CN105362383A - Traditional Chinese medicine effervescent tablets for treating gynecologic inflammations and preparation method thereof - Google Patents
Traditional Chinese medicine effervescent tablets for treating gynecologic inflammations and preparation method thereof Download PDFInfo
- Publication number
- CN105362383A CN105362383A CN201510937325.7A CN201510937325A CN105362383A CN 105362383 A CN105362383 A CN 105362383A CN 201510937325 A CN201510937325 A CN 201510937325A CN 105362383 A CN105362383 A CN 105362383A
- Authority
- CN
- China
- Prior art keywords
- powder
- radix sophorae
- sophorae flavescentis
- chinese medicine
- treatment
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/489—Sophora, e.g. necklacepod or mamani
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/718—Coptis (goldthread)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/35—Extraction with lipophilic solvents, e.g. Hexane or petrol ether
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses traditional Chinese medicine effervescent tablets for treating gynecologic inflammations. The traditional Chinese medicine effervescent tablets are composed of medicine powder, auxiliary materials playing the role of effervescence and other auxiliary materials, wherein the medicine powder for treating the gynecologic inflammations is mixed medicine powder prepared from goldthread roots, radix sophorae flavescentis, dahurian patrinia herb and borneol, the auxiliary materials playing the role of effervescence are composed of organic acid and carbonate, and other auxiliary materials are composed of one or more of filler, a bonding agent, a disintegrating agent and a lubricating agent. The invention further discloses a preparation method of the traditional Chinese medicine effervescent tablets. The prepared traditional Chinese medicine effervescent tablets for treating the gynecologic inflammations is good in stability and convenient to use, has the significant pharmacologic action of resisting bacteria and inflammations, relieving pain and inhibiting and killing trichomonas and has a good treating effect on the gynecologic diseases such as vaginitis, cervicitis, cervical erosion, pruritus vulvae and ulceration of vulvae.
Description
Art
The invention belongs to the preparing technical field of pharmaceuticals, be specifically related to a kind of Chinese patent medicine for the treatment of gynaecological inflammation disease and preparation method thereof.
Background technology
Gynaecological inflammation disease is as adnexitis, pelvic inflammatory disease, vaginitis, cervicitis, cervical erosion, vulva pruritus, vulval ulcers etc. are commonly encountered diseases, frequently-occurring disease clinically, more for the Chinese medicine preparation of such disease at present, but due to the factor such as onset is slow or curative effect is unstable, still can not meet clinical needs.It is be the suppository that raw material is made by Rhizoma Coptidis, Radix Sophorae Flavescentis, Herba Patriniae, Borneolum Syntheticum four taste Chinese medicine that " Drug Standard of Ministry of Public Health of the Peoples Republic of China " (Traditional Chinese medicine historical preparation eight) records kind " rehabilitation spirit bolt ", there is heat-clearing and toxic substances removing, removing dampness and killing parasites, restrains antipruritic effect.The colpitis effect be mainly used in clinically caused by the various cause of disease is better.Its preparation method is: above four tastes, by Borneolum Syntheticum porphyrize, Herba Patriniae is ground into fine powder.Getting Rhizoma Coptidis gives as one thinks fit cataclasm, fried withered with putting in pot with Oleum sesami 650ml, removes slag.Add Radix Sophorae Flavescentis again and soak 72 hours, elimination Radix Sophorae Flavescentis, as residue Oleum sesami quantity not sufficient 365ml, the Oleum sesami after available heating is supplied as 365ml, adds semi-synthetic fatty acid ester, stirring is dissolved, and slightly lets cool, and adds Borneolum Syntheticum, Herba Patriniae fine powder, mixing, pour mould molding into, take out, make 365, to obtain final product.Storage practice: airtight, preserves below 30 DEG C.Above-mentioned preparation technology also exists certain defect, as the Rhizoma Coptidis in prescription puts fried extraction in pot with Oleum sesami more than 2 times amount is same, not only cost is high, and the composition such as water soluble ingredient-Rhizoma Coptidis tannin class Rhizoma Coptidis with antibacterial and anti-inflammation functions extracts effectively, the Radix Sophorae Flavescentis water soluble ingredient with antibacterial and anti-inflammation functions does not also utilize, therefore can not give full play to Rhizoma Coptidis, Radix Sophorae Flavescentis and this formula therapeutical effect.In addition, after Rhizoma Coptidis and Radix Sophorae Flavescentis being extracted with Oleum sesami 650ml, gained medicine shortage of oil 365ml, shows have the Oleum sesami of more than 40% to be caused waste by reason losses such as medicinal residues absorption; From storage practice, the rehabilitation spirit bolt made with Oleum sesami and semi-synthetic fatty acid ester must be preserved below 30 DEG C, and thus transport, store equal inconvenience, therefore the necessary preparation technology to this medicine improves.On the other hand, dosage form, there is not yet the development report of rehabilitation spirit Chinese medicine effervescent tablet.
Summary of the invention
The object of the invention is to overcome the deficiencies in the prior art, provide that a kind of active constituent content is high, steady quality, rapid-action, curative effect is high, be easy to storage and transport, a kind of Chinese medicine effervescent tablet agent for the treatment of gynecological inflammation easy to use.
Another object of the present invention is to provide a kind of preparation method for the treatment of the Chinese medicine effervescent tablet of gynecological inflammation.
A kind of Chinese medicine effervescent tablet for the treatment of gynecological inflammation provided by the invention, comprises the component of following weight proportioning:
Adjuvant 45-740, other adjuvant 10-365 for the treatment of gynecological inflammation ground medicated powder 40-365, an effervescent effect.
The medicated powder for the treatment of gynecological inflammation of the present invention is with Rhizoma Coptidis, Radix Sophorae Flavescentis, Herba Patriniae, Borneolum Syntheticum four taste Chinese medicine for raw material, by the medicated powder that following weight proportion is formulated: Rhizoma Coptidis 200-300 part, Radix Sophorae Flavescentis 80-130 part, Herba Patriniae 7-15 part, Borneolum Syntheticum 5-10 part.The preparation method of the medicated powder for the treatment of gynecological inflammation comprises following two kinds:
[preparation method one] comprises the following steps:
(1) Rhizoma Coptidis, Radix Sophorae Flavescentis is got, with ethanol extraction 1-3 time of 75-95%, each 1-3 hour, filter, medicinal residues are for subsequent use, and filtrate adds solubilizing agent, mixing, and decompression recycling ethanol, obtains alcohol extraction concentrated solution; Slag of getting it filled decocts with water 1-3 time, each 1-2.5 hour, and filter, filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.10-1.30, merges with alcohol extraction concentrated solution, and dry, pulverizing, obtains Rhizoma Coptidis Radix Sophorae Flavescentis extract powder;
(2) get Borneolum Syntheticum, make Borneolum Syntheticum cyclodextrin clathrate fine powder;
(3) get Herba Patriniae, micronizing becomes the superfine powder of particle diameter≤10um;
(4) get above-mentioned Rhizoma Coptidis Radix Sophorae Flavescentis extract powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, Herba Patriniae superfine powder, fully mix, be i.e. the medicated powder of obtained treatment gynecological inflammation.
[preparation method two] comprises the following steps:
(1) get Rhizoma Coptidis, be ground into coarse powder, sterilizing, micronizing becomes the superfine powder of particle diameter≤10um, obtains Rhizoma Coptidis superfine powder;
(2) Radix Sophorae Flavescentis is got, with ethanol extraction 1-3 time of 75-95%, each 1-3 hour, filter, medicinal residues are for subsequent use, and filtrate adds solubilizing agent, fully stir, decompression recycling ethanol, concentrated, obtain alcohol extraction concentrated solution; Slag of getting it filled decocts with water 1-3 time, each 1-2.5 hour, and filter, filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.10-1.30, merges with alcohol extraction concentrated solution, and dry, pulverizing, obtains Radix Sophorae Flavescentis extract fine powder;
(3) get Borneolum Syntheticum, make Borneolum Syntheticum cyclodextrin clathrate fine powder;
(4) get Herba Patriniae, micronizing becomes the superfine powder of particle diameter≤10um;
(5) get above-mentioned Rhizoma Coptidis superfine powder, Radix Sophorae Flavescentis extract fine powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, Herba Patriniae superfine powder, fully mix, be i.e. the medicated powder of obtained treatment gynecological inflammation.
In two of the medicated powder preparation method for the treatment of gynecological inflammation of the present invention, step (2) Radix Sophorae Flavescentis extract fine powder also can be adopted and prepare with the following method: (1) gets Radix Sophorae Flavescentis, uses supercritical CO
2extraction or prepare Radix Sophorae Flavescentis liposoluble extract (Radix Sophorae Flavescentis total pigment content more than 25%, best more than 50%) as normal hexane, petroleum ether, dehydrated alcohol etc. extract with conventional fat-soluble organic solvent, medicinal residues are for subsequent use; (2) get one or more mixture that cyclodextrin clathrate, phosphatide complexes, solid dispersion, micronised powder are made in Radix Sophorae Flavescentis liposoluble extract and solubilizing agent of the present invention, obtain Radix Sophorae Flavescentis liposoluble extract hydrotrope fine powder.(3) slag of getting it filled decocts with water 1-3 time, each 1-2.5 hour, filters, filtrate high speed centrifugation, and centrifugal liquid is concentrated, dry, pulverizing, mixes with Radix Sophorae Flavescentis liposoluble extract hydrotrope fine powder, i.e. obtained Radix Sophorae Flavescentis extract fine powder;
The method for making of Borneolum Syntheticum cyclodextrin clathrate can list of references method [Song Hongtao, etc. Shenyang Pharmaceutical University journal .2002; 19 (4): 249] prepare.
The medicated powder of the treatment gynecological inflammation prepared according to the method described above, every 100 weight portions are equivalent to 100-1000 part of Rhizoma Coptidis, Radix Sophorae Flavescentis, Herba Patriniae, Borneolum Syntheticum four taste Chinese medicine.
Solubilizing agent of the present invention is: cyclodextrin and derivatives class thereof are as beta-schardinger dextrin-, HP-β-CD; Phospholipid is as soybean phospholipid, lecithin; Polyvinylpyrrolidone is as PVPk
30; Polyethylene glycols is as PEG4000, PEG6000, PEG12000, PEG20000 etc.; Hydroxypropyl emthylcellulose (low-viscosity) is as HPMC-E5, HPMC-E50; Microcrystalline Cellulose; Poloxamer; Sodium laurylsulfate; Tween 80; Can be above-mentioned in one or more combination use.
The adjuvant playing effervescent effect described in the present invention is made up of sour agent and alkaline agent, and wherein sour agent is selected from one or more in tartaric acid, malic acid, glycine, fumaric acid, fumarate, maleic acid, maleate, anhydrous stubborn lemon acid, citric acid, sodium dihydrogen citrate salt; Alkaline agent is selected from sodium carbonate, sodium bicarbonate a kind of or both mixture.
In the present invention, other described adjuvant is one or more in filler, binding agent, disintegrating agent, lubricant.Wherein: (1) filler is selected from starch based as one or more in pregelatinized Starch or soluble starch, dextrin, lactose, mannitol, sorbitol, xylitol, microcrystalline Cellulose; (2) binding agent is selected from one or more in hydroxypropyl emthylcellulose, polyvinylpyrrolidone, methylcellulose, ethanol; (3) disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, Tween 80, microcrystalline Cellulose, sodium lauryl sulphate; (4) lubricant is selected from one or more in magnesium stearate, fumaric acid, fumaric acid sodium or potassium, sodium benzoate, Pulvis Talci, solid polyethylene glycol class, Stepanol MG, sodium lauryl sulphate, micropowder silica gel.In addition, other adjuvant can also include (1) aromatic: as rose essence, vanilla, Mint Essence etc., increases armaticity to improve the compliance of patient.(2) film coating agent: as full water damp-proof Opadry coating materials, improves the stability of preparation by coating.These adjuvants can combinationally use in varing proportions.
The preparation method that the present invention treats the Chinese medicine effervescent tablet of gynecological inflammation is: get the medicated powder for the treatment of gynecological inflammation, filler, the adjuvant playing effervescent effect and disintegrating agent, mixing, with the alcoholic solution soft material, the granulation that contain binding agent 3-15%, cold drying, granulate, adds lubricant, mixing, tabletting (coating), i.e. obtained effervescent tablet of the present invention.Also the full powder pressing method common process of tablet can be adopted to prepare the Chinese medicine effervescent tablet that the present invention treats gynecological inflammation.To the requirement of environment during tabletting: control tabletting ambient temperature less than 25 DEG C, humidity less than 45%.
The principle of foundation of the present invention and beneficial effect:
1, the present invention has carried out extracting comprehensively, fully and retaining to the active ingredient of Rhizoma Coptidis in formula and Radix Sophorae Flavescentis-fat-soluble and water soluble ingredient, makes effective component extraction rate, utilization rate greatly increases, thus improve drug effect.And in former rehabilitation spirit suppository technique, do not extract the water soluble ingredient retaining and there is in Rhizoma Coptidis and Radix Sophorae Flavescentis antibacterial and anti-inflammation functions, so there is no the drug effect making full use of and play Rhizoma Coptidis and Radix Sophorae Flavescentis, waste herb resource.
The main active of Rhizoma Coptidis is anthraquinone analog compound, tannin constituents, phenyl propyl ketone glycoside, stilbene glycoside and organic acid.Anthraquinone analog compound is divided into again sequestered and the large class of conjunction type two, and sequestered antibacterial action is comparatively strong, and both have good dissolubility in ethanol.Except sequestered anthraquinone analog compound, the tannin constituents in Rhizoma Coptidis, phenyl propyl ketone glycoside, stilbene glycoside and organic acid can be water-soluble.Ju bibliographical information [Huang Hao, etc. Chinese herbal medicine, 1998; 29 (3): 199], the Rhizoma Coptidis decocting liquid of Rhizoma Coptidis tannin constituents and removal anthraquinone and tannin has certain bacteriostasis.Therefore, the anthraquinone component of Rhizoma Coptidis and water soluble ingredient all should extract, retain.
The main active of Radix Sophorae Flavescentis is the liposoluble constituent-naphthaquinone derivatives (Radix Sophorae Flavescentis pigment and derivant thereof) with anti-microbial infection, antiinflammatory, antiviral, antitumor, anastalsis, comprise kurarinone, acetyl kurarinone, β, beta-dimethyl-acryloyl kurarinone, isovaleryl kurarinone, deoxidation kurarinone etc.This constituents is fat-soluble very strong, soluble in fat-soluble organic solvent as chloroform, petroleum ether, benzene, normal hexane etc., dissolve in vegetable oil, ethanol, water-soluble hardly.Have research [Yang Rong. Chinese Medicine journal, 1992; 7 (3): 34] show: the Aqueous extracts of Radix Sophorae Flavescentis and alcohol extract all have obvious bacteriostasis and antiinflammatory action.Therefore, the liposoluble constituent of Radix Sophorae Flavescentis and water soluble ingredient also all should extract reservation.
Therefore, Rhizoma Coptidis has similar physicochemical property and antibacterial and anti-inflammation functions with the quinones in Radix Sophorae Flavescentis and water soluble ingredient, all there is good dissolubility in ethanol, therefore both are combined, select cheap and easy to get, be easy to reclaim the ethanol used and first extract for solvent, the technique of water extraction water soluble ingredient used again by medicinal residues after alcohol extraction, all extracts this two constituents and retain, and with abundant effective component extracting, Appropriate application medical material, plays due drug effect.Meanwhile, the Oleum sesami used with former suppository is done compared with Extraction solvent, and present invention process had not only reduced production cost, but also free from environmental pollution, was more suitable for large need of production.
Through detecting by ultraviolet spectrophotometry method, the Radix Sophorae Flavescentis total pigment extraction ratio of present invention process is 93%, and the Radix Sophorae Flavescentis total pigment extraction ratio in former rehabilitation spirit bolt process is only 62%; The Rhizoma Coptidis tannin extraction ratio of present invention process is 91%, and the Rhizoma Coptidis tannin extraction ratio of former rehabilitation spirit bolt process is only 6.5%.Therefore the extraction ratio of present invention process to Radix Sophorae Flavescentis total pigment and Rhizoma Coptidis tannin constituents is much higher than former rehabilitation spirit bolt process.
2, the present invention adds the solubilising material (being referred to as solubilizing agent in the present invention) that can increase dissolubility, as beta-schardinger dextrin-, HP-β-CD, phospholipid, PVPk in alcohol extract
30, PEG6000, hydroxypropyl emthylcellulose (low-viscosity), microcrystalline Cellulose, poloxamer, Tween 80 etc., can make liposoluble constituent in the process reclaiming ethanol, by forming cyclodextrin clathrate, solid dispersion, phosphatide complexes etc., considerably increase Rhizoma Coptidis sequestered anthraquinone analog compound and the dissolubility of Radix Sophorae Flavescentis pigment composition in water.The effervescent tablet that the present invention obtains, compared with former rehabilitation spirit suppository, medicine can be dissolved in rapidly in vaginal secretion with the effect of effervescent, be dispersed in each diseased region of vagina pleat, give full play to antibacterial, antiviral, antiinflammatory effect, thus improve drug effect.
3, the process of Borneolum Syntheticum: this product has volatility, easily molten in ethanol, chloroform or ether, almost insoluble in water.Borneolum Syntheticum is made cyclodextrin clathrate, greatly can improve the dissolubility of Borneolum Syntheticum in juice, dispersibility and Borneolum Syntheticum stability in the formulation, give full play to the drug effect of Borneolum Syntheticum and guarantee the stable of the quality of the pharmaceutical preparations.
4, the process of Herba Patriniae: be peeling branch and the dry dry soft extracts of leguminous plant Herba Patriniae Acaciacatechu (L.f.) Willd..There is stronger inhibitory anti-virus effect, main containing tannin constituents, containing Herba Patriniae element (C
15h
14o
6) and the total amount of table Herba Patriniae element higher than 21.0%.Herba Patriniae has good dissolubility in water, but dispersive process is slower.Herba Patriniae micronizing is become the superfine powder of particle diameter≤10um by the present invention for this reason, improves the rate of dissolution of Herba Patriniae, thus can the antibiosis and antiviral functions of fast onset Herba Patriniae.
5, another preparation method of the medicated powder of gynecological inflammation is treated in effervescent tablet of the present invention, that Rhizoma Coptidis is used after becoming the superfine powder of particle diameter≤10um without extraction process, direct micronizing, effectively can retain the active component in Rhizoma Coptidis, improve its dispersion rate and stripping in juice, reach the object of bactericidal antiphlogistic.
6, the good water solubility of effervescent tablet of the present invention, can not only treat various colpitis by intravaginal administration, but also can disperse, is dissolved in the water, for washout or embrocate vulva such as treatment vulva pruritus, vulval ulcer etc.Therefore, compared with former rehabilitation spirit suppository, route of administration is expanded.
7, the present invention is solid tablet, can preserve below 40 DEG C, overcomes the easy softening transform of former suppository heat, must preserve, transport and store inconvenient shortcoming below 30 DEG C, compared with former suppository, improve stability and the effectiveness of medicine.
8, through disintegration detect show, the present invention within 3 minutes can disintegrate completely, dispersion; The disintegrate of former suppository, dispersion time limit are more than 25 minutes.Compared with former suppository, effervescent tablet of the present invention has rapid, the rapid-action advantage of disintegrate.
9, the present invention has the antipruritic effect of heat-clearing and toxic substances removing, removing dampness and killing parasites, convergence.Be mainly used in colpitis, cervicitis, cervical erosion, vulva pruritus, the gynaecopathias such as vulval ulcer, there is the advantages such as onset is rapid, determined curative effect.Show through pharmacodynamics test, but the present invention has antibacterial, antiinflammatory kills infusorian, analgesic effect, drug effect is obviously better than " rehabilitation spirit bolt ".
Embodiment 1 treats the preparation of the medicated powder of gynecological inflammation
Composition of raw materials: Rhizoma Coptidis 248g, Radix Sophorae Flavescentis 100g, Herba Patriniae 10g, Borneolum Syntheticum 7g.
Method for making: (1) gets Rhizoma Coptidis, Radix Sophorae Flavescentis, the ethanol extraction with 88% 3 times, each 2 hours, filter, medicinal residues were for subsequent use, and filtrate adds beta-schardinger dextrin-60g, PVPk
3060g and poloxamer 10g, mixing, decompression recycling ethanol, obtains alcohol extraction concentrated solution; Slag of getting it filled decocts with water 2 times, each 1.5 hours, and filter, filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.23 (60 DEG C), merges, spraying dry, pulverizing with alcohol extraction concentrated solution, obtains Rhizoma Coptidis Radix Sophorae Flavescentis extract powder;
(2) Borneolum Syntheticum is got, beta-schardinger dextrin-56g, list of references method [Song Hongtao, etc. Shenyang Pharmaceutical University journal .2002; 19 (4): 249], Borneolum Syntheticum cyclodextrin clathrate fine powder is made with polishing;
(3) get Herba Patriniae, micronizing becomes the superfine powder of particle diameter≤10um;
(4) get above-mentioned Rhizoma Coptidis Radix Sophorae Flavescentis extract powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, Herba Patriniae superfine powder, fully mix, be i.e. the medicated powder of obtained treatment gynecological inflammation.
Embodiment 2 treats the preparation of the medicated powder of gynecological inflammation
Composition of raw materials: Rhizoma Coptidis 210g, Radix Sophorae Flavescentis 120g, Herba Patriniae 12g, Borneolum Syntheticum 8g.
Method for making: (1) gets Rhizoma Coptidis, is ground into coarse powder, sterilizing, micronizing becomes the superfine powder of particle diameter≤10um, obtains Rhizoma Coptidis superfine powder;
(2) get Radix Sophorae Flavescentis, the ethanol extraction with 95% 2 times, each 2.5 hours, filter, medicinal residues are for subsequent use, and filtrate adds PVPk
3070g, hydroxypropyl emthylcellulose (HPMC-E5) 30g, soybean phospholipid 8g, stir, decompression recycling ethanol, concentrated, obtains alcohol extraction concentrated solution; Slag of getting it filled decocts with water 2 times, each 1 hour, and filter, filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.38, merges with alcohol extraction concentrated solution, and vacuum drying, superfine comminution at low temperature at 60 DEG C, obtain Radix Sophorae Flavescentis extract fine powder;
(3), (4) are respectively with embodiment 1 (2), (3);
(5) get above-mentioned Rhizoma Coptidis superfine powder, Radix Sophorae Flavescentis extract fine powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, Herba Patriniae superfine powder, fully mix, be i.e. the medicated powder of obtained treatment gynecological inflammation.
Embodiment 3 treats the preparation of the medicated powder of gynecological inflammation
Composition of raw materials: Rhizoma Coptidis 218g, Radix Sophorae Flavescentis 110g, Herba Patriniae 13g, Borneolum Syntheticum 6g.
Method for making: (1) gets Rhizoma Coptidis, is ground into coarse powder, sterilizing, micronizing becomes the superfine powder of particle diameter≤10um, obtains Rhizoma Coptidis superfine powder;
(2) get Radix Sophorae Flavescentis, with Petroleum ether extraction 3 times, each 1.5 hours, filter, medicinal residues are for subsequent use, filtrate merge, reclaim under reduced pressure petroleum ether, residue adds PEG
600080g, HP-β-CD 30g, lecithin 5g, ethanol 550ml, after reflux 40min, decompression recycling ethanol, lyophilization, pulverize at low temperature, obtain Radix Sophorae Flavescentis liposoluble extract hydrotrope fine powder; Slag of getting it filled decocts with water 2 times, each 1.5 hours, filters, filtrate high speed centrifugation, centrifugal liquid is concentrated, spraying dry, pulverizing, mix with Radix Sophorae Flavescentis liposoluble extract hydrotrope fine powder, obtain Radix Sophorae Flavescentis extract fine powder;
(3), (4) are respectively with embodiment 1 (2), (3);
(5) get above-mentioned Rhizoma Coptidis superfine powder, Radix Sophorae Flavescentis extract fine powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, Herba Patriniae superfine powder, fully mix, be i.e. the medicated powder of obtained treatment gynecological inflammation.
Embodiment 4 treats the preparation of the Chinese medicine effervescent tablet of gynecological inflammation
The medicated powder 280g of the treatment gynecological inflammation of Example 1 gained, sodium bicarbonate 180g, after mixing, add mannitol 50g, citric acid 190g, crospolyvinylpyrrolidone 50g, and mixing, uses PVPk
30the alcoholic solution soft material of 6%, granulation, cold drying, granulate, adds magnesium stearate 5.5g, mixing, tabletting, i.e. obtained effervescent tablet of the present invention.
Embodiment 5 treats the preparation of the Chinese medicine effervescent tablet of gynecological inflammation
The medicated powder 435g of the treatment gynecological inflammation of Example 2 gained, sodium bicarbonate 210g, after mixing, add lactose 30g, microcrystalline Cellulose 25g, tartaric acid 190g, carboxymethyl starch sodium 45g, and mixing, uses PVPk
30the alcoholic solution soft material of 10%, granulation, cold drying, granulate, adds micropowder silicon 8.5g, mixing, tabletting, i.e. obtained effervescent tablet of the present invention.
Embodiment 6 treats the preparation of the Chinese medicine effervescent tablet of gynecological inflammation
The medicated powder 463g of the treatment gynecological inflammation of Example 3 gained, sodium carbonate 195g, after mixing, add mannitol 40g, soluble starch 20g, citric acid 170g, cross-linking sodium carboxymethyl cellulose 60g, and mixing, uses PVPk
30the alcoholic solution soft material of 7%, granulation, cold drying, granulate, adds magnesium stearate 3.5g, sodium lauryl sulphate 4g, mixing, tabletting, i.e. obtained effervescent tablet of the present invention.
Embodiment 7 treats the preparation of the Chinese medicine effervescent tablet of gynecological inflammation
The medicated powder 283g of the treatment gynecological inflammation of Example 1 gained, sodium bicarbonate 170g, after mixing, add mannitol 50g, citric acid 160g, crospolyvinylpyrrolidone 55g, microcrystalline Cellulose 25g, PEG
400010g, magnesium stearate 5.5g, micropowder silicon 4.5g, fully mix, tabletting, with full water damp-proof Opadry film coating, i.e. and obtained effervescent tablet of the present invention.
Pharmacodynamic test of active extract is tested
One, anti-inflammation test (mice auricular concha swelling method)
Mice 50, female, body weight 19 ~ 22g, is divided into 5 groups: 0.5%CMCNa matched group at random; The present invention's 3 dosage groups (1.3,2.6,5.2g crude drug/kg); Rehabilitation spirit bolt group (5.2g crude drug/kg), often organizes 10.Mouse right ear shell is smeared and is administered once, 0.1ml/10g.Administration is after 60 minutes, and every Mus auris dextra is coated with dimethylbenzene 0.05ml and causes inflammation, and left ear is as normal control.Put to death after causing scorching 1 hour, cut ears, with the card punch of diameter 9mm, ears are cut with position homalographic, divide another name its weight, using the difference of two auricle weight as swelling, be calculated as follows suppression ratio: suppression ratio=(matched group swelling-administration group swelling)/matched group swelling × 100%.The results are shown in Table 1.
Table 1 the present invention is on the impact of mice ear
Group dosage (g/kg) number of animals (only) swelling (mg) suppression ratio (%)
Matched group-1015.9 ± 4.0
Rehabilitation spirit bolt 5.21012.0 ± 2.1
※24.5
1.31013.5 ± 3.315.1 of the present invention
2.61011.5 ± 1.7 of the present invention
※27.6
5.2109.8 ± 1.4 of the present invention
※ ※40.4
Compare with matched group:
※p < 0.05
※ ※p < 0.01
Table 1 result shows: of the present invention group of middle and high dosage with rehabilitation spirit bolt group compared with matched group, there is significant difference, the present invention P < 0.01 compared with matched group of 5.2g crude drug/kg dosage group, and dosage is rehabilitation spirit bolt group P < 0.05 compared with matched group of 5.2g crude drug/kg, show that the inhibitory action of the present invention to mice ear inflammation is better than contrast medicine rehabilitation spirit bolt.
Two, analgesic test (writhing method)
Mice 100, body weight 18 ~ 22g, is divided into 5 groups at random, and often organize 20, first group is negative control group, to isometric(al) 0.5%CMCNa; Second group is rehabilitation spirit bolt group (4g crude drug/kg); Third and fourth, five groups be the present invention little, in, large 3 dosage groups (1,2,4g crude drug/kg).With depilatory cream (barium sulfide 25g, Pulvis Talci 35g, starch 35g, soap powder 5g, add water furnishing pasty state), mouse web portion is respectively sloughed the region of a 1.5cm × 2.5cm, respectively all even coating of group is in mice epilating area, with gauze and adhesive plaster extenal fixation.After administration 60min, give the acetic acid solution 0.2ml of every mouse peritoneal injection 0.6%, observe immediately and record the number of times of mouse writhing in 15min.The results are shown in Table 2.
From table 2, the mouse writhing reaction that the present invention can suppress acetic acid to stimulate, compare with negative control group, heavy dose of group has significant difference (P < 0.05), and the pain pointing out Dichlorodiphenyl Acetate of the present invention to stimulate has analgesic activity.Positive control drug rehabilitation spirit bolt has the trend suppressing acetic acid to stimulate mouse writhing reaction, but compares there was no significant difference with negative control group.Show that analgesic activity of the present invention is obviously better than isodose rehabilitation spirit bolt.
The impact (x ± s) that table 2 the present invention reacts mouse writhing
Group dose animals number writhing response
(g crude drug/kg) (only) (secondary/15min)
Negative control group 2023.11 ± 5.34
Rehabilitation spirit bolt 42021.83 ± 5.75
Low dose 12019.85 ± 4.78 of the present invention
Dosage 22020.13 ± 3.46 in the present invention
Heavy dose 42018.39 ± 4.17* of the present invention
* P < 0.05 is compared with negative control group
Three, anti-trichomonal vaginitis test
With reference to " antiparasitic test principle " and " parasitology experimental technique " in Ministry of Public Health bureau of drug administration " new drug preclinical study guideline ", extracorporeal culture-ing is adopted to measure the minimum pesticidal concentration of effervescent tablet of the present invention to trichomonal vaginitis.Trichomonal vaginitis is cultivated 48 hours in the CPML culture medium 37 DEG C of improvement, infusorian motion ripple alive, well-grown, and natural mortality rate is less than 2%, tests with trichomonal vaginitis liquid containing worm density 1.8 × 10
3/ ml.The present invention and rehabilitation spirit bolt are carried out continuous two times of gradient dilutions with the CPML culture fluid improved respectively, make liquor strength be followed successively by 0.50,0.25,0.125,0.0625,0.0313,0.0156,0.0078,0.0039g crude drug/ml.Each Concentraton gradient establishes three parallel test pipes, often pipe 5ml.Be added in each pipe the trichomonal vaginitis suspension that 37 DEG C are cultivated 48 hours, make the final concentration of infusorian be 2.0 × 10
2/ ml.Set up matched group simultaneously.Put 37 DEG C and continue cultivation 24 hours, draw each pipe 0.1ml infusorian liquid transferred species respectively in new culture medium, cultivate the worm drop sheet microscopy getting the mixing of each pipe after 72 hours for 37 DEG C.The minimum drug level of 3 parallel test pipe equal absence of vagina trichomonacide growths is the minimum effective drug concentration of killing in vitro trichomonal vaginitis.
Result shows, the minimum effective drug concentration of killing in vitro trichomonal vaginitis of the present invention is 0.0625g crude drug/ml; And the minimum effective drug concentration of the killing in vitro trichomonal vaginitis of rehabilitation spirit bolt is 0.125g crude drug/ml, illustrate that the effect killing infusorian is obviously weaker than effervescent tablet of the present invention.
Four, In vitro Bactericidal Experiments
With reference to " antimicrobial drug In vitro Bactericidal Experiments principle " and " microbiological Test technology " in Ministry of Public Health bureau of drug administration " new drug preclinical study guideline ", adopt trace continuously doubling dilution measure the present invention and rehabilitation spirit bolt to colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, streptococcus faecalis, gonococcus, Bacillus proteus, the type strain of Candida albicans and colon bacillus, staphylococcus aureus, staphylococcus epidermidis, proteus vulgaris, Candida albicans, the minimal inhibitory concentration (MIC) of vagina Gartner bacterium clinical separation strain, adopt the minimal bactericidal concentration (MBC) of dull and stereotyped infection protocol mensuration to above-mentioned antibacterial.Colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, vagina Gartner bacterium are inoculated in MH meat soup, put standard incubator 37 DEG C and cultivate 24h; Streptococcus faecalis is inoculated in TPY meat soup (anaerobe nutrient broth), puts anaerobic culture box 37 DEG C and cultivates 48h; Gonococcus is inoculated in the MH meat soup containing 5% calf serum, puts 5%CO
2incubator 37 DEG C cultivates 48h; Candida albicans is inoculated in husky guarantor Ruo Shi meat soup, puts standard incubator 37 DEG C and cultivates 48h.Count antibacterial by turbidimetry, transferred species measures viable count and colony-forming units (CFU/ml) in bacterium liquid in flat board, is deployed into 10 with diluent
6the bacterium liquid of CFU/ml is for subsequent use.
1. the mensuration of pair colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, vagina Gartner bacterium type strain and clinical separation strain MIC and MBC: the present invention and rehabilitation spirit bolt are carried out continuous two times of gradient dilutions with MH meat soup respectively, make liquor strength be followed successively by 0.50,0.25,0.125,0.0625,0.0313,0.0156,0.0078,0.0039g crude drug/ml.Each concentration liquid is added to 96 well culture plates respectively, 0.2ml/ hole.Adding concentration is more successively 10
6the test organisms liquid 10 μ l/ hole of CFU/ml, sets up bacterial controls and culture medium contrast simultaneously.Put room temperature effect 12h, cultivate 24h observed result in standard incubator 37 DEG C.Be MIC without minimum drug level contained in bacterial growth hole.Successively the culture having no bacterial growth hole is drawn respectively 0.1ml dibbling more dull and more stereotyped in MH, put standard incubator 37 DEG C and cultivate 24h, the minimum drug level corresponding without bacterial growth inoculation region is MBC, the results are shown in Table 3 ~ 4.
2. the mensuration of couple streptococcus faecalis type strain MIC and MBC: the present invention and rehabilitation spirit bolt are carried out continuous two times of gradient dilutions with TPY meat soup respectively, each concentration liquid is added to 96 well culture plates respectively, 0.2ml/ hole.Adding concentration is more successively 10
6the test organisms liquid 10 μ l/ hole of CFU/ml, sets up bacterial controls and culture medium contrast simultaneously.Put room temperature effect 12h, in 5%CO
2incubator 37 DEG C cultivates 24h observed result.Be MIC without minimum drug level contained in bacterial growth hole.Successively the culture having no bacterial growth hole is drawn respectively 0.1ml transfection more dull and more stereotyped in TPY, put 37 DEG C of Anaerobic culturel 24h, the minimum drug level corresponding without bacterial growth inoculation region is MBC, the results are shown in Table 3 ~ 4.
3. the mensuration of gonococcus type strain and clinical separation strain MIC and MBC
Using the MH meat soup containing 5% calf serum by carrying out continuous two times of gradient dilutions the present invention and rehabilitation spirit bolt, each concentration liquid being added to 96 well culture plates respectively, 0.2ml/ hole.Adding concentration is more successively 10
6the test organisms liquid 10 μ l/ hole of CFU/ml, sets up bacterial controls and culture medium contrast simultaneously.Put room temperature effect 12h, in 5%CO
2incubator 37 DEG C cultivates 48h observed result.Be MIC without minimum drug level contained in bacterial growth hole.Successively the culture having no each hole of bacterial growth is drawn 0.1ml respectively again and be transfected into chocolate flat board, put 5%CO
2incubator 37 DEG C cultivates 48h, and the minimum drug level corresponding without bacterial growth inoculation region is MBC, the results are shown in Table 3 ~ 4.
4. the mensuration of pair Candida albicans type strain and clinical separation strain MIC and MBC: peaceful for urinary system Film coated tablets sand is protected Ruo Shi (SB) meat soup and carries out continuous two times of gradient dilutions, each concentration liquid is added to 96 well culture plates respectively, 0.2ml/ hole.Adding concentration is more successively 10
6the test organisms liquid 10 μ l/ hole of CFU/ml, sets up bacterial controls and culture medium contrast simultaneously.Put room temperature effect 12h, cultivate 48h observed result in standard incubator 37 DEG C.Be MIC without minimum drug level contained in bacterial growth hole.Successively the culture having no each hole of bacterial growth is drawn respectively 0.1ml dibbling more dull and more stereotyped in SB, put standard incubator 37 DEG C and cultivate 48h, be MBC without the minimum drug level corresponding to bacterial growth inoculation region, the results are shown in Table 3 ~ 4.
Table 3 the present invention is to MIC and MBC (g crude drug/ml) of reference culture
Rehabilitation spirit bolt of the present invention
Bacterial strain MICMBCMICMBC
(g crude drug/ml) (g crude drug/ml) (g crude drug/ml) (g crude drug/ml)
Escherichia coli ATCC25922 strain 0.03130.06250.1250.25
Staphylococcus aureus ATCC25925 strain 0.00780.01560.01560.0313
Pseudomonas aeruginosa ATCC27853 strain 0.01560.03130.06250.125
Staphylococcus epidermidis ATCC26069 strain 0.00780.01560.03130.0625
Streptococcus faecalis ATCC10541 strain 0.01560.06250.06250.125
Proteus vulgaris 49010 strain 0.06250.1250.1250.25
Gonococcus 20106 strain 0.01560.03130.03130.125
Vagina Gartner bacterium clinical reference strain 0.00780.01560.01560.0313
Candida albicans 85021 strain 0.00780.03130.03130.0625
Table 4 the present invention is to MIC, MBC (g crude drug/ml) of 502 strain Clinical isolation
Bacterial strain strain number MICMBC
(g crude drug/ml) (g crude drug/ml)
Staphylococcus aureus 1600.0078-0.01560.0156-0.0313
Escherichia coli 1100.0313-0.06250.0625-0.125
Staphylococcus epidermidis 800.0078-0.01560.156-0.313
Proteus vulgaris 900.0625-0.1250.125-0.25
Gonococcus 240.0078-0.01560.0156-0.0313
Vagina Gartner bacterium 80.0078-0.01560.0156-0.0313
Candida albicans 300.0078-0.01560.0078-0.0313
From table 3, the type strain of the present invention to the escherichia coli selected by test, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, streptococcus faecalis, gonococcus, Bacillus proteus, vagina Gartner bacterium, Candida albicans all has significantly suppression and deactivation, its MBC is 2 ~ 4 times of MIC, and suppression of the present invention and deactivation are obviously better than rehabilitation spirit bolt.From table 4, the present invention all has certain suppression and deactivation to 502 strain Clinical isolation selected by test, and its MBC is 2 ~ 4 times of MIC.
Claims (10)
1. treat a Chinese medicine effervescent tablet for gynecological inflammation, it is characterized in that the component containing following weight proportioning:
The medicated powder 40-365 for the treatment of gynecological inflammation, adjuvant 45-740, other adjuvant 10-365 of an effervescent effect.
2. the Chinese medicine effervescent tablet for the treatment of gynecological inflammation according to claim 1, is characterized in that the every 100 parts of 100-1000 parts being equivalent to Rhizoma Coptidis, Radix Sophorae Flavescentis, Herba Patriniae, Borneolum Syntheticum four taste Chinese medicine of the medicated powder of described treatment gynecological inflammation; The weight proportion of this four tastes Chinese medicine is: Rhizoma Coptidis 200-300 part, Radix Sophorae Flavescentis 80-130 part, Herba Patriniae 7-15 part, Borneolum Syntheticum 5-10 part.
3. the Chinese medicine effervescent tablet for the treatment of gynecological inflammation according to claim 1 and 2, is characterized in that the preparation method of the medicated powder of described treatment gynecological inflammation comprises the following steps:
(1) Rhizoma Coptidis, Radix Sophorae Flavescentis is got, with ethanol extraction 1-3 time of 75-95%, each 1-3 hour, filter, medicinal residues are for subsequent use, and filtrate adds solubilizing agent, mixing, and decompression recycling ethanol, obtains alcohol extraction concentrated solution; Slag of getting it filled decocts with water 1-3 time, each 1-2.5 hour, and filter, filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.10-1.30, merges with alcohol extraction concentrated solution, and dry, pulverizing, obtains Rhizoma Coptidis Radix Sophorae Flavescentis extract powder;
(2) get Borneolum Syntheticum, make Borneolum Syntheticum cyclodextrin clathrate fine powder;
(3) get Herba Patriniae, micronizing becomes the superfine powder of particle diameter≤10um;
(4) get above-mentioned Rhizoma Coptidis Radix Sophorae Flavescentis extract powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, Herba Patriniae superfine powder, fully mix, be i.e. the medicated powder of obtained treatment gynecological inflammation.
4. the Chinese medicine effervescent tablet for the treatment of gynecological inflammation according to claim 1 and 2, is characterized in that the preparation method of the medicated powder for the treatment of gynecological inflammation comprises the following steps:
(1) get Rhizoma Coptidis, be ground into coarse powder, sterilizing, micronizing becomes the superfine powder of particle diameter≤10um, obtains Rhizoma Coptidis superfine powder;
(2) Radix Sophorae Flavescentis is got, with ethanol extraction 1-3 time of 75-95%, each 1-3 hour, filter, medicinal residues are for subsequent use, and filtrate adds solubilizing agent, fully stir, decompression recycling ethanol, concentrated, obtain alcohol extraction concentrated solution; Slag of getting it filled decocts with water 1-3 time, each 1-2.5 hour, and filter, filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.10-1.30, merges with alcohol extraction concentrated solution, and dry, pulverizing, obtains Radix Sophorae Flavescentis extract fine powder;
(3) get Borneolum Syntheticum, make Borneolum Syntheticum cyclodextrin clathrate fine powder;
(4) get Herba Patriniae, micronizing becomes the superfine powder of particle diameter≤10um;
(5) get above-mentioned Rhizoma Coptidis superfine powder, Radix Sophorae Flavescentis extract fine powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, Herba Patriniae superfine powder, fully mix, be i.e. the medicated powder of obtained treatment gynecological inflammation.
5. the medicated powder preparation method for the treatment of gynecological inflammation according to claim 4, is characterized in that described Radix Sophorae Flavescentis extract fine powder can also be adopted and prepares with the following method: (1) gets Radix Sophorae Flavescentis, uses supercritical CO
2extraction or prepare Radix Sophorae Flavescentis liposoluble extract with conventional fat-soluble organic solvent extraction, medicinal residues are for subsequent use; (2) get one or more mixture that cyclodextrin clathrate, phosphatide complexes, solid dispersion, micronised powder are made in Radix Sophorae Flavescentis liposoluble extract and solubilizing agent, obtain Radix Sophorae Flavescentis liposoluble extract hydrotrope fine powder.(3) slag of getting it filled decocts with water 1-3 time, each 1-2.5 hour, filters, filtrate high speed centrifugation, and centrifugal liquid is concentrated, dry, pulverizing, mixes, obtain Radix Sophorae Flavescentis extract fine powder with Radix Sophorae Flavescentis liposoluble extract hydrotrope fine powder.
6. the Chinese medicine effervescent tablet of the treatment gynecological inflammation according to claim 3,4 or 5, is characterized in that described solubilizing agent is one or more in cyclodextrin and derivatives class thereof, phospholipid, polyvinylpyrrolidone, polyethylene glycols, hydroxypropyl emthylcellulose, microcrystalline Cellulose, poloxamer, sodium laurylsulfate, Tween 80.
7. the Chinese medicine effervescent tablet for the treatment of gynecological inflammation according to claim 1, it is characterized in that the described adjuvant playing effervescent effect is made up of sour agent and alkaline agent, wherein sour agent is selected from one or more in tartaric acid, malic acid, glycine, fumaric acid, fumarate, maleic acid, maleate, anhydrous stubborn lemon acid, citric acid, sodium dihydrogen citrate salt; Alkaline agent is selected from sodium carbonate, sodium bicarbonate a kind of or both mixture.
8. the Chinese medicine effervescent tablet for the treatment of gynecological inflammation according to claim 1, is characterized in that other described adjuvant is one or more in filler, binding agent, disintegrating agent, lubricant.
9. the Chinese medicine effervescent tablet for the treatment of gynecological inflammation according to claim 8, is characterized in that one or more that described filler is selected from starch based, dextrin, lactose, mannitol, sorbitol, xylitol, microcrystalline Cellulose; Described binding agent is selected from one or more in hydroxypropyl emthylcellulose, polyvinylpyrrolidone, methylcellulose, ethanol; Described disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, Tween 80, microcrystalline Cellulose, sodium lauryl sulphate; Described lubricant is selected from one or more in magnesium stearate, fumaric acid, fumaric acid sodium or potassium, sodium benzoate, Pulvis Talci, solid polyethylene glycol class, Stepanol MG, sodium lauryl sulphate, micropowder silica gel.
10.
powerprofit requires the Chinese medicine effervescent tablet of the treatment gynecological inflammation described in 1, it is characterized in that preparation method is: get the medicated powder for the treatment of gynecological inflammation, filler, the adjuvant playing effervescent effect and disintegrating agent, mixing, with the alcoholic solution soft material, the granulation that contain binding agent 3-15%, cold drying, granulate, add lubricant, mixing, tabletting, i.e. obtained effervescent tablet of the present invention.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510937325.7A CN105362383A (en) | 2015-12-16 | 2015-12-16 | Traditional Chinese medicine effervescent tablets for treating gynecologic inflammations and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510937325.7A CN105362383A (en) | 2015-12-16 | 2015-12-16 | Traditional Chinese medicine effervescent tablets for treating gynecologic inflammations and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105362383A true CN105362383A (en) | 2016-03-02 |
Family
ID=55365337
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510937325.7A Pending CN105362383A (en) | 2015-12-16 | 2015-12-16 | Traditional Chinese medicine effervescent tablets for treating gynecologic inflammations and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105362383A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106310234A (en) * | 2016-08-24 | 2017-01-11 | 方雅悯 | Application of bovine lactoferrin and hydrolysate or enzymatic hydrolysate in medicine for treating gynecological diseases |
| CN107468836A (en) * | 2017-09-13 | 2017-12-15 | 云南卡瓦格博生物科技有限公司 | Treat the Tibetan medicine and its processing method of gynaecological imflammation |
| CN109674903A (en) * | 2019-01-29 | 2019-04-26 | 罗梦芝 | One curing hysteromyoma, uterus adenomyosis, cervical polyp, HPV therapeutic agent |
| CN109939075A (en) * | 2019-03-06 | 2019-06-28 | 澳门大学 | A kind of Chinese medicine effervescent tablet and preparation method thereof |
-
2015
- 2015-12-16 CN CN201510937325.7A patent/CN105362383A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106310234A (en) * | 2016-08-24 | 2017-01-11 | 方雅悯 | Application of bovine lactoferrin and hydrolysate or enzymatic hydrolysate in medicine for treating gynecological diseases |
| CN107468836A (en) * | 2017-09-13 | 2017-12-15 | 云南卡瓦格博生物科技有限公司 | Treat the Tibetan medicine and its processing method of gynaecological imflammation |
| CN109674903A (en) * | 2019-01-29 | 2019-04-26 | 罗梦芝 | One curing hysteromyoma, uterus adenomyosis, cervical polyp, HPV therapeutic agent |
| CN109939075A (en) * | 2019-03-06 | 2019-06-28 | 澳门大学 | A kind of Chinese medicine effervescent tablet and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN105362383A (en) | Traditional Chinese medicine effervescent tablets for treating gynecologic inflammations and preparation method thereof | |
| CN101269192A (en) | Chinese medicinal composition for treating gynaecologic inflammation and preparation thereof | |
| WO2017101790A1 (en) | Pharmaceutical composition for treating cutaneous pruritus and use thereof | |
| CN106176430A (en) | A kind of disposable foam type women bactericidal liquid and preparation method thereof | |
| CN102429850A (en) | Traditional Chinese medicine antibacterial and nourishing bath foam and preparation method thereof | |
| CN1307986C (en) | Vaginal effervescent tablets for woman inflammation and their preparation | |
| KR20160015718A (en) | Feminine cleanser composition comprising Portulaca oleracea extract and Phytoncide | |
| CN101417068B (en) | Traditional Chinese medicine bacteriostatic lotion and preparation method thereof | |
| WO2011035734A1 (en) | Relinqing extract, preparative method and use thereof | |
| KR20200062598A (en) | A Feminine cleanser composition comprising imperata cylindrica leaf and artemisia princeps | |
| CN105287692A (en) | Dalbergia benthami prain extractive, and preparation method and application thereof | |
| CN106692403A (en) | Antipruritic ointment and preparation method thereof | |
| CN101347588B (en) | Medicament for treating gynecology disease and preparation thereof | |
| CN102106882B (en) | Natural compound medicine for treating acnes and scars | |
| DE602004005183T2 (en) | PHARMACEUTICAL COMPOSITIONS USING EXTRACT FROM EUPHORBIA PROSTRATA | |
| CN1985883A (en) | Antifungal medicine composition and its preparing method and use | |
| CN106540046A (en) | A kind of vagina antibiosis pharmaceutical gel | |
| CN105816594A (en) | Medicinal composition for treating acne as well as preparation method and application of medicinal composition | |
| CN103721138B (en) | A kind of traditional Chinese medicine for external application and its preparation method treating rosacea | |
| CN105943430A (en) | Cosmetic composition having function of removing acne | |
| CN101361950A (en) | Gynaecologic traditional Chinese medicine capable of dispelling coldness, promoting blood and alleviating pain and preparation method thereof | |
| CN100509017C (en) | Medicine for treating biliary tract infection and prepn process thereof | |
| CN101623368A (en) | Drug for treating gynecological diseases and preparation technology thereof | |
| CN105311328A (en) | Traditional Chinese medicine composition for treating gynecological inflammation and application thereof | |
| CN111686165A (en) | Pure traditional Chinese medicine composition for relieving itching of private parts, preparation and application of pure traditional Chinese medicine composition in cleaning private parts |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20160302 |