A kind of small scale adrenaline hydrochloride injection and preparation method thereof
A technology of epinephrine hydrochloride and epinephrine, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Problems such as the probability of constructing
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Method used
Image
Examples
Embodiment 1
[0025] An epinephrine hydrochloride injection, each (10mL) contains the following components: epinephrine 1mg, edetate disodium 3mg, sodium chloride 80mg; Influence of stability, respectively choose edetate calcium sodium addition amount as 3mg, 5mg, 8mg, 10mg to carry out comparative test;
[0026] The preparation method of above-mentioned epinephrine hydrochloride injection specifically comprises the following steps:
[0027] 1. Add a certain volume of water for injection into the preparation tank, wait for the temperature to drop to 55°C, fill with nitrogen for 30 minutes, and then take out an appropriate amount of water for injection for use;
[0028] 2. Add sodium chloride, sodium calcium edetate and disodium edetate in the above formula into the preparation tank, and stir for 10 minutes to dissolve;
[0029] 3. Add the prepared amount of adrenaline raw material drug into an appropriate amount of standby water for injection, and add hydrochloric acid with a concentration...
Embodiment 2
[0039] An injection of epinephrine hydrochloride, each (10 mL) contains the following components: 1 mg of epinephrine, 5 mg of calcium sodium edetate, 3 mg of disodium edetate, 80 mg of sodium chloride, and the rest is water for injection;
[0040] In order to investigate the effect of the concentration of hydrochloric acid on the stability of the prepared injection, in the preparation process of the injection, use 5%, 10%, 15%, 20%, 30% and 40% concentration of hydrochloric acid to adjust the pH value, and other preparations The process refers to Example 1; the prepared epinephrine hydrochloride injection was placed at 40°C for 0 days, 5 days and 10 days respectively, and the performance changes of the injection are shown in Table 2;
[0041] Table 2 Performance comparison of epinephrine injection prepared under different hydrochloric acid concentrations
[0042]
[0043]As can be seen from the table, when the concentration of hydrochloric acid was 5%, 10%, and 15%, the pH...
Embodiment 3
[0045] An injection of epinephrine hydrochloride, each (10 mL) contains the following components: 1 mg of epinephrine, 5 mg of calcium sodium edetate, 3 mg of disodium edetate, 100 mg of sodium chloride, and the rest is water for injection;
[0046] In order to investigate the influence of the temperature of the water for injection used in the preparation of the drug solution on the quality of the prepared epinephrine hydrochloride, during the preparation of the injection, the water for injection was filled with nitrogen when the temperature of the water for injection was 40°C, 50°C, 60°C, and 70°C; Then add sodium chloride, calcium sodium edetate and disodium edetate required for the preparation amount, and add the prepared adrenaline hydrochloride solution, and stir for 30 minutes; take samples and measure the liquid at 10 minutes, 20 minutes, and 30 minutes of the stirring time respectively. For specific parameters, refer to Example 1 for other preparation processes; the con...
PUM
Login to View More Abstract
Description
Claims
Application Information
Login to View More