CN113197869A - Famotidine freeze-dried powder injection for injection and preparation method thereof - Google Patents
Famotidine freeze-dried powder injection for injection and preparation method thereof Download PDFInfo
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- CN113197869A CN113197869A CN202110393782.XA CN202110393782A CN113197869A CN 113197869 A CN113197869 A CN 113197869A CN 202110393782 A CN202110393782 A CN 202110393782A CN 113197869 A CN113197869 A CN 113197869A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/426—1,3-Thiazoles
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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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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
Abstract
The invention relates to the technical field of medicines, and provides a famotidine freeze-dried powder injection for injection, which comprises, by weight, 1-10 parts of famotidine, 1-20 parts of an emulsifier, 10-100 parts of oil for injection, 0.01-1 part of a stabilizer and 1-30 parts of a freeze-drying protective agent. By adopting the technical scheme, the problems of solubility and stability of famotidine in the prior art are solved.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to a famotidine freeze-dried preparation for injection and a preparation method thereof.
Background
The chemical name of famotidine is: [ 1-amino-3- [ [ [2- [ (diaminomethylene) amino group]-4-thiazolyl) -methyl) thio]Propylene radical]Sulfonamide, of formula: c8H15N7O2S3Molecular weight: 337.45. the product is suitable for upper gastrointestinal hemorrhage due to peptic ulcer, and gastric and duodenal mucosa erosion hemorrhage due to various reasons except tumor, esophageal varices and gastric fundus varices. The famotidine for injection produced by the common method has poor stability, is prolonged along with the storage time, and obviously reduces the product quality; unqualified items are mainly expressed as properties, clarity of solution, related substances, visible foreign matters and the like; meanwhile, famotidine has the problem of difficult dissolution, and the product is slightly soluble in methanol, is very slightly soluble in acetone and is almost insoluble in water or trichloromethane; it is soluble in glacial acetic acid. Aiming at the problems of stability and solubility of famotidine, related patents provide a certain solution, firstly, an acid substance is added to react with famotidine to produce a salt compound to increase the solubility of the compound, for example, the preparation method of famotidine injection (patent application No. CN201310245628.3) adopts aspartic acid to increase the solubility of famotidine, although the solution solves the solubility problem, the long-term stability still has problems, and the conditions of clarity of the solution, related substances and unqualified visible foreign matters are easy to occur; secondly, adding inclusion agents such as glyceryl behenate, sulfobutylether-beta-cyclodextrin and the like to prepare the inclusion compound, for example, the method for preparing the famotidine sodium chloride injection by the inclusion method and the product thereof (patent application No. CN201110175837.6) and the famotidine inclusion compound and the preparation method thereof (patent application No. CN201310680977.8) solve the problems of solubility and stability of famotidine at the same time, but the famotidine needs to be dissolved in a certain solvent (such as glacial acetic acid) during preparation, and then the famotidine needs to be added into the solvent to prepare the inclusion compoundThe preparation method has the problems of complex operation, easy cross contamination, microbial contamination and the like.
Disclosure of Invention
The invention provides a famotidine freeze-dried powder injection for injection and a preparation method thereof, which solve the problems of solubility and stability of famotidine in the prior art.
The technical scheme of the invention is as follows:
a famotidine freeze-dried powder injection for injection comprises, by weight, 1-10 parts of famotidine, 1-20 parts of an emulsifier, 10-100 parts of oil for injection, 0.01-1 part of a stabilizer and 1-30 parts of a freeze-drying protective agent.
As a further technical scheme, the oil for injection comprises one or more of soybean oil, hydrogenated soybean oil, corn oil, olive oil and peanut oil.
As a further technical scheme, the emulsifier comprises one or more of hydrogenated lecithin, soybean lecithin, egg yolk lecithin and tween.
As a further technical scheme, the stabilizing agent comprises one or more of oleic acid, sodium oleate, cholic acid, sodium sulfite, sodium bisulfite and sodium ascorbate.
As a further technical scheme, the freeze-drying protective agent comprises one or more of glycine, mannitol, glucose, lactose and levo-glucoside.
As a further technical scheme, the water treatment agent also comprises an acidity regulator, wherein the acidity regulator comprises one or more of hydrochloric acid, phosphoric acid, citric acid, sodium hydroxide, phosphate and citrate.
As a further technical scheme, the osmotic pressure regulator also comprises an isotonic regulator, wherein the isotonic regulator comprises one or more of glycerol, sodium chloride and glucose and is used for regulating the osmotic pressure.
The application also provides a preparation method of the famotidine freeze-dried powder injection for injection, which comprises the following steps:
s1, adding the emulsifier into the oil for injection, stirring until the emulsifier is completely dissolved, adding famotidine, and stirring uniformly to obtain an oil phase;
s2, adding the stabilizer, the freeze-drying protective agent, the acidity regulator and the isotonic regulator into water for injection, stirring until the mixture is completely dissolved, and regulating the pH value to obtain a water phase;
s3, adding the oil phase into the water phase, and simultaneously processing the mixture by using a colloid mill to prepare primary emulsion;
s4, adding water for injection to a constant volume, uniformly stirring, and emulsifying to obtain a homogeneous white emulsion;
s5, sterilizing the emulsion obtained in the step S4, subpackaging, freeze-drying and capping to obtain the famotidine for injection.
As a further technical scheme, the temperature is controlled to be 50-75 ℃ in the step S1, the temperature is controlled to be 60-80 ℃ in the step S2, and the pH value of the feed liquid is adjusted to be 5-8 by using an acidity regulator.
The further technical scheme is characterized in that in the step S4, emulsification is carried out for more than 2 times under the conditions of low pressure of 5-10 MPa and high pressure of 50-100 MPa.
The invention has the beneficial effects that:
the inventive famotidine is wrapped in oil for injection to prepare an O/W type emulsifier, and then is frozen and dried to prepare the famotidine for injection. The famotidine is coated in the oil phase and isolated from the water phase or air by the emulsifier, so that the solubility problem and the stability problem of the famotidine are solved, and the obtained product has stable quality, long period of validity and low content of related substances. After re-dissolving, famotidine is still wrapped in the oil phase, so that the stability of the famotidine is improved, and the medication safety is ensured. The whole preparation process can be completed in a closed system connected by pipelines, so that the pollution problem in the production process is avoided.
Drawings
The present invention will be described in further detail with reference to the accompanying drawings and specific embodiments.
FIG. 1 is a schematic view of an O/W type emulsion droplet of the present invention;
FIG. 2 is a microscopic photograph (1000 times) of a primary emulsion in example 2;
FIG. 3 is a photograph (1000 times) of an emulsion microscopic examination in example 2;
FIG. 4 is a photograph (1000 times) of example 2 taken by microscopy after lyophilization and reconstitution with water.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious 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 inventive step, are intended to be within the scope of the present invention.
In the embodiment of the invention, the raw materials and the auxiliary materials are all injection grade, and the toxic endotoxin or pyrogen of each raw material and auxiliary material is strictly controlled. Preparing famotidine into 1mg/ml aqueous solution, and detecting according to a bacterial endotoxin method, wherein the bacterial endotoxin content in each 1mg famotidine is less than 5.0 EU; the water for injection is colorless clear liquid, and appropriate amount of the product is detected by limulus reagent, wherein the endotoxin content in each lml is less than 0.25 EU. If the bacterial endotoxin or pyrogen of the auxiliary material is unqualified, an activated carbon filter column is adopted for adsorption treatment, and the activated carbon filter column is formed by adding activated carbon with a non-powder structure into lignocellulose for compounding.
Example 1
S1, adding 2.4kg of soybean lecithin into 20.0kg of injection-grade soybean oil at 73 ℃, stirring until the soybean lecithin is completely dissolved, adding 2.0kg of famotidine, and uniformly stirring to obtain an oil phase;
s2, adding 120g of oleic acid and 10.0kg of glycine into 75 ℃ water for injection, and stirring until the oleic acid and the glycine are completely dissolved; adding glycerol to adjust osmotic pressure, and adding sodium hydride solution to adjust pH of the feed liquid to 7.20.
S3, adding the oil phase into the water phase, and treating for 2 times by using a colloid mill to prepare primary emulsion; adding water for injection to a constant volume of 200L, stirring, immediately emulsifying for 2 times by a high-pressure homogenizer under the conditions of low pressure of 10MPa and high pressure of 70MPa to obtain homogeneous white emulsion.
S4, sterilizing the homogenized emulsion, subpackaging 2.0 ml/bottle, freeze-drying and capping to obtain the famotidine for injection.
Example 2
S1, adding 2.8kg of soybean lecithin into 24.0kg of injection-grade soybean oil at 68 ℃, stirring until the soybean lecithin is completely dissolved, adding 2.0kg of famotidine, and uniformly stirring to obtain an oil phase;
s2, adding 140g of oleic acid, 10.0kg of mannitol and 3.0kg of glycine into 74 ℃ injection water, and stirring until the mixture is completely dissolved; sodium chloride is added to adjust osmotic pressure, and sodium hydride solution is added to adjust the pH value of the feed liquid to 7.10.
S3, adding the oil phase into the water phase, and treating for 1 time by using a colloid mill to prepare primary emulsion; adding water for injection to a constant volume of 200L, stirring, immediately emulsifying for 2 times by a high-pressure homogenizer under the conditions of low pressure of 10MPa and high pressure of 80MPa to obtain homogeneous white emulsion.
S4, sterilizing the homogenized emulsion, subpackaging 4.0 ml/bottle, freeze-drying and capping to obtain the famotidine for injection.
Example 3
S1, adding 2.8kg of egg yolk lecithin into 22.0kg of injection-grade corn oil at 65 ℃, stirring until the egg yolk lecithin is completely dissolved, adding 2.0kg of famotidine, and uniformly stirring to obtain an oil phase;
s2, adding 120g of oleic acid, 100g of sodium sulfite and 14.0kg of glycine into 68 ℃ water for injection, and stirring until the oleic acid, the sodium sulfite and the glycine are completely dissolved; adding glycerin to regulate osmotic pressure, and adding sodium hydride solution to regulate pH value of the feed liquid to 6.84.
S3, adding the oil phase into the water phase, and treating for 2 times by using a colloid mill to prepare primary emulsion; adding water for injection to a constant volume of 200L, stirring, immediately emulsifying for 2 times by a high-pressure homogenizer under the conditions of low pressure of 10MPa and high pressure of 70MPa to obtain homogeneous white emulsion.
S4, homogenizing, sterilizing the emulsion, subpackaging 2.0 ml/bottle, freeze-drying and capping to obtain the famotidine for injection.
Example 4
S1, adding 1kg of hydrogenated lecithin into 10.0kg of injection-grade olive oil at 50 ℃, stirring until the hydrogenated lecithin is completely dissolved, adding 1kg of famotidine, and uniformly stirring to obtain an oil phase;
s2, adding 10g of cholic acid and 1kg of lactose into 60 ℃ water for injection, and stirring until the cholic acid and the lactose are completely dissolved; adding glycerin to regulate osmotic pressure, and adding sodium hydride solution to regulate pH value of the feed liquid to 6.91.
S3, adding the oil phase into the water phase, and treating for 2 times by using a colloid mill to prepare primary emulsion; adding water for injection to a constant volume of 200L, stirring, immediately emulsifying for 2 times by a high-pressure homogenizer under the conditions of low pressure of 5MPa and high pressure of 50MPa to obtain homogeneous white emulsion.
S4, homogenizing, sterilizing the emulsion, subpackaging 2.0 ml/bottle, freeze-drying and capping to obtain the famotidine for injection.
Example 5
S1, adding 20kg of hydrogenated lecithin into 100kg of 75 ℃ injection-grade peanut oil, stirring until the hydrogenated lecithin is completely dissolved, adding 10kg of famotidine, and uniformly stirring to obtain an oil phase;
s2, 1kg of sodium ascorbate and 30kg of levoglucosan are added into water for injection at the temperature of 80 ℃ and stirred until the mixture is completely dissolved; adding glycerol to adjust osmotic pressure, and adding sodium hydride solution to adjust pH of the feed liquid to 7.14.
S3, adding the oil phase into the water phase, and treating for 2 times by using a colloid mill to prepare primary emulsion; adding water for injection to a constant volume of 200L, stirring, immediately emulsifying for 2 times by a high-pressure homogenizer under the conditions of low pressure of 10MPa and high pressure of 100MPa to obtain homogeneous white emulsion.
S4, homogenizing, sterilizing the emulsion, subpackaging 2.0 ml/bottle, freeze-drying and capping to obtain the famotidine for injection.
Comparative example 1
S1, adding 2.8kg of soybean lecithin, 2.0kg of famotidine, 140g of oleic acid, 10.0kg of mannitol and 3.0kg of glycine into water for injection at 74 ℃, and stirring until the soybean lecithin, the famotidine and the glycine are completely dissolved; sodium chloride is added to adjust osmotic pressure, and sodium hydride solution is added to adjust the pH value of the feed liquid to 7.10.
S2, processing for 1 time by a colloid mill to prepare primary emulsion; adding water for injection to a constant volume of 200L, stirring, immediately emulsifying for 2 times by a high-pressure homogenizer under the conditions of low pressure of 10MPa and high pressure of 80MPa to obtain homogeneous white emulsion.
S3, sterilizing the homogenized emulsion, subpackaging 4.0 ml/bottle, freeze-drying and capping to obtain the famotidine for injection.
Comparative example 2
S1, adding 2.4kg of soybean lecithin into 20.0kg of injection-grade soybean oil at 73 ℃, stirring until the soybean lecithin is completely dissolved, adding 2.0kg of famotidine, and uniformly stirring to obtain an oil phase;
s2, adding 10.0kg of glycine into 75 ℃ water for injection, and stirring until the glycine is completely dissolved; adding glycerol to adjust osmotic pressure, and adding sodium hydride solution to adjust pH of the feed liquid to 7.20.
S3, adding the oil phase into the water phase, and treating for 2 times by using a colloid mill to prepare primary emulsion; adding water for injection to a constant volume of 200L, stirring, immediately emulsifying for 2 times by a high-pressure homogenizer under the conditions of low pressure of 10MPa and high pressure of 70MPa to obtain homogeneous white emulsion.
S4, sterilizing the homogenized emulsion, subpackaging 2.0 ml/bottle, freeze-drying and capping to obtain the famotidine for injection.
1. And (3) detecting the particle size, namely taking the colostrum and the emulsion of the embodiment 1-5, and carrying out particle size detection on the re-dissolved emulsion after freezing. And (3) adding 1 drop of the emulsion on a glass slide, slightly covering a cover glass, amplifying by 1000 times under an inverted microscope, and detecting to obtain uniform emulsion drops of the sample. Representative pictures 2 to 4 were selected as the photomicrograph, which are respectively the primary emulsion photomicrograph (1000 times), the emulsion photomicrograph (1000 times), and the water-reconstituted photomicrograph (1000 times) of example 2. The particle size detection of the colostrum is to observe whether the emulsion drops are uniform or not and ensure the quality of the next emulsification, which is related to whether the emulsification is possible to succeed or not. The uniform emulsion droplets of the emulsion of the example 2 can be seen from fig. 2, the emulsion of the example 2 has uniform size and belongs to high-quality emulsion droplets, the conditions of emulsion breaking, layering, precipitation and the like do not occur, the stability is good, and the uniform emulsion droplets of the emulsion after redissolution and good form can be seen from fig. 3, which indicates that the freeze-drying-redissolution process does not destroy emulsification, and substances contained in the emulsion are not released, so that the aim of increasing the solubility can be achieved.
2. Constant of sedimentation velocity (K-segment-displacement, K)E): stability tests were performed on the examples and comparative examples. Centrifuging 20mL of emulsion at 3000r/min for 10min, placing 50 μ L of emulsion subnatant before and after centrifuging in 10mL measuring flask, adding distilled water to scale, taking water as blank, measuring absorbance at 500nm, respectively recording asA0A, the emulsion stability of the examples and comparative examples was evaluated according to the following formula:
KE＝(A0－A)/A0×100％。
in the formula KEIs the sedimentation rate constant of the emulsion.
KESmaller values indicate less floating of the emulsion droplets under centrifugal force and more stable emulsion.
Table 1 examples and comparative examples sedimentation rate constants of colostrum, emulsion, reconstituted emulsion after freezing
K for reconstitution of emulsions of embodiments of the invention after freezingEThe absolute value is less than 5.5%, which shows that the emulsion obtained by the invention has good stability. While comparative example 1, in which famotidine was not coated in the oil phase, resulted in an emulsion with reduced stability, indicating that famotidine coated in the oil phase in the examples, improved stability by isolating the emulsifier from the water phase or air. The emulsion stability of comparative example 2, without the addition of oleic acid, was also reduced compared to example 2.
The famotidine contents were measured for examples and comparative examples according to the method in the pharmacopoeia (four) of the people's republic of China, 2015 edition, and the results are shown in Table 2:
table 2 examples and comparative examples lyophilized powder for injection famotidine content
| Examples | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 | Comparative example 1 | Comparative example 2 |
| Content/% | 99.1 | 100.6 | 99.8 | 98.3 | 98.9 | 90.3 | 92.1 |
In comparative example 1, famotidine is not wrapped in an oil phase, the content of famotidine in the obtained freeze-dried powder injection is far lower than that of the freeze-dried powder injection in the embodiment of the invention, and the famotidine is wrapped in oil for injection to be prepared into an O/W type emulsifier, and then freeze drying is carried out, so that the prepared famotidine for injection not only can improve the stability, but also can improve the content of famotidine by improving the solubility, and the treatment effect is ensured. Compared with the example 2, the content of famotidine obtained by the comparative example 2 without adding oleic acid is also reduced, and therefore, the stabilizer adopted by the invention can also play a role in improving the content of famotidine.
The present invention is not limited to the above preferred embodiments, and any modifications, equivalent substitutions, improvements, etc. within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The famotidine freeze-dried powder injection for injection is characterized by comprising, by weight, 1-10 parts of famotidine, 1-20 parts of an emulsifier, 10-100 parts of oil for injection, 0.01-1 part of a stabilizer and 1-30 parts of a freeze-drying protective agent.
2. The freeze-dried famotidine powder injection as claimed in claim 1, wherein the oil for injection comprises one or more of soybean oil, hydrogenated soybean oil, corn oil, olive oil and peanut oil.
3. The famotidine freeze-dried powder injection for injection according to claim 1, wherein the emulsifier comprises one or more of hydrogenated lecithin, soybean lecithin, egg yolk lecithin and tween.
4. The famotidine freeze-dried powder injection for injection as claimed in claim 1, wherein the stabilizer comprises one or more of oleic acid, sodium oleate, cholic acid, sodium sulfite, sodium bisulfite and sodium ascorbate.
5. The famotidine freeze-dried powder injection for injection according to claim 1, wherein the freeze-drying protective agent comprises one or more of glycine, mannitol, glucose, lactose and L-glucoside.
6. The famotidine freeze-dried powder injection for injection according to claim 1, further comprising an acidity regulator, wherein the acidity regulator comprises one or more of hydrochloric acid, phosphoric acid, citric acid, sodium hydroxide, phosphate and citrate.
7. The famotidine freeze-dried powder injection for injection according to claim 1, further comprising an isotonic regulator, wherein the isotonic regulator comprises one or more of glycerol, sodium chloride and glucose and is used for regulating osmotic pressure.
8. A preparation method of famotidine freeze-dried powder injection for injection is characterized by comprising the following steps:
s1, adding the emulsifier into the oil for injection, stirring until the emulsifier is completely dissolved, adding famotidine, and stirring uniformly to obtain an oil phase;
s2, adding the stabilizer, the freeze-drying protective agent, the acidity regulator and the isotonic regulator into water for injection, stirring until the mixture is completely dissolved, and regulating the pH value to obtain a water phase;
s3, adding the oil phase into the water phase, and simultaneously processing the mixture by using a colloid mill to prepare primary emulsion;
s4, adding water for injection to a constant volume, uniformly stirring, and emulsifying to obtain a homogeneous white emulsion;
s5, sterilizing the emulsion obtained in the step S4, subpackaging, freeze-drying and capping to obtain the famotidine for injection.
9. The preparation method of the famotidine freeze-dried powder injection for injection according to claim 8, wherein the temperature is controlled to be 50-75 ℃ in the step S1, the temperature is controlled to be 60-80 ℃ in the step S2, and the pH value of a feed liquid is adjusted to be 5-8 by using an acidity regulator.
10. The preparation method of the famotidine freeze-dried powder injection for injection according to claim 8, wherein the emulsification in the step S4 is carried out for more than 2 times under the conditions of low pressure of 5-10 MPa and high pressure of 50-100 MPa.
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