CN112006982A - Stable levocetirizine hydrochloride oral solution and preparation method thereof - Google Patents
Stable levocetirizine hydrochloride oral solution and preparation method thereof Download PDFInfo
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- CN112006982A CN112006982A CN202010921323.XA CN202010921323A CN112006982A CN 112006982 A CN112006982 A CN 112006982A CN 202010921323 A CN202010921323 A CN 202010921323A CN 112006982 A CN112006982 A CN 112006982A
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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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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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
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a stable levocetirizine hydrochloride oral solution and a preparation method thereof. The levocetirizine hydrochloride oral solution uses propionic acid as a preservative, and the volume percentage of the propionic acid in the levocetirizine hydrochloride oral solution is 0.05-0.15%. Compared with the traditional preservative, the levocetirizine hydrochloride oral solution has the same preservative effect, and has lower toxicity and higher safety. The levocetirizine hydrochloride oral solution prepared by the invention has high stability, simple prescription, smaller antiseptic toxicity and higher safety, and the method for preparing the levocetirizine hydrochloride oral solution has simple operation and is easy for industrial production.
Description
The patent is a divisional application of 'a stable levocetirizine hydrochloride oral solution and a preparation method thereof', and the original application numbers are as follows: 201711338009.3, application date 12/14/2017.
Technical Field
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a stable levocetirizine hydrochloride oral solution and a preparation method thereof.
Background
Chronic urticaria is a common skin disease, the age span of the attack is large, the recurrent attack phenomenon exists, and after the attack, a patient often has obvious symptoms of wheezy mass, pruritus and the like, so that the life quality of the patient is affected. At present, the etiology of the chronic urticaria of most patients cannot be determined, so that the difficulty of clinical medication treatment is increased.
The specific pathogenesis of chronic urticaria is not very clear at present, but the existing clinical research shows that medicines, chronic infection, food and the like are all likely to cause chronic urticaria. The attack of chronic urticaria causes great troubles to the daily life of patients, thereby affecting the mental state and work of the patients. The levocetirizine is developed on the basis of cetirizine, and not only can be efficiently acted on selective peripheral H1The receptor antagonist can also inhibit the release of inflammatory mediators, has the anti-inflammatory effect, takes effect quickly, has long action time, can stabilize the clinical symptoms of patients, and clinically, the levocetirizine and other medicaments are generally used for treating chronic urticaria.
With the wide clinical application of levocetirizine medicines, the problem of stability of levocetirizine oral solutions becomes more important.
The patent of CN03129155.4 provides a cetirizine hydrochloride gel, which consists of a medicine, a high molecular matrix material, a solvent, a humectant and a preservative, and is characterized in that the medicine is cetirizine hydrochloride, and the high molecular matrix material is selected from carbopol, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose and polyvinylpyrrolidone; the solvent is water; the humectant is glycerol; the antiseptic is selected from ethylparaben and benzalkonium bromide. The patent of CN200580023473.2 provides a liquid pharmaceutical composition comprising cetirizine active and at least one preservative, wherein the preservative is a paraben. CN200810003294.8 provides a pharmaceutical composition for improving the stability of cetirizine formulation, which comprises cetirizine or its pharmaceutically acceptable salt and at least one basic compound as a stabilizer, wherein the stabilizer used is at least one of basic compound such as carbonate, bicarbonate, hydroxide. The patent CN201110059091.2 provides a stable cetirizine oral solution, which comprises 1g of cetirizine hydrochloride, 80-100 g of propylene glycol and 360-400 g of sorbitol in 1000ml of solution; wherein the preservative is methyl paraben or the combination of methyl paraben and butyl paraben.
In the prior art, most of the preservatives added in the composition are aromatic hydrocarbon compounds which are toxic in organisms and difficult to degrade.
Therefore, the development of the levocetirizine oral solution which has the same preservative effect as the traditional preservative, has lower toxicity and higher safety has important clinical significance.
Disclosure of Invention
In view of the above, the present invention aims to provide a stable levocetirizine hydrochloride oral solution and a preparation method thereof. The levocetirizine hydrochloride oral solution has good stability, uses propionic acid as preservative, has the same preservative effect as the traditional preservative, and has lower toxicity and higher safety.
In order to achieve the purpose, the technical scheme of the invention is as follows:
application of propionic acid as a preservative in preparing levocetirizine hydrochloride oral solution.
Further, the volume percentage of propionic acid in the levocetirizine hydrochloride oral solution is 0.05-0.15%.
When the volume percentage of the propionic acid is less than 0.05%, the bacteriostatic effect is not ideal, and the number of part of strains is increased. When the volume percentage of propionic acid exceeds 0.15%, the taste is poor and is unacceptable to most patients. Therefore, the volume percentage of the propionic acid is between 0.05 and 0.15 percent, which meets the safety and compliance of the use of patients.
In the prior art, most of preservatives added in the composition are aromatic hydrocarbon compounds which are toxic in organisms and difficult to degrade. Compared with the traditional preservative, the levocetirizine hydrochloride oral solution added with propionic acid has the same preservative effect, and has the advantages of lower toxicity and higher safety.
Further, the volume percentage of propionic acid in the levocetirizine hydrochloride oral solution is 0.05-0.1%.
Preferably, the volume percentage of the propionic acid in the levocetirizine hydrochloride oral solution is 0.07-0.1%.
The invention also aims to provide a stable levocetirizine hydrochloride oral solution, wherein 1000ml of the levocetirizine hydrochloride oral solution contains 0.2-0.6 g of levocetirizine hydrochloride, 130-180 g of propylene glycol, 220-280 g of glycerol, 220-280 g of sorbitol and 0.5-1.5 ml of propionic acid.
Furthermore, 1000ml of the levocetirizine hydrochloride oral solution also comprises 0.05-0.15 g of saccharin sodium, 18-30 g of sodium acetate and 2.1-3.2 g of glacial acetic acid.
Glacial acetic acid-sodium acetate buffer solution can ensure that the pH value of the oral solution is stable in the storage process.
Furthermore, 1000ml of the levocetirizine hydrochloride oral solution contains 0.2-0.6 g of levocetirizine hydrochloride, 140-175 g of propylene glycol, 230-270 g of glycerol, 230-270 g of sorbitol, 0.08-0.12 g of saccharin sodium, 0.5-1.5 ml of propionic acid, 20-28 g of sodium acetate and 2.1-3.0 g of glacial acetic acid.
Under the condition of the content ratio of the components, the prepared levocetirizine hydrochloride oral solution has better curative effect and higher stability.
Preferably, 1000ml of the levocetirizine hydrochloride oral solution contains 0.6g of levocetirizine hydrochloride, 160.5g of propylene glycol, 248g of glycerol, 255g of sorbitol, 0.09g of saccharin sodium, 0.5-1.5 ml of propionic acid, 25g of sodium acetate and 2.68g of glacial acetic acid.
Preferably, 1000ml of the levocetirizine hydrochloride oral solution contains 0.5g of levocetirizine hydrochloride, 155.7g of propylene glycol, 250g of glycerol, 250g of sorbitol, 0.1g of saccharin sodium, 0.5-1.5 ml of propionic acid, 24g of sodium acetate and 2.518g of glacial acetic acid.
Preferably, 1000ml of the levocetirizine hydrochloride oral solution contains 0.5g of levocetirizine hydrochloride, 155.7g of propylene glycol, 250g of glycerol, 250g of sorbitol, 0.1g of saccharin sodium, 0.7-1.0 ml of propionic acid, 24g of sodium acetate and 2.518g of glacial acetic acid.
Preferably, 1000ml of the levocetirizine hydrochloride oral solution contains 0.5g of levocetirizine hydrochloride, 155.7g of propylene glycol, 250g of glycerol, 250g of sorbitol, 0.1g of saccharin sodium, 0.7ml of propionic acid, 24g of sodium acetate and 2.518g of glacial acetic acid.
Preferably, 1000ml of the levocetirizine hydrochloride oral solution contains 0.5g of levocetirizine hydrochloride, 155.7g of propylene glycol, 250g of glycerol, 250g of sorbitol, 0.1g of saccharin sodium, 1.0ml of propionic acid, 24g of sodium acetate and 2.518g of glacial acetic acid.
The levocetirizine hydrochloride oral solution has high stability, simple prescription, lower toxicity of the used preservative and higher safety. The levocetirizine hydrochloride oral solution has good bacteriostatic effect and stability, and meets the requirements in accelerated stability investigation for 6 months and long-term stability investigation for 24 months.
The invention also aims to provide a preparation method of the levocetirizine hydrochloride oral solution, which comprises the following steps:
1) dissolving the sorbitol in the prescribed amount in an aqueous medium, heating and stirring to completely dissolve the sorbitol, and cooling to obtain a sorbitol solution;
2) adding the saccharin sodium, the sodium acetate, the propylene glycol, the glycerol and the propionic acid in the amount according to the prescription into the sorbitol solution prepared in the step 1), uniformly mixing, and adding the glacial acetic acid in the amount according to the prescription to adjust the pH value to obtain a matrix solution;
3) adding the aqueous medium into the matrix solution in the step 2), adding the levocetirizine hydrochloride with the prescription amount, and stirring until the main drug is completely dissolved.
The preparation method according to claim 7, wherein the heating temperature in the step 1) is 45-50 ℃, and the stirring is carried out for 25-35 min.
Further, the PH value is adjusted to 5.0-5.6 in the step 2).
Further, the preparation method of the levocetirizine hydrochloride oral solution also comprises the following steps:
4) stirring until the main drug is completely dissolved, adding an aqueous medium to 1000ml, and continuously stirring for 20-25 minutes to obtain the levocetirizine hydrochloride oral solution.
The invention has the beneficial effects that:
1) the invention provides an application of propionic acid as a preservative in preparing levocetirizine hydrochloride oral solution, which solves the problems that the preservative added in the prior art is toxic to a certain extent in a living body and is difficult to degrade.
2) The levocetirizine hydrochloride oral solution provided by the invention has the advantages of high stability, simple prescription, lower toxicity of the used preservative and higher safety. And the method for preparing the levocetirizine hydrochloride oral solution is simple to operate and easy for industrial production.
Detailed Description
Hereinafter, preferred embodiments of the present invention will be described in detail. The experimental methods of the preferred embodiments, which do not indicate specific conditions, are generally performed according to conventional conditions, and the examples are given for better illustration of the present invention, but the present invention is not limited to the examples. Therefore, those skilled in the art should make insubstantial modifications and adaptations to the embodiments of the present invention in light of the above teachings and remain within the scope of the invention.
Examples levocetirizine hydrochloride oral solutions
TABLE 1 Levocetirizine hydrochloride oral solution
EXAMPLE 8 preparation of levocetirizine hydrochloride oral solution
Dissolving sorbitol: dissolving sorbitol in a prescription amount in a proper amount of purified water, heating, controlling the temperature to be 45-50 ℃, stirring for 30 minutes to completely dissolve the sorbitol, and then cooling.
Adding auxiliary materials: adding saccharin sodium, sodium acetate, propylene glycol, glycerol and propionic acid into the preparation tank.
Regulating the pH value: and adding a proper amount of glacial acetic acid to adjust the pH value to 5.0-5.6 to obtain a matrix solution.
Adding main medicine and supplementing purified water: adding a proper amount of purified water, adding levocetirizine hydrochloride into the mixture, and stirring until the main medicine is completely dissolved. And adding purified water into the solution until the volume of the solution is 1000ml, and continuously stirring for 20-25 minutes to obtain the levocetirizine hydrochloride oral solution.
Example 9 bacteriostatic efficacy test
Examples 1-7 and comparative examples 1 and 2 are prepared according to the above process, and the bacteriostatic efficacy is detected by referring specifically to the bacteriostatic efficacy examination method 1121 in the four-part rule of pharmacopoeia 2015, edition. The results are shown in Table 2.
TABLE 2 results of the detection of bacteriostatic efficacy
The test result shows that the levocetirizine hydrochloride oral solution prepared in the embodiment 1-7 meets the judgment standard of the 'oral preparation' under the checking method of the bacteriostatic efficacy of 1121 in the national pharmacopoeia 2015 edition of the general rules. The effective bacteriostatic effect can be kept within the range of 0.05-0.15% of propionic acid by volume percentage.
Example 10 taste testing experiment
The taste test was performed on 30 healthy subjects by blind method, and the results are shown in table 3.
TABLE 3 taste testing experiments and results
Note: the term "+++ denotes good mouthfeel," + + denotes good mouthfeel, "+ denotes normal mouthfeel, -denotes poor mouthfeel, and-" denotes poor mouthfeel.
Among the results, more than half of 30 subjects evaluated the taste of example 5, the acceptability of examples 1, 2, 3, 4, 6, and 7 and comparative example 1 was better, and the taste of example 2 was generally poor or inferior. The result shows that the propionic acid has a slightly sour taste after the volume percentage of the propionic acid exceeds 0.15 percent, and the propionic acid is accepted by people to a lower extent.
Example 11 stability study
Stability investigation is carried out on the samples 1-7 respectively, the microbial limit of the product meets the requirement in 6 months and 24 months, and the stability investigation results of the minimum dosage sample are shown in tables 3 and 4:
TABLE 3 accelerated examination (40 ℃. + -. 2 ℃ C., RH 75%. + -. 5)
| Microbial limitation regulation | 0 month | 3 month | 6 month |
| Total aerobic bacteria count: each 1g of the composition should not exceed 800cfu | Compliance with regulations | Compliance with regulations | Compliance with regulations |
| Total number of mold and yeast: not more than 80cfu per 1g | Compliance with regulations | Compliance with regulations | Compliance with regulations |
| Escherichia coli: cannot be detected every 1g | Compliance with regulations | Compliance with regulations | Compliance with regulations |
TABLE 4 Long term examination (25 ℃. + -. 2 ℃ C., RH 60%. + -. 5)
| Microbial limitation regulation | 0 month | 12 month | 24 months |
| Total aerobic bacteria count: each 1g of the composition should not exceed 800cfu | Compliance with regulations | Compliance with regulations | Compliance with regulations |
| Total number of mold and yeast: not more than 80cfu per 1g | Compliance with regulations | Compliance with regulations | Compliance with regulations |
| Escherichia coli: cannot be detected every 1g | Compliance with regulations | Compliance with regulations | Compliance with regulations |
The experimental result shows that the levocetirizine hydrochloride oral solution has good stability, and meets the requirements in accelerated stability investigation for 6 months and long-term stability investigation for 24 months.
Finally, the above embodiments are only for illustrating the technical solutions of the present invention and not for limiting, although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions may be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all of them should be covered in the claims of the present invention.
Claims (7)
1. The levocetirizine hydrochloride oral solution is characterized by being prepared by the following method:
1000ml of levocetirizine hydrochloride oral solution contains 0.2-0.6 g of levocetirizine hydrochloride, 130-180 g of propylene glycol, 220-280 g of glycerol, 220-280 g of sorbitol and 0.5-1.5 ml of propionic acid; 0.05-0.15 g of saccharin sodium, 18-30 g of sodium acetate and 2.1-3.2 g of glacial acetic acid;
1) dissolving the sorbitol in the prescribed amount in an aqueous medium, heating and stirring to completely dissolve the sorbitol, and cooling to obtain a sorbitol solution;
2) adding the saccharin sodium, the sodium acetate, the propylene glycol, the glycerol and the propionic acid in the amount according to the prescription into the sorbitol solution prepared in the step 1), uniformly mixing, and adding the glacial acetic acid in the amount according to the prescription to adjust the pH value to obtain a matrix solution;
3) adding an aqueous medium into the matrix solution in the step 2), adding the levocetirizine hydrochloride in the prescription amount, and stirring until the main drug is completely dissolved to obtain the levocetirizine hydrochloride oral solution 1.
2. The levocetirizine hydrochloride oral solution according to claim 1, wherein the heating temperature in the step 1) is 45 ℃ to 50 ℃, and the stirring is carried out for 25 min to 35 min.
3. The levocetirizine hydrochloride oral solution of claim 1, wherein the PH is adjusted to 5.0 to 5.6 in step 2).
4. The levocetirizine hydrochloride oral solution of claim 1 further comprising the steps of: 4) stirring until the main drug is completely dissolved, adding an aqueous medium to 1000ml, and continuously stirring for 20-25 minutes to obtain the levocetirizine hydrochloride oral solution.
5. The levocetirizine hydrochloride oral solution of claim 1, wherein the sodium acetate 24.0g and the glacial acetic acid 2.518g are glacial acetic acid-sodium acetate buffer in the levocetirizine hydrochloride oral solution.
6. The method for carrying out the bacteriostatic efficacy test by using the levocetirizine hydrochloride oral solution as claimed in claim 1, wherein the test objects are five bacteria of escherichia coli, staphylococcus aureus, pseudomonas aeruginosa, candida albicans and aspergillus niger.
7. The method for carrying out a taste test by using the levocetirizine hydrochloride oral solution of claim 1 is characterized by comprising the following steps:
a set up comparison group
Each 1000ml of the oral liquid of the comparison group contains 0.500g of levocetirizine hydrochloride, 155.7g of propylene glycol, 250g of glycerin, 250g of sorbitol, 0.100g of saccharin sodium, 1.6ml of propionic acid, 24.0g of sodium acetate and 2.518g of glacial acetic acid, and purified water is added to 1000 ml;
and B, performing taste test on healthy subjects by adopting a blind method, and comparing the levocetirizine hydrochloride oral solution of a test subject with the oral solution of the comparison group.
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| CN201711338009.3A CN107823647A (en) | 2017-12-14 | 2017-12-14 | A kind of levo-cetirizine hydrochloride oral administration solution of stabilization and preparation method thereof |
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| CN115645359A (en) * | 2022-09-30 | 2023-01-31 | 厦门紫旭医药科技有限公司 | Formula and preparation process of levocetirizine hydrochloride oral drop |
| CN115770214A (en) * | 2022-12-06 | 2023-03-10 | 四川健能制药有限公司 | Oral solution containing cetirizine hydrochloride |
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Cited By (2)
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| CN115645359A (en) * | 2022-09-30 | 2023-01-31 | 厦门紫旭医药科技有限公司 | Formula and preparation process of levocetirizine hydrochloride oral drop |
| CN115770214A (en) * | 2022-12-06 | 2023-03-10 | 四川健能制药有限公司 | Oral solution containing cetirizine hydrochloride |
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Application publication date: 20201201 |