CN108635585A - A kind of pharmaceutical composition for treating senile vahinitis and temperature sensitive slow-releasing gel used and preparation method - Google Patents
A kind of pharmaceutical composition for treating senile vahinitis and temperature sensitive slow-releasing gel used and preparation method Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
Abstract
The present invention provides a kind of pharmaceutical composition for treating senile vahinitis and its temperature sensitive slow-releasing gel used and preparation methods, belong to senile vahinitis field of medicine preparing technology, described to treat the temperature sensitive slow-releasing gel used of senile vahinitis drug, including following raw material：The pH buffer solutions of nitroimidazoles medicine, quinolone drugs, estrogen drugs, glucocorticoid medicine, glucose, poloxamer, poloxamer, sodium carboxymethylcellulose, moisturizer, preservative, purified water and surplus, pH value are 3.5~4.8.The temperature sensitive of the present invention slow-releasing gel used has the characteristics that be uniformly dispersed and be sustained in vaginal canal, and the contact area of drug and tissue is made to increase, bioavilability is improved, achievees the purpose that heighten the effect of a treatment, treated effect is improved, good therapeutic effect is realized.And said preparation, which also has, to be not easy to flow out cavity, not pollution clothes, and times for spraying is less, easy to use, the preferable advantage of patient's compliance.
Description
Technical field
The present invention relates to senile vahinitis field of medicine preparing technology more particularly to a kind of senile vahinitis for the treatment of
Pharmaceutical composition and its temperature sensitive slow-releasing gel used and preparation method.
Background technology
Senile vahinitis (Senile Vaginitis, SV) is mainly in postclimacteric elderly woman, because ovarian function declines
It moves back, estrogen level reduces, and vagina mucosa loses estrogen and supports to protect and vaginal wall atrophy occur, and mucous membrane is thinning, and epithelium is thin
Phenomena such as intracellular glycogen content is reduced, and intravaginal pH value rises to 5.0~7.0 by normal 3.8~4.4 causes vagina local
Resistance reduces, and pathogenic bacteria invasion breeding causes inflammation.A small number of women are since chemicotherapy leads to hypo-ovaria, or due to ovum
After nest resection estrogen reduce or hyposecretion and cause senile vahinitis.In addition, estrogen level reduces, the moon can be caused
Road biological community structure and function are difficult to the pathologic reversed variation, lead to vaginal dysbacteriosis, to be distributed in vagina
The condition of invasion and breeding is provided with the pathogenic bacteria in the external world, and then causes the inflammation of vagina part.
Senile vahinitis cardinal symptom increases for vaginal fluid and pruritus vulvue, burning heat sensation.Inspection is shown in vagina in old
Year sexually revises, epithelial atrophy, and pleat disappears, and smooth muscle layer is thinning, and vagina contraction power reduces etc..Vaginal mucosa hyperemia is shown as,
Mucous membrane petechial hemorrhage or sheet bleeding, are shown in superficial ulcer sometimes.Clinic is usually to supplement to the principle of reatment of senile vahinitis
Estrogen enhances vagina resistance, inhibits bacterial growth.
The drug for the treatment of senile vahinitis is disclosed in currently available technology can be prepared into thermo-sensitive gel dosage form.It utilizes
High molecular material after gelling agent is made with certain drug in it, can be such that drug is administered in liquid form the sensibility of temperature, and
It is adhered to therapentic part, when therapentic part temperature is constant (30~35 DEG C), medicament gelling agent forms the gel of semi-solid state.
This technology can make drug be uniformly dispersed in therapentic part, increase medicament contact area, and not easily to fall off or outflow, reach increasing
The purpose of strong curative effect.But the gelling agent there are administration number of times frequent, the poor situation of patient's compliance.
Invention content
The purpose of the present invention is to provide a kind of pharmaceutical composition for treating senile vahinitis and its temperature sensitive sustained-release gels
Agent and preparation method, this it is temperature sensitive it is slow-releasing gel used make senile vaginitis patients reduce times for spraying, increase its compliance.
In order to achieve the above-mentioned object of the invention, the present invention provides following technical scheme：
It is described the present invention provides a kind of pharmaceutical composition for treating senile vahinitis, including active component and auxiliary material
Active component includes the raw material of following parts by weight：
5~20 parts of nitroimidazoles medicine, 1~5 part of quinolone drugs, 0.01~0.08 part of estrogen drugs, sugar
5~20 parts of 0.05~0.2 part of corticoid drug and glucose.
Preferably, the auxiliary material includes the raw material of following parts by weight：1~50 part of matrix, 0.1~10 part of moisturizer, anti-corrosion
The pH value of 4~88 parts of 0.01~0.5 part of agent and pH buffer solutions, described pharmaceutical composition is 3.5~4.8.
Preferably, the nitroimidazoles medicine is one or more of metronidazole, Tinidazole and Ornidazole；The quinoline
Promise ketone drug is one or more of Ofloxacin, lavo-ofloxacin, Ciprofloxacin and pefloxacin；The estrogens
Drug is one or more of diethylstilbestrol, estradiol, estriol and ethinyloestradiol；The glucocorticoid medicine is that ground is filled in
One or more of meter Song, hydrocortisone and prednisone.
Preferably, the matrix includes chitosan, carbomer, poloxamer, sodium carboxymethylcellulose, polycarbophil and sea
One or more of mosanom.
Preferably, the moisturizer is glycerine and/or propylene glycol；The preservative is methyl hydroxybenzoate, ethyl hydroxy benzoate, oxybenzene
One or more of propyl ester, benzalkonium bromide and benzoic acid.
Preferably, the pH buffer solutions are Acetate-acetate buffer solution.
Preferably, the dosage form of described pharmaceutical composition be ointment, capsule, gelling agent, powder, effervescent tablet, suppository or
Solution.
The present invention provides the pharmaceutical compositions of the treatment senile vahinitis described in said program to prepare treatment old age
Application in the drug of property vaginitis.
The temperature sensitive slow-releasing gel used of senile vahinitis drug is treated the present invention provides a kind of, includes following per 1000mL
Raw material：50~200g of nitroimidazoles medicine, 10~50g of quinolone drugs, 0.1~0.8g of estrogen drugs, sugared cortex
0.5~2g of hormone medicine, 50~200g of glucose, 100~300g of PLURONICS F87,100~400g of poloxamer188,
The pH of 30~60g of sodium carboxymethylcellulose, 5~15g of moisturizer, 1.5~2.5g of preservative, 500~900mL of purified water and surplus
Buffer solution, pH value are 3.5~4.8.
The present invention provides the temperature sensitive slow-releasing gel used preparations of the treatment senile vahinitis drug described in said program
Method includes the following steps：
1) it takes sodium carboxymethylcellulose to mix swelling with purified water, obtains component A；
2) the component A obtained in PLURONICS F87, poloxamer188 and step 1) is stirred, obtains component B；
3) by nitroimidazoles medicine, quinolone drugs, estrogen drugs, glucocorticoid medicine, glucose,
After the component B obtained in moisturizer, preservative and step 2) is stirred, pH buffer solutions are added, obtain temperature sensitive sustained-release gel
Agent.
In step 2) 0~4 DEG C is stood alone as with the temperature being stirred described in step 3).
Beneficial effects of the present invention
The method of the present invention can pointedly solve the various symptoms of senile vahinitis, from improve estrogen level,
Eliminate pathogenic flora, reduce vagina pH, adjust vaginal flora etc. treatment is various caused by being reduced due to estrogen level
Senile vahinitis.It is of the present invention treatment senile vahinitis drug it is temperature sensitive it is slow-releasing gel used have disperse in vaginal canal
The characteristics of uniformly and being sustained, and the contact area of drug and tissue is made to increase, bioavilability is improved, reaches enhancing and treats
The purpose of effect realizes good therapeutic effect to improve treated effect.And said preparation, which also has, to be not easy to flow out chamber
Road, not pollution clothes, times for spraying is less, easy to use, the preferable advantage of patient's compliance.
Specific implementation mode
It is described the present invention provides a kind of pharmaceutical composition for treating senile vahinitis, including active component and auxiliary material
Active component includes the raw material of following parts by weight：5~20 parts of nitroimidazoles medicine, 1~5 part of quinolone drugs, estrogen
5~20 parts of 0.01~0.08 part of class drug, 0.05~0.2 part of glucocorticoid medicine and glucose；Preferably, the activity
Component includes the raw material of following parts by weight：9~16 parts of nitroimidazoles medicine, 2~4 parts of quinolone drugs, Alora
9~16 parts of 0.03~0.06 part of object, 0.1~0.15 part of glucocorticoid medicine and glucose；It is furthermore preferred that the activearm
It point include the raw material of following parts by weight：11~14 parts of nitroimidazoles medicine, 3 parts of quinolone drugs, estrogen drugs
11~14 parts of 0.04~0.05 part, 0.12~0.14 part of glucocorticoid medicine and glucose.
In the present invention, the nitroimidazoles medicine is one or more of metronidazole, Tinidazole and Ornidazole, excellent
It is selected as metronidazole.Metronidazole is the representative drug in nitroimidazoles medicine, main in addition to for anti-trichomonal and anti-Amoeba
Be used for system or local infection caused by treating or preventing anaerobic bacteria, as alimentary canal, female reproductive system, skin and soft tissue,
The anaerobic infection at the positions such as bone and joint.There is preferable antibacterial action to following anaerobic bacteria:1. Bacteroides, including it is fragile quasi-
Bacillus；2. fusobacterium；3. Clostridium, including clostridium tetani；4. part Eubacterium；5. peptococcus and disappearing
Change streptococcus etc..
In the present invention, the quinolone drugs is in Ofloxacin, lavo-ofloxacin, Ciprofloxacin and pefloxacin
One or more, preferably Ofloxacin.Ofloxacin belongs to quinolone drugs, with the DNA of bacterium
(DNA) it is target spot, inhibits DNA gyrases, further result in the irreversible lesion of DNA of bacteria, reach antibacterial effect.Common drug
There are Ofloxacin, Norfloxacin, lavo-ofloxacin, Ciprofloxacin etc..There is bactericidal effect to a variety of gram-negative bacterias, is widely used in
Disease of the genitourinary system, gastrointestinal disease and respiratory tract, skin histology gram-negative bacterial infection treatment.
In the present invention, the estrogen drugs be diethylstilbestrol, estradiol, estriol and ethinyloestradiol in one kind or
It is several, preferably diethylstilbestrol.Diethylstilbestrol is artificial synthesized nonsteroidal estrogen substance, can be generated and natural estradiol
Identical all pharmacology and therapeutic effect.It is mainly used for various diseases caused by estrogen is low or deficiency disease and hormonal balance disorder
Disease.
In the present invention, the glucocorticoid medicine is one kind in dexamethasone, hydrocortisone and prednisone
Or several, preferably dexamethasone.Dexamethasone is glucocorticosteroid hormone, and derivative has hydrocortisone, prednisone etc., main
It is anti-inflammatory to act on, the reaction for mitigating and preventing tissue to inflammation, the performance to reduce inflammation, and eliminates oedema, reduces exudation.
In the present invention, glucose can cause local penetration pressure difference, improve the dry and astringent environment of intravaginal, moisten vagina, molten
Liquid pH can improve intravaginal acid-base value between 3.2~6.5, be conducive to vagina beneficial bacterium and breed, while also having trophism.
Auxiliary material described in the pharmaceutical composition for the treatment of senile vahinitis of the present invention includes the raw material of following parts by weight：
4~88 parts of 1~50 part of matrix, 0.1~10 part of moisturizer, 0.01~0.5 part of preservative and pH buffer solutions, described pharmaceutical composition
PH value be 3.5~4.8；Preferably, the auxiliary material includes the raw material of following parts by weight：5~30 parts of matrix；Moisturizer 2~8
The pH value of 10~70 parts of part, 0.1~0.4 part of preservative and pH buffer solutions, described pharmaceutical composition is 3.8~4.5；More preferably
, the auxiliary material includes the raw material of following parts by weight：9~20 parts of matrix；4~6 parts of moisturizer, 0.2~0.3 part of preservative and pH
The pH value of 20~50 parts of buffer solution, described pharmaceutical composition is 4.2.
In the present invention, the matrix includes chitosan, carbomer, poloxamer, sodium carboxymethylcellulose, polycarbophil
One or more of with sodium alginate, preferably poloxamer.Matrix refers to institute of the material system in addition to analyte
It is the excipient and carrier of drug to have ingredient, matrix, and the quality and therapeutic effect of drug are had a major impact.Wherein carboxymethyl
Certain slow releasing function is all had after sodium cellulosate and poloxamer swelling, is common slow-release material in pharmacy.This
Outside, it can control gelling agent phase transition temperature after the mixing of different model poloxamer.
In the present invention, the moisturizer is glycerine and/or propylene glycol, preferably glycerine.Glycerine is common moisturizer,
It can play the role of moisturizing, lubrication.
In the present invention, the preservative is in methyl hydroxybenzoate, ethyl hydroxy benzoate, Nipasol, benzalkonium bromide and benzoic acid
One or more, preferably methyl hydroxybenzoate and Nipasol.Preservative can effectively inhibit the breeding of microorganism in drug.
In the present invention, the pH buffer solutions are Acetate-acetate buffer solution, are that pharmacy often uses buffer solution；The vinegar
Steps are as follows for the preparation method of sour sodium-acetate buffer solution：Anhydrous sodium acetate is taken to be dissolved in a small amount of purified water, mixed with glacial acetic acid
After conjunction, adds purified water to be diluted to 1L and obtain Acetate-acetate buffer solution；The concentration of the anhydrous sodium acetate is preferably 83g/L；Institute
The concentration for stating glacial acetic acid is preferably 60mL/L；The pH of the Acetate-acetate buffer solution ranging from 3.2~6.0.
The pH of pharmaceutical composition can also be adjusted using pH adjusting agent in the specific implementation process of the present invention, it is excellent
The pH adjusting agent of choosing is one or more of in sodium hydroxide, hydrochloric acid, boric acid, citric acid, tartaric acid and sodium acetate.
In the present invention, the dosage form of the pharmaceutical composition of the treatment senile vahinitis is ointment, capsule, gel
Agent, powder, effervescent tablet, suppository or solution.
The present invention provides the pharmaceutical compositions of the treatment senile vahinitis described in said program to prepare treatment old age
Application in the drug of property vaginitis.
The temperature sensitive slow-releasing gel used of senile vahinitis drug is treated the present invention provides a kind of, includes following per 1000mL
Raw material：50~200g of nitroimidazoles medicine, 10~50g of quinolone drugs, 0.1~0.8g of estrogen drugs, sugared cortex
0.5~2g of hormone medicine, 50~200g of glucose, 100~300g of PLURONICS F87,100~400g of poloxamer188,
The pH of 30~60g of sodium carboxymethylcellulose, 5~15g of moisturizer, 1.5~2.5g of preservative, 500~900mL of purified water and surplus
Buffer solution, pH value are 3.5~4.8；Preferably, in terms of 1000mL, including following raw material：90~150g of nitroimidazoles medicine,
20~40g of quinolone drugs, 0.2~0.6g of estrogen drugs, 1~1.5g of glucocorticoid medicine, glucose 90~
150g, 150~250g of PLURONICS F87,200~300g of poloxamer188,40~50g of sodium carboxymethylcellulose, moisturizer
The pH buffer solutions of 8~12g, 1.8~2.2g of preservative, 600~800mL of purified water and surplus, pH value are 3.8~4.5；More preferably
, in terms of 1000mL, including following raw material：Nitroimidazoles medicine 100g, quinolone drugs 30g, estrogen drugs
0.5g, glucocorticoid medicine 1.2g, glucose 100g, PLURONICS F87 200g, poloxamer188 250g, carboxymethyl are fine
The pH buffer solutions of the plain sodium 45g of dimension, moisturizer 10g, preservative 2g, purified water 700mL and surplus, pH value 4.2.In the present invention
In, the purified water is preferably deionized purified water.
The present invention provides the temperature sensitive slow-releasing gel used preparations of the treatment senile vahinitis drug described in said program
Method takes sodium carboxymethylcellulose to mix swelling with purified water in the present invention, stands, obtains component A；The present invention is to swelling
Temperature and time be not particularly limited, sodium carboxymethylcellulose of being subject to is sufficiently humidified so as to and evenly dispersed in purified water.
In the present invention, the component A obtained in PLURONICS F87, poloxamer188 and above-mentioned steps is stirred,
Obtain component B；The temperature being stirred is 0~4 DEG C, preferably 1~3 DEG C.The present invention does not have the time being stirred
Specifically limited, component of being subject to is uniformly mixed；The present invention is not particularly limited to stating the stir speed (S.S.) being stirred, mixed with component
It closes uniformly and does not generate subject to a large amount of bubbles.
In the present invention, by nitroimidazoles medicine, quinolone drugs, estrogen drugs, glucocorticoids medicine
After the component B obtained in object, glucose, moisturizer, preservative and above-mentioned steps is stirred, pH buffer solutions are added, are adjusted
Embedding after pH obtains temperature sensitive slow-releasing gel used；The temperature being stirred is 0~4 DEG C, preferably 1~3 DEG C.The present invention couple
The time being stirred is not particularly limited, and component of being subject to is uniformly mixed；The present invention does not have to stating the stir speed (S.S.) being stirred
Have it is specifically limited, component of being subject to be uniformly mixed and do not generate a large amount of bubbles.In the present invention, the mode of the embedding is conventional medicine
Agent embedding mode；The temperature sensitive slow-releasing gel used specification is preferably 10g/10mL.
The temperature sensitive slow-releasing gel used storage temperature for the treatment of senile vahinitis drug of the present invention is preferably 0~4 DEG C.
With reference to embodiment to it is provided by the invention it is a kind of treat the temperature sensitive slow-releasing gel used of senile vahinitis and system
Preparation Method is described in detail, but they cannot be interpreted as limiting the scope of the present invention.
Embodiment 1 is temperature sensitive slow-releasing gel used to be made of following drug：
Steps are as follows for the temperature sensitive slow-releasing gel used preparation method：Sodium carboxymethylcellulose is dispersed in appropriate purifying first
It in water, stands, after it is fully swollen, in the case where 0~4 DEG C is stirred continuously, it is added in PLURONICS F87 and poloxamer188
In；Then recipe quantity drug, moisturizer, preservative are sequentially added, is stirred continuously, is uniformly mixed, adjust pH to 3.5~4.8
Afterwards, embedding, 0~4 DEG C of preservation.
Embodiment 2 is temperature sensitive slow-releasing gel used to be made of following drug：
The preparation method is the same as that of Example 1.
Embodiment 3 is temperature sensitive slow-releasing gel used to be made of following drug：
The preparation method is the same as that of Example 1.
Embodiment 4 is temperature sensitive slow-releasing gel used to be made of following drug：
The preparation method is the same as that of Example 1.
Embodiment 5 is temperature sensitive slow-releasing gel used to be made of following drug：
The preparation method is the same as that of Example 1.
Embodiment 6 is temperature sensitive slow-releasing gel used to be made of following drug：
The preparation method is the same as that of Example 1.
7 clinical test of embodiment：
The present invention has certain curative effect for senile vahinitis, and to observe the Clinical efficacy of this preparation, the present invention provides
To making a definite diagnosis the clinical test results of senile vaginitis patients treatment.
1) general information：50~65 years old out-patients 100.
2) clinical symptoms：Cardinal symptom increases for vaginal fluid and pruritus vulvue, burning heat sensation.Inspection is shown in vagina in old age
It sexually revises, epithelial atrophy, pleat disappears, and smooth muscle layer is thinning, and vagina contraction power reduces etc..Vaginal mucosa hyperemia is shown as, is sticked
Film petechial hemorrhage or sheet bleeding, are shown in superficial ulcer sometimes.
3) dosage regimen：
Treatment group：Vagina gives the preparation of the embodiment of the present invention 6,10g/ times, 1 time every night, 7 days as one therapeutic course；
Control group：Vagina gives metronidazole,clotrimazole and chlorhexidine acetate suppositories, one time 1 piece, 1 time every night, 7 days as one therapeutic course.
4) treatment results：
Temperature sensitive sustained-release gel in 1 present invention of table treats senile vahinitis test result with metronidazole,clotrimazole and chlorhexidine acetate suppositories
By the experimental result of table 1 it is found that the present invention's is temperature sensitive slow-releasing gel used compared with metronidazole,clotrimazole and chlorhexidine acetate suppositories, therapeutic effect is more
It is good, total effective rate higher, it is seen then that of the invention temperature sensitive slow-releasing gel used to realize good control for treating senile vahinitis
Therapeutic effect.
As seen from the above embodiment, the present invention provides a kind of temperature sensitive sustained-release gels for treating senile vahinitis drug
Agent, not only convenient drug administration, number are few for treating senile vahinitis for the gelling agent, and compared with the prior art in polybenzobisoxazole
Safe bolt therapeutic effect is more preferable, efficient higher, it is seen then that treatment senile vahinitis drug of the invention it is temperature sensitive slow-releasing gel used
With good therapeutic effect.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered
It is considered as protection scope of the present invention.
Claims (10)
1. a kind of pharmaceutical composition for treating senile vahinitis, including active component and auxiliary material, the active component include with
The raw material of lower parts by weight：
5~20 parts of nitroimidazoles medicine, 1~5 part of quinolone drugs, 0.01~0.08 part of estrogen drugs, sugared cortex
5~20 parts of 0.05~0.2 part of hormone medicine and glucose.
2. the pharmaceutical composition for the treatment of senile vahinitis according to claim 1, which is characterized in that the auxiliary material includes
The raw material of following parts by weight：1~50 part of matrix, 0.1~10 part of moisturizer, 0.01~0.5 part of preservative and pH buffer solutions 4~88
Part；The pH value of described pharmaceutical composition is 3.5~4.8.
3. the pharmaceutical composition for the treatment of senile vahinitis according to claim 1, which is characterized in that the nitroimidazole
Class drug is one or more of metronidazole, Tinidazole and Ornidazole；The quinolone drugs is Ofloxacin, left oxygen fluorine
One or more of Sha Xing, Ciprofloxacin and pefloxacin；The estrogen drugs are diethylstilbestrol, estradiol, female three
One or more of alcohol and ethinyloestradiol；The glucocorticoid medicine is in dexamethasone, hydrocortisone and prednisone
One or more.
4. the pharmaceutical composition for the treatment of senile vahinitis according to claim 2, which is characterized in that the matrix includes
One or more of chitosan, carbomer, poloxamer, sodium carboxymethylcellulose, polycarbophil and sodium alginate.
5. the pharmaceutical composition for the treatment of senile vahinitis according to claim 2, which is characterized in that the moisturizer is
Glycerine and/or propylene glycol；The preservative is one in methyl hydroxybenzoate, ethyl hydroxy benzoate, Nipasol, benzalkonium bromide and benzoic acid
Kind is several.
6. the pharmaceutical composition for the treatment of senile vahinitis according to claim 2, which is characterized in that the pH buffer solutions
For Acetate-acetate buffer solution.
7. according to the pharmaceutical composition for treating senile vahinitis described in claim 1~6 any one, which is characterized in that institute
The dosage form for stating pharmaceutical composition is ointment, capsule, gelling agent, powder, effervescent tablet, suppository or solution.
8. the pharmaceutical composition of the treatment senile vahinitis described in claim 1~7 any one is senile in preparation treatment
Application in the drug of vaginitis.
Include following raw material per 1000mL 9. a kind for the treatment of the temperature sensitive slow-releasing gel used of senile vahinitis drug：Nitroimidazole
50~200g of class drug, 10~50g of quinolone drugs, 0.1~0.8g of estrogen drugs, glucocorticoid medicine 0.5
~2g, 50~200g of glucose, 100~300g of PLURONICS F87,100~400g of poloxamer188, sodium carboxymethylcellulose
The pH buffer solutions of 30~60g, 5~15g of moisturizer, 1.5~2.5g of preservative, 500~900mL of purified water and surplus, pH value are
3.5~4.8.
10. treating the temperature sensitive slow-releasing gel used preparation method of senile vahinitis drug, including following step described in claim 8
Suddenly：
1) it takes sodium carboxymethylcellulose to mix swelling with purified water, obtains component A；
2) the component A obtained in PLURONICS F87, poloxamer188 and step 1) is stirred, obtains component B；
3) by nitroimidazoles medicine, quinolone drugs, estrogen drugs, glucocorticoid medicine, glucose, moisturizing
After the component B obtained in agent, preservative and step 2) is stirred, pH buffer solutions are added, are obtained temperature sensitive slow-releasing gel used.
In step 2) 0~4 DEG C is stood alone as with the temperature being stirred described in step 3).
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| CN112089684A (en) * | 2020-10-30 | 2020-12-18 | 华东医药（西安）博华制药有限公司 | Levoornidazole/ornidazole oil-in-water emulsion temperature-sensitive gel suppository and preparation method thereof |
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| CN113940915A (en) * | 2021-12-07 | 2022-01-18 | 南京麦澜德医疗科技股份有限公司 | Gel for vagina and preparation method thereof |
| CN113940915B (en) * | 2021-12-07 | 2024-04-26 | 南京麦澜德医疗科技股份有限公司 | Gel for intravaginal use and preparation method thereof |
| CN114848582A (en) * | 2022-05-05 | 2022-08-05 | 江苏春申堂生物科技有限公司 | Slow-release antibacterial gel for treating female leukoplakia vulvae and preparation method thereof |
| CN114848582B (en) * | 2022-05-05 | 2023-08-08 | 江苏春申堂药业有限公司 | Sustained-release antibacterial gel for treating female vulvar leukoplakia and preparation method thereof |
| CN115006697A (en) * | 2022-05-14 | 2022-09-06 | 河南沃迈生物科技有限公司 | Medical gynecological gel dressing microecological preparation device and manufacturing method |
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