Terbutaline sulfate oral liquid and production method thereof

A technology of terbutaline sulfate and its production method, which can be applied in the fields of pharmaceutical formula, dispersion liquid delivery, sanitary equipment for toilets, etc. It can solve the problems of increasing impurity content, affecting product quality, and product color darkening, etc., so as to reduce impurities The production of impurities, the effect of reducing the content of impurities and increasing the content

Pending Publication Date: 2021-11-30
杭州上禾健康科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The chemical name of terbutaline sulfate is α-[(tert-butylamino)methyl]-3,5-dihydroxyphenylmethanol sulfate, its molecule contains 2 phenolic hydroxyl groups, and it is very easy to prepare oral solutions. Oxidation occurs, which increases the content of impurities and causes the color of the product to become darker, which seriously affects the quality of the product

Method used

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  • Terbutaline sulfate oral liquid and production method thereof
  • Terbutaline sulfate oral liquid and production method thereof
  • Terbutaline sulfate oral liquid and production method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1, a kind of terbutaline sulfate oral liquid, the selection of each raw material component and its corresponding content are as shown in Table 1, and adopt following liquid preparation tank to prepare, and this liquid preparation tank comprises tank body 1, tank body The top of 1 is connected with feed pipe 4, liquid inlet pipe, vacuum suction pipe 2 and the first nitrogen filling pipe 3, the top of tank 1 is also provided with a manhole, and the bottom of tank 1 is connected with discharge pipe 5 and the second nitrogen filling pipe. Pipe 6, each pipe is provided with a control valve, and the tank body 1 is provided with a stirring assembly 7 and several deoxidation pipes 8. The stirring assembly 7 includes a stirring rod 72 , a stirring blade 73 arranged at the bottom of the stirring rod 72 , and a motor 71 for driving the stirring rod 72 .

[0047] Several deoxygenation tubes 8 are distributed in the tank body 1 in a circumferential shape around the stirri...

Embodiment 2～3

[0054] Embodiments 2-3, a terbutaline sulfate oral liquid, differ from Embodiment 1 in that the selection of each raw material component and its corresponding content are shown in Table 1.

[0055] Components and consumption (kg) of terbutaline sulfate oral liquid in table 1, embodiment 1~3

[0056]

Embodiment 4

[0057] Example 4, a terbutaline sulfate oral liquid, differs from Example 1 in that in step S1, the vacuum pump 83 connected to the deoxygenation pipe 8 is not turned on during the stirring process, that is, the dissolved oxygen is not removed.

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PUM

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Abstract

The invention discloses a production method of a terbutaline sulfate oral liquid. The production method comprises the following steps of: S1, adding terbutaline sulfate and an auxiliary agent into a liquid preparation tank, introducing nitrogen into the tank, completely discharging air in the tank, then performing vacuum suction, discharging the nitrogen, sucking preparation water into the liquid preparation tank by utilizing negative pressure, and stirring for dissolving to obtain a liquid medicine; S2, adding 1 to 3 weight percent of sodium hydroxide solution into the liquid medicine, adjusting the pH value to 4.0 + / -0.5, then adding purified water, diluting the liquid medicine to a prescription dosage, and uniformly mixing to obtain a filling liquid; and S3, introducing the nitrogen into the liquid preparation tank, transferring the filling liquid into a filter for filtering to obtain a filtrate, and filling the filtrate into a medicine bottle to obtain the terbutaline sulfate oral liquid. The production method disclosed by the invention can effectively reduce the oxidation of the oral liquid and reduce the impurity content of the oral liquid.

Description

technical field [0001] The invention relates to the field of medicinal liquid production, in particular to a terbutaline sulfate oral liquid and a production method thereof. Background technique [0002] Terbutaline sulfate has anti-asthma and expectorant effects, and is clinically used as a beta 2 Adrenergic receptor agonists are widely used in the treatment of symptoms such as bronchial asthma, asthmatic bronchitis and bronchiectasis, and can also be used to prevent premature birth. [0003] The chemical name of terbutaline sulfate is α-[(tert-butylamino)methyl]-3,5-dihydroxyphenylmethanol sulfate, its molecule contains 2 phenolic hydroxyl groups, and it is very easy to prepare oral solutions. Oxidation occurs, which increases the content of impurities and causes the color of the product to become darker, seriously affecting the quality of the product. Contents of the invention [0004] The application provides a terbutaline sulfate oral liquid and a production method ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/04A61K47/14A61K47/12A61K47/26A61P11/06A61P11/10A61P11/00A61P15/06A61L2/02
CPCA61K9/0095A61K31/137A61K47/02A61K47/14A61K47/12A61K47/26A61P11/06A61P11/10A61P11/00A61P15/06A61L2/0017A61L2202/21
Inventor 王宝金李慧杰郭鹏飞
Owner 杭州上禾健康科技有限公司
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