CN106237337A - A kind of liquid pharmaceutical formulation anticorrosive composite - Google Patents
A kind of liquid pharmaceutical formulation anticorrosive composite Download PDFInfo
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- CN106237337A CN106237337A CN201610642831.8A CN201610642831A CN106237337A CN 106237337 A CN106237337 A CN 106237337A CN 201610642831 A CN201610642831 A CN 201610642831A CN 106237337 A CN106237337 A CN 106237337A
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- preservative
- glycerol
- pharmaceutical formulation
- liquid pharmaceutical
- antiseptic composition
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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
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
-
- 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
- A61K9/08—Solutions
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
Present invention relates particularly to a kind of anticorrosive composite, including the raw material of following percentage by weight: 1,2 propylene glycol 2～25%, glycerol 5～30%, sugar alcohol 45～75%, preservative 0～0.5%.The present invention has high-efficiency broad spectrum fungistatic effect, all has inhibitory action to Pseudomonas aeruginosa, escherichia coli, staphylococcus aureus, Candida albicans and aspergillus niger, and secure threshold is higher, and toxicity is few.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of anticorrosive composite being applicable to liquid pharmaceutical formulation.
Background technology
Liquid pharmaceutical formulation includes oral administration solution, syrup, suspensoid and Emulsion etc..If medicine itself does not have sufficiently
Antibacterial efficacy, then should add suitable antibacterial according to formulation properties (such as water soluble preparation), to prevent preparation in normal storage
Owing to microorganism pollution and breeding cause medicine rotten, user is worked the mischief during hiding or using, especially multiple dose
The preparation of packaging.Suitable antibacterial should meet effectiveness, three aspects of safety and stability in principle, and all antibacterial are all
There is certain toxicity, so the consumption of antibacterial should be minimal effective dose in preparation, meanwhile, for ensureing drug safety, finished product
In preparation, the valid density of antibacterial should be less than harmful concentration；Therefore, in the medicament research and development stage, inhibitory effect is studied
Should be used as the very important aspect of quality research.But, the research and development of current domestic preparation focuses on the pharmacological action of principal agent, dense
Degree and points for attention etc., reasonable employment and quality control to antibacterial but do not have enough attention.Version " middle traditional Chinese medicines in 2010
Allusion quotation " annex lists inhibitory effect inspection technique guideline, and the quality research to adding antibacterial in related preparations has been carried out by force
Mediation specification, 2015 " Chinese Pharmacopoeia " is classified as general rule " inhibitory effect inspection technique ", becomes and must do project.
At present, having the report much about preservative, correct selection with reasonable employment is to control oral liquid content of microorganisms
Pollute, reduce the premise of toxic and side effects with minimizing.Different preservative should be selected for different oral liquids in use, and examine
Consider its antiseptic effect and toxic action, reasonable compatibility.The prior consumption being intended to control well it, it is impossible to exceed regulation
Safety range, can add different preservative in a kind of oral liquid, and to reduce by the consumption of every kind, some preservative is in application
Time they are made sodium salt, potassium salt etc., can make part lack sodium, the patient of potassium element is supplemented.Also some preservative is forbidden
Apply in Children Oral Liquid medium, as benzyl alcohol is typically used as the preservative of injection, but owing to neonate can not turn effectively
Change benzoic acid, and the metabolite benzoic acid of benzyl alcohol, can the most gradually accumulate thus produce toxicity.Therefore, to this age
Group, the adjuvant in preparation prescription, should avoid selecting benzyl alcohol, in other age bracket children preparations, benzyl alcohol/benzoic acid/benzene
The use of sodium formate, need to conscientiously study and assess, and avoids as far as possible using, and strictly observes in domestic and international oral disposition liquid anti-
The regulation of rotten agent.
Before 8 years old child due to can't swallowable capsule and tablet well, liquid dosage form is best suitable for this age group
Virgin use.Adjuvant is despite without biological active substances, it is also possible to cause adverse effect.In child's body, some adjuvant
Adult and child's (especially Infant and neonates) may need to be paid special attention to its metabolism or elimination as in adult body
The difference of physiological condition, and the application of preservative is particularly important, avoids as far as possible using.
Hereinafter conventional several preservative (preservative) are mainly introduced in medicament:
1) oxybenzene esters: also referred to as parabens, is that P-hydroxybenzoic acid obtains through esterification with alcohol, and this type of is the anticorrosion that a class is excellent
Agent, nontoxic, tasteless, odorless, stable chemical nature, act on relatively strong in an acidic solution, in the range of pH3～8, be resistant to 100 DEG C
2h sterilizing.Conventional has methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben, butoben etc., and this class preservative compatibility makes
With there being synergism.Surfactant has solubilization to this class preservative, can increase its dissolubility in water, but not increase
Its Antifungal activity, even can weaken its antimicrobial acivity.
2) benzoic acid and salt thereof: for white crystals or powder, odorlessness or micro-scent of.The molecule that benzoic acid does not dissociates presses down
Bacterium effect is strong, therefore fungistatic effect is preferable in an acidic solution, and optimum pH is 4, and consumption is generally 0.1%～0.25%.Benzoic acid
Sodium and Potassium Benzoate just have bacteriostasis after having to transition to benzoic acid, and consumption is based on acid.Benzoic acid and benzoate are applicable to
Subacidity and neutral for oral administration and topical agent.Benzoic acid mildew-proof function is weak compared with parabens, anti-fermentability the most relatively Ni Bo
Gold class is strong, can be with parabens use in conjunction.
3) sorbic acid and salt thereof: for white to yellow-white crystalline powder, tasteless, has faint special odor.Sorbic acid
Antisepsis is the molecule not dissociated, therefore fungistatic effect is preferable in the aqueous solution that pH value is 4, typical concentrations be 0.05%～
0.2%.Sorbic acid and other preservative share generation synergism.This product poor stability, the most oxidized, the most especially
Sensitivity, can add suitable stabilizer, bacteriostatic activity can be made to reduce by plastic adherence during chance light more very.Potassium sorbate, calcium sorbate
Acting on identical with sorbic acid, in water, dissolubility is relatively big, need to use in an acidic solution, and consumption is based on acid.
4) benzalkonium bromide: also known as bromo geramine, cation type surfactant, for light yellow viscous liquid, during low temperature
Become waxy solid.Taste is the most bitter, has special smell, nonirritant, is dissolved in water and ethanol, and aqueous solution is alkalescence.This product is acid, alkaline molten
Liquid is stablized, resistance to hot pressing.To metal, rubber, the corrosion-free effect of plastics.Be served only in topical agent, concentration be 0.02%～
0.2%。
The most all kinds of preservative have respective pluses and minuses, but toxicity problem is common problem, are easily generated side effect clinically.
Summary of the invention
For problem above, the present invention provides a kind of antiseptic composition, it is adaptable to liquid pharmaceutical formulation, and said composition is prevented
Rotten respond well, and do not contain or contain only trace preservative, non-toxic and safe.
For solving above-mentioned technical problem, the present invention is realized by techniques below problem:
A kind of liquid pharmaceutical formulation antiseptic composition of design, including the raw material of following percentage by weight: 1,2-PD 2～
25%, glycerol 5～30%, sugar alcohol 45～75%, preservative 0～0.5%.
Wherein, at least one during described sugar alcohol is preferably sorbitol, mannitol and xylitol；Described preservative is preferably
At least one in oxybenzene esters, benzoic acid and salt thereof, sorbic acid and salt thereof.
The present invention can be used alone it can also be used in multiple dose pharmaceutical preparation, be used for strengthening the antibacterial effect of other preservative
Power, reduces the consumption of other preservative.
In a preferred embodiment of the present invention, described antiseptic composition includes: 1,2-PD 5%, glycerol 30%, mountain
Pears alcohol 55%, surplus is water.
The method utilizing foregoing preservatives compositions to prepare liquid pharmaceutical formulation, comprises the following steps:
(1) described preservative is added in described 1,2-PD, be heated to 60～65 DEG C, stirring and dissolving, obtained solution A；
(2) described sugar alcohol is added in suitable quantity of water, be heated to 60～65 DEG C, stirring and dissolving, obtained solution B；
(3) solution A is added solution B, then add described glycerol and other customary adjuvant, after stirring and dissolving, cool to 20
DEG C, add principal agent, use water constant volume, stir 30 minutes, filter, fill and get final product.
In the present composition is raw materials used:
The nontoxic low irritant of propylene glycol, in U.S.'s marketed products, its research on maximum utilized quantity is 91.50%.
Glycerol is naturally occurring in animal and plant fat and oil, can be digested as a part for usual food.
Glycerol is easily by intestinal absorption, and metabolism is carbon dioxide, glycogen, or compound body fat.Glycerol is widely used in being administered orally, eye,
Topical preparation, untoward reaction is mainly derived from the dehydration property of glycerol.Oral dose is the aperient relaxed, and heavy dose may be led
Cause headache, thirsty, nauseating and hyperglycemia, be slowly administered and have no toxicity.When using as adjuvant or food additive, it is considered that
Glycerol, without ill effect, is nontoxic, without excitatory material.In U.S.'s marketed products, its research on maximum utilized quantity is 30%.
Sorbitol is widely used in many formulation products, and is naturally occurring in much edible fruit and berry,
Its absorptance sucrose in the gastrointestinal tract is slow, mainly becomes fructose and glucose at liver metabolism, nontoxic.At U.S.'s marketed products
In, its research on maximum utilized quantity is 68%.
Said composition antifungal mechanism is: the sorbitol of high concentration has the biggest osmotic pressure, moisture content less, improper micro-life
The growth of thing, has the alcohols (glycerol and propylene glycol) of bacteriostasis simultaneously and can strengthen fungistatic effect, and alcohols and oxybenzene
Class preservative has collaborative fungistatic effect.
The present invention has a following positive beneficial effect:
The present composition is as the antiseptic composition made an addition in liquid pharmaceutical formulation, and each component had both coordinated potentiation, again
Can relax or reduce the toxicity of individual components (such as preservative), there is high-efficiency broad spectrum fungistatic effect on the whole, to P. aeruginosa
Bacterium, escherichia coli, staphylococcus aureus, Candida albicans and aspergillus niger all have inhibitory action, and secure threshold is higher, poison
Side reaction is few.
Detailed description of the invention
Technical solution of the present invention will be clearly and completely described below, it is clear that described embodiment is only this
Bright a part of embodiment rather than whole embodiments.
Embodiment one:
A kind of liquid pharmaceutical formulation anticorrosive composite, by weight percentage, is made up of following raw material: 1,2-PD 5%,
Glycerol 30%, sorbitol 55%.
Utilize its technique preparing liquid pharmaceutical formulation: weigh recipe quantity sorbitol and add in 30% configuration amount water, heat 60
～65 DEG C, stirring and dissolving, add other adjuvants such as glycerol, propylene glycol, essence, pH adjusting agent, stirring and dissolving, cool to 20 DEG C,
Add principal agent, use water constant volume, stir 30 minutes, filter, fill.
Embodiment two:
A kind of liquid pharmaceutical formulation antiseptic composition, by weight percentage, is made up of following raw material: 1,2-PD
5%, glycerol 20%, xylitol 45%.
It is utilized to prepare the technique of liquid pharmaceutical formulation with embodiment 1.
Embodiment three:
A kind of liquid pharmaceutical formulation antiseptic composition, by weight percentage, is made up of following raw material: 1,2-PD
25%, glycerol 5%, mannitol 70%.
It is utilized to prepare the technique of liquid pharmaceutical formulation with embodiment 1.
Embodiment four:
A kind of liquid pharmaceutical formulation antiseptic composition, by weight percentage, is made up of following raw material: 1,2-PD
2%, glycerol 23%, sorbitol 75%.
It is utilized to prepare the technique of liquid pharmaceutical formulation with embodiment 1.
Embodiment five:
A kind of liquid pharmaceutical formulation antiseptic composition, by weight percentage, is made up of following raw material: 1,2-PD
10%, glycerol 29.8%, sorbitol 60%, methyl hydroxybenzoate 0.18%, propyl hydroxybenzoate 0.02%.
Utilize its technique preparing liquid pharmaceutical formulation: methyl hydroxybenzoate and propyl hydroxybenzoate add recipe quantity propylene glycol (anhydrous)
In, heat 60 DEG C-65 DEG C, stirring and dissolving, obtained solution 1；Weigh recipe quantity sorbitol and add in 30% configuration amount water, heat 60
DEG C-65 DEG C, stirring and dissolving, obtained solution 2, solution 1 is added solution 2, other are auxiliary to add glycerol, essence, pH adjusting agent etc.
Material, stirring and dissolving, cool to 20 DEG C, add principal agent, use water constant volume, stir 30 minutes, filter, fill.
Embodiment six:
A kind of liquid pharmaceutical formulation antiseptic composition, by weight percentage, is made up of following raw material: 1,2-PD
20%, glycerol 29.8%, sorbitol 50%, benzoic acid 0.2%.
Utilize its technique preparing liquid pharmaceutical formulation: benzoic acid adds in recipe quantity propylene glycol (anhydrous), heat 60 DEG C-
65 DEG C, stirring and dissolving, obtained solution 1；Weigh recipe quantity sorbitol and add in 30% configuration amount water, heat 60 DEG C-65 DEG C, stirring
Dissolve, obtained solution 2, solution 1 is added solution 2, add other adjuvants such as glycerol, essence, pH adjusting agent, stirring and dissolving, fall
Temperature, to 20 DEG C, adds principal agent, uses water constant volume, stir 30 minutes, filters, fill.
Inhibitory effect is tested:
Carry out inhibitory effect experiment according to Chinese Pharmacopoeia four 1121 inhibitory effect inspection techniques of version in 2015, the results are shown in Table 1.
Table 1 inhibitory effect test result (CFU/ml)
Result of the test being compared with criterion, inhibitory effect result of the test is logical higher than " Chinese Pharmacopoeia version in 2015 " four
The then standard-required of table 2-3 in inhibitory effect inspection technique, and test shows adding after object bacteria, sample during 14d, 28d counting
Middle microorganism does not all increase, and illustrates that this sample bacteriostasis is relatively strong, and antibacterial system is effective, can guarantee that product is susceptible to microorganism
Pollute, it is ensured that product safe and effective.
The foregoing is only embodiments of the invention, not thereby limit the scope of the claims of the present invention, every utilize this
Equivalent structure or equivalence flow process that bright description is made convert, or are directly or indirectly used in other relevant technology neck
Territory, is the most in like manner included in the scope of patent protection of the present invention.
Claims (5)
1. a liquid pharmaceutical formulation antiseptic composition, it is characterised in that include the raw material of following percentage by weight: 1,2-
Propylene glycol 2～25%, glycerol 5～30%, sugar alcohol 45～75%, preservative 0～0.5%.
Antiseptic composition the most according to claim 1, it is characterised in that: described sugar alcohol is sorbitol, mannitol and wood
At least one in sugar alcohol.
Antiseptic composition the most according to claim 1, it is characterised in that: described preservative is oxybenzene esters, benzoic acid
And at least one in salt, sorbic acid and salt thereof.
Antiseptic composition the most according to claim 1, it is characterised in that include the raw material of following percentage by weight: 1,
2-propylene glycol 5%, glycerol 30%, sorbitol 55%, surplus is water.
5. the method utilizing antiseptic composition described in claim 1 to prepare liquid pharmaceutical formulation, comprises the following steps:
(1) described preservative is added in described 1,2-PD, be heated to 60～65 DEG C, stirring and dissolving, obtained solution A；
(2) described sugar alcohol is added in suitable quantity of water, be heated to 60～65 DEG C, stirring and dissolving, obtained solution B；
(3) solution A is added solution B, then add described glycerol and other customary adjuvant, after stirring and dissolving, cool to 20
DEG C, add principal agent, use water constant volume, stir 30 minutes, filter, fill and get final product.
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| CN201610642831.8A CN106237337B (en) | 2016-08-05 | 2016-08-05 | A kind of liquid pharmaceutical formulation anticorrosive composite |
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| CN104000283A (en) * | 2014-06-16 | 2014-08-27 | 太仓市荣德生物技术研究所 | Preservative added into foods |
| CN104224923A (en) * | 2014-07-07 | 2014-12-24 | 海南华拓天涯制药有限公司 | Tea tree essential oil antimicrobial gel for treating vaginal disease in gynecology |
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|---|---|---|---|---|
| CN1857197A (en) * | 2006-03-10 | 2006-11-08 | 贵州宏宇药业有限公司 | Oral cavity cleaning bacteriostat and its preparing process |
| CN1903165A (en) * | 2006-08-03 | 2007-01-31 | 迪庆香格里拉舒达有机食品有限公司 | Skin-care cream made of wild walnut oil and its prepn. method |
| CN101959500A (en) * | 2008-03-17 | 2011-01-26 | 爱尔康研究有限公司 | Aqueous pharmaceutical compositions containing borate-polyol complexes |
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| CN106237337B (en) | 2019-11-08 |
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