Preparation method of pharmaceutical composition containing deslanoside

A technology for deacetylsaurin and mixtures, which is applied in the field of preparation of deacetylsaurin compositions, and can solve the problems of low sterility assurance level, high injection risk, and large impurity level in deacetylsaulicidin injections. , to achieve the effect of improving the level of sterility assurance, ensuring sterility, and eliminating the risk of introducing impurities

Inactive Publication Date: 2021-02-09
SHANGHAI XUDONG HAIPU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The deacetyllanatoside injection prepared by this patent has a relatively large level of impurities, a low level of sterility assurance, and a high risk of injection

Method used

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  • Preparation method of pharmaceutical composition containing deslanoside
  • Preparation method of pharmaceutical composition containing deslanoside
  • Preparation method of pharmaceutical composition containing deslanoside

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073]The composition of the prescription is as follows:

[0074] prescription Prescription 1 a

Prescription 2 b

Deacetyloside 12.9g43g Ethanol (95%) c

5.29kg 17.63kg glycerin 9.59kg 31.98kg Add water for injection to 65.89kg 219.9kg

[0075]Remarks:

[0076]a: The batch is 30,000, and the filling quantity is 2.15ml / piece. The glycerin manufacturer is Hunan Erkang Pharmaceutical Co., Ltd. The total weight of the liquid medicine is calculated based on the solution density of 1.0216g / ml.

[0077]b: The batch is 100,000 bottles, and the volume is 2.15ml / bottle. The glycerin manufacturer is Aug.Hedinger GmbH&Co.KG. The total weight of the liquid medicine is calculated based on the solution density of 1.0228g / ml.

[0078]c: The density of 95% ethanol is 0.81g / cm3It is calculated that the mass of ethanol in 5.29 kg of 95% ethanol is 4.9 kg, and the mass of ethanol in 17.63 kg of 95% ethanol is 16.33 kg.

[0079]Prescription 1 preparation process: add about 60% (about 39.55kg) of water for injection ...

Embodiment 2

[0086]Terminal sterilization was performed on the samples of prescription 2, and the sterilization conditions were 116°C for 30 minutes and 121°C for 15 minutes. Compare the quality of the products before sterilization and different sterilization conditions, and take samples after sterilization at a high temperature of 60°C, 5 days, 10 days, and a high temperature of 80°C, in 1 day and 3 days to test the product quality (The test method is the same as above). The test results are as follows:

[0087]

[0088]

[0089]The experimental results show that deacetyl lanolin injection can withstand the terminal sterilization process, and the increase of impurities is small during the stability process.

Embodiment 3

[0091]The composition of the prescription is as follows:

[0092] ingredient Dosage (200,000 pieces / batch, 2.15ml / piece) Deacetyloside 86.0g Ethanol (95%) 35.26kg glycerin 63.96kg Add water for injection to a

439.80kg

[0093]a: The total weight of the drug solution is calculated based on the solution density of 1.0228g / ml.

[0094]Add about 60% of the prepared amount (about 264.00kg) of water for injection into the dispensing tank. After the water temperature is reduced to ≤40°C, add the prescription amount of glycerin and start stirring. Add the prescription amount of ethanol to the stainless steel barrel, and then add an appropriate amount of water for injection (about 12.60 kg) to dilute the prescription amount of ethanol into an ethanol solution with a concentration of about 70%. Add the prescribed amount of deacetyl lanolin to the above about 70% ethanol solution, and stir for at least 20 minutes until it is uniformly dissolved. Pour the above-mentioned liquid medicine into the ...

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PUM

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Abstract

The invention discloses a preparation method of a pharmaceutical composition containing deslanoside. The invention provides a preparation method of a deslanoside injection. The preparation method is characterized by comprising the following step: sterilizing a mixture containing the deslanoside, ethanol, glycerol and water for injection by adopting a terminal sterilization mode of sterilizing at 121 DEG C for 15 minutes. The deslanoside injection prepared by a prescription and process disclosed by the invention is stable in quality and low in impurity content, and can be placed for 5 days and10 days at a high temperature (60 DEG C) and for 1 day and 3 days at a high temperature (80 DEG C), and results show that the deslanoside injection is stable in product quality and relatively small inimpurity increase.

Description

Technical field[0001]The present invention belongs to a method for preparing a deacetyl lanolin composition, and relates to preparing desacetyl lanolin composition into a preparation with suitable content, suitable pH value, and capable of being injected and administered. The bacteria guarantee level and the growth of impurities during the preparation and storage process.Background technique[0002]Deacetyl lanolin is a cardiac glycoside naturally present in digitalis. During the extraction process, it can lose glucose and acetic acid by hydrolysis to form digoxin. It is a fast-acting cardiac glycoside with a more powerful effect. Rehmannia glutinosa and digoxin are faster, but a little slower than toxin K. Deacetyl lanolin injection is mainly used for heart failure. Because of its fast action, it is suitable for patients with acute cardiac insufficiency or acute exacerbation of chronic cardiac insufficiency; it can also be used to control atrial fibrillation and atrial flutter with r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61K36/80A61K9/08A61K47/10A61P9/04A61P9/06
CPCA61K9/0019A61K9/08A61K31/7048A61K36/80A61K47/10A61P9/04A61P9/06
Inventor 胡慧张帆梁屹杨易可刘婧
Owner SHANGHAI XUDONG HAIPU PHARMA
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