CN106692033A

CN106692033A - Blank gel

Info

Publication number: CN106692033A
Application number: CN201510782751.8A
Authority: CN
Inventors: 谭惠娟
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-11-13
Filing date: 2015-11-13
Publication date: 2017-05-24

Abstract

The invention provides a blank gel. The blank gel comprises the following components by weight percentage: 5-15% of gel matrix, 1-5% of a transdermal absorption enhancer, 1-5% of a humectant, 0.5-3% of a cosolvent, 0.1-0.5% of a preservative and a proper amount of deionized water. The blank gel is suitable for a water soluble medicine, has the capabilities of bearing and releasing the medicines, meets the requirement of quantitatively adding the ingredients of the medicine conveniently, guarantees stability and uniformity of medicine storage and medicine concentration in the treatment process, is good in stability, and does not mildew or dehydrate easily.

Description

A kind of Blank gel agent

Technical field

The present invention relates to pharmaceutical technology field, spy is related to a kind of Blank gel agent.

Background technology

Ointment is a kind of classical formulation of comparing.Just there are this medicament of ointment in ancient times, have arrived modern development and have gone out transdermal delivery system. Transdermal delivery system be it is a kind of using skin as administration channel pharmaceutical dosage form, with through skin constant speed, enduringly release medicine enter The advantages of entering body circulation, avoid medicine from being decomposed in alimentary canal, reduce the infringement to stomach and liver.

Gel in percutaneous drug administration preparation with its transparent appearance, smooth feel and not pollution clothes the advantages of, increasingly receive Welcome to people.But in general existing water gelling agent easy dehydration and goes mouldy, therefore develop a kind of gel of good stability Matrix has the meaning of reality.

The content of the invention

Regarding to the issue above, the present invention provides a kind of Blank gel agent, consists of the following components in percentage by weight：Gel-type vehicle 5~15%, skin penetration enhancer 1~5%, NMF 1~5%, cosolvent 0.5~3%, preservative 0.1~0.5%, deionized water Surplus.

Further, consist of the following components in percentage by weight：Gel-type vehicle 7~12%, skin penetration enhancer 2~4%, NMF 2~4%, cosolvent 0.8~2%, preservative 0.2~0.4%, deionized water surplus.

Further, consist of the following components in percentage by weight：Gel-type vehicle 10%, skin penetration enhancer 34%, guarantor Humectant 3%, cosolvent 1%, preservative 0.3%, deionized water surplus.

Specifically, the gel-type vehicle is the one kind in Carbomer, PVPP, Hydroxypropyl methylcellulose.

Specifically, the skin penetration enhancer is peppermint oil and Laurocapram.

Specifically, the cosolvent is glycerine or propane diols.

Specifically, the NMF is hyaluronic acid and chondroitin sulfate.

Specifically, the preservative is the mixed of one or more in ethyl hydroxy benzoate, Phenoxyethanol, methylisothiazolinone Compound.

Carbomer is the matrix commonly used in water gelling agent, Carbomer to acid, alkali and all certain tolerance of alcohol, low-temperature-resistant and High pressure moist heat sterilization, there is good biocompatibility, non-stimulated to eye and skin.

Hydroxypropyl methylcellulose is a kind of excellent gel substrate, its preparation process is simple, good stability, good biocompatibility, Excitant is small, and product is attractive in appearance, it is comfortable to apply exhibition.

Polyvinylpyrrolidone is not involved in human metabolism, and with excellent biocompatibility, to skin, mucous membrane, eye etc. Any stimulation is not formed.And the action time of medicine can be extended.

Chondroitin sulfate is to be covalently attached the class glycosaminoglycan that proteoglycans is formed on protein.There is protection to collagenous fibres Effect, with strong water-retaining property, can improve the water metabolism of tissue.

Compared with prior art, Blank gel agent of the invention is aqueous matrix, is suitable for water soluble drug, with carrying and release The ability of medicine is put, drug ingedient is met and is easy to quantitative addition, it is ensured that the stabilization of medicine reserves, drug concentration over the course for the treatment of With it is uniform；Good stability, is difficult to go mouldy and dehydration, and walking altering property peppermint oil with fragrance can further increase Transdermal absorption of the present invention Ability, the addition of chondroitin sulfate enhances the compatibility of preparation and skin histology.

In order to more fully understand and implement, the following detailed description of the present invention.

Specific embodiment

Embodiment 1

Preparation method：Stirring under the Carbomer plus suitable quantity of water normal temperature of formula ratio is taken, is made its swelling and is dissolved；The thin of formula ratio is taken again Stirring dissolves it under lotus oil, Laurocapram, hyaluronic acid, chondroitin sulfate, glycerine and ethyl hydroxy benzoate add excess water normal temperature, And in adding to the Carbomer aqueous solution；Plus appropriate triethanolamine adjusts mixed solution pH value to 6.5~7.5, is stirred under normal temperature, Obtain final product.

Embodiment 2

Preparation method：The lower stirring of PVPP plus suitable quantity of water heating for taking formula ratio makes its dissolving complete；Take again and match somebody with somebody Peppermint oil, Laurocapram, hyaluronic acid, chondroitin sulfate, propane diols and the Phenoxyethanol that side measures are stirred under adding excess water normal temperature Mixing dissolves it, and adds to the PVPP aqueous solution, continues to be cooled to normal temperature under stirring, and obtains final product.

Embodiment 3

Preparation method：Taking PVPP plus the suitable quantity of water stirring of formula ratio makes its dissolving complete；Formula ratio is taken again Stirring makes it under peppermint oil, Laurocapram, hyaluronic acid, chondroitin sulfate, propane diols and Phenoxyethanol add excess water normal temperature Dissolving, and add to the cross-linked hydroxypropyl methylcellulose aqueous solution, continue to be stirred until homogeneous under normal temperature, obtain final product.

Embodiment 4

Embodiment 5

Irritant experiment embodiment

Tested material：Prepare the gained sample of embodiment 1~5 obtained in embodiment

Subject：Totally 36 people, men and women half and half, 20~30 years old age, meets subject's aspiration inclusion criteria.

Test method：Tested material is put into spot examination device, consumption is 0.02g.Control wells are blank (not putting any material). The back or forearm song side of subject will be pasted on added with the spot of the tested material examination non-stimulated adhesive tape of device, be gently pressed with palm and is allowed to uniform Be pasted on skin, continue 24h.30min after removal tested material spot examination device, dermoreaction is observed after impression disappears.Such as Result is feminine gender, is observed again once respectively in 24h after patch test and 48h.By table 3 (skin adverse reaction grade scale table) Record reaction result.

Result of the test is shown in Table 4：

The result that 24h and 48h are observed again respectively after patch test is with table 4.Result above shows, Blank gel agent of the invention To the nonirritant effect of human body skin.

Stability experiment embodiment

This is tested with Diclofenac Potassium as model drug, as made by the embodiment 1~5 of the above-mentioned specific embodiment of the present invention Gel be respectively preformed gel 1~5, commercially available diclofenac potassium gel is control gel, and the present invention is illustrated with experimental result Technical advantage.

By each one group of sealing of preformed gel 1~5 and control gel, the change for observing gel character at ambient temperature is placed.Knot Fruit shows that the former can place more than 2 years at room temperature, and the latter places and peptization phenomenon can occur in more than 1 year.By two kinds of gels Each one group is placed on heating, observed and recorded gel-sol phase transition temperature in water bath.The gel-sol phase of acetonideexample 1~5 Transition temperature is more than 45 DEG C, and control gel is less than 40 DEG C.

Can draw the present invention can make gel stability be improved significantly.

The invention is not limited in above-mentioned implementation method, if not departing from spirit of the invention to various changes of the invention or deformation And scope, if these are changed and within the scope of deformation belongs to claim of the invention and equivalent technologies, then the present invention is also intended to Comprising these changes and deformation.

Claims

1. a kind of Blank gel agent, it is characterised in that consist of the following components in percentage by weight：Gel-type vehicle 5~15%, transdermal is inhaled Receive accelerator 1~5%, NMF 1~5%, cosolvent 0.5~3%, preservative 0.1~0.5%, deionized water surplus.

2. Blank gel agent according to claim 1, it is characterised in that consist of the following components in percentage by weight：Gel base Matter 7~12%, skin penetration enhancer 2~4%, NMF 2~4%, cosolvent 0.8~2%, preservative 0.2~0.4%, go Ion water surplus.

3. Blank gel agent according to claim 2, it is characterised in that consist of the following components in percentage by weight：Gel base Matter 10%, skin penetration enhancer 34%, NMF 3%, cosolvent 1%, preservative 0.3%, deionized water surplus.

4. the Blank gel agent according to claims 1 to 3 any one, it is characterised in that：The gel-type vehicle be Carbomer, One kind in PVPP, Hydroxypropyl methylcellulose.

5. the Blank gel agent according to claims 1 to 3 any one, it is characterised in that：The skin penetration enhancer is thin Lotus oil and Laurocapram.

6. the Blank gel agent according to claims 1 to 3 any one, it is characterised in that：The cosolvent is glycerine or the third two Alcohol.

7. the Blank gel agent according to claims 1 to 3 any one, it is characterised in that：The NMF be hyaluronic acid with Chondroitin sulfate.

8. the Blank gel agent according to claims 1 to 3 any one, it is characterised in that：The preservative be ethyl hydroxy benzoate, One or more mixture in Phenoxyethanol, methylisothiazolinone.