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Carbocisteine oral solution and preparation method thereof

A technology of oral solution and carbocisteine, which is applied in the fields of pharmaceutical formulation, dispersion liquid delivery, and medical preparations of non-active ingredients, etc. It can solve problems such as poor product quality, reduction of active ingredients, and unstable long-term storage

Active Publication Date: 2021-03-05
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the aqueous solution of carbocisteine ​​after adding alkali to form a salt is weakly acidic and has poor compatibility with excipients. Not all syrup bases and flavoring agents are compatible with it. Long-term storage is unstable, and oxidized impurities and degraded impurities in the drug increase. , the active ingredients are reduced, the drug efficacy is reduced, the product quality is poor, and the safety of clinical medication is reduced
Therefore, the stability of carbocisteine ​​oral solution needs to be further improved

Method used

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  • Carbocisteine oral solution and preparation method thereof
  • Carbocisteine oral solution and preparation method thereof
  • Carbocisteine oral solution and preparation method thereof

Examples

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Effect test

preparation example Construction

[0031] The present invention also provides a kind of preparation method of carbocisteine ​​oral solution, the method comprises the following steps:

[0032] (1) Take water for injection, add sodium hydroxide (the molar ratio to carbocisteine ​​is 0.950~1.025) to dissolve completely, add carbocisteine, stir, dissolve completely, filter the membrane to obtain carbocisteine ​​solution for subsequent use;

[0033] (2) Take water for injection, add methylparaben, stir and dissolve, pass through a sieve, and keep warm for subsequent use;

[0034] (3) Add the carbocisteine ​​solution obtained in step (1) into the solution obtained in step (2), dilute to full volume with water for injection, stir evenly, fill, and melt seal.

[0035] Wherein, when the carbocisteine ​​oral solution contains one or more of glycerin, caramel, and stevioside, add carbocisteine ​​in step (1) and stir to dissolve completely, then add glycerin, caramel, and stevioside One or more of them, then stir evenly, ...

Embodiment 1

[0048] Embodiment 1 single auxiliary material compatibility investigation

[0049] In this embodiment, investigate carbocisteine ​​or carbocisteine ​​single adjuvant, in the compatibility test of multiple adjuvants, carbocisteine ​​and each adjuvant are added by content shown in table 2, and described antibacterial agent can be It is methylparaben or sodium methylparaben; the syrup base can be caramel, sucrose, sorbitol or sodium saccharin; the flavoring agent can be stevia, glycerin, vanillin, lemon flavor, cherry flavor , spearmint essence, mint essence or raspberry essence, wherein if the corrective agent selects glycerin, the addition amount of glycerin is 1 gram, and in addition, the addition amount of other corrective agents is 0.1 gram.

[0050] Table 2 Addition amount of each component in the compatibility test of excipients

[0051] Element Amount added / g carbocisteine 5 antibacterial agent 0.15 Hydroxypropyl Cellulose / Ethyl Cellulose / Sodi...

Embodiment 2

[0068] Embodiment 2: investigation of full prescription compatibility

[0069] According to the test results of Example 1, several prescriptions were selected, and the full prescription compatibility test was carried out according to the addition amount in Table 2. The specific prescriptions and test results are shown in Table 6-8.

[0070] Table 6 full prescription compatibility test (0 days)

[0071]

[0072]

[0073] Table 7 Full prescription compatibility test (30 days at 40°C)

[0074]

[0075] Table 8 full prescription compatibility test (light for 30 days)

[0076]

[0077]

[0078] It is not difficult to find out from the above results that the compatibility of each prescription auxiliary material shown is good with the raw material, especially compounded with carbocisteine, methyl paraben, sucrose, allura red and cherry essence, or carbocisteine, The compound of methyl paraben, sucrose and caramel, or the compound of carbocisteine, methyl paraben, suc...

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Abstract

The invention provides a carbocisteine oral solution and a preparation method thereof. The carbocisteine oral solution comprises carbocisteine, sodium hydroxide, methylparaben, a syrup matrix and water, the pH value of the oral solution is 5.0-7.0, the carbocisteine oral solution also can selectively contain a flavoring agent, the total impurity content of the oral solution is lower than 3.20% after the oral solution is stored at 40 DEG C for 30 days, and the total impurity content of the oral solution is lower than 1.10% after the oral solution is stored for 30 days. The preparation method ofthe oral solution comprises the following steps: dissolving the sodium hydroxide, and performing mixing with the carbocisteine to obtain a first solution containing the carbocisteine; dissolving themethylparaben to obtain a second solution containing the methylparaben; and mixing the syrup matrix with the flavoring agent and the first solution containing the carbocisteine or / and the second solution containing the methylparaben, and mixing all the solutions to obtain the carbocisteine oral solution. The carbocisteine oral solution provided by the invention is high in stability and low in impurity content.

Description

technical field [0001] The invention relates to the technical field of oral pharmaceutical preparations, in particular to a carbocisteine ​​oral solution and a preparation method thereof. Background technique [0002] The respiratory system is an important physiological barrier for the human body. In recent years, due to the continuous changes in the global natural environment and atmospheric environment, the incidence of respiratory diseases and the number of medications in the world have continued to increase. Respiratory diseases, especially tracheitis, bronchitis, asthma, etc. are often accompanied by excessive sputum in the respiratory tract. Excessive sputum will block the respiratory tract, stimulate the respiratory mucosa to damage it, induce coughing, and block the bronchi, etc., seriously affecting life and work and disease recovery. At present, expectorants mainly fall into three categories: nausea and stimulant expectorants, phlegm dissolvers, and mucus regulato...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/198A61K47/02A61K47/26A61P11/10
CPCA61K31/198A61K9/0095A61K47/02A61K47/26A61P11/10Y02A50/30
Inventor 詹慧宗晓季李倩吴娟曾薇张玲蔡超郭亚兵
Owner WUHAN WUYAO SCI & TECH
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