CN110652493A - Method for improving stability of bioactive peptide emulsifiable paste - Google Patents
Method for improving stability of bioactive peptide emulsifiable paste Download PDFInfo
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- CN110652493A CN110652493A CN201911050433.7A CN201911050433A CN110652493A CN 110652493 A CN110652493 A CN 110652493A CN 201911050433 A CN201911050433 A CN 201911050433A CN 110652493 A CN110652493 A CN 110652493A
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
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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
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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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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Abstract
The invention relates to a method for increasing the stability of bioactive peptide emulsifiable paste, which is characterized in that on the basis of the primary screening of an emulsifiable paste matrix formula, the emulsification process conditions are determined to be that the homogenization revolution is 1.5-4.5 Kr/min, the homogenization temperature is 78-85 ℃ and the homogenization time is 5-25 min, the size of an emulsification ball of the emulsifiable paste is initially controlled to be 4-8 mu m, then the dosage of a thickening agent is adjusted to be 0.5-2.5 percent and the dosage of an auxiliary emulsifying agent is adjusted to be 1-3 percent, and finally the size of the emulsification ball of the emulsifiable paste is adjusted to be 2-7 mu m. Finally, adding the dissolved bioactive peptide into the initially formed cream matrix, slowly stirring, and naturally cooling to obtain the cream. The cream prepared by the method has good stability, the physiological function of the bioactive peptide is retained to the maximum extent, the storage period of the cream is 2-3 years, and the content of the functional components of the cream is stable and is more than 22 mug/mL. The cream has simple production process, low production cost and good industrialization prospect.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a method for improving the stability of a bioactive peptide emulsifiable paste.
Background
The preparation method of the cream mainly comprises a split-phase mixing method, a mixing method, an emulsifier postaddition method and the like. The split-phase mixing method is commonly used in hospitals to prepare the cream, the operation of the method is simple, but the stability of the finished product needs to be improved. Moreover, the dosage level of the polypeptide drugs is generally at the level of mug and ng, and by adopting the method, the phenomenon of uneven distribution of the polypeptide drugs can be caused, and the physiological function of the bioactive peptide can be damaged due to excessive shearing, so that the cream can not achieve the ideal treatment effect. Moreover, when the cream is stored, the efficacy of the cream is reduced due to the instability of the cream, which not only affects the illness state of patients, but also brings economic loss to enterprises and patients.
Disclosure of Invention
In order to make up for the above deficiencies, the present invention aims to provide a method for increasing the stability of a bioactive peptide cream. The method can improve the uniformity of active polypeptide distribution in the cream, and improve the stability of polypeptide cream, thereby improving the storage time of cream under daily living conditions. Also provides a new idea for preparing the polypeptide cream.
The invention relates to a method for improving the stability of bioactive peptide emulsifiable paste, which adopts the technical scheme for solving the technical problem that the method comprises the following steps:
homogenizing raw materials and adjuvants, thickener and auxiliary emulsifier at homogenizing speed of 1.5-4.5 Kr/min and homogenizing temperature of 78-85 deg.C for 5-25 min, and mixing to obtain cream; when the cream matrix is initially formed, polypeptide aqueous solution with concentration less than 0.2% is added, and then the mixture is stirred to be uniform and naturally cooled to obtain the cream.
The raw and auxiliary materials comprise the following raw materials in percentage by mass: 1-2% of glycerin, 1-2% of propylene glycol, 0.2-0.3% of diazolidinyl urea, 1-2% of tween 20, 79-91% of deionized water, 0.1-0.5% of carbomer, 1-3% of white vaseline, 1-3% of octadecanol, 1-4% of anhydrous lanolin, 1-3% of coconut oil, 1-2% of span 85 and 0.1-0.5% of triethanolamine, wherein the sum of the mass fractions of the above raw materials is 100%.
The thickening agent belongs to one of cp-941, cp-934, cp-940, sodium carboxymethyl cellulose, gum arabic, guar gum, xanthan gum, agar, gelatin, sodium alginate, pectin and propylene glycol alginate, and the addition amount of the thickening agent is 0.5-2.5% of the total mass of the raw and auxiliary materials.
The auxiliary emulsifier belongs to one of octadecanol, hexadecanol, polyethylene glycol and monostearyl fatty acid glyceride, and the addition amount of the auxiliary emulsifier is 1-3% of the total mass of the raw and auxiliary materials.
The addition amount of bioactive peptide is less than 0.2%.
The method for improving the stability of the bioactive peptide emulsifiable paste adopts an emulsifying machine of a common experimental grade, and raw materials used in the method can be purchased and obtained from markets.
The invention has the following remarkable advantages: the invention fully utilizes the physical properties of the bioactive peptide, and ensures the uniformity of the polypeptide distribution in the cream by preparing the excellent oil-in-water cream matrix carrier and adding the functional components. The cream has bright milky appearance, easy spreading, and no odor. Under normal storage conditions, the cream has a shelf life of up to 24 months and its appearance is unchanged. The preparation method remarkably improves the stability and uniformity of the polypeptide cream, and can provide a thought for the subsequent research thereof.
Drawings
FIG. 1 is the microscope result picture of the bioactive peptide cream finished product.
FIG. 2 is the diagram of the finished bioactive peptide cream.
Detailed Description
The following examples illustrate a method of increasing the stability of a bioactive peptide cream of the present invention.
Example 1
1 mg bioactive peptide (dissolved by reserved 20% deionized water), 5mL of glycerol, 5mL of propylene glycol, 1.5 mL of diazolidinyl urea, 10 g of white vaseline, 5 g of octadecanol, 15 g of anhydrous lanolin, 10 g of coconut oil, 1 g of carbomer, 1 mL of triethanolamine, 5mL of span 85, 5mL of Tween 20 and 449 mL of deionized water, wherein the homogenization time is 15 min, the homogenization revolution is 3 Kr/min, and the homogenization temperature is 80 ℃.
In the embodiment 1, 5 g of octadecanol is selected, the particle size of the prepared emulsifiable paste ball is 3.24 μm, the roundness and uniformity of the emulsifiable paste ball are poor, the viscosity of the emulsifiable paste is proper, and the emulsifiable paste has a good appearance. The cream is placed in a screw-cap glass bottle and is placed for 24 months under normal conditions, the hardness of the cream is not increased compared with 0 month, no caking phenomenon occurs, and the applicability is good. The cream in the upper part, the middle part and the lower part of the glass bottle is extracted, and the functional components in the finished cream product are detected, and the result shows that the contents of the bioactive peptides in the three samples are all 2 mu g/mL, and the functional components are uniformly distributed.
Example 2
1 mg bioactive peptide (dissolved by reserved 20% deionized water), 5mL of glycerol, 5mL of propylene glycol, 1.5 mL of diazolidinyl urea, 10 g of white vaseline, 10 g of octadecanol, 15 g of anhydrous lanolin, 10 g of coconut oil, 1 g of carbomer, 1 mL of triethanolamine, 5mL of span 85, 5mL of Tween 20 and 449 mL of deionized water, wherein the homogenization time is 15 min, the homogenization revolution is 3 Kr/min, and the homogenization temperature is 80 ℃.
Example 2 the dosage of the octadecanol is 10 g, the particle size of the emulsion ball of the cream is 3.44 μm, the roundness and uniformity of the emulsion ball and the viscosity of the cream are better than those of example 1. The cream is placed in a screw-cap glass bottle and is placed for 24 months under normal conditions, the hardness of the cream is not increased compared with 0 month, no caking phenomenon occurs, and the applicability is good. The cream in the upper part, the middle part and the lower part of the glass bottle is extracted, and the functional components in the finished cream product are detected, and the result shows that the contents of the bioactive peptides in the three samples are all 2 mu g/mL, and the functional components are uniformly distributed.
Example 3
1 mg bioactive peptide (dissolved by reserved 20% deionized water), 5mL of glycerol, 5mL of propylene glycol, 1.5 mL of diazolidinyl urea, 10 g of white vaseline, 15 g of octadecanol, 15 g of anhydrous lanolin, 10 g of coconut oil, 1 g of carbomer, 1 mL of triethanolamine, 5mL of span 85, 5mL of Tween 20 and 449 mL of deionized water, wherein the homogenization time is 15 min, the homogenization revolution is 3 Kr/min, and the homogenization temperature is 80 ℃.
In example 3, the dosage of the octadecanol is 15 g, the particle size of the emulsion ball of the cream is 2.54 μm, the roundness and uniformity of the emulsion ball and the viscosity of the cream are poorer than those of the cream in examples 1 and 2. The cream is placed in a screw-cap glass bottle and is placed for 24 months under normal conditions, the hardness of the cream is increased compared with 0 month, the phenomenon of slight caking appears, the applicability is poor, and the cream is not easy to smear. The cream in the upper part, the middle part and the lower part of the glass bottle is extracted, and the functional components in the finished cream product are detected, and the result shows that the contents of the bioactive peptides in the three samples are all 2 mu g/mL, and the functional components are uniformly distributed.
Example 4
1 mg bioactive peptide (dissolved by reserved 20% deionized water), 5mL of glycerol, 5mL of propylene glycol, 1.5 mL of diazolidinyl urea, 10 g of white vaseline, 20 g of octadecanol, 15 g of anhydrous lanolin, 10 g of coconut oil, 1 g of carbomer, 1 mL of triethanolamine, 5mL of span 85, 5mL of Tween 20 and 449 mL of deionized water, wherein the homogenization time is 15 min, the homogenization revolution is 3 Kr/min, and the homogenization temperature is 80 ℃.
In example 4, the dosage of the octadecanol is 20 g, the particle size of the emulsion ball of the cream is 2.14 μm, the roundness and uniformity of the emulsion ball and the viscosity of the cream are poor, and the cream is poor in examples 1, 2 and 3. The cream is placed in a screw-cap glass bottle and is placed for 24 months under normal conditions, the hardness of the cream is increased compared with 0 month, the caking phenomenon occurs, the cream is coarsened and is not easy to smear, and the applicability is poor. The cream in the upper part, the middle part and the lower part of the glass bottle is extracted, and the functional components in the finished cream product are detected, and the result shows that the contents of the bioactive peptides in the three samples are all 2 mu g/mL, and the functional components are uniformly distributed.
Example 5
1 mg bioactive peptide (dissolved by reserved 20% deionized water), 5mL of glycerol, 5mL of propylene glycol, 1.5 mL of diazolidinyl urea, 10 g of white vaseline, 25 g of octadecanol, 15 g of anhydrous lanolin, 10 g of coconut oil, 1 g of carbomer, 1 mL of triethanolamine, 5mL of span 85, 5mL of Tween 20 and 449 mL of deionized water, wherein the homogenization time is 15 min, the homogenization revolution is 3 Kr/min, and the homogenization temperature is 80 ℃.
In example 5, the amount of octadecanol used is 25 g, the particle size of the emulsion ball of the cream is 2.04 μm, the roundness and uniformity of the emulsion ball and the viscosity of the cream are inferior to those of examples 1, 2 and 3, but the same is almost the same as example 4. The cream is placed in a screw-cap glass bottle and is placed for 24 months under normal conditions, the hardness of the cream is increased compared with 0 month, the phenomenon of agglomeration occurs, the cream is coarsened, the cream is not easy to smear, and the applicability is poor. The cream in the upper part, the middle part and the lower part of the glass bottle is extracted, and the functional components in the finished cream product are detected, and the result shows that the contents of the bioactive peptides in the three samples are all 2 mu g/mL, and the functional components are uniformly distributed.
The embodiment described above is not all embodiments of the present invention, and the detailed description of the embodiment is not intended to limit the present invention, but only shows selected embodiments of the present invention. Those skilled in the art can now appreciate that many changes can be made to the embodiments described above.
Claims (5)
1. A method of increasing the stability of a bioactive peptide cream, characterized by: the method comprises the following steps: homogenizing raw materials and adjuvants, thickener and auxiliary emulsifier at homogenizing speed of 1.5-4.5 Kr/min and homogenizing temperature of 78-85 deg.C for 5-25 min, and mixing to obtain cream; when the cream matrix is initially formed, polypeptide aqueous solution with concentration less than 0.2% is added, and then the mixture is stirred to be uniform and naturally cooled to obtain the cream.
2. The method of claim 1, wherein the bioactive peptide cream is selected from the group consisting of: the raw and auxiliary materials comprise the following raw materials in percentage by mass: 1-2% of glycerin, 1-2% of propylene glycol, 0.2-0.3% of diazolidinyl urea, 1-2% of tween 20, 79-91% of deionized water, 0.1-0.5% of carbomer, 1-3% of white vaseline, 1-3% of octadecanol, 1-4% of anhydrous lanolin, 1-3% of coconut oil, 1-2% of span 85 and 0.1-0.5% of triethanolamine, wherein the sum of the mass fractions of the above raw materials is 100%.
3. The method of claim 1, wherein the bioactive peptide cream is selected from the group consisting of: the thickening agent belongs to one of cp-941, cp-934, cp-940, sodium carboxymethyl cellulose, gum arabic, guar gum, xanthan gum, agar, gelatin, sodium alginate, pectin and propylene glycol alginate, and the addition amount of the thickening agent is 0.5-2.5% of the total mass of the raw and auxiliary materials.
4. The method of claim 1, wherein the bioactive peptide cream is selected from the group consisting of: the auxiliary emulsifier belongs to one of octadecanol, hexadecanol, polyethylene glycol and monostearyl fatty acid glyceride, and the addition amount of the auxiliary emulsifier is 1-3% of the total mass of the raw and auxiliary materials.
5. The method of claim 1, wherein the bioactive peptide cream is selected from the group consisting of: the addition amount of bioactive peptide is less than 0.2%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201911050433.7A CN110652493A (en) | 2019-10-31 | 2019-10-31 | Method for improving stability of bioactive peptide emulsifiable paste |
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| CN201911050433.7A CN110652493A (en) | 2019-10-31 | 2019-10-31 | Method for improving stability of bioactive peptide emulsifiable paste |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0038511A2 (en) * | 1980-04-17 | 1981-10-28 | Rolf Dr. Schäfer | Wound healing compositions |
| EP0205051A1 (en) * | 1985-05-30 | 1986-12-17 | ZAMBON S.p.A. | A pharmaceutical composition in the form of a cream for dermal and ophthalmic use |
| CN107823637A (en) * | 2017-11-29 | 2018-03-23 | 安徽中医药大学 | A kind of leech peptide albumen cream and its preparation method and application |
-
2019
- 2019-10-31 CN CN201911050433.7A patent/CN110652493A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0038511A2 (en) * | 1980-04-17 | 1981-10-28 | Rolf Dr. Schäfer | Wound healing compositions |
| EP0205051A1 (en) * | 1985-05-30 | 1986-12-17 | ZAMBON S.p.A. | A pharmaceutical composition in the form of a cream for dermal and ophthalmic use |
| CN107823637A (en) * | 2017-11-29 | 2018-03-23 | 安徽中医药大学 | A kind of leech peptide albumen cream and its preparation method and application |
Non-Patent Citations (2)
| Title |
|---|
| 喻维新，等: "《药师手册》", 31 July 2019, 中国医药科技出版社 * |
| 陈翠环等: "不同工艺对配制新康松乳膏质量的影响", 《实用医技杂志》 * |
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Application publication date: 20200107 |