A composition for injection with oxaliplatin as the main component
A technology of oxaliplatin and composition, which is applied in the field of injection composition and its preparation, can solve problems such as poor moldability, and achieve the effects of simple preparation method, reduced degradation, and high production efficiency
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Method used
Image
Examples
Embodiment 1
[0058] Embodiment 1: Oxaliplatin large-volume injection.
[0059]
[0060] The injection preparation process is as follows:
[0061] a. Take an appropriate amount of water for injection, and inject nitrogen gas by bubbling, so that the dissolved oxygen content is less than 0.1ppm, and set aside;
[0062] b. Take oxaliplatin bulk drug, aspartic acid, glutamic acid, pulverize, pass through a 200 mesh sieve, and set aside;
[0063] c. Take an appropriate amount of water for injection with a dissolved oxygen content less than 0.1ppm obtained in step a, add the prescribed amount of aspartic acid or glutamic acid, and mannitol, stir to dissolve, and adjust the pH value of the solution to 4.5 with 0.1mol / L sodium hydroxide -5.5;
[0064] d. Take the solution obtained in step c, and add the prescribed amount of oxaliplatin bulk drug under stirring conditions to dissolve;
[0065] e. Take the drug-containing solution obtained in step d, measure the pH value, and adjust the pH val...
Embodiment 3
[0085] Embodiment 3: Sample influencing factor test.
[0086] Take four prescriptions of large-capacity injections in Example 1 and two samples of small-capacity injections in Example 2 in appropriate amounts, place them under high temperature (40° C.), high temperature (60° C.) and strong light (4500Lx±500Lx) respectively. 10 days, test the samples on 0 day, 5 days, and 10 days, and the test data are as follows:
[0087] Table 1 Test results of each sample under high temperature (40°C) condition
[0088]
[0089] Table 2 Test results of each sample under high temperature (60°C) conditions
[0090]
[0091]
[0092] Table 3 Test results of each sample under strong light (4500Lx±500Lx) conditions
[0093]
[0094] It can be seen from the above data that the oxaliplatin large-volume and small-volume injections prepared according to the prescription and process disclosed in Example 1 and Example 2 of the present invention are stable under high temperature and strong...
Embodiment 4
[0095] Example 4: Comparison of the long-term stability of the samples of Example 1 and Example 2 and the commercially available oxaliplatin large-volume injection.
[0096] Take the oxaliplatin large-volume and small-volume injection samples (including packaging materials) prepared in Example 1 and Example 2 and three specifications of commercially available oxaliplatin injection (including packaging materials) and place them at 25°C ± 2°C , stored under the condition of 60%±5%RH for 36 months, took samples in 0 months, 6 months, 12 months, 2 years, and 3 years to determine the relevant properties, and obtained the corresponding data, as shown in the following table:
[0097] Various specification oxaliplatin injections and commercially available oxaliplatin injection 3 years long-term stability experiment results in the embodiment 1 and embodiment 2 of table 4
[0098]
[0099]
[0100] As can be seen from the data in the above table, compared with the commercially ava...
PUM
Login to View More Abstract
Description
Claims
Application Information
Login to View More