CN110812326A - Simvastatin suspension emulsion and preparation method and application thereof - Google Patents
Simvastatin suspension emulsion and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a simvastatin suspension emulsion and a preparation method and application thereof, the components comprise simvastatin, a surfactant, an emulsifier, a sustained-release agent, an antioxidant, a preservative and the balance of water for injection, according to the preparation process of the simvastatin pharmaceutical combination microcapsule preparation, the simvastatin is firstly prepared into a microcapsule structure with a slow release function, and then is mixed with other auxiliary agents to prepare a suspension emulsion, the surfactant and the emulsifier have the advantages of a suspension and an emulsion, the effective dosage of simvastatin in the carrier is increased, the simvastatin quickly reaches a target organ after intramuscular injection, the effective blood concentration of the target organ is maintained for a long time, the slow release function of the microcapsule structure prolongs the half life of the medicine, the bioavailability of the medicine is increased, the administration frequency is reduced, the toxic and side effects of the medicine are reduced, and most importantly, the simvastatin is free of antibiotic residues, so that the simvastatin has a wide clinical application prospect.
Description
Technical Field
The invention relates to the field of veterinary medicine, in particular to a simvastatin suspension emulsion and a preparation method and application thereof.
Background
Mastitis is one of three diseases which are harmful to the health of dairy cows, the number of somatic cells of the diseased dairy cows is increased, the milk yield and the milk quality are reduced, and in the past treatment, antibiotic medicines are mostly adopted, but improper application and abuse of antibiotics can cause the medicine residues in milk to influence the milk quality, and can also cause a large amount of drug-resistant strains to be generated, so that the subsequent treatment failure is caused, and the health of dairy users is harmed.
In the prior art, most of substitution schemes aiming at antibiotic drug treatment means are traditional Chinese medicine compositions, traditional Chinese medicine compositions are improved, mastitis vaccines and yolk antibodies are developed to prevent diseases, but because the traditional Chinese medicine compositions, the vaccines and the like have poor effects, the treatment failure with high probability is caused, and cows are eliminated, so that the development of non-antibiotic drugs with strong specificity, low toxicity and low residue to prevent and treat mastitis of cows is a main direction for preventing and treating mastitis of cows in future.
The statin medicine belongs to a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, is the most effective lipid-lowering medicine at present, can not only strongly reduce Total Cholesterol (TC) and low-density lipoprotein (LDL), but also reduce Triacylglycerol (TG) and increase high-density lipoprotein (HDL) to a certain extent, is mainly used for treating human atherosclerosis clinically, and is the most effective medicine for preventing and treating coronary heart disease at present. In recent years, the research shows that the statins have the effects of alleviating rejection after organ transplantation, treating osteoporosis, resisting tumors, resisting senile dementia and the like besides the lipid-lowering effect, and also have the effects of resisting inflammation, regulating body immunity, resisting oxidation, resisting bacteria activity and resisting coagulation.
Simvastatin is the most commonly used blood fat reducing drug in statins at present, and in vitro experimental research shows that simvastatin has an obvious inhibiting and killing effect on staphylococcus aureus and escherichia coli, pathogenic bacteria of cow mastitis, and the inhibiting and killing effect is obviously higher than that of a clinically commonly used antibiotic, and based on the high antibacterial activity of simvastatin except for reducing blood fat, the simvastatin can replace part of antibiotics in prevention and treatment of cow mastitis. However, simvastatin is good in lipophilic property and poor in hydrophilicity, so that the current pharmacopoeia collection is limited to tablets and capsules, the effective dose is low, but after raw powder of simvastatin is directly prepared into a water-soluble injection for animal intramuscular injection, the stimulation is large, the medicine absorption is not good, adverse reactions are easily caused, and the requirements of industrial production and clinical medication cannot be met. Therefore, the problem to be solved by those skilled in the art is how to provide a simvastatin pharmaceutical composition with high effective drug content, low irritation and high drug utilization rate in other dosage forms.
Disclosure of Invention
In view of the above, the invention provides a simvastatin suspension emulsion and a preparation method thereof, according to the pharmaceutical properties of simvastatin and the preparation process, the simvastatin suspension emulsion is prepared by adding a surfactant, an emulsifier and a stabilizer, so that the simvastatin suspension emulsion has the advantages of the suspension and the emulsion, the effective dosage of simvastatin in a carrier is increased, the simvastatin quickly reaches a target organ after intramuscular injection, the effective blood concentration of the target organ is maintained for a long time, the half-life period of a medicament is prolonged, the bioavailability of the medicament is increased, the administration frequency is reduced, the toxic and side effects of the medicament are reduced, and no antibiotic residue is generated.
In order to achieve the purpose, the invention adopts the following technical scheme:
firstly, the invention provides a simvastatin suspension emulsion which is characterized by comprising the following components in percentage by weight: simvastatin 5-25%, surfactant 1-5%, emulsifier 2-5%, sustained release agent 6-8%, antioxidant 0.5%, preservative 0.005%, and the balance of water for injection.
Preferably, the paint comprises the following components in percentage by weight: 10 to 20 percent of simvastatin, 3.5 to 4.5 percent of surfactant, 2.5 to 3.5 percent of emulsifier, 7 percent of sustained-release agent, 0.5 percent of antioxidant, 0.005 percent of preservative and the balance of water for injection.
Preferably, the surfactant is one or a mixture of sodium dodecyl sulfate, stearic acid and secondary alkyl sodium sulfonate.
Preferably, the emulsifier is one or a mixture of several of lauric acid monoglyceride, polyoxyethylene lauryl ether and water.
Preferably, the slow release agent is one or a mixture of more of sodium alginate, sodium carboxymethylcellulose and chitin.
Preferably, the antioxidant is one of SOD and CAT.
Preferably, the preservative is one of chlorobutanol, sodium benzoate and o-phenylphenol.
The invention also provides a preparation method of the simvastatin suspension emulsion in the technical scheme, which comprises the following steps:
adding the slow release agent into part of water for injection, stirring and heating to 60-80 ℃ until the slow release agent is melted to form a stable prepolymer solution, then adding the simvastatin into the prepolymer solution, fully shearing, stirring and dispersing the simvastatin into superfine particles, continuing heating to 60-80 ℃ until the particles form microcapsules, then adding the emulsifier, the surfactant, the antioxidant, the preservative and the balance of water, and uniformly stirring to obtain the simvastatin suspension emulsion.
The invention also provides application of the simvastatin suspension emulsion in the technical scheme, namely application of the simvastatin suspension emulsion in treatment of cow mastitis.
According to the technical scheme, compared with the prior art, the simvastatin suspension emulsion and the preparation method and application thereof are disclosed, according to the pharmaceutical properties of the simvastatin and the preparation process of a microcapsule preparation, the simvastatin is firstly prepared into a microcapsule structure with a slow release function, and then the microcapsule structure is mixed with other auxiliary agents to prepare the suspension emulsion, wherein the surfactant and the emulsifier have the advantages of a suspension and an emulsion, the effective dosage of the simvastatin in a carrier is increased, the simvastatin quickly reaches a target organ after intramuscular injection, the effective blood concentration of the target organ is maintained for a long time, the slow release function of the microcapsule structure prolongs the half-life of a medicament, the bioavailability of the medicament is improved, the administration frequency is reduced, the toxic and side effects of the medicament are reduced, most importantly, no antibiotic medicine residue exists, and the simvastatin suspension emulsion has a wide clinical application.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
The preparation method of the simvastatin suspension emulsion specifically adopts the following process:
adding the slow release agent into part of water for injection, stirring and heating to 60-80 ℃ until the slow release agent is melted to form a stable prepolymer solution, then adding the simvastatin into the prepolymer solution, fully shearing, stirring and dispersing the simvastatin into superfine particles, continuing heating to 60-80 ℃ until the particles form microcapsules, then adding the emulsifier, the surfactant, the antioxidant, the preservative and the balance of water, and uniformly stirring to obtain the simvastatin suspension emulsion.
Example 2
By adopting the preparation process of the embodiment 1, the specific raw materials and components are as follows based on the preparation amount of 1L of the medicine:
simvastatin 50mL, sodium dodecyl sulfate 10mL, lauric acid monoglyceride 20mL, sodium alginate 60mL, SOD5mL and chlorobutanol 0.05mL, and the balance being water for injection.
Example 3
By adopting the preparation process of the embodiment 1, the specific raw materials and components are as follows based on the preparation amount of 1L of the medicine:
simvastatin 100mL, stearic acid 30mL, polyoxyethylene lauryl ether 25mL, sodium carboxymethylcellulose 62mL, CAT5mL and sodium benzoate 0.05mL, and the balance of water for injection.
Example 4
By adopting the preparation process of the embodiment 1, the specific raw materials and components are as follows based on the preparation amount of 1L of the medicine:
simvastatin 150mL, secondary alkyl sodium sulfonate 40mL, water 30mL, chitin 70mL, CAT5mL, o-phenylphenol 0.05mL, and the balance of water for injection.
Example 5
By adopting the preparation process of the embodiment 1, the specific raw materials and components are as follows based on the preparation amount of 1L of the medicine:
200mL of simvastatin, 45mL of mixture of sodium dodecyl sulfate, stearic acid and secondary alkyl sodium sulfonate in any proportion, 35mL of mixture of lauric acid monoglyceride, polyoxyethylene lauryl ether and water in any proportion, 80mL of mixture of sodium alginate, sodium carboxymethylcellulose and chitin in any proportion, 0.05mL of CAT5mL and o-phenylphenol in any proportion, and the balance of water for injection.
Example 6
250mL of simvastatin, 50mL of mixture of sodium dodecyl sulfate and stearic acid in any proportion, 50mL of mixture of lauric acid monoglyceride and polyoxyethylene lauryl ether in any proportion, 80mL of mixture of sodium alginate and sodium carboxymethyl cellulose in any proportion, 5mL of CAT and 0.05mL of o-phenylphenol, and the balance of water for injection.
Example 7
200mL of simvastatin, 45mL of a mixture of sodium dodecyl sulfate and secondary alkyl sulfonate in any proportion, 35mL of a mixture of lauric acid monoglyceride and water in any proportion, 80mL of a mixture of sodium alginate and chitin in any proportion, 5mL of CAT and 0.05mL of o-phenylphenol, and the balance of water for injection.
Example 8
200mL of simvastatin, 45mL of a mixture of stearic acid and secondary alkyl sodium sulfonate in any proportion, 35mL of a mixture of lauryl alcohol polyoxyethylene ether and water in any proportion, 80mL of a mixture of sodium carboxymethylcellulose and chitin in any proportion, 5mL of CAT and 0.05mL of o-phenylphenol in any proportion, and the balance of water for injection.
Test examples
The medicines prepared by adopting the raw materials of the embodiments 2-8 are marked as A2, A3, A4, A5, A6, A7 and A8 in sequence, common antibiotic medicines in the prior art are used as a comparative experiment 1, the number is B1, traditional Chinese medicine composition medicines in the prior art are used as a comparative experiment 2, the number is B2, an injection vaccine is used as a comparative experiment 3, and the number is B3;
b3 is injected into healthy cows, A2, A3, A4, A5, A6, A7, A8, B1 and B2 act on the cows with the same mastitis inflammation condition respectively in equivalent dose until the inflammation of the cows disappears, and the results show that the cows injected with A2, A3, A4, A5, A6, A7 and A8 can be cured after being injected for 3 times, and no drug residue is found in the cow milk after the milk quality detection; the dairy cows treated by B1 are also cured after being injected for 3 times, but after the milk quality detection, a large amount of drug residues are found in the dairy cows; the cow with B2 has symptoms relieving after 5 injections, and has slow treatment process and medicine component secretion in milk.
Continuously culturing the cows cured by injecting A2, A3, A4, A5, A6, A7, A8 and B1, wherein the cows cured by injecting A4, A5, A6, A7 and A8 have no related disease relapse, and the cows cured by injecting A2 and A3 have slight relapse and are respectively cured by injecting A2 and A3 in equal amount; the recurrence of the cow cured by B1 injection is serious, no obvious effect is generated after B1 injection treatment is adopted again, and no obvious effect of promoting cure is generated after the injection dosage is increased, which indicates that related germs have drug resistance.
The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other. The device disclosed by the embodiment corresponds to the method disclosed by the embodiment, so that the description is simple, and the relevant points can be referred to the method part for description.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (9)
1. Simvastatin suspension emulsion is characterized by comprising the following components in percentage by weight: simvastatin 5-25%, surfactant 1-5%, emulsifier 2-5%, sustained release agent 6-8%, antioxidant 0.5%, preservative 0.005%, and the balance of water for injection.
2. The simvastatin suspension emulsion according to claim 1, comprising the following components in percentage by weight: 10 to 20 percent of simvastatin, 3.5 to 4.5 percent of surfactant, 2.5 to 3.5 percent of emulsifier, 7 percent of sustained-release agent, 0.5 percent of antioxidant, 0.005 percent of preservative and the balance of water for injection.
3. The simvastatin suspension emulsion according to claim 1 or 2, wherein the surfactant is one or a mixture of sodium dodecyl sulfate, stearic acid and secondary alkyl sodium sulfonate.
4. The simvastatin suspension emulsion according to claim 1 or 2, wherein the emulsifier is one or a mixture of lauric acid monoglyceride, polyoxyethylene lauryl ether and water.
5. The simvastatin suspension emulsion according to claim 1 or 2, wherein the sustained-release agent is one or a mixture of sodium alginate, sodium carboxymethylcellulose and chitin.
6. The simvastatin suspension emulsion according to claim 1 or 2, wherein the antioxidant is one of SOD and CAT.
7. The simvastatin suspension emulsion according to claim 1 or 2, wherein the preservative is one of chlorobutanol, sodium benzoate and o-phenylphenol.
8. A process for preparing the simvastatin suspension emulsion of claims 1-7, comprising the steps of:
adding the slow release agent into part of water for injection, stirring and heating to 60-80 ℃ until the slow release agent is melted to form a stable prepolymer solution, then adding the simvastatin into the prepolymer solution, fully shearing, stirring and dispersing the simvastatin into superfine particles, continuing heating to 60-80 ℃ until the particles form microcapsules, then adding the emulsifier, the surfactant, the antioxidant, the preservative and the balance of water, and uniformly stirring to obtain the simvastatin suspension emulsion.
9. Use of the simvastatin suspension emulsion of claims 1-7 for the treatment of bovine mastitis.
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2019
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| CN101431982A (en) * | 2006-04-26 | 2009-05-13 | 罗斯蒙特制药有限公司 | Liquid oral compositions |
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| CN103315960A (en) * | 2012-03-19 | 2013-09-25 | 胡容峰 | Solid self-microemulsion based on spherical crystallization technique and preparation method thereof |
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| 周庆民等: "奶牛乳房炎防治现状", 《今日畜牧兽医》 * |
| 孟健等: "辛伐他汀微乳的制备及犬体内药物动力学", 《中国医药工业杂志》 * |
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