Asparaginase freeze-dried powder injection and preparation method thereof, as well as asparaginase solution
A technology of asparaginase and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, powder transportation, pharmaceutical formulations, etc., can solve the problems of uncertain pH value, unfavorable operation, and injection defects, etc., and achieves convenient clinical use and improved Safety, irritation-reducing effect
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Method used
Image
Examples
Embodiment 1
[0022] (Example 1, asparaginase freeze-dried powder injection)
[0023] The prescription of present embodiment asparaginase lyophilized powder injection is as follows:
[0024] Asparaginase 10 million units, poloxamer 188 (F68) 4.0g, mannitol (20%w / v) 300g, sodium dihydrogen phosphate dihydrate 6.24g, 0.1mol / L NaOH aqueous solution (appropriate amount to adjust the system The pH is 7.5±0.2), water for injection is added to 2000g, and a total of 1000 tubes are made.
[0025] The preparation method of the present embodiment asparaginase freeze-dried powder injection is as follows:
[0026] Add 300 g of sodium dihydrogen phosphate dihydrate, poloxamer 188 (F68) (CAS No.: 9003-11-6), and mannitol (20% w / v) accurately weighed according to the above prescription and pre-cool to 10 After dissolving in water for injection below ℃, use 0.1mol / L NaOH to adjust the pH value of the solution to 7.3~7.5; 0.1 mol / L HCl to adjust the pH value to 7.3±0.2 (7.5 in this example); add water to ...
Embodiment 2 to Embodiment 5
[0036] (Example 2 to Example 5, asparaginase freeze-dried powder injection)
[0037] The prescriptions of the asparaginase freeze-dried powder injections of Examples 2 to 5 are shown in Table 1 below.
[0038] Table 1
[0039]
[0040] Examples 2 to 5 were prepared according to the prescriptions in the above table, and the preparation method was the same as that of the asparaginase freeze-dried powder injection in Example 1.
[0041] The freeze-dried powder injections prepared according to the prescriptions and preparation methods of Examples 2 to 5 were sequentially designated as samples S2, S3, S4, and S5.
Embodiment 6
[0042] (Example 6, asparaginase solution)
[0043] The configuration method of the asparaginase lysate of the present embodiment is as follows:
[0044] First, accurately weigh 6.24 g of sodium dihydrogen phosphate dihydrate and 4.0 g of surfactant poloxamer 188 (F68); add 300 g of the above accurately weighed sodium dihydrogen phosphate dihydrate and poloxamer 188 (F68) After dissolving in water for injection, use 0.1mol / L NaOH solution to adjust the pH value of the solution to 7.1-7.5 (7.5 in this example); then add water for injection until the total weight of the solution is 5000g, and use 0.22 Sterilize by filtration with a microporous membrane; divide the filtrate into ampoules according to 5.0 g per bottle, stopper and cap, and label to obtain 1000 special solvents, store at room temperature, and use it as sample S6.
[0045] The buffer system of the asparaginase lysate in this embodiment is composed of disodium hydrogen phosphate and sodium dihydrogen phosphate, wher...
PUM
Abstract
Description
Claims
Application Information
- R&D Engineer
- R&D Manager
- IP Professional
- Industry Leading Data Capabilities
- Powerful AI technology
- Patent DNA Extraction
Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.
© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com