CN107213177A - A kind of preparation method for the Chinese medicine composition and its gel for treating cervical erosion - Google Patents
A kind of preparation method for the Chinese medicine composition and its gel for treating cervical erosion Download PDFInfo
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Abstract
A kind of preparation method of Chinese medicine composition and its gel for treating cervical erosion disclosed by the invention, it is composed of the following components according to mass percent：Matrine 1 2%, Osthole 0.02 0.5%, Seabuckthorm Seed Oil 5 20%, Acritamer 940 1 1.2%, NMF 8 12%, solubilizer 6 7%, pH adjusting agent 0.2 0.5%, remaining is purified water, and above-mentioned mass percent sum is 100%.The gel of the Chinese medicine composition of the present invention is in preparation process, step is simple to operation, process stabilizing, safe and effective, insoluble drug release is abundant, quality controllable after use, technical problems such as " thick, big, black " of the preparations such as existing vagina lotion, suppository, film, spray and effervescent tablet is overcome completely, has good practical value on treatment gynecological cervical erosion.
Description
Technical field
The invention belongs to gynecologic medicine technical field, and in particular to a kind of Chinese medicine composition for treating cervical erosion, this hair
It is bright to further relate to a kind of preparation method of the gel for the Chinese medicine composition for treating cervical erosion.
Background technology
Cervical erosion is commonly encountered disease, frequently-occurring disease, and its incidence of disease increases year by year, seriously endangers women's health.Its is main
Pathogenic factor has：1. pathogenic infection, is typically due to staphylococcus, streptococcus bacterium, EHEC, anaerobic bacteria, thought
Pearl bacterium, Neisser diplococcus, Ureaplasma urealyticum, herpes simplex virus, chlamydia trachomatis, cytomegalovirus, trichomonas vaginalis
And the infection of the pathogen such as human papilloma virus, chronic inflammatory inflammation can destroy cervical mucosal squamous cell, and post
There is paraplasm in the presence of high estrogen level in columnar epithelium cell, instead of the normotopic scaly epithelium, covering
Uterine neck, shows the form of " erosion "；2. long-term chronic mechanical stimulus or damage, immoderate sexual life, multiple induced abortion
, can coup injury cervical tissue, the infection of induction pathogen Deng stimulation；3. microecology in vaginas environment disruption, irrational vagina
Medication or long-term taking antibacterials, it is suppressed that the growth of vagina lactic acid bacteria, destroy the weak acid environment of vagina, are pathogen
Infection provides condition.
It is clinical at present main using physics, operation and drug therapy cervical erosion.Physical treatment be with infrared ray, laser,
The columnar epithelium in the physical methods such as microwave, freezing destruction cervical erosion face, then reached by proliferation of fibrous tissue and epithelial repair
The purpose of healing；Operation is general using the side such as conization, excision of cervical polyp, electric knife (LEEP knives) method
Method, is primarily adapted for use in severe cervical erosion patients；Both the above therapy is costly, it is necessary to special installation, and can excessively damage
Normal cervical tissue, wound face is big, and postoperative secretion is more, and wound healing is slower.Drug therapy is applied to slight and moderate
Erosion patients, the existing medicine of in the market has Albothyl (Policresulen) and compound seabuckthorn fruit oil suppository, woman's health treasured, Remedies-introducing device for women health care
With palace protect it is peaceful wait traditional Chinese medicine lotion, suppository, film, spray and effervescent tablet etc., Chinese patent " one kind treat cervical erosion and its
The suppository of colpitis " (application number：CN02114512.1, publication date：2004.12.08, publication number：CN1178687C it is) also public
A kind of suppository drug for treating cervical erosion is opened, due to existing Chinese medicine vagina lotion, suppository, film, spray and bubble
The problems such as preparations such as piece easily cause " thick, big, black " after is risen, therefore, a kind of Small side effects, the sufficient medicine of insoluble drug release are prepared
Thing is very important.
The content of the invention
It is an object of the invention to provide a kind of Chinese medicine composition for treating cervical erosion, existing treatment cervical erosion is solved
Side effect is big during medicine use, and insoluble drug release is insufficient, the problem of easily causing phenomenons such as " thick, big, black ".
It is a further object to provide a kind of preparation side of the gel for the Chinese medicine composition for treating cervical erosion
Method.
The technical solution adopted in the present invention is, a kind of Chinese medicine composition for treating cervical erosion, according to mass percent
It is composed of the following components：Matrine 1-2%, Osthole 0.02-0.5%, Seabuckthorm Seed Oil 5-20%, Carbomer-940 1-
1.2%, NMF 8-12%, solubilizer 6-7%, pH adjusting agent 0.2-0.5%, remaining is purified water, above-mentioned mass percent
Sum is 100%.
It is a feature of the present invention that
NMF is glycerine.
PH adjusting agent is triethanolamine.
Solubilizer is hydroxypropyl-β-cyclodextrin.
Another technical scheme of the present invention is, a kind of gel for the Chinese medicine composition for treating cervical erosion
Preparation method, specifically includes following steps：
Step 1, matrine 1-2%, Osthole 0.02-0.5%, Seabuckthorm Seed Oil 5- are weighed respectively according to mass percent
20%, Carbomer-940 1-1.2%, NMF 8-12%, solubilizer 6-7%, pH adjusting agent 0.2-0.5%, remaining is purifying
Water, above-mentioned mass percent sum is 100%；
Step 2, the Carbomer-940 in step 1 is uniformly sprinkled into the beaker equipped with quantitative distilled water, then in 4 DEG C of ice
Stood overnight in case, the pH adjusting agent added after taking-up in step 1 is mixing uniformly to form transparent semisolid, i.e. gel-type vehicle,
It is standby；
Step 3, the Osthole in step 1 is inserted in quantitative absolute ethyl alcohol, stirs to being completely dissolved, obtain cnidium monnieri
Sub- element solution, it is standby；
By the solubilizer in step 1 and purified water according to mass ratio 1:1.33 mixing, heating stirring are until its solubilizer is complete
Fully dissolved, obtains solubilizer solution, standby；
Step 4, the Osthole solution in step 3, the matrine in step 1 and Seabuckthorm Seed Oil are put into solubilizer in the lump
Solution, stirs, and is subsequently added the NMF in step 1, stirs, obtains mixed solution；
Step 5, the mixed solution that step 4 is obtained is put into the gel-type vehicle that step 2 is obtained, adds determining in step 1
Purified water is measured, stirs, produces.
It is of the invention to be further characterized in that,
NMF is glycerine.
PH adjusting agent is triethanolamine.
Solubilizer is hydroxypropyl-β-cyclodextrin.
The beneficial effects of the invention are as follows：The gel of the present invention is in preparation process, and step is simple to operation, technique is steady
Fixed, safe and effective, insoluble drug release is abundant, quality controllable after use, and existing vagina lotion, suppository, film, spray are overcome completely
Technical problems such as " thick, big, black " of the preparation such as mist agent and effervescent tablet, there is practical valency well on treatment gynecological cervical erosion
Value.
Brief description of the drawings
Fig. 1 is the microscope photograph to rat cervical erosion model histopathology form, wherein 1 group of A- gels, and B- coagulates
2 groups of glue, 3 groups of C- gels, 4 groups of D- gels, E- seabuckthorn fruit oil suppository groups, F- model groups, G- normal groups；
Fig. 2 is the microscope photograph expressed cervical erosion rat model tissue EGF, wherein 1 group of A- gels, B- gels 2
Group, 3 groups of C- gels, 4 groups of D- gels, E- seabuckthorn fruit oil suppository groups, F- model groups, G- normal groups；
Fig. 3 is the influence (HE × 100) dyed to cervical erosion rat tissue HE, wherein A- model groups, B- normal groups, C-
Bare substrate group, D- gel small dose groups, E- gel middle dose groups, F- gels heavy dose group, G- compound seabuckthorn fruit oil suppository groups；
Fig. 4 is the influence (SP × 100) expressed cervical erosion rat model tissue EGF, wherein A- model groups, and B- is normal
Group, C- bare substrate groups, D- gel small dose groups, E- gel middle dose groups, F- gels heavy dose group, G- compound seabuckthorn fruit oil suppositories
Group.
Embodiment
The present invention is described in detail with reference to the accompanying drawings and detailed description.
First, the component of Chinese medicine composition and its gel of the present invention, content and preparation method thereof
A kind of Chinese medicine composition for treating cervical erosion, it is composed of the following components according to mass percent：Matrine 1-
2%, Osthole 0.02-0.5%, Seabuckthorm Seed Oil 5-20%, Carbomer-940 1-1.2%, NMF 8-12%, solubilizer
6-7%, pH adjusting agent 0.2-0.5%, remaining is purified water, and above-mentioned mass percent sum is 100%；Wherein, NMF is
Glycerine, pH adjusting agent is triethanolamine, and solubilizer is hydroxypropyl-β-cyclodextrin.
Seabuckthorm Seed Oil is that sea-buckthorn (HippopHae rhamnoides L.) fruit or seed pass through a series of working process
Obtained natural materials.Seabuckthorm Seed Oil contains a variety of nutrition such as vitamins, lipid, organic acid, flavonoids and trace element
Composition, has been widely used in food, cosmetics and medicine, is the high material of medical value.Modern medicine study
It has been shown that, Seabuckthorm Seed Oil energy anti-inflammatory, enhancing immune function of human body, to staphylococcus aureus, Escherichia coli, hemolytic streptococcus and
Some anaerobic bacterias have stronger bactericidal action, can effectively prevent wound infection, promotion organization regeneration, epithelial tissue and wound healing
Deng effect.
Matrine be widely present in kuh-seng (SopHora flaescensAit), Sophora alopecuroide (S.AlopecuroidesL) and
It is the principle active component of kuh-seng, its pharmacological action is extensive in root of subprostrate sophora (S.subprostrata Chun et T.Chen)：
1. there is significant anti-inflammatory, antianaphylactic effect, the release of inflammatory mediator and the hyperplasia of granulation tissue can be suppressed；2. to large intestine bar
The pathogenic microorganisms such as bacterium, staphylococcus aureus, proteus have obvious inhibitory action；3. macrophage is significantly inhibited
Phagocytic function, with certain immunoregulation effect；4. anti parasitic is acted on.
Osthole is frutus cnidii (Cnidium monnieri (L.) Cuss.) principle active component, its pharmacological action
Specifically have：1. estrogen-like action, Osthole is to the blood lipid level of Ovariectomized Rats, lipoproteinesterase, liver fat
Enzyme and estradiol have a certain impact；2. antiinflammatory action, Osthole can significantly inhibit a variety of inflammatory factors, and to COX-
The expression of 2 albumen also has certain inhibitory action；3. antibacterial action, Osthole has antibacterial desinsection, antimicrobial acivity
Effect；4. immunization is strengthened, Osthole strengthens the non-specific immune function of mouse.
Conventional aqueous gel matrix has tragcanth, cellulose derivative, carbomer, gelatin, alginate, non-fiber
Plain polysaccharide etc., the gel-type vehicle of vaginal gel requires smooth in appearance, exquisiteness, can reach good drug release effect and safe nothing
Stimulate, therefore selection Carbomer-940 is gel substrate, with attractive in appearance, easy cleaning, that property is stable, viscosity is suitable etc. is excellent
Point.
Gel it is possible that phenomenon of losing water, therefore need to add NMF and carry out moisturizing and keep gel in storage
It is stable, while promoting medicine dissolving.Conventional NMF has the polyalcohols such as glycerine, propane diols, PEG-400, and present invention selection is sweet
Oil is used as NMF.
Carbomer-940 can form the acid solution of muddiness after being swelled in water, pH adjusting agent need to be added, to increase matrix
Toughness, reduce turbidity.Common pH adjusting agent has sodium hydroxide and triethanolamine, and by experiment of single factor, the present invention will
Triethanolamine is used as pH adjusting agent.
Hydroxypropyl-β-cyclodextrin (2-hydroxypropyl--cyclodexirin, HP- β-CD) is the parent of beta-schardinger dextrin
Aqueous derivative, its good water solubility and heat endurance are high, can be used as solubilizer, stabilizer and penetrating agent etc..Because HP- β-CD are low
Malicious and safe and effective, it is considered to be great potential pharmaceutic adjuvant, the present invention is as solubilizer.
The present invention combines literature research, pharmacology and clinical test results and Seabuckthorm Seed Oil, matrine, Osthole is determined
Dosage, using Star point design-effect surface method and external drug dissolution experiment investigation, the proportioning for optimizing each auxiliary material and preparation
Technological parameter.The gel major function of the present invention：Heat-clearing and damp-drying drug, swelling and pain relieving, desinsection are antipruritic, blood activating and promoting tissue regeneration, are mainly used in
Treat the cervical erosion and postoperative caused by damp invasion of lower energizer.External genital is cleaned when using, gel vagina deep is squeezed into, daily
1.
A kind of preparation method of the gel for the Chinese medicine composition for treating cervical erosion, it is characterised in that specifically include with
Lower step：
Step 1, matrine 1-2%, Osthole 0.02-0.5%, Seabuckthorm Seed Oil 5- are weighed respectively according to mass percent
20%, Carbomer-940 1-1.2%, glycerine 8-12%, hydroxypropyl-β-cyclodextrin 6-7%, triethanolamine 0.2-0.5%, its
Remaining is purified water, and above-mentioned mass percent sum is 100%；
Step 2, the Carbomer-940 in step 1 is uniformly sprinkled into the beaker equipped with quantitative distilled water, then in 4 DEG C of ice
Stood overnight in case, the triethanolamine added after taking-up in step 1 is mixing uniformly to form transparent semisolid, i.e. gel-type vehicle,
It is standby；
Step 3, the Osthole in step 1 is inserted in quantitative absolute ethyl alcohol, stirs to being completely dissolved, obtain cnidium monnieri
Sub- element solution, it is standby；
By the hydroxypropyl-β-cyclodextrin in step 1 and purified water according to mass ratio 1:1.33 mixing, heating stirring is up to it
Hydroxypropyl-β-cyclodextrin is completely dissolved, and obtains hydroxypropyl-β-cyclodextrin solution, standby；
Step 4, the Osthole solution in step 3, the matrine in step 1 and Seabuckthorm Seed Oil are put into hydroxypropyl in the lump
Group-beta-cyclodextrin solution, stirs, and is subsequently added the glycerine in step 1, stirs, obtains mixed solution；
Step 5, the mixed solution that step 4 is obtained is put into the gel-type vehicle that step 2 is obtained, adds determining in step 1
Purified water is measured, stirs, produces.
2nd, by Pyrogentisinic Acid's rubber cement+estradiol cause the Experiment on therapy of rat cervical erosion illustrate main component of the present invention it
Between compatibility relationship.
1. experiment material：Experimental animal is SD rats, female, unpregnancy, body weight 200g ± 20g, Xi'an Communications University's medical science
Portion's Experimental Animal Center is provided, credit number SCXK (Shan) 2012-003.Seabuckthorm Seed Oil, Haitian Pharmacy Co., Ltd., Shaanxi carries
For；Matrine (concentration >=98%), Nanjing Zelang Pharmaceutical Technology Inc. provides；Osthole (concentration >=98%), Shaanxi
The bioengineering Co., Ltd of aviation 1 provides.The preparation of experiment gel：Carbomer-940 0.8g is weighed, plus it is pure
Water 30mL, stirring stands 24h, dissolving；Weigh after tragcanth 0.4g glycerol addings 1mL wettings, be separately added into Seabuckthorm Seed Oil, snake
Machine tool element and matrine (by the experiment of the proportioning dose design of table 1), add glycerine 15mL mixings；Said mixture is added into card ripple
In the gel-type vehicle of nurse -940, stir, produce the gel of 4 kinds of various combinations, it is standby.
The matched proportion density of each component in the gel of table 1
2. experimental method：Take female unpregnancy SD rats 59, adaptability feed one week after in addition to 8 animals of normal group, its
The first disposable intramuscular injection oestradiol benzoate 0.14mg/100g of its rat, then uses the 1mL syringes for polishing head in rat
Uterus neck accurately injects the 50% Hydroxybenzene mucilage 0.08mL (preparations of 50% Hydroxybenzene mucilage：1.50g tragacanths are weighed, plus
Glycerine 6mL is soaked, plus phenol 10mL and water 4mL is mixed, and is produced), modeling.First by syringe pintle pumpback 0.4ml during operation, in
Cotton balls 0.03g is uniformly tamped in front end, adds Hydroxybenzene mucilage 0.08mL, lubrication of liquid paraffin rat vagina is used before injection, inject
When Hydroxybenzene mucilage and cotton balls are together injected, limit Hydroxybenzene mucilage range of scatter, prevent from causing extensive vaginitis.Normal group is big
Mouse injects cotton, no abnormality seen according to aforesaid operations.Modeling in 2 days 1 time, totally 4 times, observes vulvar secretions character daily.After modeling
2nd day modeling rat is aquiparous, introitus redness occur；Continue to aggravate after 3rd day；Modeling the 8th day is by modeling rat
It is randomly divided into 1 group of gel, 2 groups of gel, 3 groups of gel, 4 groups of gel, compound seabuckthorn fruit oil suppository group and model group and is administered.Gel is each
Group injects gel 1, gel 2, gel 3, each 0.2mL of gel 4 respectively at vagina depths；Compound seabuckthorn fruit oil suppository group gives 0.6mm
× 1mm spiles；Model group, normal rats saline injection.It is administered once daily, totally 7 days, last dose is after 24 hours,
The intraperitoneal injection 0.3mL/100g anesthesia of 10% chloraldurate, opens abdominal cavity, wins uterine neck and vagina, 10% formal is used after weighing
Woods is fixed, conventional film-making, HE dyeing, tissues observed pathological change under light microscopic；Determine big by EGF immunohistochemical reagents box
Mouse cervical tissue EGF EGF is expressed.
3. experimental result：Normal group, 1 group of gel, 2 groups of gel, 3 groups of gel, 4 groups of gel, seabuckthorn fruit oil suppository group and model
Group compares uterine neck weight and organ index difference substantially, the results are shown in Table 2.
Mouse uterine neck pathology morphological image is as shown in Figure 1：Normal rats cervical tissue structural integrity, squamous epithelial layer is intact
It is lossless；Substantially, stratified squamous epithelium layer surface is seriously damaged model group rats cervical tissue columnar epithelium hyperplasia, or even post
Columnar epithelium hyperplasia substitutes scaly epithelium, a large amount of cell infiltrations of interstitial；In seabuckthorn fruit oil suppository group squamous metaplasia substitution column
Skin, therapeutic effect is good；1 group of Metaplastic squamous epithelium of gel does not replace columnar epithelium completely；2 groups of Metaplastic squamous epithelium layers of gel take
For columnar epithelium layer, but squamous epithelial layer is relatively thin；Substantially, cervical tissue structure outline is clearly complete for 3 groups of hyperplasia of squamous epithelium of gel
It is whole；4 groups of gel, cervical tissue structure outline is clear but squamous epithelial layer is relatively thin.
Influence of the table 2 to cervical erosion rat model uterine neck weight and organ index
Note：Compared * P ＜ 0.05, * * P ＜ 0.01, * * * P ＜ 0.001 with model group
EGF is in weak expression in normal rat cervical tissue, and model group EGF is hardly expressed.Gel each group has difference
The EGF positive stainings of degree, the positive particle of brown color is distributed mainly on endochylema, and nucleus also has part expression, wherein uterine neck
Epithelial cell is in strong positive, and interstitial dyeing is less.3 groups of positive expression amounts of gel are maximum, and color is most deep, specific as shown in Figure 2.
4. conclusion：Gel (Seabuckthorm Seed Oil 10g/100ml, 0.72~1.44g/100ml of matrine, Osthole 0.1~
0.4g/100ml) by promoting hyperplasia of squamous epithelium reparation, mitigate cervical edema, treatment is played in the EGF expression of increase cervical tissue
The effect of rat cervical erosion.Wherein matrine, Osthole are acted in terms of antipathogen, anti-cervical cancer cell, anti-inflammatory
With synergy, Seabuckthorm Seed Oil can promote rotten to the corn face and organization healing, meet compound compatibility principle.
3rd, pharmacological toxicology is tested
It is prepared as described above method and step and prepares high (Seabuckthorm Seed Oil 2.5g/100mL, matrine 0.5g/100mL, Osthole
0.01g/100mL), (Seabuckthorm Seed Oil 5g/100mL, matrine 1g/100mL, Osthole 0.02g/100mL), low (sea-buckthorn in
Seed oil 10g/100mL, matrine 2g/100mL, Osthole 0.04g/100mL) three kinds of various concentrations Chinese medicine composition it is solidifying
Jelly carries out Pharmacodynamic test of active extract and the excitant and sensitivity test of local administration, evaluates the safety and effectiveness of medicine.
(1) Pharmacodynamic test of active extract
1. Pyrogentisinic Acid's rubber cement+estradiol causes the influence of cervical erosion rat
1.1 experimental animal：SD rats, female, body weight 200g ± 20g, unpregnancy, SPF grades；ICR mouse, female, body weight 18-
22g, SPF grades, provided by Xi'an Communications University's medical board Experimental Animal Center, animal quality quality certification number：
No.61001700001473, production licence number：SCXK (Shan) 2012-003.In the herbal pharmacology experiment of Shaanxi university of TCM
Room (State Administration of Traditional Chinese Medicine's traditional Chinese medicine scientific research three-level laboratory) is raised, and free water is ingested.Fitted before animal administration
Answering property is fed one week.
1.2 method
SD rats 70 are taken, in addition to normal group 10, the disposable intramuscular injection oestradiol benzoate 0.14mg/ of remaining rat
100g.The next day 50% Hydroxybenzene mucilage 0.06mL is precisely given at rat uterine neck, per the next day 1 time, totally 4 times.Phenol glue is given every time
Lubricated before slurry with appropriate amount of fluid paraffin, normal group gives normal saline.Continuous Observation rat general state, observation daily is simultaneously
The change of private parts secretion is recorded, vagina oral mucous membrane whether there is redness, hyperemia etc..Modeling rat is randomly divided into blank on the 8th day by modeling
Matrix group, model group, gel be small, in, heavy dose of group and compound seabuckthorn fruit oil suppository group, every group 10.Gel is small, in, it is heavy dose of
Group rat gives the gel 0.2mL of basic, normal, high concentration respectively；It is small that compound seabuckthorn fruit oil suppository group gives compound seabuckthorn fruit oil suppository
Bolt；Bare substrate group gives the gel-type vehicle without Seabuckthorm Seed Oil, matrine and Osthole；Normal group and model group give life
Manage salt solution.Each group is administered once daily, continuous 7 days.Observe daily and record the general growth conditions of rat, introitus secretion and
Change etc..It is administered after 1 week and is injected intraperitoneally with 10% chloraldurate 0.3mL/100g, anesthetized rat opens abdominal cavity, wins uterine neck group
Knit, fixed with 10% formalin under conventional section, HE dyeing, light microscopic and carry out histopathological examination.Using immuning tissue
EGF in technology for detection each group rat cervical tissue is learned to express.
1.3 result
1.3.1 to the influence of cervical erosion rat general signs
After 50% Hydroxybenzene mucilage modeling, animal generally occurs shaking, flocks together, erects the phenomenons such as hair；Second day vagina lipstick
Swollen, secretion increases；After 4 modelings, rat vagina lipstick is swollen serious, is in yellow, viscous, most animals food secretion object amount more
It is intended to decline, activity is reduced.After drug treatment, compared with bare substrate group, model group gel it is small, in, heavy dose of group animal
General signs are obviously improved, and secretion is reduced, introitus redness disappears, and normal group compares no significant difference.And bare substrate group,
The above-mentioned general signs of model group change not notable.
1.3.2 on the morphologic influence of cervical erosion rat cervical tissue
Each group rat cervical tissue HE dyeing pathological analysis result is shown, as shown in figure 3, model group and bare substrate group are big
The universal defect of mouse cervical epithelial tissue, columnar epithelial cell hyperplasia substantially, instead of original scaly epithelium, interstitial has substantial amounts of
Inflammatory cell infiltration, and visible interstitial fibers hyperblastosis, being compared with normal group has significant difference.The combined gels are small, in,
Heavy dose group and compound seabuckthorn fruit oil suppository group are compared with model group, and cervical tissue lesion is substantially repaired, and Metaplastic squamous epithelium layer takes
For part cylindrical epithelial layer.The wherein still visible a small amount of cell infiltration of small dose group, Metaplastic squamous epithelium does not replace completely
Columnar epithelium；Middle dose group and heavy dose of group and compound seabuckthorn fruit oil suppository group rat cervical tissue structure outline are more visible complete
Whole, epithelial repair degree is preferable.
The influence expressed cervical erosion rat cervical tissue EGF：As shown in Fig. 4 and table 3, normal rats cervical tissue
EGF is expressed in weakly positive, and model group is hardly expressed；Model group and bare substrate group EGF integral optical density value are less than normal
Group, difference has significant (P<0.05).The combined gels low-dose, medium-dose, high-dose group and compound seabuckthorn fruit oil suppository
Group rat cervical tissue has different degrees of EGF positive stainings, and positive staining particle is distributed mainly on endochylema, and interstitial cell is few
There is expression, but epithelial cell is expressed in strong positive.Wherein gel middle dosage, heavy dose of group positive expression are relatively strong, and color is deeper,
EGF integral optical density values are above model group and bare substrate group, and difference has significant (P<0.05).
The influence that table 3 is expressed cervical erosion rat cervical tissue EGF
Compared with model group, *：P ﹤ 0.05, are compared with bare substrate group,#：P ﹤ 0.05
2. paraxylene causes the influence of mice auricle swelling
ICR kinds mouse 50 is taken, is randomly divided into that control group, gel be small, middle dose, heavy dose of group and Compound Dexamethasone ointment
Group, every group 10.Gel is small, in, heavy dose of group applies and gives basic, normal, high concentration gel outside respectively at Mice Auricle single
0.05mL；Compound Dexamethasone ointment group applies the Compound Dexamethasone ointment for giving isometric(al) outside；Control group applies bare substrate.Give
Medicine gently removes medicine after 1 hour with the cotton swab for collecting together physiological saline, is dried with cotton balls.In the auris dextra drop coating of every mouse of each group
Dimethylbenzene 0.05mL, left ear is without any processing.Animal is put to death after 15 minutes, with diameter 6mm card punch in the same position of ears
Sweep away auricle, accurately weighed calculating swelling and swelling inhibiting rate.
Swelling=auris dextra piece weight-left auricle weight
Swelling inhibiting rate (%)=(the average swelling of the average swelling-administration group of control group) average swelling of/control group
× 100%
As a result show, gel low-dose, medium-dose, high-dose group mice auricle swelling degree is significantly less than control group, poor
It is different to have significant (P<0.05).As shown in table 4, the combination gel has antiinflammatory action.
The paraxylene of table 4 to mice auricle swelling influence
Compared with control group：* P ﹤ 0.01
It can to sum up obtain：The combination gel combines the cervical erosion that oestradiol benzoate method is set up to 50% Hydroxybenzene mucilage
Rat model has certain therapeutic effect, can promote EGF in hyperplasia and the reparation of cervical tissue scaly epithelium, increase cervical tissue
Expression, wound healing.Mice auricle swelling caused by paraxylene has certain antiphlogistic effects.
(2) excitant and sensitivity test
1. experimental animal：SD rats, female, body weight 200g ± 20g, unpregnancy, SPF is real by Xi'an Communications University's medical board
Animal center offer, animal quality quality certification number are provided：No.61001700001473, production licence number：SCXK (Shan) 2012-
003；Cavy, female, white, 250~330g of body weight, regular grade is provided by Xi'an Communications University's medical board Experimental Animal Center,
Animal quality quality certification number：No.61001700001594, production licence number：SCXK (Shan) 2014-003.In Shaanxi traditional Chinese medicine
University's herbal pharmacology laboratory (State Administration of Traditional Chinese Medicine's traditional Chinese medicine scientific research three-level laboratory) is raised, and free water is taken the photograph
Food.Adaptability is fed one week before animal administration.
2. experimental method
2.1 vagina medicinal irritation tests
2.1.1 single medication Vaginal irritation effects are tested
Take health adult SD rats 50, be randomly divided into 5 groups, be respectively the combined gels small dose group, middle dose group,
Heavy dose of group, bare substrate group and blank control group, every group 10.Each tested material 0.2mL is given respectively in rat vagina depths.
1h, 24h, 48h and 72h check rat vagina upon administration, and visually observe standards of grading according to the Vaginal irritation effects of table 5 and commented
Point.After last time is observed, animal is put to death, anatomical isolation animal vagina observes mucosa lesions situation, then uses 10% Fu Er
Malin fixes, specimens paraffin embedding slices, conventional H E dyeing, observes vagina pathological change, is scored, most terminated according to the standard of table 6
Fruit combines naked eyes and histopathology, and classification judgement is carried out to the excitant of medicine by table 7.
The stimulus standard of the visual appraisal vagina of table 5
Evaluation criteria of the pathology of table 6 to vagina tissue
The stimulation grade scale of the vagina of table 7
2.1.2 many medication Vaginal irritation effects experiments
Except successive administration 7 days, remaining was with single-dose skin irritation test.
2.2 guinea pig skin sensitivity tests
Female white cavy 40 is taken, negative control group, gel group (Seabuckthorm Seed Oil 5g/100mL, matrine is randomly divided into
1g/100mL, Osthole 0.02g/100mL), bare substrate group and 1% DNFB group (positive controls, 2,
4- dinitrofluorobenzene faces the used time and 1% sensitization concentration and 0.1% is made into proper amount of acetone excites concentration), every group 10.Administration
First 24 hours, smear guinea pig back left of spine with 8% vulcanized sodium and go to hair-fields, area is about 3cm × 3cm.Unhairing 24 hours
Unhairing region is checked afterwards, selects the intact person of skin to enter experiment.Hair removal section skin applies tested material 0.2mL and caused on the left of every animal
Quick, negative control group applies same amount of physiological saline.Covered, hospital gauze is fixed, used after being kept for 6 hours with preservative film after administration
Warm water washes away tested material.In testing the 7th day and the 14th day in kind repeat administration, observe daily and record cavy administration area
The oedema and erythema situation in domain.Tested material is applied on the right side of back part of animal respectively with same method within 28th day goes to hair-fields to be excited
Contact, tested material is washed away after 6 hours, at once, is observed guinea pig skin allergic reaction situation within 24,48,72 hours, is entered according to table 8
Row scoring, calculates every group of average response value, and calculates sensitization incidence, and sensitization degree is evaluated according to table 9.
Every group of average response value=∑ (erythema formation total score+oedema formation total score)/total number of animals
Allergic animal number/total number of animals × 100% occurs for sensitization incidence %=
The cutaneous anaphylaxis standards of grading of table 8
The hypersensitive evaluation criterion of table 9
3. experimental result
3.1 vagina medicinal irritation tests
Experimental result is shown, after rat vagina single and multiple dosing, visually observes and does not occur erythema, oedema and secretion
Thing, vagina tissue pathological examination result shows that each group section epithelial tissue is complete, no hyperemia, no oedema.Show the combination
Gel and matrix vagina administration are nonirritant.
3.2 skin allergy test
As a result show, negative control group and the combined gels group are after tested material is removed at once and in 72 hours, cavy
Skin does not occur erythema and oedema, does not also observe that animal has the serious systemic allergic such as asthma, astasia or shock
Reaction, shows the combined gels without sensitization；Bare substrate group finds have an animal appearance slight red after tested material is removed
Spot, but do not find that erythema has recovered normal after oedema and general reaction, and 24 hours, it is believed that without sensitization；2,4- dinitro-chlorines
After the tested area's self-excitation administration 6h of benzene group animal skin, there is obvious slight erythema to occur, no oedema, sensitization rate 100%, as a result such as
Shown in table 10.
The cutaneous anaphylaxis experimental result (n=10) of table 10
4. brief summary
After the combined gels and matrix rat vagina single and multiple dosing, examined by the naked eye with vagina tissue pathology
The fruit that comes to an end represents nonirritant；Guinea pig skin sensitivity test result of study shows the combined gels and matrix without sensitization.
Embodiment 1
Matrine 1.5%, Osthole 0.3%, Seabuckthorm Seed Oil 15%, Carbomer-940 are taken according to mass percent
1.1%, glycerine 10%, hydroxypropyl-β-cyclodextrin 6.5%, triethanolamine 0.25%, remaining is purified water, above-mentioned quality percentage
It is 100% than sum.
Embodiment 2
Matrine 1% is taken according to mass percent, Osthole 0.02%, Seabuckthorm Seed Oil 5%, Carbomer-940 1%,
Glycerine 8%, hydroxypropyl-β-cyclodextrin 6%, triethanolamine 0.2%, remaining is purified water, and above-mentioned mass percent sum is
100%.
Embodiment 3
Matrine 2%, Osthole 0.5%, Seabuckthorm Seed Oil 20%, Carbomer-940 are taken according to mass percent
1.2%, glycerine 12%, hydroxypropyl-β-cyclodextrin 7%, triethanolamine 0.5%, remaining is purified water, above-mentioned mass percent it
With for 100%.
Embodiment 4
Matrine 1.3%, Osthole 0.2%, Seabuckthorm Seed Oil 8%, Carbomer-940 are taken according to mass percent
1.15%, glycerine 9%, hydroxypropyl-β-cyclodextrin 6.3%, triethanolamine 0.33%, remaining is purified water, above-mentioned quality percentage
It is 100% than sum.
Embodiment 5
Matrine 1.8%, Osthole 0.45%, Seabuckthorm Seed Oil 18%, Carbomer-940 are taken according to mass percent
1.17%, glycerine 11%, hydroxypropyl-β-cyclodextrin 6.7%, triethanolamine 0.23%, remaining is purified water, above-mentioned quality percentage
It is 100% than sum.
Embodiment 1-5 components follow the steps below operation respectively：Carbomer-940 is uniformly sprinkled into equipped with quantitative steaming
In the beaker of distilled water, then stood overnight in 4 DEG C of refrigerators, triethanolamine is added after taking-up, be mixing uniformly to form transparent half
Solid, i.e. gel-type vehicle；Osthole is inserted in quantitative absolute ethyl alcohol, stir to being completely dissolved, obtain Osthole molten
Liquid；By hydroxypropyl-β-cyclodextrin and purified water according to mass ratio 1:1.33 mixing, heating stirring obtains hydroxyl up to being completely dissolved
Propyl-beta-cyclodextrin solution；Osthole solution, matrine and Seabuckthorm Seed Oil are put into hydroxypropyl-β-cyclodextrin solution in the lump,
Glycerine is subsequently added, inserts mixed solution in gel-type vehicle after stirring, quantitative purified water is added, stirs, produce
Gel.
The gel of the Chinese medicine composition of the present invention is in preparation process, and step is simple to operation, process stabilizing, after use
Safely and effectively, insoluble drug release is abundant, quality controllable, overcome completely existing vagina lotion, suppository, film, spray and
Technical problems such as " thick, big, black " of the preparations such as effervescent tablet, has good practical value on treatment gynecological cervical erosion.
Claims (8)
1. a kind of Chinese medicine composition for treating cervical erosion, it is characterised in that composed of the following components according to mass percent：It is bitter
Join alkali 1-2%, Osthole 0.02-0.5%, Seabuckthorm Seed Oil 5-20%, Carbomer-940 1-1.2%, NMF 8-12%,
Solubilizer 6-7%, pH adjusting agent 0.2-0.5%, remaining is purified water, and above-mentioned mass percent sum is 100%.
2. a kind of Chinese medicine composition for treating cervical erosion according to claim 1, it is characterised in that the NMF is
Glycerine.
3. a kind of Chinese medicine composition for treating cervical erosion according to claim 1, it is characterised in that the pH adjusting agent
For triethanolamine.
4. a kind of Chinese medicine composition for treating cervical erosion according to claim 1, it is characterised in that the solubilizer is
Hydroxypropyl-β-cyclodextrin.
5. a kind of preparation method of the gel for the Chinese medicine composition for treating cervical erosion, it is characterised in that specifically include following
Step：
Step 1, matrine 1-2%, Osthole 0.02-0.5%, Seabuckthorm Seed Oil 5- are weighed respectively according to mass percent
20%, Carbomer-940 1-1.2%, NMF 8-12%, solubilizer 6-7%, pH adjusting agent 0.2-0.5%, remaining is purifying
Water, above-mentioned mass percent sum is 100%；
Step 2, the Carbomer-940 in step 1 is uniformly sprinkled into the beaker equipped with quantitative distilled water, then in 4 DEG C of refrigerators
Stand overnight, the pH adjusting agent added after taking-up in step 1 is mixing uniformly to form transparent semisolid, i.e. gel-type vehicle, standby
With；
Step 3, the Osthole in step 1 is inserted in quantitative absolute ethyl alcohol, stirs to being completely dissolved, obtain Osthole
Solution, it is standby；
By the solubilizer in step 1 and purified water according to mass ratio 1:1.33 mixing, heating stirring are until its solubilizer is completely molten
Solution, obtains solubilizer solution, standby；
Step 4, that the Osthole solution in step 3, the matrine in step 1 and Seabuckthorm Seed Oil are put into solubilizer in the lump is molten
Liquid, stirs, and is subsequently added the NMF in step 1, stirs, obtains mixed solution；
Step 5, the mixed solution that step 4 is obtained is put into the gel-type vehicle that step 2 is obtained, added quantitative pure in step 1
Change water, stir, produce.
6. a kind of preparation method of the gel of Chinese medicine composition for treating cervical erosion according to claim 5, it is special
Levy and be, the NMF is glycerine.
7. a kind of preparation method of the gel of Chinese medicine composition for treating cervical erosion according to claim 5, it is special
Levy and be, the pH adjusting agent is triethanolamine.
8. a kind of preparation method of the gel of Chinese medicine composition for treating cervical erosion according to claim 5, it is special
Levy and be, the solubilizer is hydroxypropyl-β-cyclodextrin.
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Cited By (3)
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| CN111000890A (en) * | 2019-12-30 | 2020-04-14 | 重庆宫妙生物科技有限公司 | Gel dressing for preventing and inhibiting HPV virus infection and preparation method thereof |
| CN112999128A (en) * | 2021-03-19 | 2021-06-22 | 陕西倍康健生物科技有限公司 | Natural galenical composition with mosquito repelling and itching relieving functions |
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| CN112999128A (en) * | 2021-03-19 | 2021-06-22 | 陕西倍康健生物科技有限公司 | Natural galenical composition with mosquito repelling and itching relieving functions |
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Application publication date: 20170929 |