CN1583088A - Vaginal effervescent tablets for woman inflammation and their preparation - Google Patents
Vaginal effervescent tablets for woman inflammation and their preparation Download PDFInfo
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- CN1583088A CN1583088A CN 200410027370 CN200410027370A CN1583088A CN 1583088 A CN1583088 A CN 1583088A CN 200410027370 CN200410027370 CN 200410027370 CN 200410027370 A CN200410027370 A CN 200410027370A CN 1583088 A CN1583088 A CN 1583088A
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Abstract
A vaginal effervescent tablet for treating gynecologic inflammation, such as vaginitis, cervicitis, cervical erosion, etc is prepared from rhubard, arnebia root, catechu, borneol, and the auxiliary chosen from organic acid, carbonate, filler, adhesive, disintegrant and lubricant.
Description
Affiliated technical field
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 such as adnexitis, pelvic inflammatory disease, vaginitis, cervicitis, cervical erosion, vulva pruritus, vulval ulcers etc. are commonly encountered diseases, frequently-occurring diseases clinically, the Chinese medicine preparation that is used for such disease at present is more, but because factors such as the slow or curative effect instability of onset still can not meet clinical needs.It is to be the suppository that raw material is made by Radix Et Rhizoma Rhei, Radix Arnebiae (Radix Lithospermi), catechu, Borneolum Syntheticum four flavor Chinese medicines that " Drug Standard of Ministry of Public Health of the Peoples Republic of China " (eight in Chinese traditional patent formulation preparation) records kind " rehabilitation spirit bolt ", has heat-clearing and toxic substances removing, removing dampness and killing parasites, convergence itching relieving effect.The colpitis effect that is mainly used in clinically due to the various causes of disease is better.Its preparation method is: above four flavors, with the Borneolum Syntheticum porphyrize, catechu is ground into fine powder.Get Radix Et Rhizoma Rhei give as one thinks fit cataclasm, fried withered with Oleum sesami 650ml with putting in the pot, remove slag.Add Radix Arnebiae (Radix Lithospermi) again and soaked 72 hours, the elimination Radix Arnebiae (Radix Lithospermi), as residue Oleum sesami quantity not sufficient 365ml, the Oleum sesami after the available heating is supplied and is 365ml, adds semi-synthetic fatty acid ester, stirring is dissolved, and puts coldly slightly, adds Borneolum Syntheticum, catechu fine powder, mixing, pour mould molding into, take out, make 365, promptly.Storage practice: airtight, preserving below 30 ℃.Above-mentioned preparation technology exists certain defective, put a pot interior fried extraction as the Radix Et Rhizoma Rhei in the prescription together with 2 times of Oleum sesami more than the amount, cost height not only, and the water soluble ingredient-compositions such as rhatannin class that Radix Et Rhizoma Rhei can not be had antibacterial and anti-inflammation functions extract effectively, Radix Arnebiae (Radix Lithospermi) water soluble ingredient with antibacterial and anti-inflammation functions does not utilize yet, therefore can not give full play to Radix Et Rhizoma Rhei, Radix Arnebiae (Radix Lithospermi) and this prescription therapeutical effect.In addition, after Radix Et Rhizoma Rhei and Radix Arnebiae (Radix Lithospermi) usefulness Oleum sesami 650ml extraction, gained medicine shortage of oil 365ml shows that the Oleum sesami that has more than 40% is caused waste by the loss of reasons such as medicinal residues absorption; From storage practice, must preserve below 30 ℃ with the clever bolt of rehabilitation that Oleum sesami and semi-synthetic fatty acid ester are made, thereby transport, storing all inconveniences, therefore necessary preparation technology to this medicine improves.On the other hand, on dosage form, do not see the development report of rehabilitation spirit vagina effervescence as yet.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, provide a kind of active constituent content height, steady quality, rapid-action, curative effect is high, be easy to storage and transport, a kind of vagina effervescence 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 vagina effervescence of gynecological inflammation.
A kind of vagina effervescence for the treatment of gynecological inflammation provided by the invention comprises the component of following weight proportioning:
Medicated powder 40-365, the adjuvant 45-740 that plays the effervescent effect, other adjuvant 10-365 of treatment gynecological inflammation.
The medicated powder of treatment gynecological inflammation of the present invention is to be raw material with Radix Et Rhizoma Rhei, Radix Arnebiae (Radix Lithospermi), catechu, Borneolum Syntheticum four flavor Chinese medicines, by the formulated medicated powder of following weight proportion: Radix Et Rhizoma Rhei 200-300 part, Radix Arnebiae (Radix Lithospermi) 80-130 part, catechu 7-15 part, Borneolum Syntheticum 5-10 part.The preparation method of the medicated powder of treatment gynecological inflammation comprises following two kinds:
[preparation method one] may further comprise the steps:
(1) get Radix Et Rhizoma Rhei, Radix Arnebiae (Radix Lithospermi), with the ethanol extraction of 75-95% 1-3 time, each 1-3 hour, filter, medicinal residues are standby, and filtrate adds solubilizing agent, mixing, decompression recycling ethanol gets the alcohol extraction concentrated solution; The slag of getting it filled decocts with water 1-3 time, and 1-2.5 hour at every turn, filter, the filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.10-1.30, merges with the alcohol extraction concentrated solution, and dry, pulverizing gets Radix Et Rhizoma Rhei Radix Arnebiae (Radix Lithospermi) extract powder;
(2) get Borneolum Syntheticum, make Borneolum Syntheticum cyclodextrin clathrate fine powder;
(3) get catechu, micronizing becomes the superfine powder of particle diameter≤10um;
(4) get above-mentioned Radix Et Rhizoma Rhei Radix Arnebiae (Radix Lithospermi) extract powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, catechu superfine powder, fully mixing promptly makes the medicated powder for the treatment of gynecological inflammation.
[preparation method two] may further comprise the steps:
(1) get Radix Et Rhizoma Rhei, be ground into coarse powder, sterilization, micronizing becomes the superfine powder of particle diameter≤10um, gets the Radix Et Rhizoma Rhei superfine powder;
(2) get Radix Arnebiae (Radix Lithospermi), with the ethanol extraction of 75-95% 1-3 time, each 1-3 hour, filter, medicinal residues are standby, and filtrate adds solubilizing agent, fully stirs, and decompression recycling ethanol, concentrates, and gets the alcohol extraction concentrated solution; The slag of getting it filled decocts with water 1-3 time, and 1-2.5 hour at every turn, filter, the filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.10-1.30, merges with the alcohol extraction concentrated solution, and dry, pulverizing gets the Radix Arnebiae extract fine powder;
(3) get Borneolum Syntheticum, make Borneolum Syntheticum cyclodextrin clathrate fine powder;
(4) get catechu, micronizing becomes the superfine powder of particle diameter≤10um;
(5) get above-mentioned Radix Et Rhizoma Rhei superfine powder, Radix Arnebiae extract fine powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, catechu superfine powder, fully mixing promptly makes the medicated powder for the treatment of gynecological inflammation.
The medicated powder preparation method of treatment gynecological inflammation of the present invention two in, step (2) Radix Arnebiae extract fine powder also can adopt following method preparation: (1) gets Radix Arnebiae (Radix Lithospermi), uses supercritical CO
2Extraction or extract preparation Radix Arnebiae (Radix Lithospermi) liposoluble extract (Radix Arnebiae (Radix Lithospermi) total pigment content more than 25%, best more than 50%) with fat-soluble organic solvent commonly used such as normal hexane, petroleum ether, dehydrated alcohol etc., medicinal residues are standby; (2) get one or more mixture that cyclodextrin clathrate, phosphatide complexes, solid dispersion, micronised powder are made in Radix Arnebiae (Radix Lithospermi) liposoluble extract and solubilizing agent of the present invention, promptly get Radix Arnebiae (Radix Lithospermi) liposoluble extract hydrotrope fine powder.(3) slag of getting it filled decocts with water 1-3 time, each 1-2.5 hour, filter, the filtrate high speed centrifugation, centrifugal liquid concentrates, dry, pulverize, with Radix Arnebiae (Radix Lithospermi) liposoluble extract hydrotrope fine powder mixing, promptly make the Radix Arnebiae extract fine powder;
But the method for making list of references method of Borneolum Syntheticum cyclodextrin clathrate [Song Hongtao, etc. the journal .2002 of Shenyang Pharmaceutical University; 19 (4): 249] preparation.
The medicated powder of Zhi Bei treatment gynecological inflammation according to the method described above, per 100 weight portions are equivalent to 100-1000 part of Radix Et Rhizoma Rhei, Radix Arnebiae (Radix Lithospermi), catechu, Borneolum Syntheticum four flavor Chinese medicines.
Solubilizing agent of the present invention is: cyclodextrin and derivatives class thereof such as beta-schardinger dextrin-, HP-; Phospholipid such as soybean phospholipid, lecithin; Polyvinylpyrrolidone such as PVPk
30Polyethylene glycols such 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 that one or more combination in above-mentioned is used.
The adjuvant that plays the 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, the sodium dihydrogen citrate salt; Alkaline agent is selected from a kind of of sodium carbonate, sodium bicarbonate or both mixture.
In the present invention, described other adjuvant is one or more in filler, binding agent, disintegrating agent, the lubricant.Wherein: (1) filler is selected from one or more in starch based such as pregelatinized Starch or soluble starch, dextrin, lactose, mannitol, sorbitol, xylitol, the microcrystalline Cellulose; (2) binding agent is selected from one or more in hydroxypropyl emthylcellulose, polyvinylpyrrolidone, methylcellulose, the 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, the 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, the micropowder silica gel.In addition, other adjuvant can also include (1) aromatic: as rose essence, vanilla, Herba Menthae essence etc., increase armaticity to improve patient's compliance.(2) film coating agent:, improve stability of formulation by coating as full water damp-proof Opadry coating materials.These adjuvants can be used in combination in varing proportions.
The preparation method that the present invention treats the vagina effervescence of gynecological inflammation is: medicated powder, filler, the adjuvant that plays the effervescent effect and the disintegrating agent of getting the treatment gynecological inflammation, mixing, with the alcoholic solution system soft material, the granulation that contain binding agent 3-15%, cold drying, granulate adds lubricant, mixing, tabletting (coating) promptly makes effervescent tablet of the present invention.Also can adopt the full powder pressing method common process of tablet to prepare the vagina effervescence that the present invention treats gynecological inflammation.During tabletting to environment requirement: control tabletting ambient temperature is below 25 ℃, and humidity is below 45%.
The principle of foundation of the present invention and beneficial effect:
1, the present invention has carried out comprehensively, extracted fully and has kept the active ingredient of Radix Et Rhizoma Rhei and Radix Arnebiae (Radix Lithospermi) in the prescription-fat-soluble and water soluble ingredient, effective component extraction rate, utilization rate is increased greatly, thereby improved drug effect.And in the former rehabilitation spirit suppository technology, extract the water soluble ingredient that has antibacterial and anti-inflammation functions in reservation Radix Et Rhizoma Rhei and the Radix Arnebiae (Radix Lithospermi), and therefore do not make full use of and bring into play the drug effect of Radix Et Rhizoma Rhei and Radix Arnebiae (Radix Lithospermi), wasted herb resource.
The main active of Radix Et Rhizoma Rhei is anthraquinone analog compound, tannin constituents, phenyl propyl ketone glycoside, stilbene glycoside and organic acid.Anthraquinone analog compound is divided into free type and conjunction type two big classes again, and free type antibacterial action is stronger, and both have good dissolubility in ethanol.Except that free type anthraquinone analog compound, the tannin constituents in the Radix Et Rhizoma Rhei, phenyl propyl ketone glycoside, stilbene glycoside and organic acid can both be water-soluble.The a tree name bibliographical information [Huang Hao, etc. Chinese herbal medicine, 1998; 29 (3): 199], the Radix Et Rhizoma Rhei decocting liquid of rhatannin constituents and removal anthraquinone and tannin all has certain bacteriostasis.Therefore, the anthraquinone component of Radix Et Rhizoma Rhei and water soluble ingredient all should extract, keep.
The main active of Radix Arnebiae (Radix Lithospermi) is the liposoluble constituent-naphthoquinone analog derivative (alkannin and derivant thereof) with anti-microbial infection, antiinflammatory, antiviral, antitumor, anastalsis, comprise shikonin, acetylshikonin, β, beta-dimethyl-acryloyl shikonin, isovaleryl shikonin, deoxyshikonin etc.This constituents is fat-soluble very strong, easily is dissolved in fat-soluble organic solvent such as chloroform, petroleum ether, benzene, normal hexane etc., dissolves in vegetable oil, ethanol, and is water-soluble hardly.Have research [Yang Rong. Chinese Medicine journal, 1992; 7 (3): 34] show: water extract and the alcohol extract of Radix Arnebiae (Radix Lithospermi) all have tangible bacteriostasis and antiinflammatory action.Therefore, liposoluble constituent of Radix Arnebiae (Radix Lithospermi) and water soluble ingredient also all should extract reservation.
Therefore, Radix Et Rhizoma Rhei has similar physicochemical property and antibacterial and anti-inflammation functions with quinones in the Radix Arnebiae (Radix Lithospermi) with water soluble ingredient, dissolubility is preferably all arranged in ethanol, therefore both are combined, select for use cheap and easy to get, to be easy to reclaim the ethanol that uses be that solvent extracts earlier, the technology of the medicinal residues reuse water extraction water soluble ingredient after the alcohol extraction is all extracted and is kept this two constituents, with abundant effective component extracting, rationally utilize medical material, bring into play due drug effect.Simultaneously, make to extract the solvent phase ratio with the Oleum sesami that former suppository uses, technology of the present invention had not only reduced production cost, but also free from environmental pollution, was more suitable in big production needs.
Through detecting with the ultraviolet spectrophotometry method, the Radix Arnebiae (Radix Lithospermi) total pigment extraction ratio of technology of the present invention is 93%, and the Radix Arnebiae (Radix Lithospermi) total pigment extraction ratio in the former rehabilitation spirit bolt process only is 62%; The rhatannin extraction ratio of technology of the present invention is 91%, and the rhatannin extraction ratio of former rehabilitation spirit bolt process only is 6.5%.Therefore technology of the present invention is much higher than former rehabilitation spirit bolt process to the extraction ratio of Radix Arnebiae (Radix Lithospermi) total pigment and rhatannin constituents.
2, the present invention has added the solubilising material (being referred to as solubilizing agent in the present invention) that can increase dissolubility in alcohol extract, as beta-schardinger dextrin-, HP-, phospholipid, PVPk
30, PEG6000, hydroxypropyl emthylcellulose (low-viscosity), microcrystalline Cellulose, poloxamer, Tween 80 etc., can make liposoluble constituent in reclaiming alcoholic acid process, by forming cyclodextrin clathrate, solid dispersion, phosphatide complexes etc., rhubarb free type anthraquinone analog compound and the dissolubility of alkannin constituents in water have been increased greatly.The effervescent tablet that the present invention makes, compare with former rehabilitation spirit suppository, medicine can be dissolved in the vaginal secretion rapidly with the effect of effervescent, be dispersed in each diseased region of vagina pleat,, give full play to antibiotic, antiviral, antiphlogistic effect, thereby improved drug effect.
3, the processing of Borneolum Syntheticum: this product has volatility, and is easily molten in ethanol, chloroform or ether, almost insoluble in water.Borneolum Syntheticum is made cyclodextrin clathrate, can improve dissolubility, dispersibility and Borneolum Syntheticum the stability in preparation of Borneolum Syntheticum in juice greatly, give full play to the drug effect of Borneolum Syntheticum and guarantee the stable of the quality of the pharmaceutical preparations.
4, the processing of catechu: be the peeling branch of leguminous plant catechu Acacia catechu (L.f.) Willd. and the dry soft extracts of doing.Have stronger inhibitory anti-virus effect, mainly contain the tannin constituents, contain catechin (C
15H
14O
6) and the total amount of epicatechin be higher than 21.0%.Catechu has dissolubility preferably in water, but dispersive process is slower.The present invention becomes the superfine powder of particle diameter≤10um with the catechu micronizing for this reason, has improved the rate of dissolution of catechu, thereby can bring into play the antibiosis and antiviral functions of catechu fast.
5, another preparation method of the medicated powder of treatment gynecological inflammation in the effervescent tablet of the present invention, be to use behind the superfine powder that Radix Et Rhizoma Rhei is handled without extracting, direct micronizing becomes particle diameter≤10um, can effectively keep active component in the Radix Et Rhizoma Rhei, improve its dispersion rate and stripping in juice, reach the purpose of bactericidal antiphlogistic.
6, the good water solubility of effervescent tablet of the present invention can not only be treated various colpitis by intravaginal administration, but also can be disperseed, be dissolved in the water, and supplies washout or embrocates vulva such as treatment vulva pruritus, vulval ulcer.Therefore, compare, enlarged route of administration with former rehabilitation spirit suppository.
7, the present invention is a solid tablet, can preserve below 40 ℃, has overcome former suppository and has met the easy softening transform of heat, must and store inconvenient shortcoming in preservation below 30 ℃, transportation, compares with former suppository, has improved the stability and the effectiveness of medicine.
8, detect through disintegration and show, the present invention at 3 minutes with interior disintegrate fully, dispersion; The disintegrate of former suppository, dispersion time limit are more than 25 minutes.Compare with former suppository, effervescent tablet of the present invention has rapid, the rapid-action advantage of disintegrate.
9, the present invention has heat-clearing and toxic substances removing, removing dampness and killing parasites, convergence itching relieving effect.Be mainly used in colpitis, cervicitis, cervical erosion, vulva pruritus, gynaecopathias such as vulval ulcer have advantages such as onset is rapid, determined curative effect.Show that through pharmacodynamics test that the present invention has is antibiotic, antiinflammatory, press down infusorian, the analgesic effect of killing, drug effect obviously is better than " rehabilitation spirit bolt ".
The preparation of the medicated powder of embodiment 1 treatment gynecological inflammation
Composition of raw materials: Radix Et Rhizoma Rhei 248g, Radix Arnebiae (Radix Lithospermi) 100g, catechu 10g, Borneolum Syntheticum 7g.
Method for making: (1) gets Radix Et Rhizoma Rhei, Radix Arnebiae (Radix Lithospermi), the ethanol extraction with 88% 3 times, and each 2 hours, filter, medicinal residues are standby, and filtrate adds beta-schardinger dextrin-60g, PVPk
3060g and poloxamer 10g, mixing, decompression recycling ethanol gets the alcohol extraction concentrated solution; The slag of getting it filled decocts with water 2 times, and each 1.5 hours, filter, the filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.23 (60 ℃), merges with the alcohol extraction concentrated solution, and spray drying, pulverizing get Radix Et Rhizoma Rhei Radix Arnebiae (Radix Lithospermi) extract powder;
(2) get Borneolum Syntheticum, beta-schardinger dextrin-56g, the list of references method [Song Hongtao, etc. the journal .2002 of Shenyang Pharmaceutical University; 19 (4): 249], make Borneolum Syntheticum cyclodextrin clathrate fine powder with polishing;
(3) get catechu, micronizing becomes the superfine powder of particle diameter≤10um;
(4) get above-mentioned Radix Et Rhizoma Rhei Radix Arnebiae (Radix Lithospermi) extract powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, catechu superfine powder, fully mixing promptly makes the medicated powder for the treatment of gynecological inflammation.
The preparation of the medicated powder of embodiment 2 treatment gynecological inflammations
Composition of raw materials: Radix Et Rhizoma Rhei 210g, Radix Arnebiae (Radix Lithospermi) 120g, catechu 12g, Borneolum Syntheticum 8g.
Method for making: (1) gets Radix Et Rhizoma Rhei, is ground into coarse powder, sterilization, and micronizing becomes the superfine powder of particle diameter≤10um, gets the Radix Et Rhizoma Rhei superfine powder;
(2) get Radix Arnebiae (Radix Lithospermi), the ethanol extraction with 95% 2 times, each 2.5 hours, filter, medicinal residues are standby, and filtrate adds PVPk
3070g, hydroxypropyl emthylcellulose (HPMC-E5) 30g, soybean phospholipid 8g stir, and decompression recycling ethanol, concentrated gets the alcohol extraction concentrated solution; The slag of getting it filled decocts with water 2 times, each 1 hour, filter, the filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.38, merge with the alcohol extraction concentrated solution, 60 ℃ of following vacuum dryings, superfine comminution at low temperature, the Radix Arnebiae extract fine powder;
(3), (4) are respectively with embodiment 1 (2), (3);
(5) get above-mentioned Radix Et Rhizoma Rhei superfine powder, Radix Arnebiae extract fine powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, catechu superfine powder, fully mixing promptly makes the medicated powder for the treatment of gynecological inflammation.
The preparation of the medicated powder of embodiment 3 treatment gynecological inflammations
Composition of raw materials: Radix Et Rhizoma Rhei 218g, Radix Arnebiae (Radix Lithospermi) 110g, catechu 13g, Borneolum Syntheticum 6g.
Method for making: (1) gets Radix Et Rhizoma Rhei, is ground into coarse powder, sterilization, and micronizing becomes the superfine powder of particle diameter≤10um, gets the Radix Et Rhizoma Rhei superfine powder;
(2) get Radix Arnebiae (Radix Lithospermi), with Petroleum ether extraction 3 times, each 1.5 hours, filter, medicinal residues are standby, and filtrate merges, the reclaim under reduced pressure petroleum ether, and residue adds PEG
600080g, HP-30g, lecithin 5g, ethanol 550ml, behind the reflux 40min, decompression recycling ethanol, lyophilization, pulverize at low temperature get Radix Arnebiae (Radix Lithospermi) liposoluble extract hydrotrope fine powder; The slag of getting it filled decocts with water 2 times, and each 1.5 hours, filter, the filtrate high speed centrifugation, centrifugal liquid concentrates, spray drying, pulverizing, with Radix Arnebiae (Radix Lithospermi) liposoluble extract hydrotrope fine powder mixing, promptly gets the Radix Arnebiae extract fine powder;
(3), (4) are respectively with embodiment 1 (2), (3);
(5) get above-mentioned Radix Et Rhizoma Rhei superfine powder, Radix Arnebiae extract fine powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, catechu superfine powder, fully mixing promptly makes the medicated powder for the treatment of gynecological inflammation.
The preparation of the vagina effervescence of embodiment 4 treatment gynecological inflammations
Get medicated powder 280g, the sodium bicarbonate 180g of the treatment gynecological inflammation of embodiment 1 gained, behind the mixing, add mannitol 50g, citric acid 190g, crospolyvinylpyrrolidone 50g, mixing is used PVPk
306% alcoholic solution system soft material, granulation, cold drying, granulate adds magnesium stearate 5.5g, mixing, tabletting promptly makes effervescent tablet of the present invention.
The preparation of the vagina effervescence of embodiment 5 treatment gynecological inflammations
Get medicated powder 435g, the sodium bicarbonate 210g of the treatment gynecological inflammation of embodiment 2 gained, behind the mixing, add lactose 30g, microcrystalline Cellulose 25g, tartaric acid 190g, carboxymethyl starch sodium 45g, mixing is used PVPk
3010% alcoholic solution system soft material, granulation, cold drying, granulate adds micropowder silicon 8.5g, mixing, tabletting promptly makes effervescent tablet of the present invention.
The preparation of the vagina effervescence of embodiment 6 treatment gynecological inflammations
Get medicated powder 463g, the sodium carbonate 195g of the treatment gynecological inflammation of embodiment 3 gained, behind the mixing, add mannitol 40g, soluble starch 20g, citric acid 170g, cross-linking sodium carboxymethyl cellulose 60g, mixing is used PVPk
307% alcoholic solution system soft material, granulation, cold drying, granulate adds magnesium stearate 3.5g, sodium lauryl sulphate 4g, mixing, tabletting promptly makes effervescent tablet of the present invention.
The preparation of the vagina effervescence of embodiment 7 treatment gynecological inflammations
Get medicated powder 283g, the sodium bicarbonate 170g of the treatment gynecological inflammation of embodiment 1 gained, behind the mixing, add mannitol 50g, citric acid 160g, crospolyvinylpyrrolidone 55g, microcrystalline Cellulose 25g, PEG
400010g, magnesium stearate 5.5g, micropowder silicon 4.5g, abundant mixing, tabletting with full water damp-proof Opadry bag film-coat, promptly makes effervescent tablet of the present invention.
Pharmacodynamic test of active extract is tested
One, antiinflammatory test (mice auricular concha swelling method)
50 of mices, female, body weight 19～22g is divided into 5 groups: the 0.5%CMCNa matched group at random; 3 dosage groups of the present invention (1.3,2.6,5.2g crude drug/kg); Rehabilitation spirit bolt group (the 5.2g crude drug/kg), 10 every group.The mouse right ear shell is smeared and is administered once, 0.1ml/10g.After the administration 60 minutes, 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, card punch with diameter 9mm downcuts ears with the position homalographic, divide another name its weight, as the swelling degree, be calculated as follows suppression ratio: suppression ratio=(matched group swelling degree-administration group swelling degree)/matched group swelling degree * 100% with the difference of two auricle weight.The results are shown in Table 1.
Table 1 the present invention is to the influence of mice ear
Group dosage (g/kg) number of animals (only) swelling degree (mg) suppression ratio (%)
Matched group-10 15.9 ± 4.0
Rehabilitation spirit bolt 5.2 10 12.0 ± 2.1
※24.5
The present invention 1.3 10 13.5 ± 3.3 15.1
The present invention 2.6 10 11.5 ± 1.7
※27.6
The present invention 5.2 10 9.8 ± 1.4
※ ※40.4
Compare with matched group:
※P＜0.05
※ ※P＜0.01
Table 1 is the result show: of the present invention group of middle and high dosage and rehabilitation spirit bolt group are compared with matched group, significant difference is arranged, 5.2g the present invention of crude drug/kg dosage group compares P＜0.01 with matched group, and dosage to be the rehabilitation spirit bolt group of 5.2g crude drug/kg compare P＜0.05 with matched group, show that the present invention is better than contrasting medicine rehabilitation spirit bolt to the inhibitory action of mice ear inflammation.
Two, analgesic test (writhing method)
100 of mices, body weight 18～22g is divided into 5 groups at random, and 20 every group, first group of negative matched group given isometric(al) 0.5%CMCNa; Second group is rehabilitation spirit bolt group (4g crude drug/kg); Third and fourth, five groups little for the present invention, in, big 3 dosage groups (1,2,4g crude drug/kg).With the zone that depilatory cream (barium sulfide 25g, Pulvis Talci 35g, starch 35g, soap powder 5g add water furnishing pasty state) is respectively sloughed one 1.5cm * 2.5cm with mouse web portion, each group all evenly coating is regional in the mice depilation, with gauze and adhesive plaster external fixation.Behind the administration 60min, give the acetic acid solution 0.2ml of every mouse peritoneal injection 0.6%, observe and write down the number of times of mouse writhing in the 15min immediately.The results are shown in Table 2.
By table 2 as seen, the present invention can suppress the mouse writhing reaction that acetic acid stimulates, and compares with negative control group, and heavy dose of group has significant difference (P＜0.05), and the pain of pointing out Dichlorodiphenyl Acetate of the present invention to stimulate has analgesic activity.Positive control drug rehabilitation spirit bolt has the trend that suppresses the reaction of acetic acid stimulation mouse writhing, but compares there was no significant difference with negative control group.Show that analgesic activity of the present invention obviously is better than isodose rehabilitation spirit bolt.
The influence that table 2 the present invention reacts mouse writhing (x ± s)
Group dosage number of animals writhing response
(g crude drug/kg) (only) (inferior/15min)
Negative control group 20 23.11 ± 5.34
Rehabilitation spirit bolt 4 20 21.83 ± 5.75
The present invention low dose of 1 20 19.85 ± 4.78
Dosage 2 20 20.13 ± 3.46 among the present invention
The heavy dose of 4 20 18.39 ± 4.17* of the present invention
Compare * P＜0.05 with negative control group
Three, anti-trichomonal vaginitis test
With reference to " antiparasitic test principle " and " parasitology experimental technique " in the Ministry of Public Health bureau of drug administration " new drug preclinical study guideline ", adopt extracorporeal culture-ing to measure the minimum parasite killing concentration of effervescent tablet of the present invention to trichomonal vaginitis.Trichomonal vaginitis was cultivated 48 hours for 37 ℃ in the CPML culture medium of improvement, infusorian motion ripple alive, and well-grown, natural mortality rate is less than 2%, and experiment contains worm density 1.8 * 10 with trichomonal vaginitis liquid
3/ ml.The present invention and rehabilitation spirit bolt is carried out continuous two times of gradient dilutions with the CPML culture fluid of improveing respectively, make that liquor strength is 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 is established three parallel test pipes, every pipe 5ml.Be added in 37 ℃ of trichomonal vaginitis suspensions of cultivating 48 hours in each pipe, the final concentration that makes infusorian is 2.0 * 10
2/ ml.Set up matched group simultaneously.Put 37 ℃ and continue to cultivate 24 hours, draw respectively and respectively manage 0.1ml infusorian liquid transferred species in new culture medium, cultivate after 72 hours for 37 ℃ and get the worm drop sheet microscopy of respectively managing mixing.The minimum drug level of 3 equal absence of vagina trichomonacide growths of parallel test pipe is the minimum effective drug concentration of killing in vitro trichomonal vaginitis.
The result shows that 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, illustrates that the effect of killing infusorian obviously is weaker than effervescent tablet of the present invention.
Four, in-vitro antibacterial test
With reference to " antimicrobial drug in-vitro antibacterial test principle " and " microbiological Test technology " in the Ministry of Public Health bureau of drug administration " new drug preclinical study guideline ", adopt continuous doubling dilution mensuration the present invention of trace 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 adopts 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 common incubator and cultivate 24h for 37 ℃; Streptococcus faecalis is inoculated in TPY meat soup (anaerobe nutrient broth), puts the anaerobism incubator and cultivates 48h for 37 ℃; Gonococcus is inoculated in the MH meat soup that contains 5% calf serum, puts 5%CO
2Incubator is cultivated 48h for 37 ℃; Candida albicans is inoculated in the husky Ruo Shi of guarantor meat soup, puts common incubator and cultivates 48h for 37 ℃.Count antibacterial with turbidimetry, transferred species viable count in flat board mensuration bacterium liquid is colony-forming units (CFU/ml), is deployed into 10 with diluent
6The bacterium liquid of CFU/ml is standby.
1. to the mensuration of 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 that liquor strength is 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, the 0.2ml/ hole.Adding concentration more successively is 10
6The test organisms liquid 10 μ l/ holes of CFU/ml are set up antibacterial contrast and culture medium contrast simultaneously.Put room temperature effect 12h, cultivate the 24h observed result for 37 ℃ in common incubator.Contained minimum drug level is MIC in the no bacterial growth hole.To not see successively that again the culture in bacterial growth hole draws the 0.1ml dibbling respectively in the MH flat board, and put common incubator and cultivate 24h for 37 ℃ that the minimum drug level of no bacterial growth inoculation zone correspondence is MBC, the results are shown in Table 3～4.
2. to the mensuration of 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, the 0.2ml/ hole.Adding concentration more successively is 10
6The test organisms liquid 10 μ l/ holes of CFU/ml are set up antibacterial contrast and culture medium contrast simultaneously.Put room temperature effect 12h, in 5%CO
2Incubator is cultivated the 24h observed result for 37 ℃.Contained minimum drug level is MIC in the no bacterial growth hole.To not see successively that again the culture in bacterial growth hole draws the 0.1ml transfection respectively in the TPY flat board, and put 37 ℃ of anaerobism and cultivate 24h that the minimum drug level of no bacterial growth inoculation zone correspondence is MBC, the results are shown in Table 3～4.
3. the mensuration of gonococcus type strain and clinical separation strain MIC and MBC
Use the MH meat soup that contains 5% calf serum by carrying out continuous two times of gradient dilutions the present invention and rehabilitation spirit bolt, each concentration liquid is added to 96 well culture plates respectively, the 0.2ml/ hole.Adding concentration more successively is 10
6The test organisms liquid 10 μ l/ holes of CFU/ml are set up antibacterial contrast and culture medium contrast simultaneously.Put room temperature effect 12h, in 5%CO
2Incubator is cultivated the 48h observed result for 37 ℃.Contained minimum drug level is MIC in the no bacterial growth hole.Culture that to not see each hole of bacterial growth is more successively drawn the 0.1ml transfection respectively to the chocolate flat board, puts 5%CO
2Incubator is cultivated 48h for 37 ℃, and the corresponding minimum drug level in no bacterial growth inoculation zone is MBC, the results are shown in Table 3～4.
4. to the mensuration of Candida albicans type strain and clinical separation strain MIC and MBC: the peaceful Film coated tablets of urinary system is carried out continuous two times of gradient dilutions with husky Ruo Shi (SB) meat soup of protecting, each concentration liquid is added to 96 well culture plates respectively, the 0.2ml/ hole.Adding concentration more successively is 10
6The test organisms liquid 10 μ l/ holes of CFU/ml are set up antibacterial contrast and culture medium contrast simultaneously.Put room temperature effect 12h, cultivate the 48h observed result for 37 ℃ in common incubator.Contained minimum drug level is MIC in the no bacterial growth hole.To not see successively that again the culture in each hole of bacterial growth draws the 0.1ml dibbling respectively in the SB flat board, and put common incubator and cultivate 48h for 37 ℃ that no bacterial growth inoculation area relative minimum drug level is MBC, the results are shown in Table 3～4.
Table 3 the present invention is to the MIC of reference culture and MBC (g crude drug/ml)
Rehabilitation spirit bolt of the present invention
Bacterial strain MIC MBC MIC MBC
(the g crude drug/ml) (the g crude drug/ml) (the g crude drug/and ml) (the g crude drug/ml)
Escherichia coli ATCC25922 strain 0.0313 0.0625 0.125 0.25
Staphylococcus aureus ATCC25925 strain 0.0078 0.0156 0.0156 0.0313
Pseudomonas aeruginosa ATCC27853 strain 0.0156 0.0313 0.0625 0.125
Staphylococcus epidermidis ATCC26069 strain 0.0078 0.0156 0.0313 0.0625
Streptococcus faecalis ATCC10541 strain 0.0156 0.0625 0.0625 0.125
Proteus vulgaris 49010 strains 0.0625 0.125 0.125 0.25
Gonococcus 20106 strains 0.0156 0.0313 0.0313 0.125
Vagina Gartner bacterium is clinical in strain 0.0078 0.0156 0.0156 0.0313
Candida albicans 85021 strains 0.0078 0.0313 0.0313 0.0625
Table 4 the present invention is to MIC, the MBC of 502 strain clinical isolates strains (g crude drug/ml)
MIC MBC is counted in the bacterial strain strain
(the g crude drug/and ml) (the g crude drug/ml)
Staphylococcus aureus 160 0.0078-0.0156 0.0156-0.0313
Escherichia coli 110 0.0313-0.0625 0.0625-0.125
Staphylococcus epidermidis 80 0.0078-0.0156 0.156-0.313
Proteus vulgaris 90 0.0625-0.125 0.125-0.25
Gonococcus 24 0.0078-0.0156 0.0156-0.0313
Vagina Gartner bacterium 8 0.0078-0.0156 0.0156-0.0313
Candida albicans 30 0.0078-0.0156 0.0078-0.0313
By table 3 as seen, the present invention all has than obvious suppression and deactivation the type strain of testing selected escherichia coli, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, streptococcus faecalis, gonococcus, Bacillus proteus, vagina Gartner bacterium, Candida albicans, its MBC is 2～4 times of MIC, and inhibition of the present invention and deactivation obviously are better than rehabilitation spirit bolt.By table 4 as seen, the present invention all has certain inhibition and deactivation to testing 502 selected strain clinical isolates strains, and its MBC is 2～4 times of MIC.
Claims (10)
1, a kind of vagina effervescence for the treatment of gynecological inflammation is characterized in that containing the component of following weight proportioning:
Medicated powder 40-365, the adjuvant 45-740 that plays the effervescent effect, other adjuvant 10-365 of treatment gynecological inflammation.
2, the vagina effervescence of treatment gynecological inflammation according to claim 1 is characterized in that the per 100 parts of 100-1000 parts that are equivalent to Radix Et Rhizoma Rhei, Radix Arnebiae (Radix Lithospermi), catechu, Borneolum Syntheticum four flavor Chinese medicines of the medicated powder of described treatment gynecological inflammation; The weight proportion of this four flavors Chinese medicine is: Radix Et Rhizoma Rhei 200-300 part, Radix Arnebiae (Radix Lithospermi) 80-130 part, catechu 7-15 part, Borneolum Syntheticum 5-10 part.
3, the vagina effervescence of treatment gynecological inflammation according to claim 1 and 2 is characterized in that the preparation method of the medicated powder of described treatment gynecological inflammation may further comprise the steps:
(1) get Radix Et Rhizoma Rhei, Radix Arnebiae (Radix Lithospermi), with the ethanol extraction of 75-95% 1-3 time, each 1-3 hour, filter, medicinal residues are standby, and filtrate adds solubilizing agent, mixing, decompression recycling ethanol gets the alcohol extraction concentrated solution; The slag of getting it filled decocts with water 1-3 time, and 1-2.5 hour at every turn, filter, the filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.10-1.30, merges with the alcohol extraction concentrated solution, and dry, pulverizing gets Radix Et Rhizoma Rhei Radix Arnebiae (Radix Lithospermi) extract powder;
(2) get Borneolum Syntheticum, make Borneolum Syntheticum cyclodextrin clathrate fine powder;
(3) get catechu, micronizing becomes the superfine powder of particle diameter≤10um;
(4) get above-mentioned Radix Et Rhizoma Rhei Radix Arnebiae (Radix Lithospermi) extract powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, catechu superfine powder, fully mixing promptly makes the medicated powder for the treatment of gynecological inflammation.
4, the vagina effervescence of treatment gynecological inflammation according to claim 1 and 2, the preparation method that it is characterized in that treating the medicated powder of gynecological inflammation may further comprise the steps:
(1) get Radix Et Rhizoma Rhei, be ground into coarse powder, sterilization, micronizing becomes the superfine powder of particle diameter≤10um, gets the Radix Et Rhizoma Rhei superfine powder;
(2) get Radix Arnebiae (Radix Lithospermi), with the ethanol extraction of 75-95% 1-3 time, each 1-3 hour, filter, medicinal residues are standby, and filtrate adds solubilizing agent, fully stirs, and decompression recycling ethanol, concentrates, and gets the alcohol extraction concentrated solution; The slag of getting it filled decocts with water 1-3 time, and 1-2.5 hour at every turn, filter, the filtrate high speed centrifugation, centrifugal liquid is concentrated into relative density 1.10-1.30, merges with the alcohol extraction concentrated solution, and dry, pulverizing gets the Radix Arnebiae extract fine powder;
(3) get Borneolum Syntheticum, make Borneolum Syntheticum cyclodextrin clathrate fine powder;
(4) get catechu, micronizing becomes the superfine powder of particle diameter≤10um;
(5) get above-mentioned Radix Et Rhizoma Rhei superfine powder, Radix Arnebiae extract fine powder, Borneolum Syntheticum cyclodextrin clathrate fine powder, catechu superfine powder, fully mixing promptly makes the medicated powder for the treatment of gynecological inflammation.
5, the medicated powder preparation method of treatment gynecological inflammation according to claim 4, it is characterized in that described Radix Arnebiae extract fine powder can also adopt following method preparation: (1) gets Radix Arnebiae (Radix Lithospermi), uses supercritical CO
2Extraction or prepare the Radix Arnebiae (Radix Lithospermi) liposoluble extract with fat-soluble organic solvent extraction commonly used, medicinal residues are standby; (2) get one or more mixture that cyclodextrin clathrate, phosphatide complexes, solid dispersion, micronised powder are made in Radix Arnebiae (Radix Lithospermi) liposoluble extract and solubilizing agent, promptly get Radix Arnebiae (Radix Lithospermi) liposoluble extract hydrotrope fine powder.(3) slag of getting it filled decocts with water 1-3 time, each 1-2.5 hour, filter, the filtrate high speed centrifugation, centrifugal liquid concentrates, dry, pulverize, with Radix Arnebiae (Radix Lithospermi) liposoluble extract hydrotrope fine powder mixing, promptly get the Radix Arnebiae extract fine powder;
6,, it 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, the Tween 80 according to the vagina effervescence of claim 3,4 or 5 described treatment gynecological inflammations.
7, the vagina effervescence of treatment gynecological inflammation according to claim 1, it is characterized in that the described adjuvant that plays the 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, the sodium dihydrogen citrate salt; Alkaline agent is selected from a kind of of sodium carbonate, sodium bicarbonate or both mixture.
8, the vagina effervescence of treatment gynecological inflammation according to claim 1 is characterized in that described other adjuvant is one or more in filler, binding agent, disintegrating agent, the lubricant.
9, the vagina effervescence of treatment gynecological inflammation according to claim 8 is characterized in that described filler is selected from one or more in starch based, dextrin, lactose, mannitol, sorbitol, xylitol, the microcrystalline Cellulose; Described binding agent is selected from one or more in hydroxypropyl emthylcellulose, polyvinylpyrrolidone, methylcellulose, the 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, the 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, the micropowder silica gel.
10, the vagina effervescence of the described treatment gynecological inflammation of claim 1, it is characterized in that preparation method is: medicated powder, filler, the adjuvant that plays the effervescent effect and the disintegrating agent of getting the treatment gynecological inflammation, mixing, with the alcoholic solution system soft material, the granulation that contain binding agent 3-15%, cold drying, granulate, add lubricant, mixing, tabletting promptly makes effervescent tablet of the present invention.
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