CN109820901A - A kind of Traditional Chinese medicinal gel preparation with sterilization - Google Patents
A kind of Traditional Chinese medicinal gel preparation with sterilization Download PDFInfo
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- CN109820901A CN109820901A CN201910319010.4A CN201910319010A CN109820901A CN 109820901 A CN109820901 A CN 109820901A CN 201910319010 A CN201910319010 A CN 201910319010A CN 109820901 A CN109820901 A CN 109820901A
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Abstract
The invention discloses a kind of Traditional Chinese medicinal gel preparations with sterilization, the gel preparation includes that the bulk pharmaceutical chemicals of following parts by weight are made: 10~30 parts of Chinese hawthorn seed, 5~9 parts of aqueous matrix, 5~15 parts of emulsifier, 10~30 parts of moisturizer, 3~9 parts of triethanolamine, 0.2~2 part of sodium benzoate, the Traditional Chinese medicinal gel preparation is to Escherichia coli, staphylococcus aureus has stronger inhibiting effect, and can play the role for the treatment of and prevention to female gynecological disease.
Description
Technical field
The present invention relates to a kind of Traditional Chinese medicinal gel preparations with sterilization, belong to sanitizer technical field.
Background technique
Due to the extensive use of antibiotic, or because hormone, serious communicable disease, gestational period vagina epithelium is used for a long time
The increase of cell glycogen content, ovarian failure, certain allergy or infectious diseases person more easy infection.In recent years, gynaecologic vaginal
Scorching disease incidence is on the rise, is one of frequently-occurring disease of Out-patient Clinic of Department of Gynecology.Clinically common vaginitis is mainly that white is read
Pearl bacterium property vaginitis, bacterial vaginitis and trichomonas vaginitis.Clinical manifestation is abnormal leucorrhea, pruritus vulvue, peculiar smell,
Pain, burn feeling, when secondary urinary tract infections, will appear frequent micturition, urgent urination, urodynia etc., and serious person can lead to cervical erosion, infertile etc.
Gynecological diseases, physical and mental health and love life generation to women seriously affect.Currently on the market treatment bacterial vaginosis BV and
The external preparation of colpomycosis has: kuh-seng gel, Baofukang suppository etc..Correlative study shows nearly 50% vaginitis patient
For mixed infection, this infection type recurrence rate is relatively high, and a kind of most of only bacterium to symptom or mould of said medicine preparation
Bacterium is effective, and to patient's unsatisfactory curative effect of a variety of mixing germ infection, and the selling price of most of Chinese patent drug on the market compares
The influence of the factors such as valuableness, clinical application are limited.
Honghefujie Lotion by GC is the core gynecological external use product of Shandong Buchang Shenzhou Pharmaceutical Co., Ltd., and the traditional Chinese medicines of the medicine are quasi-
Font size is Z10980131, and effective component is raw material by Chinese hawthorn seed a herb material, through the modern preparation process purification such as destructive distillation
At rich in more than 70 effective active components such as phenols, aldehydes, ketone, organic acids, with detoxifying, removing dampness, the antipruritic function of desinsection
Effect, for the active drug for treating colpomycosis and nonspecific vaginitis.Apply for that more than one piece invention is special before the product
Benefit application: its number of patent application be 03139655.0,201210071276.X, 201210070908.0,201210070797.3,
201410348891.X, above-mentioned patent protection content are concentrated mainly on washing lotion, suppository, oral preparation and relevant clinical new application
Aspect.Since the product clinically applies more washing lotion, there is also the larger existing irritation of dosage is larger and inconvenient for use
Defect, in order to further increase the quality curative effect of product, our company, which carries out from effective component, novel formulation the product, prepares work
A large amount of research in terms of skill parameter and drug effect.Gelling agent system drug and can be formed made of the auxiliary material of gel it is uniform, be suspended or cream
The glop or semisolid preparation of shape liquid type.Gel preparation is widely used in slow-release controlled-release etc. newly as novel pharmaceutical preparation
Type drug delivery system can be divided into whole body gelling agent and part two class of gelling agent.Since gel has good biocompatibility,
There is slow-release controlled-release effect to drug release, preparation process is simple and beautiful shape, is easy to be coated with use, easy after local administration
Absorption, not pollution clothes, the preferable advantage of stability.Vagina gel preparation is made in Chinese hawthorn seed by the present invention, can be had
Effect extends drug in the residence time of patient's lesions position, and pharmaceutical release time is longer, and sufferer compliance is preferable, and vagina is used solidifying
Jelly is a kind of pharmaceutical dosage form of ideal treatment gynecological disease, has good development prospect.
Summary of the invention
To achieve the above object, a kind of Traditional Chinese medicinal gel preparation with sterilization, the Traditional Chinese medicinal gel preparation have
The advantage that production cost is low, processing quality is stable.Gel novel form, biology benefit with higher can be made in the Chinese materia medica preparation
Expenditure, and easy to carry, easy cleaning, not pollution clothes the advantages that.Using gel preparation made of Chinese hawthorn seed of the present invention,
Carbomer matrix and vaginal mucosa group as selected by it are woven with good adhesion, can be improved drug local concentration, have
Drug effect is locally played in lesion conducive to drug.Compared with the gynaecologic washing lotion of the prior art, the pharmaceutic adjuvant of inventive gel preparation is matched
Than, contingent income after a lot of trial and error, and obtain the preferable prescription of stable curative effect.Inventive gel preparation can extend
The release process of drug reduces the stimulation allergic reaction to patient, enhances the compliance of the clinical application of patient.Inventive gel
Rich in a variety of effective active components such as phenols, aldehydes, ketone, organic acids contained in preparation, microecology in vaginas is maintained to balance,
Be conducive to the growth of intravaginal normal flora, improve vagina mucosa immunity, prevents and treats gynaecologic vaginal inflammation to reach
Purpose.
The invention provides the following technical scheme:
A kind of Traditional Chinese medicinal gel preparation with sterilization, the gel preparation include the raw material of following parts by weight
Medicine is made: 10~30 parts of Chinese hawthorn seed, 5~9 parts of aqueous matrix, 5~15 parts of emulsifier, 10~30 parts of moisturizer, three second
3~9 parts of hydramine, 0~2 part of sodium benzoate.
Aqueous matrix in the gel preparation be carbomer, alginate, gelatin, xanthan gum, it is a kind of in chitin or
Several combinations.
Emulsifier in the gel preparation is one in Tween-80, -40 rilanit special of polyoxyethylene ether or poloxamer
Kind or several combinations.
Moisturizer in the gel preparation is glycerol, glycerine, D-sorbite, one or more combination in xylitol.
The gel preparation includes that the bulk pharmaceutical chemicals of following parts by weight are made: 10~30 parts of Chinese hawthorn seed, carbomer 5
~9 parts, Tween-80 (5~15) part, 10~30 parts of glycerol, 3~9 parts of triethanolamine, 0.2~2 part of sodium benzoate.
As the preferred of Traditional Chinese medicinal gel preparation of the present invention, the gel preparation includes the bulk pharmaceutical chemicals system of following parts by weight
At: 20 parts of Chinese hawthorn seed, 7 parts of carbomer, polyoxyethylene sorbitan monoleate, 10 parts, 20 parts of glycerol, 6 parts of triethanolamine.
As the preferred of Traditional Chinese medicinal gel preparation of the present invention, the gel preparation includes the bulk pharmaceutical chemicals system of following parts by weight
At: 20 parts of Chinese hawthorn seed, 7 parts of carbomer, polyoxyethylene sorbitan monoleate, 10 parts, 20 parts of glycerol, 6 parts of triethanolamine, sodium benzoate 1
Part.
As the preferred of Traditional Chinese medicinal gel preparation of the present invention, the gel preparation includes the bulk pharmaceutical chemicals system of following parts by weight
At: 20 parts of Chinese hawthorn seed, 9 parts of carbomer, Tween-80,15 parts, 30 parts of glycerol, 9 parts of triethanolamine, sodium benzoate 0.2
Part.
As the preferred of Traditional Chinese medicinal gel preparation of the present invention, the gel preparation includes the bulk pharmaceutical chemicals system of following parts by weight
At: 20 parts of Chinese hawthorn seed, 5 parts of carbomer, Tween-80,5 parts, 10 parts of glycerol, 3 parts of triethanolamine, 2 parts of sodium benzoate.
Chinese hawthorn seed of the invention is mainly made of dry distillation liquid of Chinese hawthorn seed and Chinese hawthorn seed empyreumatic oil, Chinese hawthorn seed destructive distillation
The parts by weight of liquid are 1-5 parts, and the parts by weight of Chinese hawthorn seed empyreumatic oil are 99-95 parts.
Chinese hawthorn seed of the invention is mainly made of dry distillation liquid of Chinese hawthorn seed and Chinese hawthorn seed empyreumatic oil, Chinese hawthorn seed destructive distillation
The parts by weight of liquid are 5 parts, and the parts by weight of Chinese hawthorn seed empyreumatic oil are 95 parts.
Containing protocatechuic acid, catechol in Chinese hawthorn seed, the content of protocatechuic acid is 0.19-0.57mg/ml,
The content of catechol is 0.07-0.21mg/ml.
The content detection analysis method of its above-mentioned protocatechuic acid, catechol are as follows: use high performance liquid chromatography, chromatostrip
Part: Agilent C18 column (250mm × 4.6mm, 5 μm) is stream with methanol (A phase)-(- 0.6% glacial acetic acid solution of acetonitrile) (B phase)
Dynamic phase, carries out gradient elution, gradient ratio are as follows: 0-2min, 98%A, 2%B；2-5min, 98-70%A, 2-30%B；5-
18min, 70-63%A, 30-37%；Flow velocity: 1.0ml/min；Column temperature: 30 DEG C, Detection wavelength: 260nm.
Also contain furfural, guaiacol in Chinese hawthorn seed, through detection it is found that furfural content >=8mg/ in its ingredient
Ml, Determination of Guaiacol >=1.5mg/ml.
The present invention is used using the gas chromatography of furfural, two constituent content of guaiacol in measurement Chinese hawthorn seed
DB-FFAP capillary column (30m × 0.32mm × 0.25 μm)；Fid detector；Chromatographic condition: column temperature is since 95 DEG C with 1 DEG C
min-1105 DEG C are raised to, then with 10 DEG C of min-1140 DEG C (being kept for 8 minutes) are raised to, with 20 DEG C of min-1It is raised to 190 DEG C and (keeps 5
Minute).205 DEG C of injector temperature, 210 DEG C of detector temperature；Split sampling, split ratio 1: 15.
Chinese hawthorn seed used in the present invention is provided from Shandong step-length Divine Land pharmaceutical factory, the effective component substances of institute
For dry distillation liquid of Chinese hawthorn seed and Chinese hawthorn seed empyreumatic oil, mainly contain organic acid, ursolic acid, furfural class, phenols etc. it is a variety of effectively at
Point.
Preparation method technique is as follows:
Chinese hawthorn seed is taken, Chinese hawthorn seed is placed in retort, inventory is the 55% of volume of equipment rate, is used with nitrogen as drive
The dynamic distillation process of power, heating ramp rate are 40 DEG C/h, control the reaction process of dry distillation liquid, keep in retort
Pressure 0.04-0.12MPa reaches 160~190 DEG C in heating temperature, and the heating and thermal insulation time is 1 hour, collects 160 DEG C or more
Destructive distillation product, and reach 250~280 DEG C in heating temperature, keeping temperature is 3 hours, carries out fraction collection, can obtain of the invention
Dry distillation liquid of Chinese hawthorn seed and empyreumatic oil.It is brownish red to black by the appearance that its Chinese hawthorn seed empyreumatic oil and dry distillation liquid is made in the above method
Color liquid has sootiness fragrance, and PH is 2.0~3.0, furfural content >=8mg/ml in ingredient, and Determination of Guaiacol >=
1.5mg/ml。
Experimental example 1: the science in order to protrude inventive gel preparation process, we are by the preferred part Experiment example of technique
As a result presented below.
The selection of 1.1 gel-type vehicle types
Since the effective component in Chinese hawthorn seed of the present invention is complicated, effect often can be generated with matrix auxiliary material, can make to coagulate
Water extravasation in gel matrix reticular structure, so that gel structure be made to generate irreversible destruction.Therefore traditional Chinese medicine gel is prepared
Key is Screening matrix.Suitable matrix is selected, drug delivery system stabilization can be made, effectively played a role, conversely, selection matrix is not
Properly, then ideal effect is not achieved.We should consider when selecting gel-type vehicle appearance whether glossy clear, whether quality
Whether uniform and smooth, viscosity, consistency are suitable for being easy to be coated with, and whether compatible change can occur with main ingredient, medicine after gelling agent is made
In terms of the release property effect of object.Specific experiment design is as follows:
Chinese hawthorn seed (bulk pharmaceutical chemicals) 2g is weighed, adds distilled water to 80g, stirs evenly, standing 12h keeps it sufficiently molten
It is swollen, 10% triethanolamine solution is added dropwise and adjusts pH value.Respectively with 30% Arabic gum, 10% gelatin, 0.5% Carbomer-940,
2.0%CMC-Na, 3.0% sodium alginate, 5.0% chitosan are that the gelling agent of different auxiliary material is made in gel-type vehicle, with gel outside
See character (include it is matt, whether there is or not precipitatings, have non-foam etc.), mouldability, clarity, greasy feeling, the uniformity, exquisiteness,
Sticked sense (complexity when provoking gel), stickiness, mobility be evaluation index, carry out scoring screening, standards of grading
Are as follows: fine 9~10 points, preferable 7~8 points, general 5~6 points, poor 3~4 points, very poor 1~2 point.Comprehensive score is compared in calculating,
Select scoring highest as gel-type vehicle auxiliary material.Its experiment the results are shown in Table 1.
1 gel-type vehicle screening of table prepares supplementary product consumption ratio choice experiment
From table 1 the result shows that, face shaping, formability, from the point of view of multiple reference indexs such as clarity, Arabic gum, gelatin
Mouldability and clarity it is all poor；The sodium alginate of selection and the uniformity of chitosan are not especially desirable.The present invention is solidifying
Glue preparation selects the gel clear of carbomer preparation, and mouldability is preferable, and uniform and smooth, stickiness is more moderate, and oil-free
Soapy feeling, and stretchability is good.Therefore, select Carbomer-940 as gel-type vehicle.
The experiment of 1.2 gel formulation optimizations
The carbomer plus appropriate purified water for weighing prescribed dose proportion impregnate 6 hours, and to its complete swelling, card wave is made
Nurse solution, it is spare；Chinese hawthorn seed is weighed again, Tween-80, is uniformly mixed, and is added in carbomer solution, stirring is equal
It is even；Purified water is added again to 1000ml, is stirred and evenly mixed, is instilled triethanolamine, solution stirring is surveyed pH value and is made after mixing evenly
Chinese hawthorn seed gel preparation of the present invention, and its face shaping is observed, viscosity and pH value result refer to for overall merit
Mark, and it is preferred to carry out prescription, the results are shown in Table 2.
2 gel of table prepares supplementary product consumption ratio choice experiment
From 2 experimental result of table it is found that prescription selected by prescription 3 assembles rationally, manufactured gel is translucent and thick
Spend optimizing prescriptions that are moderate, and can be used as inventive gel preparation.
1.3 study on the stability
Stability experiment is that pharmaceutical preparation safely and effectively guarantees, main character, content for examining or check drug etc. is in certain temperature
The rule changed over time under the influence of the extraneous factors such as degree, humidity, illumination and microorganism.According to 1 group of the embodiment of the present invention
Gel preparation made from preparation method, this experiment is in this, as investigation object, according to steady as defined in 2005 editions Chinese Pharmacopoeia annex
Qualitative condition, that is, cold test, investigates the stability of its gel preparation.
1.3.1 experimental method
1.3.1.1 long-term stable experiment
Gel preparation three batches are taken made from the preparation method of following inventive embodiments 1, and commercially available back is 25 DEG C in temperature
It+2 DEG C, under conditions of relative humidity is 60%+10%, places and was sampled respectively at the 0th, 3,6,9,12 month, investigate test sample
The indexs such as character, viscosity, pH value, medicament contg.
1.3.1.2 viscosimetric analysis
The gelling agent 50g for accurately weighing following 1 prescription method of embodiment of the present invention preparations respectively, places it in 25 DEG C of water-baths
In, with the viscosity of SNB-1 type Digital Viscometer measurement gelling agent.
1.3.1.3 pH value
The dilution of 30ml purified water is added in the gelling agent 5g for accurately weighing following 1 prescription method of embodiment of the present invention preparations, dilute
PH value of solution is measured after releasing.As a result 3 be see the table below.
The experimental result of 3 inventive gel preparation long-time stability of table
Experimental result table 3 illustrates, in long-term stable experiment, which places 0 month, March, June, 9
Month, after 12 months, observes its character, viscosity, pH value, content and significant changes do not occur, it is above-mentioned the experiment results show that of the invention
Gel preparation has good stability.
The measurement of 1.4 inventive gel preparation drug release rates
Precision weighs following embodiment of the present invention 1 (prescription 1), the embodiment of the present invention 2 (prescription 2), the embodiment of the present invention 3
The gel preparation of (prescription 3) method preparation amounts to 15g, and each prescription weighs 5g, is placed in bag filter that (every bag filter is long
6cm), both ends with line at a certain distance from tighten (remove bag in bubble), be placed in and turn basket, and be put into cuvette.Dissolution medium is
Ultrasonic distilled water 200ml, circulating water temperature control at 37.0 ± 1 DEG C, turn basket speed be 75r/min, respectively at release 0.5h, 1h,
2h, 4h, 6h, 8h, for 24 hours, take release liquid 15ml, the fresh dissolution medium of equivalent are replenished in time.Sample is by above-mentioned " furfural content survey
Determine method " it measures, measurement result is shown in attached drawing 1.
Experimental example 2: the science in order to protrude inventive gel preparation, we provide the analysis side of inventive gel preparation
Method is as follows:
Sample preparation:
The gel preparation for taking following embodiment of the present invention 1, the embodiment of the present invention 2,3 method of the embodiment of the present invention to prepare
3.0ml, it is extracted 3 times with ether 20.0ml, merges ether extraction liquid, after nitrogen concentration and anhydrous sodium sulfate are dry, be added
1.0ml trimethylsilyl and acetamide+0.6ml trim,ethylchlorosilane vibrate 30min, are centrifugated 5min, and centrifugation rate is
1000rpm/min takes supernatant, seals -10 DEG C of preservations, as analysis sample.
Chromatographiccondition:
The present invention is using the gas chromatography for measuring furfural content in Chinese hawthorn seed, using DB-FFAP capillary column
(30m×0.32mm×0.25μm)；Fid detector；Chromatographic condition: column temperature is since 95 DEG C with 1 DEG C of min-1105 DEG C are raised to,
Again with 10 DEG C of min-1140 DEG C (being kept for 8 minutes) are raised to, with 20 DEG C of min-1It is raised to 190 DEG C (being kept for 5 minutes).Injection port temperature
205 DEG C, 210 DEG C of detector temperature of degree；Split sampling, split ratio 1: 15.
Experimental example 3: inventive gel preparation the utility model has the advantages that
In inventive gel prescription, using Chinese hawthorn seed as principle active component, and it is prepared into quality and stablizes, curative effect is true
The gelling agent cut.We's choosing can be used as rheology control agent using carbomer as gel forming matrix, have thickening power.It should
Matrix can skin surface adhesiveness it is strong, and drug can be extended in the residence time of skin surface, improve the biology of drug
Availability.Selecting Tween-80 again is naturally occurring emulsifying agent, drug can be made to form uniformly small lotion, and it is steady to form quality
Fixed gel preparation.Add triethanolamine, not only the pH value of adjustable invention formulation, can with its main ingredient ingredient with
The emulsification of other effective components enhances.Glycerol is added as moisturizer in formula, and plays good moisturizing and moisture-keeping function.
Gel made of the present invention not only has many advantages, such as process stabilizing, nonirritant, quality is easily controllable, curative for effect.
Detailed description of the invention
The drawings described herein are used to provide a further understanding of the present invention, constitutes a part of the invention, this hair
Bright illustrative embodiments and their description are used to explain the present invention, and are not constituted improper limitations of the present invention.
Fig. 1-inventive gel preparation drug release profiles figure.
Specific embodiment
It is the specific embodiment of the content of present invention below, for illustrating the skill of the technical problem of being solved in present specification
Art scheme facilitates those skilled in the art understand that the content of present invention, but the realization of technical solution of the present invention is not limited to these
Embodiment.Chinese hawthorn seed raw material of the present invention comes from Shandong ShenZhou Pharmaceutical Co., Ltd, and specific lot number is
20170808.Its specific targets method is as follows: taking 1700 grams of Chinese hawthorn seed, Chinese hawthorn seed is placed in retort, inventory is equipment
The 55% of plot ratio uses the dynamic distillation process using nitrogen as driving force, and heating ramp rate is 40 DEG C/h, and control is dry
The reaction process of distillate keeps pressure 0.04-0.12MPa in retort, reaches 160~190 DEG C in heating temperature, heating and thermal insulation
Time is 1 hour, collects 160 DEG C or more of destructive distillation product, and reach 250~280 DEG C in heating temperature, keeping temperature is 3 small
When, fraction collection is carried out, dry distillation liquid of Chinese hawthorn seed and empyreumatic oil of the invention can be obtained.Its Chinese hawthorn seed destructive distillation is made by the above method
The appearance of oil and dry distillation liquid is brownish red to black liquor, has sootiness fragrance, PH is 2.0~3.0, the chaff in effective component
Aldehyde >=8mg/ml, Determination of Guaiacol >=1.5mg/ml.Chinese hawthorn seed can be made using above-mentioned preparation method.
Embodiment 1
(1), it weighs Acritamer 940 (7g) plus appropriate purified water is impregnated 6 hours, to its complete swelling, it is molten that wave nurse is made
Liquid, it is spare；
(2), Chinese hawthorn seed 20ml, polyoxyethylene sorbitan monoleate are weighed, 10ml, glycerol 20g, sodium benzoate 1g are uniformly mixed,
(1) addition step in carbomer solution, stirs evenly；
(3) purified water, is added again to 1000ml, is stirred and evenly mixed, triethanolamine 6g is instilled, and solution stirring is made after uniform
Gel.
Embodiment 2
Preparation method is same as Example 1, the prescribed dose proportion of the gel preparation are as follows: Chinese hawthorn seed 20ml, card
Wave nurse 940,9g, Tween-80,15ml, glycerol 30g, triethanolamine 9g, sodium benzoate 0.2g.
Embodiment 3
Preparation method is same as Example 1, the prescribed dose proportion of the gel preparation are as follows: Chinese hawthorn seed 20ml, card
Wave nurse 940,5g, Tween-80,5ml, glycerol 10g, triethanolamine 3g, sodium benzoate 2g.
Embodiment 4
Preparation method is same as Example 1, the prescribed dose proportion of the gel preparation are as follows: Chinese hawthorn seed 10ml, sea
Alginates 6g, polyoxyethylene sorbitan monoleate, 11ml, glycerine 15g, triethanolamine 4g, sodium benzoate 1g.
Embodiment 5
Preparation method is same as Example 1, the prescribed dose of gel preparation proportion are as follows: Chinese hawthorn seed 30ml, bright
Glue 8g, polyoxyethylene sorbitan monoleate, 13ml, glycerine 20g, triethanolamine 7g, sodium benzoate 0.8g.
Embodiment 6
Preparation method is same as Example 1, the prescribed dose proportion of the gel preparation are as follows: Chinese hawthorn seed 20ml, card
Wave nurse 8g, -40 rilanit special of polyoxyethylene ether, 12ml, xylitol 18g, triethanolamine 8g, sodium benzoate 1.2g.
Embodiment 7
Preparation method is same as Example 1, the prescribed dose proportion of the gel preparation are as follows: Chinese hawthorn seed 20ml, shell
Polysaccharide 7g, polyoxyethylene sorbitan monoleate, 7ml, glycerine 22g, triethanolamine 6g, sodium benzoate 1g.
Embodiment 8
Preparation method is same as Example 1, the prescribed dose proportion of the gel preparation are as follows: Chinese hawthorn seed 20ml, Huang
Virgin rubber 9g, poloxamer, 10ml, D-sorbite 15g, triethanolamine 9g, sodium benzoate 2g.
Embodiment 9
Preparation method is same as Example 1, the prescribed dose proportion of the gel preparation are as follows: Chinese hawthorn seed 20ml, Huang
Virgin rubber 9g, poloxamer, 10ml, D-sorbite 15g, triethanolamine 9g.
In order to further verify the curative effect of Traditional Chinese medicine gel of the present invention, we by above-mentioned specific embodiment 1, embodiment 2, implement
Traditional Chinese medicine gel prepared by example 3, has carried out corresponding pharmacology and pharmacodynamic test, has now been reported as follows result.
One, the fungistatic effect evaluation of gel
1.1 instruments and reagent
Ten a ten thousandth electronic analytical balance of CP225D type；HH-2 type digital display thermostat water bath；Electro-heating standing-temperature cultivator；
JB-CJ-1000FX aseptic superclean bench；TransferpetteS brand liquid-transfering gun；Sodium chloride, it is commercially available；Nutrient agar, city
It sells；Water is ultrapure water；Other reagents are that commercially available analysis is pure.
1.2 strain
Staphylococcus aureus Staphylococcus aureus, Escherichia coli Escherichia coli, Pseudomonas aeruginosa
P.Aeruginosa。
1.3 animal
Healthy rabbits 40, half male and half female (female unpregnancy), 4~5kg of weight, regular grade is commercially available.
1.4 experimental method
1.4.1 the preparation of culture medium
Nutrient agar 35g is weighed, is dissolved in 1000mL ultrapure water, and constantly stir evenly, reheating is boiled until fine jade
Rouge is completely dissolved, and in 121 DEG C of autoclave sterilization 30min, when temperature is down to 70 DEG C, is dispensed into sterilized culture dish,
It is spare.
1.4.2 actication of culture
The 500 μ L of bacterium for drawing staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa respectively, is added in teat glass,
1/4~1/2 nutrient broth fluid nutrient medium for entering test tube, after 37 DEG C of activation culture 8h, when culture solution by clarifying gradually completely
When becoming muddiness, this shows that the above-mentioned strain has activated.
1.4.3 the dilution of bacterium solution
Take activated bacterium solution it is appropriate, with sterile saline will activate bacterium solution be diluted to 100 respectively, 1000,
10000, it 10000 times, is put into culture dish, then pours into nutrient broth agar culture medium, after the solidification of above-mentioned culture medium, back-off
Plate, 37 DEG C of culture 20h.And bacterial plate counts method is used, then by the concentration dilution of various bacteria suspensions to 5 × 105~5 ×
106Cfu/mL, it is spare.
1.4.4 Bactericidal test
Experiment uses hole method, and control group drug takes Chinese hawthorn seed, purified water is added to be configured to 0.2% solution.With this
The gel of 1 method of inventive embodiments preparation, 2 gel of the embodiment of the present invention, 3 gel of the embodiment of the present invention, as administration group.It is accurate
Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa are drawn for trying 300 μ L of bacterium bacterium solution, is drawn into sterile petri dish, and fall
Enter nutrition 10~16mL of broth agar culture medium, constantly shaking keeps bacterium solution uniform, to culture medium cooled and solidified, carries out on culture dish
It punches, marks Deng using distance.Be added 100 μ L control, it is above-mentioned shake gently mixing for examination group sample, after dry,
Detain plate, be placed in 37 DEG C of aerobic constant temperature incubators and cultivate, and 1h, 2h, 8h, 12h, for 24 hours afterwards observation as a result, measurement inhibition zone
Size is measured 3 times, is averaged, Bactericidal test the results are shown in Table 5.
Bactericidal test criterion: antibacterial circle diameter is greater than 20mm, extremely quick: 15~20mm, Gao Min: 10~15mm, in
Quick: 7~9mm, muting sensitive: less than 7mm are insensitive.
1.4.5, safety and efficacy result
Inhibition zone measurement result of 5 inventive gel of table to 3 kinds of bacterium
Compared with the control group: * * P < 0.01, * P < 0.05.
Experimental result table 5 illustrates that after administration 1 hour, control group drug is to staphylococcus aureus, Escherichia coli, copper
Rapidly, in the antibacterial circle diameter size of 2h~8h, its growth difference is little, in 8h~12h for green pseudomonad antibacterial circle diameter variation
Antibacterial circle diameter has the tendency that being gradually reduced afterwards.This therefrom illustrates that drug release peak value of the control group solution in 1h is reachable maximum,
The drug of control group starts to degrade after 8h, and the curative effect of drug is also gradually reduced.Compared with the control group, after 1h and 2h administration, this
1 group of inventive embodiments, 2 groups of the embodiment of the present invention, 3 groups of the embodiment of the present invention to staphylococcus aureus, Escherichia coli and green pus
The antibacterial circle diameter growth amplitude of variation of bacillus is smaller, determines after 8h according to inhibition zone test criterion, inventive gel
Preparation has apparent inhibiting effect to above-mentioned germ.Compared with the control group, drug release of the traditional Chinese medicine gel of the present invention in 1h and 2h
Rate is slower, but in drug release 8h or so, the bacteriostasis and control group solution therapeutic equivalence of medicine group solution of the present invention,
And in 8h~for 24 hours, the antibacterial inhibition zone compared with the control group of traditional Chinese medicine gel of the present invention is significantly increased.1 group of the embodiment of the present invention,
2 groups and 3 groups of the embodiment of the present invention have inhibition to make staphylococcus aureus, Escherichia coli, pseudomonas aeruginosa antibacterial circle diameter
With (P < 0.01).Above-mentioned pharmacological datum the result shows that, traditional Chinese medicine gel of the present invention starts to reach peak value in 8h, 12~for 24 hours
Therapeutic effect continues, so as to reach the sterilization purpose of sustained release high-efficient and lasting.
1.4.6, rabbit skin irritation test
Experimental selection healthy rabbits 32, it is divided into 4 groups, every group 8, half male and half female is preceding for 24 hours by family's rabbit back ridge in experiment
Skin is dried in column two sides skin depilatory, the left and right each about 3cm × 3cm of depilation range, warm water cleaning, and whether there is or not red for observation epilating area
Spot, oedema and breakage.Family's rabbit back left of spine test block skin smears tea uniformly with 0.2% Chinese hawthorn seed solution and is
Contrast solution, the gel of 1 method of embodiment of the present invention preparation, 2 gel of the embodiment of the present invention, 3 gel of the embodiment of the present invention, as
Administration group.Dosage 0.5g/kg is covered and is fixed with nonirritant adhesive plaster, other side skin with two layers of antiseptic gauze
As own control.Using blocking test, a topical application of drug time is 4h.After 4h is administered, residual tested material, Yu Qing are removed with warm water
Except 1h after residual tested material, for 24 hours, 48h, 72h observe and record percutaneous drug delivery position whether there is or not the skin irritatins such as erythema, oedema are anti-
It answers, and scores.Methods of marking and stimulus index calculation method are calculated according to the following formula daily referring to " disinfection technology standard "
Every animal average integral (stimulus index) determines skin irritatin intensity.Every animal average integral is every animal 14d daily
Erythema and oedema total mark/(animal subject number × number of days).
Table 6 is to the multiple skin irritation test appraisal result of rabbit
According to experimental result 6 it is found that multiple skin irritatin, using control group drug and traditional Chinese medicine gel of the present invention, even
It is continuous that rabbit intact skin is smeared, after 24d, do not find the abnormal responses such as its erythema, oedema, skin irritatin sex index
It is 0, is nonirritant to family's rabbit skin.It can be seen that the Chinese hawthorn seed solution of control group has subexcite work to rabbit
With, and the gel preparation of 1-3 group of the embodiment of the present invention its without skin wound repair, show that its completeness is higher.
To sum up from the point of view of experimental result, the dosage form curative effect of the embodiment of the present invention 1, embodiment 2 and embodiment 3 can be than existing skill
Other dosage forms of art have reached the beneficial effects such as irritation is small, patient dependence is high, curative effect high-efficient and lasting, and other embodiments
The dosage form of preparation also has similar curative effect in an experiment, embodies the superiority of gelling agent.
Claims (9)
1. a kind of Traditional Chinese medicinal gel preparation with sterilization, which is characterized in that the gel preparation includes following weight
The bulk pharmaceutical chemicals of number are made: 10~30 parts of Chinese hawthorn seed, 5~9 parts of aqueous matrix, 5~15 parts of emulsifier, moisturizer 10~
30 parts, 3~9 parts of triethanolamine, 0.2~2 part of sodium benzoate.
2. Traditional Chinese medicinal gel preparation as described in claim 1, which is characterized in that the aqueous matrix in the gel preparation is card wave
Nurse, alginate, gelatin, xanthan gum, one or more combination in chitin.
3. Traditional Chinese medicinal gel preparation as described in claim 1, which is characterized in that the emulsifier in the gel preparation is tween-
80, one or more combination in -40 rilanit special of polyoxyethylene ether or poloxamer.
4. Traditional Chinese medicinal gel preparation as described in claim 1, which is characterized in that moisturizer in the gel preparation be glycerol,
Glycerine, D-sorbite, one or more combination in xylitol.
5. Traditional Chinese medicinal gel preparation as described in claim 1, which is characterized in that the master of Chinese hawthorn seed in the gel preparation
Ingredient is wanted to be made of dry distillation liquid of Chinese hawthorn seed and Chinese hawthorn seed empyreumatic oil, the parts by weight of dry distillation liquid of Chinese hawthorn seed are 1-5 parts, and Chinese hawthorn seed is dry
The parts by weight for evaporating oil are 99-95 parts.
6. Traditional Chinese medicinal gel preparation as described in claim 1, which is characterized in that the gel preparation includes following parts by weight
Bulk pharmaceutical chemicals are made: 10~30 parts of Chinese hawthorn seed, 5~9 parts of carbomer, Tween-80,5~15 parts, 10~30 parts of glycerol, three
3~9 parts of ethanol amine, 0~2 part of sodium benzoate.
7. Traditional Chinese medicinal gel preparation as claimed in claim 6, which is characterized in that the gel preparation includes following parts by weight
Bulk pharmaceutical chemicals are made: 20 parts of Chinese hawthorn seed, 7 parts of carbomer, Tween-80,10 parts, 20 parts of glycerol, 6 parts of triethanolamine, benzene first
1 part of sour sodium.
8. Traditional Chinese medicinal gel preparation as claimed in claim 6, which is characterized in that the gel preparation includes following parts by weight
Bulk pharmaceutical chemicals are made: 20 parts of Chinese hawthorn seed, 9 parts of carbomer, Tween-80,15 parts, 30 parts of glycerol, 9 parts of triethanolamine, benzene first
0.2 part of sour sodium.
9. Traditional Chinese medicinal gel preparation as claimed in claim 6, which is characterized in that the gel preparation includes following parts by weight
Bulk pharmaceutical chemicals are made: 20 parts of Chinese hawthorn seed, 5 parts of carbomer, Tween-80,5 parts, 10 parts of glycerol, 3 parts of triethanolamine, benzoic acid
2 parts of sodium.
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| CN113521165A (en) * | 2021-09-08 | 2021-10-22 | 广西白云山盈康药业有限公司 | Gynecological external antibacterial gel and preparation method thereof |
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