CN104983673A - Anti-HIV JB protein rectum gel preparation and preparation method thereof - Google Patents

Anti-HIV JB protein rectum gel preparation and preparation method thereof Download PDF

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Publication number
CN104983673A
CN104983673A CN201510360657.3A CN201510360657A CN104983673A CN 104983673 A CN104983673 A CN 104983673A CN 201510360657 A CN201510360657 A CN 201510360657A CN 104983673 A CN104983673 A CN 104983673A
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gel
kilogram
albumen
namely
concentration
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CN104983673B (en
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姜世勃
陆路
朱赟
王茜
杨霞
兰小宾
何振瑞
王志强
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Shanxi Jin Bo Biomedics Inc
Fudan University
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Shanxi Jin Bo Biomedics Inc
Fudan University
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Abstract

The invention discloses an anti-HIV JB protein rectum gel preparation and a preparation method thereof. Potent microbicide JB protein is used as the main active ingredient of the rectum gel preparation which is mainly used for preventing AIDS pathophoresis. The optimized rectum gel preparation comprises, by mass concentration, 0.1-5% of JB protein, 0.1-10% of Carbomer, 0.5-10% of propylene glycol, 5-15% of glycerinum, 0.1-3% of hydroxyethyl cellulose, 0.1-1% of methylparaben and 0.1-1% of propylparaben and the balance water. The anti-HIV JB protein rectum gel preparation can be used for preventing AIDS pathophoresis and has the wide market prospect and high application value.

Description

The JB albumen rectal gel pharmaceutical formulation of anti HIV-1 virus and preparation method
Technical field
The invention belongs to medical art, be specifically related to a kind of gel products prevented AIDS and preparation method thereof.
Background technology
Acquired immune deficiency syndrome (AIDS) (Acquired immunodeficiency syndrome, AIDS) be by HIV (human immunodeficiency virus) (Human immunodeficiency virus, HIV) infectious disease being feature with systemic immune system grievous injury caused is infected, since it is found, the existence of the serious threat mankind, the healthy and socioeconomic development generation tremendous influence to population in the world.Route of transmission mainly unsafe property contact, intravenous injection, blood transfusion, childbirth, the suckling etc. of HIV.Initial HIV only propagates in drug abuse and homosexual crowd, and spread through sex intercourse now, especially spreading through sex intercourse between the opposite sex has become the main path of aids transmission, and its ratio reaches 80%, in some countries of Africa more up to 90%, wherein Female-cases ratio is in the trend increased gradually.China found first case HIV sufferers from 1985, HIV number constantly rises, especially swift and violent with the development in recent years impetus.Along with the transformation of China's aids transmission pattern, property contacts the major transmission path that oneself becomes China HIV/AIDS gradually.Therefore, for the country that our such population base is huge, in order to effectively control acquired immune deficiency syndrome (AIDS), needing the input strengthening prevention aspect, especially will note the prevention that HIV spreads through sex intercourse.
To spread through sex intercourse or sexually transmitted disease (STD) takes a lot of preventive measure for reducing HIV, comprising sexual repression, monogamy, conventional use safety cover and male's posthetomy.But the crowd in area of causing a disease for HIV height, because society, economy and cultural factor can not effectively utilize above-mentioned preventive measure.UNAIDS and World Health Organization (WHO) propose exploitation and have the new technique of prophylactic function to protect crowd from infection.In various new technique, of greatest concern with the microbicide of local use again, even if the microbicide that local uses can make sexual avoid infection when not use safety cover HIV, but regrettably at present to develop microbicide be because safety, effectiveness and acceptable problem cause developing unsuccessfully mostly.Therefore, developing effective microbicide to prevent the transmission through sex of HIV is top priority and the important topic of current global aids prevention.Nearest clinical trial display, a kind of containing 1% TDF(efabirenz, NRTI) vaginal jellies significantly can reduce the risk that HIV spreads through sex intercourse.Before intercourse with women's HIV rate decreased average of rear this gel of use 39%.In the women of those medication high compliances (namely all adhering to using this gel in >80% situation), the infection rate of HIV can reduce 54%, and in the women of the low compliance of those medications (namely adhering to using this gel in <50% situation), the infection rate of HIV only decreases 28%.These achievements in research are that new hope has been lighted again in the research and development of the gel preparation of microbicide.
Microbicide is a kind of preparation containing AntiHIV1 RT activity composition, comprises the different dosage form such as gel, butterfat, HIV can be stoped to stick or the target cell that invades in vagina or rectal mucosa or suppress viral and copy intracellular, thus play the effect prevented AIDS.Research and development have microbicide dosage form that is long-term or short-term slow-release function, and use better non-nucleoside reverse transcriptase inhibitor (NNRTI) or HIV entry inhibitor (EI) more active in NRTI to become focus and the forefront of current international microbicide research.As far back as 1996, internationally famous virologist professor Jiang Shibo just finds that extract from milk, after chemical modification a protein (existing title " JB albumen ") has very strong HIV (human immunodeficiency virus)-resistant activity, follow-up study constantly confirms, JB albumen is the best microbicide composition that development prevention HIV spreads through sex intercourse.The microbicide activity of JB albumen can with reference to following patent: title: a kind of preparation method of biological preparation of prevention and corntrol human papilloma virus infection, the patent No.: ZL 201210066696.9.The microbiocides biological activity of JB albumen is mainly derived from the strong negative charge of its protein surface distribution, this CHARGE DISTRIBUTION makes it very easily in conjunction with the positive charge compact district of virion surface, thus stop that virion infects in conjunction with people's receptor body, reach antiviral effect.JB dietary protein origin is in native protein, and high to human body affinity, side effect is little.
Therefore, research and development have microbicide dosage form that is long-term or short-term slow-release function, and use better non-nucleoside reverse transcriptase inhibitor (NNRTI) or HIV entry inhibitor (EI) more active in NRTI to become focus and the forefront of current international microbicide research.
Summary of the invention
Novel rectum gel products that the object of the present invention is to provide a kind of anti HIV-1 virus and preparation method thereof, this gel product is main microbicide active substance with JB albumen, take carbomer as main matrix composition.
The present invention adopts following technical scheme to realize:
A JB albumen rectal gel pharmaceutical formulation for anti HIV-1 virus, comprises the component of following part by weight:
JB albumen 0.1 ~ 5%,
Carbomer 0.1 ~ 10%,
Propylene glycol 0.5 ~ 10%,
Glycerol 5 ~ 15%,
Hydroxyethyl-cellulose 0.1 ~ 3%,
Methyl hydroxybenzoate 0.1 ~ 1%,
Propylparaben 0.1 ~ 1%,
Water surplus.
Preferably, the component of following part by weight is comprised:
JB albumen 0.5 ~ 1.5%,
Carbomer 2 ~ 5%,
Propylene glycol 2 ~ 5%,
Glycerol 8 ~ 10%,
Hydroxyethyl-cellulose 1 ~ 3%,
Methyl hydroxybenzoate 0.1 ~ 0.5%,
Propylparaben 0.5 ~ 1%,
Water surplus.
The preparation method of the JB albumen rectal gel preparation of above-mentioned anti HIV-1 virus, comprises the steps:
First glycerol, propylene glycol, hydroxyethyl-cellulose are dissolved in pure water, then add carbomer, make it fully dissolve, then add methyl hydroxybenzoate and propylparaben, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then with pure water, surplus is supplied, stir, finally by NaOH solution by between the gel adjust ph to 6.5 that obtains to 7.5, get product.
Carbomer (Carbomer) is containing the crosslinked acrylate copolymer of polyalkenyl polyether, it is the very important rheology control agent of a class, carbomer after neutralization is outstanding gel-type vehicle, there is the important use such as thickening, suspension, technique is simple, good stability, just can produce efficient thickening power under very low consumption, thus prepare that the spray of very wide range of viscosities and various flows degeneration, emulsion, cream are white, gel and preparation capable of permeating skin.And the feature of tool water-soluble base, appearance transparent is attractive in appearance, puts on the skin and have special fine and smooth smooth feeling on skin, and to close effect fine with skin histology Rhizoma Nelumbinis.In formula of the present invention, the HIV of inactivation can be adsorbed by gluey carbomer, wrap up and excreting, and accelerate impaired, rotten to the corn tissue and repair fast and regeneration, Promotive union.
Glycerol is achromaticity and clarification thick liquid, and odorless has warm sweet taste.Be widely used in the industries such as medicine, food, Nicotiana tabacum L., cosmetics, toothpaste, ink, coating, national defence, leather, printing and dyeing, synthetic resin, pesticide.For regulating the character of rectal gel in formula of the present invention.
Propylene glycol is a kind of chemical reagent, with water, ethanol and multiple immiscible organic solvent.Propylene glycol can be used as the raw material of unsaturated polyester resin, can coordinate be used as wetting agent in cosmetics, toothpaste and fancy soap with glycerol or sorbitol etc.For regulating the character of rectal gel in formula of the present invention.
Hydroxyethyl-cellulose is a kind of white or faint yellow, tasteless, nontoxic threadiness or pulverulent solids, is prepared through etherification reaction by alkali cellulose and oxirane (or 2-chloroethyl alcohol), belongs to nonionic soluble fiber element ethers.Due to hydroxyethyl-cellulose, there is good thickening, suspension, dispersion, emulsifying, bonding, film forming, protection moisture and the characteristics such as protecting colloid are provided, being widely used in the fields such as oil exploitation, coating, building, medicine food, weaving, papermaking and macromolecular polymerization reaction.For coordinating the character regulating rectal gel in formula of the present invention.
Parabens is the broad spectrum activity efficient food antiseptic of generally acknowledging in the world, and scope of restraining fungi is wide, good to the inhibition of mycete, yeast and gram negative bacteria.Current Nipagin ester has been widely used in food, beverage, cosmetics, medicine and other fields.In formula of the present invention, use methyl hydroxybenzoate and propylparaben as bacteriostatic preservative.
Main active in the JB albumen rectal gel preparation of the anti HIV-1 virus in the present invention is JB albumen, and this is found by internationally famous virologist professor Jiang Shibo.Follow-up study constantly confirms, JB albumen is the best microbicide composition that development prevention HIV spreads through sex intercourse.The microbiocides biological activity of JB albumen is mainly derived from the strong negative charge of its protein surface distribution, this CHARGE DISTRIBUTION makes it very easily in conjunction with the positive charge compact district of virion surface, thus stop that virion infects in conjunction with people's receptor body, reach antiviral effect.Meanwhile, other gel-type vehicle composition in formula can be assisted and the HIV virus of inactivation be excreted.Core body of the present invention utilizes JB albumen now, by the reasonable coordination of glycerol, propylene glycol, hydroxyethyl-cellulose and carbomer, prepares the anti HIV-1 virus preparation for rectum position, and adopt optimization formula, effect is better.
The JB albumen rectal gel preparation of the anti HIV-1 virus in the present invention has the effect of very strong AntiHIV1 RT activity infection, and as described in Table 1, this gel has very strong inhibition, IC to two of HIV-1 popular at present kinds of hypotype HIV-1 IIIB and HIV-1 Bal 50all reach the magnitude level of ng/ml.And control gel does not detect any inhibition.
Table 1. JB albumen rectal gel suppresses the effect of HIV-1 viral infection
The JB albumen rectal gel preparation of the anti HIV-1 virus in the present invention is very easy to use.When using at every turn, take semi-crouch position, gel device is slowly inserted internal rectum, after then gel being pushed internal rectum, extract gel device out, 11 or 3g, the propagation that can effectively prevent AIDS.
The present invention is reasonable in design, through research repeatedly and the experiment of applicant, continuous adjustment formula and preparation process, the success of novelty develops with JB albumen as main active, take carbomer as the rectal gel preparation of the novel anti HIV-1 virus of matrix components, may be used for the various uses propagated that prevents AIDS.Therefore, the present invention has market prospect widely and using value.
Detailed description of the invention
Below specific embodiments of the invention are described in detail.
embodiment 1
A JB albumen Gel in rectal administered for anti HIV-1 virus, composition comprises mass concentration and is respectively 1% JB albumen, 2% carbomer, 0.5% propylene glycol, 15% glycerol, 0.5% hydroxyethyl-cellulose, 0.12% methyl hydroxybenzoate, 0.15% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 2%, namely 20g carbomer is contained in every kilogram of gel, PG concentration is 0.5%, namely 5g propylene glycol is contained in every kilogram of gel, glycerol concentration is 15%, namely 150g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 0.5%, namely 5g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 0.12%, namely 12g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 0.15%, namely 15g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 1%, namely 10gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 700g pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
embodiment 2
A JB albumen Gel in rectal administered for anti HIV-1 virus, composition comprises mass concentration and is respectively 0.5% JB albumen, 1.5% carbomer, 5% propylene glycol, 10% glycerol, 2% hydroxyethyl-cellulose, 0.1% methyl hydroxybenzoate, 0.5% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 1.5%, namely 15g carbomer is contained in every kilogram of gel, PG concentration is 5%, namely 50g propylene glycol is contained in every kilogram of gel, glycerol concentration is 10%, namely 100g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 2%, namely 20g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 0.1%, namely 1g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 0.5%, namely 5g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 0.5%, namely 5gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 800g pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
embodiment 3
The JB albumen Gel in rectal administered of anti HIV-1 virus and a preparation method, composition comprises mass concentration and is respectively 3% JB albumen, 0.7% carbomer, 8% propylene glycol, 12% glycerol, 3% hydroxyethyl-cellulose, 0.15% methyl hydroxybenzoate, 0.1% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 0.7%, namely 7g carbomer is contained in every kilogram of gel, PG concentration is 8%, namely 80g propylene glycol is contained in every kilogram of gel, glycerol concentration is 12%, namely 120g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 3%, namely 30g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 0.15%, namely 1.5g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 0.1%, namely 1g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 3%, namely 30gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 700g pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
embodiment 4
A JB albumen Gel in rectal administered for anti HIV-1 virus, composition comprises mass concentration and is respectively 0.1% JB albumen, 0.1% carbomer, 10% propylene glycol, 6% glycerol, 0.1% hydroxyethyl-cellulose, 0.5% methyl hydroxybenzoate, 1% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 0.1%, namely 1g carbomer is contained in every kilogram of gel, PG concentration is 10%, namely 100g propylene glycol is contained in every kilogram of gel, glycerol concentration is 6%, namely 60g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 0.1%, namely 1g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 0.5%, namely 5g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 1%, namely 10g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 0.1%, namely 1gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 800g pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
embodiment 5
The JB albumen Gel in rectal administered of anti HIV-1 virus and a preparation method, composition comprises mass concentration and is respectively 4% JB albumen, 7% carbomer, 1% propylene glycol, 5% glycerol, 1% hydroxyethyl-cellulose, 1% methyl hydroxybenzoate, 0.8% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 7%, namely 70g carbomer is contained in every kilogram of gel, PG concentration is 1%, namely 10g propylene glycol is contained in every kilogram of gel, glycerol concentration is 5%, namely 50g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 1%, namely 10g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 1%, namely 10g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 0.8%, namely 8g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 4%, namely 40gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 800 pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
embodiment 6
A kind of JB albumen Gel in rectal administered of anti HIV-1 virus and preparation method, composition comprises mass concentration and is respectively 0.8% JB albumen, 2.5% carbomer, 4.5% propylene glycol, 8% glycerol, 1.5% hydroxyethyl-cellulose, 0.3% methyl hydroxybenzoate, 0.5% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 2.5%, namely 25g carbomer is contained in every kilogram of gel, PG concentration is 4.5%, namely 45g propylene glycol is contained in every kilogram of gel, glycerol concentration is 8%, namely 80g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 1.5%, namely 15g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 0.3%, namely 3g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 0.5%, namely 5g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 0.8%, namely 8gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 800 pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
embodiment 7
A kind of JB albumen Gel in rectal administered of anti HIV-1 virus and preparation method, composition comprises mass concentration and is respectively 1.2% JB albumen, 3% carbomer, 3.5% propylene glycol, 8.5% glycerol, 3% hydroxyethyl-cellulose, 0.4% methyl hydroxybenzoate, 0.6% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 3%, namely 30g carbomer is contained in every kilogram of gel, PG concentration is 3.5%, namely 35g propylene glycol is contained in every kilogram of gel, glycerol concentration is 8.5%, namely 85g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 3%, namely 30g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 0.4%, namely 4g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 0.6%, namely 6g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 1.2%, namely 12gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 750 pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
embodiment 8
The JB albumen Gel in rectal administered of anti HIV-1 virus and a preparation method, composition comprises mass concentration and is respectively 1.5% JB albumen, 5% carbomer, 2.5% propylene glycol, 9% glycerol, 2.5% hydroxyethyl-cellulose, 0.5% methyl hydroxybenzoate, 1% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 5%, namely 50g carbomer is contained in every kilogram of gel, PG concentration is 2.5%, namely 25g propylene glycol is contained in every kilogram of gel, glycerol concentration is 9%, namely 90g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 2.5%, namely 25g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 0.5%, namely 5g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 1%, namely 10g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 1.5%, namely 15gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 750 pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
embodiment 9
A kind of JB albumen Gel in rectal administered of anti HIV-1 virus and preparation method, composition comprises mass concentration and is respectively 0.5% JB albumen, 10% carbomer, 2% propylene glycol, 9.5% glycerol, 1.2% hydroxyethyl-cellulose, 0.1% methyl hydroxybenzoate, 0.55% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 10%, namely 100g carbomer is contained in every kilogram of gel, PG concentration is 2%, namely 20g propylene glycol is contained in every kilogram of gel, glycerol concentration is 9.5%, namely 95g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 1.2%, namely 12g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 0.1%, namely 1g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 0.55%, namely 5.5g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 0.5%, namely 5gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 800 pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
embodiment 10
The JB albumen Gel in rectal administered of anti HIV-1 virus and a preparation method, composition comprises mass concentration and is respectively 5% JB albumen, 4% carbomer, 5% propylene glycol, 10% glycerol, 1% hydroxyethyl-cellulose, 0.25% methyl hydroxybenzoate, 0.7% propylparaben.
To prepare one kilogram of gel, carbomer concentration is 4%, namely 40g carbomer is contained in every kilogram of gel, PG concentration is 5%, namely 50g propylene glycol is contained in every kilogram of gel, glycerol concentration is 10%, namely 100g glycerol is contained in every kilogram of gel, hydroxyethyl-cellulose concentration is 1%, namely 10g hydroxyethyl-cellulose is contained in every kilogram of gel, Metagin ester concentration is 0.25%, namely 2.5g methyl hydroxybenzoate is contained in every kilogram of gel, propylparaben concentration is 0.7%, namely 7g propylparaben is contained in every kilogram of gel, JB albumen quality concentration is 5%, namely 50gJB albumen is contained in every kilogram of gel.
Concrete preparation method first joins in 700 pure water by glycerol, propylene glycol, hydroxyethyl-cellulose, carbomer is added after stirring and dissolving, it is made fully to dissolve with high speed dispersor, add methyl hydroxybenzoate and propylparaben again, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then one kilogram is supplied with pure water, stir, finally by NaOH solution by between one kilogram of gel adjust ph to 6.5 to 7.5 obtaining.
It should be noted last that; above embodiment is only in order to illustrate technical scheme of the present invention and unrestricted; although be described in detail with reference to the embodiment of the present invention; those of ordinary skill in the art is to be understood that; technical scheme of the present invention is modified or equivalent replacement; do not depart from the spirit and scope of technical scheme of the present invention, it all should be contained in claims of the present invention.

Claims (3)

1. a JB albumen rectal gel pharmaceutical formulation for anti HIV-1 virus, is characterized in that: the component comprising following part by weight:
JB albumen 0.1 ~ 5%,
Carbomer 0.1 ~ 10%,
Propylene glycol 0.5 ~ 10%,
Glycerol 5 ~ 15%,
Hydroxyethyl-cellulose 0.1 ~ 3%,
Methyl hydroxybenzoate 0.1 ~ 1%,
Propylparaben 0.1 ~ 1%,
Water surplus.
2. the JB albumen rectal gel pharmaceutical formulation of anti HIV-1 virus according to claim 1, is characterized in that: the component comprising following part by weight:
JB albumen 0.5 ~ 1.5%,
Carbomer 2 ~ 5%,
Propylene glycol 2 ~ 5%,
Glycerol 8 ~ 10%,
Hydroxyethyl-cellulose 1 ~ 3%,
Methyl hydroxybenzoate 0.1 ~ 0.5%,
Propylparaben 0.5 ~ 1%,
Water surplus.
3. a preparation method for the JB albumen rectal gel preparation of anti HIV-1 virus, is characterized in that: comprise the steps:
First glycerol, propylene glycol, hydroxyethyl-cellulose are dissolved in pure water, then add carbomer, make it fully dissolve, then add methyl hydroxybenzoate and propylparaben, after stirring, 115 DEG C of sterilizings 30 minutes, finally add the JB albumen crossed with the membrane filtration of 0.22 μm, continue to stir, then with pure water, surplus is supplied, stir, finally by NaOH solution by between the gel adjust ph to 6.5 that obtains to 7.5, get product.
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