CN105147827A - Bacteriostatic drug and preparation method thereof - Google Patents
Bacteriostatic drug and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a bacteriostatic drug and a preparation method thereof. The bacteriostatic drug is prepared from the following raw materials: radix sophorae flavescentis, melastoma dodecandrum, radix zanthoxyli, angelica, cudrania cochinchinensis and radix fici simplicissimae; when the bacteriostatic drug is in the form of gel, the preparation method comprises the following steps: adding the radix sophorae flavescentis to ethanol and refluxing so as to prepare an extract A; decocting the melastoma dodecandrum, the radix zanthoxyli, the angelica, the cudrania cochinchinensis and the radix fici simplicissimae in water so as to prepare an extract B; and preparing a blank matrix from carbomer, glycerol and propylene glycol, and adding vitamin E, eucalyptus oil, the extract A and the extract B to the blank matrix so as to obtain the bacteriostatic drug. The bacteriostatic drug disclosed by the invention is good in bacteriostatic effect, and the bacteriostatic drug is suitable for treating gynecologic inflammations; and the bacteriostatic drug, when in the form of gel, is quite low in irritation to vagina mucosa.
Description
Technical field
The present invention relates to a kind of medicine and preparation method thereof, be specifically related to a kind of antibacterial medicines and preparation method thereof.
Background technology
Vaginitis, cervicitis, pelvic inflammatory disease are commonly encountered diseases, the frequently-occurring disease of gynecological, mainly adopt to take orally clinically at present and treat with external two kinds of approach, oral medicine mostly is capsule, tablet, drop pill, granule etc., and medicine for external use is then in the majority with built-in suppository, lotion.In recent years along with the progress of gel preparations, Chinese medicine gel there has also been very large development.Gel has good adhesiveness and film forming characteristics, can be closely adhered to lesions position, directly at Lesional Skin, mucosa and tract release medicine, avoids the first-pass effect of oral administration, improves bioavailability.Treatment medicine for gynecopathy is selected to make vagina gel preparation, can effectively prolong drug in the focus holdup time, pharmaceutical release time is relatively long, and the sense of intravaginal foreign, not easily pollution clothes, sufferer compliance is better, and vaginal gel is a kind of pharmaceutical dosage form of desirable treatment gynaecopathia, has good DEVELOPMENT PROSPECT.
Summary of the invention
The object of the invention is to overcome the deficiencies in the prior art part and the antibacterial medicines that a kind of fungistatic effect is good is provided.
Corresponding therewith, present invention also offers the preparation method of the good antibacterial medicines of above-mentioned fungistatic effect.
For achieving the above object, the technical scheme that the present invention takes is: a kind of antibacterial medicines, comprises following raw materials: Radix Sophorae Flavescentis, Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae.
In the raw materials of above-mentioned antibacterial medicines, Radix Sophorae Flavescentis has effect of heat clearing and damp drying, wind dispelling insecticide, is mainly used in damp-heat dysentery, discharging fresh blood stool, jaundice, dysuria, edema, leukorrhagia, pudendal pruritus, scabies, leprosy, skin pruritus, noxious dampness skin infection etc.; Further, Radix Sophorae Flavescentis has the pharmacological action such as antibacterial, antiinflammatory, leukocyte increasing, antitumor, arrhythmia, diuresis, relieving cough and asthma, is clinically used for pudendal pruritus, eczema scabies, dysuria, gynecological inflammation etc. under treatment belt.In addition, Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae are used simultaneously, there is clearing away heat-damp and promoting diuresis, stasis-dispelling and pain-killing and convergence leukorrhagia stopping effect, can be used for married woman's lower abdomen dull pain, leukorrheal diseases caused by dampness and heat stasis, disease sees married woman's lower abdomen dull pain, and dark menses, have block, and leucorrhea with yellow discharge matter is thick.
In the present invention, applicant, using Radix Sophorae Flavescentis and Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and the Herba Fici Simplicissimae raw materials as antibacterial medicines, surprisingly to find, under the combined effect of each component, obtained antibacterial medicines fungistatic effect is better, can be used for treating gynecological inflammation.
As the preferred implementation of antibacterial medicines of the present invention, described antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 150 ~ 250 parts, Herba Melastomatis dodecandri 20 ~ 60 parts, Radix Zanthoxyli 20 ~ 60 parts, Radix Angelicae Sinensis 20 ~ 60 parts, Radix Cudraniae 20 ~ 60 parts, Herba Fici Simplicissimae 20 ~ 60 parts.
As the preferred implementation of antibacterial medicines of the present invention, described antibacterial medicines also comprises following raw materials: Oleum Eucalypti and vitamin E.More preferably, described Oleum Eucalypti is 2 ~ 20 weight portions, and described vitamin E is 1 ~ 10 weight portion.Oleum Eucalypti has antibacterial, antiinflammatory, promotion Transdermal absorption effect, and vitamin E can be used for antioxidation, and, after adding Oleum Eucalypti and vitamin E in raw materials, be more conducive to antibacterial medicines to make medicine for external use.
As the preferred forms of antibacterial medicines of the present invention, described antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 200 parts, Herba Melastomatis dodecandri 40 parts, Radix Zanthoxyli 40 parts, Radix Angelicae Sinensis 40 parts, Radix Cudraniae 40 parts, Herba Fici Simplicissimae 40 parts, Oleum Eucalypti 10 parts, vitamin E 5 parts.Applicant is in the favorite outer discovery of large quantity research, and when adopting the raw materials of described weight portion, obtained antibacterials fungistatic effect is best, and the best results for the treatment of gynecological inflammation.
As the preferred implementation of antibacterial medicines of the present invention, described antibacterial medicines is gel or suppository.
As the preferred implementation of antibacterial medicines of the present invention, described antibacterial medicines is gel, and this antibacterial medicines also comprises the raw materials of following weight parts: carbomer 2 ~ 20 parts, wetting agent 200 ~ 450 parts; Wherein, described wetting agent is the mixture of glycerol and propylene glycol, and the weight ratio of described glycerol and described propylene glycol is 1.0 ~ 2.5:1.0 ~ 2.0.Certainly, when described antibacterial medicines is gel, its raw materials also can comprise water and ethanol further, and those skilled in the art can select according to routine, adopt appropriate water and ethanol.
Above-mentioned carbomer is as gel-type vehicle, and it has without greasy feeling, be easy to coating, nonirritant, the advantage such as have good uniformity; In raw materials, glycerol, propylene glycol mainly play lubrication, moisture-keeping function.Adopt carbomer as gel-type vehicle, and using glycerol and propylene glycol as wetting agent, the antibacterial medicines bacteriostasis property made is good, and extremely low to vaginal mucosa irritation, is a kind of preparation for the treatment of gynaecopathia well, can be used as vaginal gel.
As the more preferably embodiment of antibacterial medicines of the present invention, described carbomer is 4 weight portions, and described wetting agent is 350 weight portions; In described wetting agent, the weight ratio of glycerol and propylene glycol is 2:1.5.When selecting carbomer and the wetting agent of described weight portion, obtained antibacterial medicines is minimum to vaginal mucosa irritation.
As the preferred implementation of antibacterial medicines of the present invention, described carbomer is Acritamer 940.
As the preferred implementation of antibacterial medicines of the present invention, described antibacterial medicines is suppository, and this antibacterial medicines also comprises following raw materials: lanoline and semi-synthetic fatty acid ester.More preferably, described lanoline is 8 ~ 12 weight portions, and described semi-synthetic fatty acid ester is 180 ~ 200 weight portions.
In addition, present invention also offers a kind of preparation method of antibacterial medicines.Described antibacterial medicines is gel, and its preparation method comprises the following steps:
Preparation extract A: take 150 ~ 250 weight portion Radix Sophorae Flavescentiss, add the ethanol of Radix Sophorae Flavescentis weight 6 ~ 10 times respectively, reflux, extract, 1 ~ 3 time, extracts 1 ~ 3 hour at every turn; Filter after having refluxed, merging filtrate, gained filtrate is concentrated into the thick paste that relative density is 1.20 ~ 1.25, obtains extract A;
Preparation extract B: take Herba Melastomatis dodecandri 20 ~ 60 weight portion, Radix Zanthoxyli 20 ~ 60 weight portion, Radix Angelicae Sinensis 20 ~ 60 weight portion, Radix Cudraniae 20 ~ 60 weight portion and Herba Fici Simplicissimae 20 ~ 60 weight portion, add respectively Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 6 ~ 10 times water (namely refer to the water yield at every turn added be Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 6 ~ 10 times), decoct 1 ~ 3 time, decoct 1 ~ 3 hour at every turn; Filter after having decocted, merging filtrate, it is 1.20 ~ 1.25 thick pastes that filtrate is concentrated into relative density, obtains extract B;
Take 2 ~ 20 weight portion carbomers, add water, stir and make carbomer evenly swelling, then add 200 ~ 450 weight portion wetting agents, stir, make bare substrate; In bare substrate, add 1 ~ 10 part by weight of vitamin E, stir; Then take 2 ~ 20 weight portion Oleum Eucalyptis, in Oleum Eucalypti, add ethanol make it dissolve, the Oleum Eucalypti after dissolving is added in bare substrate, stirs; Get extract A, in extract A, add ethanol make it dissolve, the extract A after dissolving is added in bare substrate, stirs; Finally add in bare substrate by extract B, stir, supplementing surplus ad pond om with water is 1000 weight portions, obtains antibacterial medicines; Wherein, described wetting agent is the mixture of glycerol and propylene glycol, and the weight ratio of described glycerol and described propylene glycol is 1.0 ~ 2.5:1.0 ~ 2.0.
As the more preferably embodiment of the preparation method of antibacterial medicines of the present invention, during described preparation extract A, take 150 ~ 250 weight portion Radix Sophorae Flavescentiss, add the ethanol of Radix Sophorae Flavescentis weight 8 times respectively, reflux, extract, 2 times, each extraction 2 hours; Filter after having refluxed, merging filtrate, gained filtrate is concentrated into the thick paste that relative density is 1.20 ~ 1.25, obtains extract A; During described preparation extract B, take Herba Melastomatis dodecandri 20 ~ 60 weight portion, Radix Zanthoxyli 20 ~ 60 weight portion, Radix Angelicae Sinensis 20 ~ 60 weight portion, Radix Cudraniae 20 ~ 60 weight portion and Herba Fici Simplicissimae 20 ~ 60 weight portion, add respectively Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 8 times water (namely refer to the water yield at every turn added be Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 8 times), decoct 2 times, each decoction 2 hours; Filter after having decocted, merging filtrate, it is 1.20 ~ 1.25 thick pastes that filtrate is concentrated into relative density, obtains extract B.
In the preparation method of above-mentioned antibacterial medicines, when measuring relative density, the temperature of thick paste is 55 ~ 60 DEG C; The preparation method of described antibacterial medicines, carbomer is preferably Acritamer 940.
Beneficial effect of the present invention is: the present invention is using Radix Sophorae Flavescentis and Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae as raw materials, obtained antibacterial medicines has heat clearing and damp drying, the effect of the blood stasis dispelling that dispels the wind, and the effects such as it is antibacterial, antiinflammatory, diuretic, pain relieving are enhanced.The antibacterial medicines fungistatic effect that the present invention obtains is better, can be used for treating gynecological inflammation.
In addition, gel preparations antibacterial medicines provided by the invention, it can not only improve drug-eluting speed and drug bioavailability, the more important thing is, this gel preparations antibacterial medicines bacteriostasis property is good, and extremely low to vaginal mucosa irritation, be a kind of preparation for the treatment of gynaecopathia well, can focus be directly used in.
Finally, the preparation method of above-mentioned gel preparations antibacterial medicines is simple, be easy to operation, and technology stability is good, for suitability for industrialized production provides reference frame.
Accompanying drawing explanation
Fig. 1 is antibacterial medicines of the present invention when being gel, the process chart of its preparation method.
Detailed description of the invention
For better the object, technical solutions and advantages of the present invention being described, below in conjunction with the drawings and specific embodiments, the invention will be further described.
In embodiment, when antibacterial medicines is gel, the technological process of its preparation method as shown in Figure 1; When measuring relative density in preparation method, the temperature of thick paste is 55 ~ 60 DEG C.
In embodiment, when antibacterial medicines is suppository, its preparation method comprises the following steps:
Prepare fine powder A: take 150 ~ 250 weight portion Radix Sophorae Flavescentiss, add the ethanol of Radix Sophorae Flavescentis weight 6 ~ 10 times respectively, reflux, extract, 1 ~ 3 time, extract 1 ~ 3 hour; Filter after having refluxed, merging filtrate, decompression recycling ethanol is extremely without alcohol taste, and drying under reduced pressure, is ground into fine powder, obtains fine powder A;
Preparation extract B: take Herba Melastomatis dodecandri 20 ~ 60 weight portion, Radix Zanthoxyli 20 ~ 60 weight portion, Radix Angelicae Sinensis 20 ~ 60 weight portion, Radix Cudraniae 20 ~ 60 weight portion and Herba Fici Simplicissimae 20 ~ 60 weight portion, add respectively Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 6 ~ 10 times water (namely refer to the water yield at every turn added be Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 6 ~ 10 times), decoct 1 ~ 3 time, decoct 1 ~ 3 hour; Filter after having decocted, merging filtrate, solvent evaporated under reduced pressure, then drying under reduced pressure, be ground into fine powder, obtain fine powder B;
Take 8 ~ 12 weight portion lanolines, heating melts, and is poured into by the lanoline of melting in high-efficient homogeneous machine, then 2 ~ 20 weight portion Oleum Eucalyptis, 1 ~ 10 part by weight of vitamin E and the fine powder A obtained and fine powder B is added, open agitating device, after stirring, stop stirring; Add the semi-synthetic fatty acid ester of 180 ~ 200 weight portion again, after melting completely at 60 DEG C of temperature, stir 30min, after becoming homogeneous medicinal liquid, the medicinal liquid prepared is poured in the heat-preserving container of perfusion unit, and insulation is stirred at 40 DEG C, regulate loading amount, start full-automatic suppository perfusion unit and carry out the embedding of suppository, freezing, sealing.
Embodiment 1
A kind of embodiment of antibacterial medicines of the present invention, antibacterial medicines described in the present embodiment is gel, and this antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 200 parts, Herba Melastomatis dodecandri 40 parts, Radix Zanthoxyli 40 parts, Radix Angelicae Sinensis 40 parts, Radix Cudraniae 40 parts, Herba Fici Simplicissimae 40 parts, Oleum Eucalypti 10 parts, vitamin E 5 parts, Acritamer 940 is 4 parts, wetting agent 350 parts; Wherein, wetting agent is made up of (weight ratio of glycerol and propylene glycol is 2:1.5) 200 parts of glycerol and 150 parts of propylene glycol.
The preparation method of antibacterial medicines described in the present embodiment is:
Preparation extract A: take Radix Sophorae Flavescentis, add the ethanol of Radix Sophorae Flavescentis weight 8 times respectively, reflux, extract, 2 times, each extraction 2 hours; Filter after having refluxed, merging filtrate, gained filtrate is concentrated into the thick paste that relative density is 1.20 ~ 1.25, obtains extract A;
Preparation extract B: take Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae, adds the water of Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 8 times, decocts 2 times, each decoction 2 hours; Filter after having decocted, merging filtrate, it is 1.20 ~ 1.25 thick pastes that filtrate is concentrated into relative density, obtains extract B;
Take Acritamer 940, add 125 weight portion purified water, stir and make Acritamer 940 evenly swelling, then add wetting agent, stir, make bare substrate; In bare substrate, add vitamin E, stir; Then take Oleum Eucalypti, in Oleum Eucalypti, add 100 weight portion 95% ethanol make it dissolve, the Oleum Eucalypti after dissolving is added in bare substrate, stirs; Get extract A, in extract A, add 300 weight portion 50% ethanol make it dissolve, the extract A after dissolving is added in bare substrate, stirs; Finally add in bare substrate by extract B, stir, supplementing surplus ad pond om by purified water is 1000 weight portions, obtains antibacterial medicines.
Embodiment 2
A kind of embodiment of antibacterial medicines of the present invention, antibacterial medicines described in the present embodiment is gel, and this antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 250 parts, Herba Melastomatis dodecandri 60 parts, Radix Zanthoxyli 20 parts, Radix Angelicae Sinensis 20 parts, Radix Cudraniae 60 parts, Herba Fici Simplicissimae 20 parts, Oleum Eucalypti 20 parts, vitamin e1 part, Acritamer 940 is 20 parts, wetting agent 450 parts; Wherein, wetting agent is made up of (weight ratio of glycerol and propylene glycol is 1.0:2.0) 150 parts of glycerol and 300 parts of propylene glycol.
The preparation method of antibacterial medicines described in the present embodiment is:
Preparation extract A: take Radix Sophorae Flavescentis, add the ethanol of Radix Sophorae Flavescentis weight 6 times respectively, reflux, extract, 3 times, each extraction 1 hour; Filter after having refluxed, merging filtrate, gained filtrate is concentrated into the thick paste that relative density is 1.20 ~ 1.25, obtains extract A;
Preparation extract B: take Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae, adds the water of Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 6 times, decocts 3 times, each decoction 1 hour; Filter after having decocted, merging filtrate, it is 1.20 ~ 1.25 thick pastes that filtrate is concentrated into relative density, obtains extract B;
Take Acritamer 940, add purified water, stir and make Acritamer 940 evenly swelling, then add wetting agent, stir, make bare substrate; In bare substrate, add vitamin E, stir; Then take Oleum Eucalypti, in Oleum Eucalypti, add 95% ethanol make it dissolve, the Oleum Eucalypti after dissolving is added in bare substrate, stirs; Get extract A, in extract A, add 50% ethanol make it dissolve, the extract A after dissolving is added in bare substrate, stirs; Finally add in bare substrate by extract B, stir, supplementing surplus ad pond om by purified water is 1000 weight portions, obtains antibacterial medicines.
Embodiment 3
A kind of embodiment of antibacterial medicines of the present invention, antibacterial medicines described in the present embodiment is gel, and this antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 150 parts, Herba Melastomatis dodecandri 20 parts, Radix Zanthoxyli 60 parts, Radix Angelicae Sinensis 60 parts, Radix Cudraniae 20 parts, Herba Fici Simplicissimae 60 parts, Oleum Eucalypti 2 parts, vitamin e1 0 part, Acritamer 940 is 2 parts, wetting agent 200 parts; Wherein, wetting agent is made up of (weight ratio of glycerol and propylene glycol is 2.5:1.0) 143 parts of glycerol and 57 parts of propylene glycol.
The preparation method of antibacterial medicines described in the present embodiment is:
Preparation extract A: take Radix Sophorae Flavescentis, add the ethanol of Radix Sophorae Flavescentis weight 10 times, reflux, extract, 1 time, extract 3 hours; Filter after having refluxed, gained filtrate is concentrated into the thick paste that relative density is 1.20 ~ 1.25, obtains extract A;
Preparation extract B: take Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae, adds the water of Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 10 times, decocts 1 time, decoct 3 hours; Filter after having decocted, obtain filtrate, it is 1.20 ~ 1.25 thick pastes that filtrate is concentrated into relative density, obtains extract B;
Take Acritamer 940, add purified water, stir and make Acritamer 940 evenly swelling, then add wetting agent, stir, make bare substrate; In bare substrate, add vitamin E, stir; Then take Oleum Eucalypti, in Oleum Eucalypti, add 95% ethanol make it dissolve, the Oleum Eucalypti after dissolving is added in bare substrate, stirs; Get extract A, in extract A, add 50% ethanol make it dissolve, the extract A after dissolving is added in bare substrate, stirs; Finally add in bare substrate by extract B, stir, supplementing surplus ad pond om by purified water is 1000 weight portions, obtains antibacterial medicines.
Embodiment 4
A kind of embodiment of antibacterial medicines of the present invention, antibacterial medicines described in the present embodiment is suppository, this antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 200 parts, Herba Melastomatis dodecandri 40 parts, Radix Zanthoxyli 40 parts, Radix Angelicae Sinensis 40 parts, Radix Cudraniae 40 parts, Herba Fici Simplicissimae 40 parts, Oleum Eucalypti 10 parts, vitamin E 5 parts, lanoline 10 parts and semi-synthetic fatty acid ester 200 parts.
The preparation method of antibacterial medicines described in the present embodiment is:
Prepare fine powder A: take Radix Sophorae Flavescentis, add the ethanol of Radix Sophorae Flavescentis weight 8 times respectively, reflux, extract, 2 times, each extraction 2 hours; Filter after having refluxed, merging filtrate, decompression recycling ethanol is extremely without alcohol taste, and drying under reduced pressure, is ground into fine powder, obtains fine powder A;
Preparation extract B: take Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae, adds the water of Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 8 times, decocts 2 times, each decoction 2 hours; Filter after having decocted, merging filtrate, solvent evaporated under reduced pressure, then drying under reduced pressure, be ground into fine powder, obtain fine powder B;
Take lanoline, heating melts, and is poured into by the lanoline of melting in high-efficient homogeneous machine, then adds Oleum Eucalypti, vitamin E and the fine powder A obtained and fine powder B, opens agitating device, after stirring, stops stirring; Add semi-synthetic fatty acid ester again, after melting completely at 60 DEG C of temperature, stir 30min, after becoming homogeneous medicinal liquid, the medicinal liquid prepared is poured in the heat-preserving container of perfusion unit, and insulation is stirred at 40 DEG C, regulate loading amount, start full-automatic suppository perfusion unit and carry out the embedding of suppository, freezing, sealing.
Embodiment 5
A kind of embodiment of antibacterial medicines of the present invention, antibacterial medicines described in the present embodiment is suppository, this antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 250 parts, Herba Melastomatis dodecandri 60 parts, Radix Zanthoxyli 20 parts, Radix Angelicae Sinensis 20 parts, Radix Cudraniae 60 parts, Herba Fici Simplicissimae 20 parts, Oleum Eucalypti 20 parts, vitamin e1 part, lanoline 8 parts and semi-synthetic fatty acid ester 200 parts.
The preparation method of antibacterial medicines described in the present embodiment is:
Prepare fine powder A: take Radix Sophorae Flavescentis, add the ethanol of Radix Sophorae Flavescentis weight 6 times respectively, reflux, extract, 3 times, each extraction 1 hour; Filter after having refluxed, merging filtrate, decompression recycling ethanol is extremely without alcohol taste, and drying under reduced pressure, is ground into fine powder, obtains fine powder A;
Preparation extract B: take Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae, adds the water of Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 6 times, decocts 3 times, each decoction 1 hour; Filter after having decocted, merging filtrate, solvent evaporated under reduced pressure, then drying under reduced pressure, be ground into fine powder, obtain fine powder B;
Take lanoline, heating melts, and is poured into by the lanoline of melting in high-efficient homogeneous machine, then adds Oleum Eucalypti, vitamin E and the fine powder A obtained and fine powder B, opens agitating device, after stirring, stops stirring; Add semi-synthetic fatty acid ester again, after melting completely at 60 DEG C of temperature, stir 30min, after becoming homogeneous medicinal liquid, the medicinal liquid prepared is poured in the heat-preserving container of perfusion unit, and insulation is stirred at 40 DEG C, regulate loading amount, start full-automatic suppository perfusion unit and carry out the embedding of suppository, freezing, sealing.
Embodiment 6
A kind of embodiment of antibacterial medicines of the present invention, antibacterial medicines described in the present embodiment is suppository, this antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 150 parts, Herba Melastomatis dodecandri 20 parts, Radix Zanthoxyli 60 parts, Radix Angelicae Sinensis 60 parts, Radix Cudraniae 20 parts, Herba Fici Simplicissimae 60 parts, Oleum Eucalypti 2 parts, vitamin e1 0 part, lanoline 12 parts and semi-synthetic fatty acid ester 180 parts.
The preparation method of antibacterial medicines described in the present embodiment is:
Prepare fine powder A: take Radix Sophorae Flavescentis, add the ethanol of Radix Sophorae Flavescentis weight 10 times, reflux, extract, 1 time, extract 3 hours; Filter after having refluxed, obtain filtrate, decompression recycling ethanol is extremely without alcohol taste, and drying under reduced pressure, is ground into fine powder, obtains fine powder A;
Preparation extract B: take Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae, adds the water of Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 10 times, decocts 1 time, decoct 3 hours; Filter after having decocted, obtain filtrate, solvent evaporated under reduced pressure, then drying under reduced pressure, be ground into fine powder, obtain fine powder B;
Take lanoline, heating melts, and is poured into by the lanoline of melting in high-efficient homogeneous machine, then adds Oleum Eucalypti, vitamin E and the fine powder A obtained and fine powder B, opens agitating device, after stirring, stops stirring; Add semi-synthetic fatty acid ester again, after melting completely at 60 DEG C of temperature, stir 30min, after becoming homogeneous medicinal liquid, the medicinal liquid prepared is poured in the heat-preserving container of perfusion unit, and insulation is stirred at 40 DEG C, regulate loading amount, start full-automatic suppository perfusion unit and carry out the embedding of suppository, freezing, sealing.
Embodiment 7
The fungistatic effect of the present embodiment to the antibacterial medicines that the present invention obtains measures.The antibacterial medicines that the present invention obtains by we packs, (temperature 37 DEG C in climatic chamber, relative humidity 65%) deposit 3 months, (experimental strain is escherichia coli, staphylococcus aureus and Candida albicans to experimental strain to deposit front and back sample former state, this experimental strain is provided by Military Medical Science Institute) carry out bacteriostatic test, mensuration the results are shown in Table 1.
The fungistatic effect measurement result of table 1 antibacterial medicines of the present invention
Note: negative control: the equal asepsis growth of diluent, culture medium.
From result: the antibacterial medicines that the present invention obtains, effect 2min, is 100% to the bacteriostasis rate of staphylococcus aureus, escherichia coli and Candida albicans.Sample deposits 3 months in climatic chamber (temperature 37 DEG C, relative humidity 65%), sample former state on the fungistatic effect of escherichia coli and Candida albicans all without impact.As can be seen here, antibacterial medicines of the present invention has good fungistatic effect.
Embodiment 8
The present embodiment, by vaginal mucomembranous irritant test, has investigated the obtained antibacterial medicines (gel) of the embodiment of the present invention 1 ~ 3 to the stimulation of vaginal mucosa.The method of test is: choose Female New Zealand rabbit 6, body weight 2.0kg ~ 2.5kg, be divided into tested group and matched group, often organizes 3.By the raw sample that test solution is the antibacterial medicines that the embodiment of the present invention 1 ~ 3 obtains, contrast liquid is normal saline.Tested treated animal gets the rear soft insertion vagina of the tested liquid wetting of 3 conduits 4 ~ 5cm respectively, and slowly injects 2ml by test solution with syringe, extracts conduit out.Control animals normal saline does same process.After 24h, aeroembolism method puts to death animal, takes out complete vagina, is fixed on more than 24h in 10% formalin solution after longitudinally cutting, and that chooses vagina central authorities and 3 positions, two ends organizes film-making, and HE carries out histopathological examination, the results are shown in Table 2 after dyeing.
Table 2 new zealand rabbit vaginal mucosa irritation reaction grade form
Note: 1. in scoring hurdle, irritant reaction scoring is every animal vagina 3 position irritant reaction scoring sums.
2. average integral=3 animal irritant reaction scoring sum/observation animal number
3. stimulation index=tested group of average integral-matched group average integral
From result: tested group and matched group new zealand rabbit topical vaginal organize perusal all to have congested reaction, and through reaction scoring, vaginal mucosa irritation index is 2.78.Therefore antibacterial medicines of the present invention (gel) belongs to extremely slight zest to Female New Zealand rabbit vaginal mucosa irritation.
Embodiment 9
We are for inventive gel dosage form antibacterial medicines, have investigated the impact on medicine fungistatic effect and treatment gynecological inflammation result of raw materials and content thereof.We prepare experimental group and the matched group of antibacterial medicines according to method of the present invention, are respectively used to treat the roughly the same gynecological inflammation women of state of an illness sign, investigate curative effect.The gynecological inflammation women totally 200 that state of an illness sign selected by us is roughly the same, often organize 40, it is between probation, painting every day experimental group and matched group medicine 5g, once a day, is coated with 7 days altogether.
In following experimental group 1 ~ 3 and matched group 1 ~ 2, the adjuvant of preparing of medicine is: carbomer 2 ~ 20 parts, wetting agent 200 ~ 450 parts; Wherein, described wetting agent is the mixture of glycerol and propylene glycol, and the weight ratio of described glycerol and described propylene glycol is 1.0 ~ 2.5:1.0 ~ 2.0; Other materials in raw materials are as follows:
Experimental group 1: Radix Sophorae Flavescentis 200 parts, Herba Melastomatis dodecandri 40 parts, Radix Zanthoxyli 40 parts, Radix Angelicae Sinensis 40 parts, Radix Cudraniae 40 parts, Herba Fici Simplicissimae 40 parts, Oleum Eucalypti 10 parts, vitamin E 5 parts;
Experimental group 2: Radix Sophorae Flavescentis 250 parts, Herba Melastomatis dodecandri 60 parts, Radix Zanthoxyli 20 parts, Radix Angelicae Sinensis 20 parts, Radix Cudraniae 60 parts, Herba Fici Simplicissimae 20 parts, Oleum Eucalypti 20 parts, vitamin e1 part;
Experimental group 3: Radix Sophorae Flavescentis 150 parts, Herba Melastomatis dodecandri 20 parts, Radix Zanthoxyli 60 parts, Radix Angelicae Sinensis 60 parts, Radix Cudraniae 20 parts, Herba Fici Simplicissimae 60 parts, Oleum Eucalypti 2 parts, vitamin e1 0 part;
Matched group 1: Radix Sophorae Flavescentis 150 ~ 250 parts;
Matched group 2: Herba Melastomatis dodecandri 20 ~ 60 parts, Radix Zanthoxyli 20 ~ 60 parts, Radix Angelicae Sinensis 20 ~ 60 parts, Radix Cudraniae 20 ~ 60 parts, Herba Fici Simplicissimae 20 ~ 60 parts.
The concrete preparation method of experimental group and matched group antibacterial medicines is:
Preparation extract A: take Radix Sophorae Flavescentis, add the ethanol of Radix Sophorae Flavescentis weight 6 ~ 10 times respectively, reflux, extract, 1 ~ 3 time, extracts 1 ~ 3 hour at every turn; Filter after having refluxed, merging filtrate, gained filtrate is concentrated into the thick paste that relative density is 1.20 ~ 1.25, obtains extract A;
Preparation extract B: take Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae, adds the water of Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 6 ~ 10 times, decocts 1 ~ 3 time, decoct 1 ~ 3 hour at every turn; Filter after having decocted, merging filtrate, it is 1.20 ~ 1.25 thick pastes that filtrate is concentrated into relative density, obtains extract B;
Take carbomer, add water, stir and make carbomer evenly swelling, then add wetting agent, stir, make bare substrate; In bare substrate, add vitamin E, stir; Then take Oleum Eucalypti, in Oleum Eucalypti, add ethanol make it dissolve, the Oleum Eucalypti after dissolving is added in bare substrate, stirs; Get extract A, in extract A, add ethanol make it dissolve, the extract A after dissolving is added in bare substrate, stirs; Finally add in bare substrate by extract B, stir, supplementing surplus ad pond om with water is 1000 weight portions, obtains antibacterial medicines.When preparing matched group 1, as stated above extract A is added in bare substrate, stir, add water and supplement surplus and namely obtain antibacterial medicines; When preparing matched group 2, without the need to adding extract A in preparation process.
The result that above-mentioned experimental group and matched group antibacterial medicines are used for the treatment of gynecological inflammation is as shown in table 3.
Table 3
| Recovery from illness number of cases | Effective number of cases | Effective number of cases | Invalid number of cases | Cure rate/% | Inefficiency/% | |
| Experimental group 1 | 32 | 4 | 2 | 2 | 80 | 5 |
| Experimental group 2 | 26 | 3 | 6 | 5 | 65 | 12.5 |
| Experimental group 3 | 25 | 3 | 7 | 5 | 62.5 | 12.5 |
| Matched group 1 | 8 | 2 | 14 | 16 | 20 | 40 |
| Matched group 2 | 12 | 2 | 14 | 12 | 30 | 30 |
Note: after full effect refers to and terminates the course for the treatment of, symptom, sign disappear; Effective refer to terminate the course for the treatment of after, symptom, sign disappear substantially; Effectively refer to after terminating the course for the treatment of, symptom, sign alleviate; Invalid refer to terminate the course for the treatment of after, symptom, sign and other indexs are without obvious improvement.
The above results shows, during using Radix Sophorae Flavescentis and Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae jointly as the raw materials of antibacterial medicines, and the better effects if of obtained antibacterial medicines treatment gynecological inflammation; Further, when adopting following raw materials: Radix Sophorae Flavescentis 200 parts, Herba Melastomatis dodecandri 40 parts, Radix Zanthoxyli 40 parts, Radix Angelicae Sinensis 40 parts, Radix Cudraniae 40 parts, Herba Fici Simplicissimae 40 parts, Oleum Eucalypti 10 parts, vitamin E 5 parts, the best results of antibacterial drug therapy gynecological inflammation.
Finally to should be noted that; above embodiment is only in order to illustrate technical scheme of the present invention but not limiting the scope of the invention; although be explained in detail the present invention with reference to preferred embodiment; those of ordinary skill in the art is to be understood that; can modify to technical scheme of the present invention or equivalent replacement, and not depart from essence and the scope of technical solution of the present invention.
Claims (10)
1. an antibacterial medicines, is characterized in that: described antibacterial medicines comprises following raw materials: Radix Sophorae Flavescentis, Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae.
2. antibacterial medicines as claimed in claim 1, is characterized in that: described antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 150 ~ 250 parts, Herba Melastomatis dodecandri 20 ~ 60 parts, Radix Zanthoxyli 20 ~ 60 parts, Radix Angelicae Sinensis 20 ~ 60 parts, Radix Cudraniae 20 ~ 60 parts, Herba Fici Simplicissimae 20 ~ 60 parts.
3. antibacterial medicines as claimed in claim 1 or 2, is characterized in that: described antibacterial medicines also comprises following raw materials: Oleum Eucalypti and vitamin E.
4. antibacterial medicines as claimed in claim 3, it is characterized in that: described Oleum Eucalypti is 2 ~ 20 weight portions, described vitamin E is 1 ~ 10 weight portion.
5. antibacterial medicines as claimed in claim 4, is characterized in that: described antibacterial medicines comprises the raw materials of following weight parts: Radix Sophorae Flavescentis 200 parts, Herba Melastomatis dodecandri 40 parts, Radix Zanthoxyli 40 parts, Radix Angelicae Sinensis 40 parts, Radix Cudraniae 40 parts, Herba Fici Simplicissimae 40 parts, Oleum Eucalypti 10 parts, vitamin E 5 parts.
6. the antibacterial medicines as described in any one of claim 3 ~ 5, is characterized in that: described antibacterial medicines is gel or suppository.
7. antibacterial medicines as claimed in claim 6, is characterized in that: described antibacterial medicines is gel, and this antibacterial medicines also comprises the raw materials of following weight parts: carbomer 2 ~ 20 parts, wetting agent 200 ~ 450 parts; Wherein, described wetting agent is the mixture of glycerol and propylene glycol, and the weight ratio of described glycerol and described propylene glycol is 1.0 ~ 2.5:1.0 ~ 2.0.
8. antibacterial medicines as claimed in claim 7, it is characterized in that: described carbomer is 4 weight portions, described wetting agent is 350 weight portions; In described wetting agent, the weight ratio of glycerol and propylene glycol is 2:1.5.
9. antibacterial medicines as claimed in claim 6, is characterized in that: described antibacterial medicines is suppository, and this antibacterial medicines also comprises following raw materials: lanoline and semi-synthetic fatty acid ester.
10. a preparation method for antibacterial medicines, is characterized in that: described antibacterial medicines is gel, and its preparation method comprises the following steps:
Preparation extract A: take 150 ~ 250 weight portion Radix Sophorae Flavescentiss, add the ethanol of Radix Sophorae Flavescentis weight 6 ~ 10 times respectively, reflux, extract, 1 ~ 3 time, extracts 1 ~ 3 hour at every turn; Filter after having refluxed, merging filtrate, gained filtrate is concentrated into the thick paste that relative density is 1.20 ~ 1.25, obtains extract A;
Preparation extract B: take Herba Melastomatis dodecandri 20 ~ 60 weight portion, Radix Zanthoxyli 20 ~ 60 weight portion, Radix Angelicae Sinensis 20 ~ 60 weight portion, Radix Cudraniae 20 ~ 60 weight portion and Herba Fici Simplicissimae 20 ~ 60 weight portion, add the water of Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Radix Cudraniae and Herba Fici Simplicissimae gross weight 6 ~ 10 times, decoct 1 ~ 3 time, decoct 1 ~ 3 hour at every turn; Filter after having decocted, merging filtrate, it is 1.20 ~ 1.25 thick pastes that filtrate is concentrated into relative density, obtains extract B;
Take 2 ~ 20 weight portion carbomers, add water, stir and make carbomer evenly swelling, then add 200 ~ 450 weight portion wetting agents, stir, make bare substrate; In bare substrate, add 1 ~ 10 part by weight of vitamin E, stir; Then take 2 ~ 20 weight portion Oleum Eucalyptis, in Oleum Eucalypti, add ethanol make it dissolve, the Oleum Eucalypti after dissolving is added in bare substrate, stirs; Get extract A, in extract A, add ethanol make it dissolve, the extract A after dissolving is added in bare substrate, stirs; Finally add in bare substrate by extract B, stir, supplementing surplus ad pond om with water is 1000 weight portions, obtains antibacterial medicines; Wherein, described wetting agent is the mixture of glycerol and propylene glycol, and the weight ratio of described glycerol and described propylene glycol is 1.0 ~ 2.5:1.0 ~ 2.0.
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| CN109498700A (en) * | 2018-12-31 | 2019-03-22 | 广东罗浮山国药股份有限公司 | A kind of Novel gynecology-department external preparation |
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