CN116898799A - Desloratadine oral preparation and preparation method thereof - Google Patents
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Abstract
The invention belongs to the technical field of pharmacy, and particularly discloses a desloratadine oral preparation and a preparation method thereof. The preparation method comprises mixing chelating agent, sweetener and correctant, stirring for dissolving to obtain first mixed solution; adding a thickening agent into the first mixed solution, swelling, cooling, stirring and dissolving to form a second mixed solution; mixing the latent solvent and the pH regulator, adding the second mixed solution, and stirring and dissolving to obtain a third mixed solution; and adding the desloratadine crude drug into the third mixed solution, and stirring and dissolving to obtain the desloratadine oral preparation. The desloratadine oral preparation is stored at high temperature under illumination, the stability is greatly improved, the desloratadine oral preparation can be uniformly mixed for 10 seconds, and the desloratadine oral preparation has good content uniformity.
Description
Technical Field
The invention belongs to the technical field of pharmacy, and in particular relates to a desloratadine oral preparation and a preparation method thereof.
Background
Desloratadine, its chemical name is: 8-chloro-11- (piperidin-4-alkylene) -6, 11-dihydro-5H-benzo [5,6] cyclohepta [1,2-b ] pyridine having the structural formula:
desloratadine is a novel third generation antihistamine, a non-sedating long-acting histamine antagonist for alleviating systemic and local symptoms of chronic urticaria and allergic rhinitis. The medicament taking the desloratadine as the active ingredient has the advantages of quick response, strong efficacy, no cardiotoxicity, less side effects of the medicament, no food contraindication and the like.
However, because desloratadine is hardly soluble in water and is not resistant to high temperature and high humidity, and is sensitive to light irradiation, and is easily oxidized in air to deteriorate, desloratadine is generally prepared into oral preparations, including solutions, capsules, tablets, syrups, dry suspensions and dispersible tablets. For example, chinese patent application CN114588106a discloses a desloratadine oral solution preparation and a preparation and production process thereof, wherein the preparation is composed of desloratadine bulk drug and auxiliary materials; the preparation method comprises sequentially preparing disodium edentate, hypromellose, and other adjuvants including sorbitol, sucralose, and citric acidAnd dissolving sodium citrate and bubble gum essence, and finally dissolving the propylene glycol and desloratadine raw material medicaments together to prepare concentrated solution. Manufactured by moesadong Co., ltdAs a reference preparation, the preparation produced by the invention has the same administration route, the same treatment period and the same indication, and is safe and reliable. For example, chinese patent application CN112220748A discloses a desloratadine oral liquid preparation and a preparation method thereof, wherein the desloratadine oral liquid preparation is an aqueous solution, and comprises desloratadine active ingredient, stabilizer, pharmaceutically acceptable auxiliary material and solvent water.
However, the uniformity of the content of the desloratadine in the prior art cannot meet the production requirement, and a long stirring time is required to make the content uniform, so that a preparation process capable of making the uniformity of the content of the desloratadine better is currently required.
Disclosure of Invention
As used herein, the singular forms "a," "an," and "the" include the singular and plural referents unless the context clearly dictates otherwise. The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within that corresponding range, and the endpoints recited.
Aiming at the problems in the prior art, the invention provides a desloratadine oral preparation and a preparation method thereof, and the desloratadine oral preparation prepared by the preparation method has better stability and content uniformity.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
the invention provides a preparation method of desloratadine oral preparation, which comprises the following steps:
s1, mixing a chelating agent, a sweetener and a flavoring agent, and stirring for dissolution to obtain a first mixed solution;
s2, adding a thickening agent into the first mixed solution, swelling, cooling, stirring and dissolving to form a second mixed solution;
s3, mixing the latent solvent and the pH regulator, adding the mixture into the second mixed solution, and stirring and dissolving the mixture to obtain a third mixed solution;
s4, adding desloratadine raw material medicines into the third mixed solution, and stirring and dissolving to obtain the desloratadine.
Preferably, the chelating agent of step S1 comprises disodium edentate, the sweetener comprises sorbitol and/or sucralose, and the flavoring agent comprises bubble gum flavor.
Preferably, the thickener of step S2 comprises hypromellose.
Preferably, the latent solvent in step S3 comprises propylene glycol, and the pH adjuster comprises citric acid and/or sodium citrate.
Preferably, the stirring conditions in step S1 are: the temperature is 60-70 ℃, the rotating speed is 50-100r/min, and the time is 2-3 minutes.
Preferably, the swelling time in the step S2 is 5-8 minutes, and the temperature of the cooling is 30-40 ℃.
Preferably, the stirring conditions in step S2 are: the rotating speed is 50-100r/min, and the time is 30-40 minutes.
Preferably, the stirring conditions in step S3 are: the temperature is 30-35 ℃, the rotating speed is 50-100r/min, and the time is 30-40 minutes.
Preferably, the stirring conditions in step S4 are: the temperature is 0-20 ℃, the rotating speed is 50-100r/min, and the time is 1-2 hours.
The invention also provides a desloratadine oral preparation prepared by the preparation method.
Preferably, the desloratadine oral preparation consists of desloratadine bulk drugs and auxiliary materials, wherein the auxiliary materials comprise chelating agents, thickening agents, latent solvents, sweeteners, pH regulators and flavoring agents.
Preferably, the chelating agent comprises disodium edentate, the sweetener comprises sorbitol and/or sucralose, the flavoring agent comprises bubble gum flavor, the thickening agent comprises hypromellose, the latent solvent comprises propylene glycol, and the pH regulator comprises citric acid and/or sodium citrate.
Preferably, the mass ratio of the desloratadine bulk drug to the thickener to the chelating agent is 1:2-6:0.5-1.5.
Compared with the prior art, the invention has the following beneficial effects:
the desloratadine oral preparation prepared by the method is stored at high temperature under illumination, so that the stability is greatly improved, and the stability of the preparation is ensured under the condition that impurities are not abnormally increased; the desloratadine oral preparation prepared by the preparation process provided by the invention can be stirred for 10 seconds to ensure that the desloratadine oral preparation is uniform in content and good in content uniformity.
Detailed Description
The following description of the present invention is provided by way of specific examples to facilitate understanding and grasping of the technical solution of the present invention, but the present invention is not limited thereto, and the described examples are only some, but not all, examples of the present invention.
The endpoints and any values of the ranges disclosed herein are not limited to the precise range or value, and are understood to encompass values approaching those ranges or values. For numerical ranges, one or more new numerical ranges may be found between the endpoints of each range, between the endpoint of each range and the individual point value, and between the individual point value, in combination with each other, and are to be considered as specifically disclosed herein.
All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, shall fall within the scope of the invention. The experimental methods described in the following examples are all conventional methods unless otherwise specified; the reagents and materials, unless otherwise specified, are commercially available.
It should be noted that:
raw material purchase information in the present invention: desloratadine drug substance (manufacturer: morepen Laboratories ltd. (india), record No. Y20170000139, execution standard is internal control quality standard).
The bubble gum essence mainly comprises propylene glycol, isoamyl acetate, isobutyl acetate and butyl butyrate.
Example 1 preparation method of Desloratadine oral preparation
The preparation method of the desloratadine oral preparation comprises the following steps:
the formulation of desloratadine oral formulation is shown in table 1;
s1, mixing a chelating agent, a sweetener, a flavoring agent and 75% of a solvent, and stirring at 65 ℃ for 2 minutes to dissolve the mixture to obtain a first mixed solution;
s2, adding a thickening agent into the first mixed solution, swelling for 6 minutes, cooling to 35 ℃, stirring for 35 minutes at 100r/min, and dissolving to form a second mixed solution;
s3, mixing the latent solvent and the pH regulator, adding the mixture into the second mixed solution, stirring at 32 ℃ for 35 minutes and dissolving at 100r/min to obtain a third mixed solution;
s4, adding the desloratadine bulk drug and the residual solvent into the third mixed solution, and stirring at 10 ℃ for 1.5 hours at 100r/min to dissolve the desloratadine bulk drug.
Table 1 table of formulations of desloratadine oral formulations in example 1
Example 2 preparation method of Desloratadine oral preparation
The preparation method of the desloratadine oral preparation comprises the following steps:
the formulation of desloratadine oral formulation is shown in table 2;
s1, mixing a chelating agent, a sweetener, a flavoring agent and 75% of a solvent, and stirring at 60 ℃ for 3 minutes at 100r/min to dissolve to obtain a first mixed solution;
s2, adding a thickening agent into the first mixed solution, swelling for 5 minutes, cooling to 30 ℃, stirring for 30 minutes at 100r/min, and dissolving to form a second mixed solution;
s3, mixing the latent solvent and the pH regulator, adding the mixture into the second mixed solution, stirring at 30 ℃ for 30 minutes at 100r/min, and dissolving to obtain a third mixed solution;
s4, adding the desloratadine bulk drug and the residual solvent into the third mixed solution, and stirring at 100r/min for 1.0 hour at the temperature of 0 ℃ to obtain the desloratadine.
Table 2 table of formulations of desloratadine oral formulations in example 2
Example 3 preparation method of Desloratadine oral preparation
The preparation method of the desloratadine oral preparation comprises the following steps:
the formulation of desloratadine oral formulation is shown in table 3;
s1, mixing a chelating agent, a sweetener, a flavoring agent and 75% of a solvent, and stirring at 70 ℃ for 3 minutes at 50r/min to dissolve to obtain a first mixed solution;
s2, adding a thickening agent into the first mixed solution, swelling for 8 minutes, cooling to 40 ℃, stirring for 40 minutes at 50r/min, and dissolving to form a second mixed solution;
s3, mixing the latent solvent and the pH regulator, adding the mixture into the second mixed solution, and stirring for 40 minutes at 35 ℃ for dissolving at 50r/min to obtain a third mixed solution;
s4, adding the desloratadine bulk drug and the residual solvent into the third mixed solution, and stirring for 2.0 hours at 20 ℃ for dissolution at 50r/min to obtain the desloratadine.
Table 3 table of formulations of desloratadine oral formulations in example 3
Comparative example 1 preparation method of desloratadine oral preparation
Compared with example 1, the only difference is that: the amounts of edetate disodium and hypromellose were different, the amount of edetate disodium of comparative example 1 was 2.4 mL/bottle, and the amount of hypromellose was 35.0 mL/bottle. Comparative example 2 preparation method of desloratadine oral preparation
The preparation method of the desloratadine oral preparation comprises the following steps:
the formulation of desloratadine oral formulation is shown in table 1;
s1, mixing a chelating agent with 75% of a solvent, and stirring at 65 ℃ for 2 minutes for dissolution at 100r/min to obtain a first mixed solution;
s2, adding a thickening agent into the first mixed solution, swelling for 6 minutes, cooling to 35 ℃, stirring for 35 minutes at 100r/min, and dissolving to form a second mixed solution;
s3, adding the sweetener, the pH regulator and the flavoring agent into the second mixed solution, stirring at 32 ℃ for 35 minutes and dissolving at 100r/min to obtain a third mixed solution;
s4, adding a latent solvent into the third mixed solution, cooling to 10 ℃, adding the desloratadine raw material medicine and the residual solvent, stirring for 1.5 hours at 100r/min, and dissolving to obtain the desloratadine.
Comparative example 3 preparation method of desloratadine oral preparation
Compared with example 1, the only difference is that: the latent solvent is 1, 2-propanediol.
Effect example
Examination of stability and content uniformity of desloratadine oral solutions of examples 1-3 and comparative examples 1-3, determination of related substances and content was performed by high-phase liquid chromatography (rule 0512 in the fourth edition of the chinese pharmacopoeia 2020), chromatographic conditions: octadecylsilane chemically bonded silica (YMC J' sphere ODS-M80.6mm.times.250 mm,4 μm) was used as a filler; buffer salt solution (0.865 g of sodium dodecyl sulfate is taken, 1000ml of water is added, 0.5ml of trifluoroacetic acid is added, so that the sodium dodecyl sulfate is dissolved) -acetonitrile (57:43) is taken as a mobile phase; the flow rate is 1.0ml per minute; the detection wavelength is 280nm; the column temperature is 30 ℃; the sample volume was 10. Mu.l.
(1) Stability detection: according to the four guidelines 9001 of the Chinese pharmacopoeia of 2020 edition and the stability test guidelines of the preparation, the desloratadine oral solutions of examples 1-3 and comparative examples 1-3 are subjected to an influence factor test, the samples are placed at a high temperature of 60 ℃ under illumination conditions, and the samples are respectively detected according to stability key investigation projects when the samples are placed for 10 days and 30 days.
TABLE 4 stability test results at 60℃high temperature
TABLE 5 stability test results under illumination
By adopting the prescription process, a sample with stable quality can be prepared. Compared with the comparative example, the properties, pH and related substances of the composition are not obviously changed at high temperature of 60 ℃ under illumination, the stability is better, and the total impurities are not more than 0.1%.
(2) Acceleration test: the desloratadine oral solutions of examples 1-3 and comparative examples 1-3 were placed under accelerated test (temperature 40 ℃ + -2 ℃/humidity 75% + -5%) and sampled and assayed at 6 months.
TABLE 6 accelerated test results
The desloratadine oral preparation prepared by the preparation process has good stability, and the properties, pH and related substances in an acceleration test are not obviously changed, and the total impurities are not more than 0.1 percent.
(3) Content uniformity performance detection
10ml of desloratadine oral solution preparations of the examples and the comparative examples are respectively taken, and after stirring for 10 seconds, 30 seconds and 60 seconds, upper layer, middle layer and lower layer of the liquid medicine are sampled, so that the uniformity of desloratadine content is studied.
TABLE 7 uniformity results
The desloratadine oral preparation prepared by the preparation method and the formula can be uniformly mixed for about 10 seconds (the content difference of the upper layer, the middle layer and the lower layer is not more than 1 percent), and the content uniformity is good.
Finally, it should be noted that the above description is only for illustrating the technical solution of the present invention, and not for limiting the scope of the present invention, and that the simple modification and equivalent substitution of the technical solution of the present invention can be made by those skilled in the art without departing from the spirit and scope of the technical solution of the present invention.
Claims (10)
1. A preparation method of desloratadine oral preparation, which is characterized in that: the method comprises the following steps:
s1, mixing a chelating agent, a sweetener and a flavoring agent, and stirring for dissolution to obtain a first mixed solution;
s2, adding a thickening agent into the first mixed solution, swelling, cooling, stirring and dissolving to form a second mixed solution;
s3, mixing the latent solvent and the pH regulator, adding the mixture into the second mixed solution, and stirring and dissolving the mixture to obtain a third mixed solution;
s4, adding desloratadine raw material medicines into the third mixed solution, and stirring and dissolving to obtain the desloratadine.
2. The method of manufacturing according to claim 1, characterized in that: the chelating agent in the step S1 comprises disodium edentate, the sweetener comprises sorbitol and/or sucralose, and the flavoring agent comprises bubble gum essence; the thickener in the step S2 comprises hypromellose; the latent solvent in the step S3 comprises 1, 3-propylene glycol, and the pH regulator comprises citric acid and/or sodium citrate.
3. The method of manufacturing according to claim 1, characterized in that: the stirring conditions in the step S1 are as follows: the temperature is 60-70 ℃, the rotating speed is 50-100r/min, and the time is 2-3 minutes.
4. The method of manufacturing according to claim 1, characterized in that: the swelling time in the step S2 is 5-8 minutes, and the temperature of the cooling is 30-40 ℃.
5. The method of manufacturing according to claim 1, characterized in that: the stirring conditions in the step S2 are as follows: the rotating speed is 50-100r/min, and the time is 30-40 minutes; the stirring conditions in the step S3 are as follows: the temperature is 30-35 ℃, the rotating speed is 50-100r/min, and the time is 30-40 minutes.
6. The method of manufacturing according to claim 1, characterized in that: the stirring conditions in the step S4 are as follows: the temperature is 0-20 ℃, the rotating speed is 50-100r/min, and the time is 1.0-2.0 hours.
7. An oral desloratadine formulation characterized by: is prepared by the preparation method according to any one of claims 1 to 6.
8. The desloratadine oral formulation of claim 7 wherein: the desloratadine is composed of desloratadine bulk drug and auxiliary materials, wherein the auxiliary materials comprise chelating agents, thickening agents, latent solvents, sweeteners, pH regulators and flavoring agents.
9. The desloratadine oral formulation of claim 8 wherein: the chelating agent comprises disodium edentate, the sweetener comprises sorbitol and/or sucralose, the flavoring agent comprises bubble gum essence, the thickening agent comprises hydroxypropyl methylcellulose, the latent solvent comprises propylene glycol, and the pH regulator comprises citric acid and/or sodium citrate.
10. The desloratadine oral formulation of claim 8 wherein: the mass ratio of the desloratadine bulk drug to the thickener to the chelating agent is as follows: 1:2-6:0.5-1.5.
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