206010047799 Vulvovaginitis trichomonal Diseases 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 150000002333 glycines Chemical class 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 244000045947 parasite Species 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000005180 public health Effects 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 238000004064 recycling Methods 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
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- 239000003440 toxic substance Substances 0.000 description 1
- 210000001215 vagina Anatomy 0.000 description 1
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- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
A composite medicine in the form of tablet, effervescent suppository, capsule, softgel, foaming agent, gel, film, or oientment for treating vaginitis, cervical erosion, mycoplasma infection, gonorrhea, etc is disclosed. Its advantages are high curative effect and high safety.
Description
Technical field the present invention relates to a kind of Chinese medicine, specifically a kind of treatment cervical erosion, colpitic pharmaceutical composition and preparation method thereof.
Background technology cervical erosion, vaginitis etc. are women's commonly encountered diseases and frequently-occurring disease, bring many miseries to the patient, have a strong impact on the healthy of numerous women.The rotten preparation that disappears is made up of ginsenoside, Radix Arnebiae (Radix Lithospermi), Cortex Phellodendri, Radix Sophorae Flavescentis, dried Alumen, Borneolum Syntheticum, catechu seven flavor medicine, has heat-clearing and toxic substances removing, removing dampness and killing parasites, the function of putrefaction-removing granulation-promoting, be used for cervical erosion, trichomonal vaginitis, colpitis mycotica, diseases such as nonspecific vaginitis and mycoplasma infection, gonorrhea diplococcus infection have significant curative effect.XIAOMI SHUAN being arranged at present, listed in the 20th of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ", is Chinese medicine protection kind.Suppository is a kind of vagina administration dosage form commonly used, but is the suppository transportation storage inconvenience of substrate with acid of polyoxyethylene monoester and glycerol, requires preserving below 30 ℃, be subjected to certain restriction in some high temperature severe cold areas uses, this pharmaceutically dosage form is single simultaneously, and quality standard is low, no quantitative target.
Summary of the invention the objective of the invention is to provide a kind of scalable, good effect that has, the rotten preparation that disappears of nonirritant, compliance advantages of higher, and the standard of improving the quality of products simultaneously further satisfies and ensures the medication demand of vast female patient.
Purpose of the present invention can take following method to realize:
A kind of treatment cervical erosion, colpitic pharmaceutical composition is characterized in that it is that component is formed or made active component and pharmaceutically acceptable additives are formed or make active component and pharmaceutically acceptable additives are formed tablet, effervescent suppository, capsule, soft capsule suppository, foam, gel, membrane, ointment by the alcohol extract of following main materials by the water extract of following main materials by following main materials: (weight portion)
Ginsenoside 5-60, Radix Arnebiae (Radix Lithospermi) 200-800, Cortex Phellodendri 200-800, Radix Sophorae Flavescentis 200-800, dried Alumen 150-700, Borneolum Syntheticum 50-400, catechu 200-800.
Formula optimization is: (weight portion)
Ginsenoside 25, Radix Arnebiae (Radix Lithospermi) 500, Cortex Phellodendri 500, Radix Sophorae Flavescentis 500, dried Alumen 400, Borneolum Syntheticum 200, catechu 500.
Described pharmaceutically acceptable additives are following one or more:
Stearic acid, semi-synthetic fatty acid ester, vaseline, liquid Paraffin, tween 80, lecithin, sodium lauryl sulphate, dimethyl sulfoxine, azone, glycerol, gelatin, Polyethylene Glycol, Polyethylene Glycol-32 glycerol monolaurate (gelucire44/14), HPMC, CMC-Na, Carbom, ethylparaben, Oleum Sesami, soybean oil, Oleum Arachidis hypogaeae semen, tartaric acid, citric acid, sodium bicarbonate, propylene glycol, carbomer.
Described tablet can also can be effervescent tablet, double-deck vaginal tablet or other various suitable tablets with suitable coating material coating or coating not.
Described capsule can be soft capsule, hard capsule, effervescent capsule, controlled release vaginal capsule or other various suitable capsules.
A kind of method for preparing treatment cervical erosion, colpitic pharmaceutical composition is characterized in that it may further comprise the steps:
In a prescription Radix Sophorae Flavescentis, Cortex Phellodendri adopt alcohol extraction water is carried or alcohol extraction after medicinal residues again water carry or acid extraction or other suitable method are extracted,
In the b prescription Radix Arnebiae (Radix Lithospermi) adopt oil carry alcohol extraction or water is carried first alcohol extraction medicinal residues again water carry or first oil carry medicinal residues again alcohol extraction or other suitable method extract,
Ginsenoside's pulverizing or superfine powder are broken into fine powder or other suitable method processing in the c prescription,
Dried Alumen pulverizing or superfine powder are broken into fine powder or other suitable method processing in the d prescription,
Catechu pulverizing or superfine powder are broken into fine powder or other suitable method processing in the e prescription,
Borneolum Syntheticum pulverizing or superfine powder are broken into fine powder or other suitable method processing in the f prescription,
The pulverizing medicinal materials that needs in the g technology to extract becomes coarse powder or middle powder to extract, be generally 5-60 purpose coarse powder or middle powder, the best was a 20-40 order coarse powder, and the medical material that need be ground into fine powder in the technology was ground into 100-160 purpose fine powder usually, the best is standby for superfine powder is broken into 200-300 purpose fine powder
The condition of alcohol extraction is in the h technology: with 50-95% ethanol is solvent, can adopt heating reflux method or percolation or other suitable method to extract,
The condition that water is carried in the i technology is: decoct with water, extract 2-4 time at 90-98 ℃, each 1-3 hour, best was to decoct at 90-98 ℃ to extract three times, and 2 hours for the first time, second and third time was respectively 1 hour,
J technology medium oil is carried and can be adopted fried method or immersion method or other proper method, and used oil can be Oleum Sesami, soybean oil, Oleum Arachidis hypogaeae semen or other suitable oil,
Extracting gained water extract in the k technology can adopt precipitate with ethanol or add the flocculating agent sedimentation or method that other is suitable is further handled, the condition of precipitate with ethanol adds ethanol in right amount for the water extract is concentrated into makes the alcohol amount of containing reach 40-75%, leave standstill, centrifugation, best measure and reach 60-75% to containing alcohol for adding ethanol
Concentrate in the l technology and adopt concentrating under reduced pressure, thin film concentration, vacuum film to concentrate or other proper method,
Drying can adopt vacuum drying or spray drying or lyophilization or other suitable method in the m technology, the vacuum drying temperature is controlled at 50-90 ℃, the best is 60-70 ℃, and spray drying is for to be condensed into the concentrated solution that relative density is 1.03-1.25 (60 ℃), spray drying with extracting solution, inlet temperature is 100-200 ℃, leaving air temp is 50-150 ℃, and best relative density is 1.05-1.15 (60 ℃), and inlet temperature is 150-170 ℃, leaving air temp is 80-100 ℃
N adds different additives as required, adopts suitable moulding process, through being prepared from tablet, effervescent suppository, capsule, soft capsule suppository, foam, gel, membrane, ointment.
Adopt the prepared rotten preparation that disappears of the present invention can fully keep its effective ingredient, has good effect, nonirritant, compliance advantages of higher, improved quality standard simultaneously, better guaranteed drug quality, enrich medicine variety, further satisfied and ensured the medication demand of vast female patient.
The specific embodiment
Embodiment 1:
Be up to the standards seven flavor medicine standby respectively; Get catechu, alumen powder is broken into fine powder, the Borneolum Syntheticum porphyrize, standby.Get Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) and decoct with water three times, be followed successively by 2,1,1 hours, collecting decoction filters, filtrate is concentrated in right amount, adds ethanol and makes that to contain alcohol amount be 75%, leaves standstill and makes precipitation, get supernatant and reclaim ethanol, be concentrated into the thick paste shape, standby with above-mentioned fine powder and ginsenoside's powder mixing; It is an amount of to get vaseline, and heat fused, temperature are reduced to about 50 ℃, adds liquid Paraffin, tween 80 is an amount of, is mixed with substrate, adds above-mentioned spares earlier, fully stirs evenly, and is pressed into soft capsule, and packing promptly.
Embodiment 2:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside's pulverize separately and become fine powder, the Borneolum Syntheticum porphyrize, standby.Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 75% ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaims ethanol, be concentrated into an amount of, spray drying, dried cream powder and above-mentioned fine powder mixing are standby; It is an amount of to get vaseline, and heat fused, temperature are reduced to about 50 ℃, adds liquid Paraffin, tween 80 is an amount of, is mixed with substrate, adds above-mentioned spares earlier, fully stirs evenly, and makes soft capsule, and packing promptly.
Embodiment 3:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside's pulverize separately and become fine powder, the Borneolum Syntheticum porphyrize, standby.Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 75% ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaims ethanol, be concentrated into an amount of, spray drying, dried cream powder and above-mentioned fine powder mixing are standby; Get soybean oil and vaseline is an amount of, heat fused, temperature are reduced to about 45 ℃, add above-mentioned spares, dimethyl sulfoxine and ethylparaben, stir evenly, and are pressed into soft capsule, and packing promptly.
Embodiment 4:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside's pulverize separately and become fine powder, the Borneolum Syntheticum porphyrize, standby.Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 95% ethanol, reflux 2 times, and each 1 hour, filter, filtrate recycling ethanol is concentrated into standby in right amount; Medicinal residues decoct with water 2 times, and each 1 hour, filter, filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, spray drying, dried cream powder and above-mentioned fine powder mixing add liquid Paraffin and stir evenly standby in right amount; Other gets vaseline, lecithin is an amount of, and heat fused, temperature are reduced to about 50 ℃,, add above-mentioned spares, fully stir evenly, be pressed into soft capsule, packing is promptly.
Embodiment 5:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside, Borneolum Syntheticum respectively superfine powder to be broken into fine powder standby; Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 75% ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaims ethanol, be concentrated into an amount of, spray drying, dried cream powder and above-mentioned fine powder and appropriate amount of auxiliary materials mixing, the encapsulating capsule is packed and is promptly got the rotten capsule that disappears.
Embodiment 6:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside, Borneolum Syntheticum respectively superfine powder to be broken into fine powder standby; Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 75% ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaims ethanol, be concentrated into an amount of, spray drying, dried cream powder and above-mentioned fine powder mixing are standby; It is an amount of to get polyoxyethylene stearate (40) ester, Polyethylene Glycol-1500, Polyethylene Glycol-6000, when heat fused, temperature are reduced to 70 ℃, adding above-mentioned medicated powder, citric acid and an amount of tween 80 stirs evenly, temperature is reduced to about 50 ℃, adds sodium bicarbonate again and stirs evenly, and injection molding is made the rotten type of effervescent suppository that disappears.
Embodiment 7:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside, Borneolum Syntheticum respectively superfine powder to be broken into fine powder standby; Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 70% ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaim ethanol, be concentrated in right amount spray drying, dried cream powder and above-mentioned fine powder and an amount of effervescent tablet auxiliary materials and mixing, dehydrated alcohol is granulated, tabletting, and packing promptly gets the rotten effervescent tablet that disappears.
Embodiment 8:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside, Borneolum Syntheticum respectively superfine powder to be broken into fine powder standby; Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 75% ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaims ethanol, is concentrated into standby in right amount; Medicinal residues decoct with water 2 times, and each 1 hour, filter, be concentrated in right amount, merge with above-mentioned alcohol extract, spray drying, dried cream powder and above-mentioned fine powder and an amount of effervescent tablet auxiliary materials and mixing, dehydrated alcohol is granulated, tabletting, packing promptly gets the rotten effervescent tablet that disappears.
Embodiment 9:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside's pulverize separately and become fine powder, the Borneolum Syntheticum porphyrize, standby.Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 75% ethanol, flood after 48 hours, slowly percolation is collected percolate, reclaim ethanol, be condensed into the thick paste shape, with dried Alumen fine powder mixing, drying under reduced pressure, be ground into fine powder, with above-mentioned dried Alumen, ginsenoside, Borneolum Syntheticum fine powder and appropriate amount of auxiliary materials mixing, encapsulating capsule, packing promptly gets the rotten capsule that disappears.
Embodiment 10:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside's pulverize separately and become fine powder, the Borneolum Syntheticum porphyrize, standby.Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 75% ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaim ethanol, be condensed into the thick paste shape, with catechu fine powder mixing, drying under reduced pressure is ground into fine powder, and is standby with above-mentioned dried Alumen, ginsenoside, Borneolum Syntheticum fine powder mixing; Taking polyethylene glycol-32 glycerol monolaurate (gelucire44/14) is an amount of, and heat fused, temperature are reduced to about 50-55 ℃, add above-mentioned spares, fully stirs evenly, and injects hard capsule, puts coldly, packs and promptly gets the rotten capsule bolt that disappears.
Embodiment 11:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside's pulverize separately and become fine powder, the Borneolum Syntheticum porphyrize, standby.Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 75% ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaims ethanol, be concentrated into an amount of, spray drying, dried cream powder and above-mentioned fine powder mixing, the adding liquid Paraffin stirs evenly standby in right amount; Other gets vaseline, lecithin is an amount of, and heat fused, temperature are reduced to about 50 ℃,, add above-mentioned spares, fully stir evenly, be pressed into soft capsule, packing promptly gets the rotten soft capsule that disappears.
Embodiment 12:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside's pulverize separately and become fine powder, the Borneolum Syntheticum porphyrize, standby.Get Radix Arnebiae (Radix Lithospermi) and add an amount of Oleum Sesami/Oleum Glycines, soaked 48 hours, squeeze and filter, fluid is standby; It is solvent that medicinal residues and Cortex Phellodendri, Radix Sophorae Flavescentis one are reinstated ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaims ethanol, is concentrated in right amount, and spray drying is collected dried cream powder, and is standby with above-mentioned fine powder mixing; Get polyoxyethylene stearate (40) ester, Polyethylene Glycol-1500, Polyethylene Glycol-6000 heat fused, add above-mentioned medicated powder, Radix Arnebiae (Radix Lithospermi) fluid and an amount of tween 80 and stir evenly, temperature is reduced to about 50 ℃, and injection molding is made XIAOMI SHUAN.
Embodiment 13:
Be up to the standards seven flavor medicine standby respectively; Getting catechu, dried Alumen, ginsenoside, Borneolum Syntheticum pulverize separately becomes fine powder standby; Soybean oil is heated to about 60 ℃, adds Radix Arnebiae (Radix Lithospermi), soaked 1-2 hour, squeeze and filter, fluid is standby; It is solvent that medicinal residues and Cortex Phellodendri, Radix Sophorae Flavescentis one are reinstated 75% ethanol, reflux 2 times, 2 hours for the first time, 1 hour for the second time, extracting solution filters, and reclaims ethanol, is concentrated into an amount of, spray drying, dried cream powder and above-mentioned fine powder mixing add above-mentioned fluid and liquid Paraffin and stir evenly standby in right amount; Other gets vaseline, lecithin is an amount of, and heat fused, temperature are reduced to about 50 ℃,, add above-mentioned spares, fully stir evenly, be pressed into soft capsule, packing is promptly.
Embodiment 14:
Be up to the standards seven flavor medicine standby respectively; Getting catechu, dried Alumen, ginsenoside, Borneolum Syntheticum pulverize separately becomes fine powder standby.Soybean oil is warmed to 120-130 ℃, drops into Radix Arnebiae (Radix Lithospermi), constantly stir, kept 0.5-1 hour, squeeze and filter, fluid is standby; Cortex Phellodendri, Radix Sophorae Flavescentis are solvent with 70% ethanol, reflux 2 times, 2 hours for the first time, 1 hour for the second time, extracting solution filters, and reclaims ethanol, is concentrated into an amount of, spray drying, dried cream powder and above-mentioned fine powder mixing add above-mentioned fluid and liquid Paraffin and stir evenly standby in right amount; Other gets vaseline, lecithin is an amount of, and heat fused, temperature are reduced to about 50 ℃,, add above-mentioned spares, fully stir evenly, be pressed into soft capsule, packing is promptly.
Embodiment 15:
Be up to the standards seven flavor medicine standby respectively; Getting catechu, dried Alumen, ginsenoside, Borneolum Syntheticum pulverize separately becomes fine powder standby.Soybean oil is warmed to 120-130 ℃, drops into Radix Arnebiae (Radix Lithospermi), constantly stir, kept 0.5-1 hour, squeeze and filter, fluid is standby; Cortex Phellodendri, Radix Sophorae Flavescentis are solvent with 70% ethanol, reflux 2 times, and 2 hours for the first time, 1 hour for the second time, extracting solution filtered, and reclaimed ethanol, be concentrated in right amount, spray drying, dried cream powder and above-mentioned fine powder mixing are standby; Get Borneolum Syntheticum add stir evenly in the Oleum Radix Arnebiae (Oleum Radix Lithospermi) standby; It is an amount of that other gets vaseline, and heat fused, temperature are reduced to about 50 ℃, add above-mentioned medicated powder, Oleum Radix Arnebiae (Oleum Radix Lithospermi) and dimethyl sulfoxine, fully stir evenly, and are pressed into soft capsule, and packing promptly.
Embodiment 16:
Be up to the standards seven flavor medicine standby respectively; Get catechu, dried Alumen, ginsenoside, Borneolum Syntheticum respectively superfine powder to be broken into fine powder standby; Getting Cortex Phellodendri, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) is solvent with 95% ethanol, floods after 48 hours, and slowly percolation is collected percolate, reclaims ethanol, is concentrated into standby in right amount; Medicinal residues decoct with water 2 times, and each 1 hour, filter, be concentrated in right amount, merge with above-mentioned alcohol extract, spray drying, dried cream powder and above-mentioned fine powder mixing add liquid Paraffin and stir evenly standby in right amount; Other gets vaseline, lecithin is an amount of, and heat fused, temperature are reduced to about 50 ℃,, add above-mentioned spares, fully stir evenly, be pressed into soft capsule, packing is promptly.
The quality control of rotten preparation disappears: former XIAOMI SHUAN is only at three physicochemical identification, no quantitative target, the present invention's rotten quality of the pharmaceutical preparations control that disappears has increased the thin layer of ginsenoside, Radix Arnebiae (Radix Lithospermi), Cortex Phellodendri, Radix Sophorae Flavescentis, Borneolum Syntheticum etc. has been differentiated, on assay ginsenoside, Radix Sophorae Flavescentis etc. has been carried out quantitatively.
Claims (6)
1, a kind of treatment cervical erosion, colpitic pharmaceutical composition is characterized in that it is that component is formed or made active component and pharmaceutically acceptable additives are formed or make active component and pharmaceutically acceptable additives are formed tablet, effervescent suppository, capsule, soft capsule suppository, foam, gel, membrane, ointment by the alcohol extract of following main materials by the water extract of following main materials by following main materials: (weight portion)
Ginsenoside 5-60, Radix Arnebiae (Radix Lithospermi) 200-800, Cortex Phellodendri 200-800, Radix Sophorae Flavescentis 200-800, dried Alumen 150-700, Borneolum Syntheticum 50-400, catechu 200-800.
2, pharmaceutical composition according to claim 1 is characterized in that formula optimization is: (weight portion)
Ginsenoside 25, Radix Arnebiae (Radix Lithospermi) 500, Cortex Phellodendri 500, Radix Sophorae Flavescentis 500, dried Alumen 400, Borneolum Syntheticum 200, catechu 500.
3, pharmaceutical composition according to claim 1 is characterized in that described pharmaceutically acceptable additives are following one or more:
Stearic acid, semi-synthetic fatty acid ester, vaseline, liquid Paraffin, tween 80, lecithin, sodium lauryl sulphate, dimethyl sulfoxine, azone, glycerol, gelatin, Polyethylene Glycol, Polyethylene Glycol-32 glycerol monolaurate (gelucire44/14), HPMC, CMC-Na, Carbom, ethylparaben, Oleum Sesami, soybean oil, Oleum Arachidis hypogaeae semen, tartaric acid, citric acid, sodium bicarbonate, propylene glycol, carbomer.
4, pharmaceutical composition according to claim 1 is characterized in that described tablet can also can be effervescent tablet, double-deck vaginal tablet or other various suitable tablets with suitable coating material coating or coating not.
5, pharmaceutical composition according to claim 1 is characterized in that described capsule can be soft capsule, hard capsule, effervescent capsule, controlled release vaginal capsule or other various suitable capsules.
6, a kind of method for preparing treatment cervical erosion, colpitic pharmaceutical composition is characterized in that it may further comprise the steps:
In a prescription Radix Sophorae Flavescentis, Cortex Phellodendri adopt alcohol extraction water is carried or alcohol extraction after medicinal residues again water carry or acid extraction or other suitable method are extracted,
In the b prescription Radix Arnebiae (Radix Lithospermi) adopt oil carry alcohol extraction or water is carried first alcohol extraction medicinal residues again water carry or first oil carry medicinal residues again alcohol extraction or other suitable method extract,
Ginsenoside's pulverizing or superfine powder are broken into fine powder or other suitable method processing in the c prescription,
Dried Alumen pulverizing or superfine powder are broken into fine powder or other suitable method processing in the d prescription,
Catechu pulverizing or superfine powder are broken into fine powder or other suitable method processing in the e prescription,
Borneolum Syntheticum pulverizing or superfine powder are broken into fine powder or other suitable method processing in the f prescription,
The pulverizing medicinal materials that needs in the g technology to extract becomes coarse powder or middle powder to extract, be generally 5-60 purpose coarse powder or middle powder, the best was a 20-40 order coarse powder, and the medical material that need be ground into fine powder in the technology was ground into 100-160 purpose fine powder usually, the best is standby for superfine powder is broken into 200-300 purpose fine powder
The condition of alcohol extraction is in the h technology: with 50-95% ethanol is solvent, can adopt heating reflux method or percolation or other suitable method to extract,
The condition that water is carried in the i technology is: decoct with water, extract 2-4 time at 90-98 ℃, each 1-3 hour, best was to decoct at 90-98 ℃ to extract three times, and 2 hours for the first time, second and third time was respectively 1 hour,
J technology medium oil is carried and can be adopted fried method or immersion method or other proper method, and used oil can be Oleum Sesami, soybean oil, Oleum Arachidis hypogaeae semen or other suitable oil,
Extracting gained water extract in the k technology can adopt precipitate with ethanol or add the flocculating agent sedimentation or method that other is suitable is further handled, the condition of precipitate with ethanol adds ethanol in right amount for the water extract is concentrated into makes the alcohol amount of containing reach 40-75%, leave standstill, centrifugation, best measure and reach 60-75% to containing alcohol for adding ethanol
Concentrate in the l technology and adopt concentrating under reduced pressure, thin film concentration, vacuum film to concentrate or other proper method,
Drying can adopt vacuum drying or spray drying or lyophilization or other suitable method in the m technology, the vacuum drying temperature is controlled at 50-90 ℃, the best is 60-70 ℃, and spray drying is for to be condensed into the concentrated solution that relative density is 1.03-1.25 (60 ℃), spray drying with extracting solution, inlet temperature is 100-200 ℃, leaving air temp is 50-150 ℃, and best relative density is 1.05-1.15 (60 ℃), and inlet temperature is 150-170 ℃, leaving air temp is 80-100 ℃
N adds different additives as required, adopts suitable moulding process, through being prepared from tablet, effervescent suppository, capsule, soft capsule suppository, foam, gel, membrane, ointment.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1857497B (en) * | 2006-03-22 | 2012-07-04 | 于结妹 | Erosion treating Chinese medicine ointment and its quality control method |
CN103565990A (en) * | 2012-07-29 | 2014-02-12 | 潘首德 | Method for preparing anti-cervical erosion suppository |
US8965213B2 (en) | 2009-05-26 | 2015-02-24 | Huawei Technologies Co., Ltd. | Antenna device |
-
2004
- 2004-04-10 CN CN 200410023106 patent/CN1679649A/en active Pending
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1857497B (en) * | 2006-03-22 | 2012-07-04 | 于结妹 | Erosion treating Chinese medicine ointment and its quality control method |
US8965213B2 (en) | 2009-05-26 | 2015-02-24 | Huawei Technologies Co., Ltd. | Antenna device |
CN103565990A (en) * | 2012-07-29 | 2014-02-12 | 潘首德 | Method for preparing anti-cervical erosion suppository |
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