Injectio of gastrodine, its preparing process and usage
The technology of gastrodin injection and gastrodin, which is applied in the field of chemical medicine, can solve problems such as muscle necrosis, pain, and potential safety hazards, and achieve the effects of high bioavailability, improved product quality, and convenient clinical use.
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Embodiment 1
[0036] A) Take fresh water for injection at 80°C, add gastrodin in a ratio of 1:4, stir well to dissolve completely, place it at room temperature, refrigerate at 10°C for 12 hours, ultrafilter with an ultrafilter with a molecular weight cut-off of less than 100,000, and then Ultrafiltration with an ultrafilter with a molecular weight cut-off of less than 5000 to obtain the gastrodin ultrafiltrate, which is sampled to detect the content.
[0037] B) Add 0.03% disodium oxalate tetraacetate in total weight to the ultrafiltrate, adjust the pH to 5.3 according to the content of gastrodin, and after the intermediate product is qualified, the liquid is filled in ampoules through terminal filtration In the process, use a water bath to sterilize, sterilize at 108° C. for 30 minutes, inspect with a light, and the clarity is 98%, pack it, and obtain the finished product of gastrodin injection.
Embodiment 2
[0039] A) Take fresh water for injection at 90°C, add gastrodin in a ratio of 2:5, stir well to dissolve completely, place it at room temperature, refrigerate at 5°C for 24 hours, ultrafilter with an ultrafilter with a molecular weight cut-off of less than 100,000, and then Ultrafiltration with an ultrafilter with a molecular weight cut-off of less than 3000 to obtain the gastrodin ultrafiltrate, which is sampled to detect the content.
[0040] B) Add 0.04% disodium oxalate tetraacetate of total weight to the ultrafiltrate, adjust the pH to 5.9 according to the content of gastrodin, and after the intermediate product is qualified, the liquid is filled in ampoules through terminal filtration In the process, use steam sterilization, sterilize at 110° C. for 35 minutes, light inspection, the clarity is 99%, and pack to obtain the finished product of gastrodin injection.
Embodiment 3
[0042] A) Take fresh water for injection at 85°C, add gastrodin in a ratio of 1:1, stir well to dissolve completely, place it at room temperature, refrigerate at 0°C for 48 hours, ultrafilter with an ultrafilter with a molecular weight cut-off of less than 100,000, and then Ultrafiltration with an ultrafilter with a molecular weight cut-off of less than 5000 to obtain the gastrodin ultrafiltrate, which is sampled to detect the content.
[0043] B) Add 0.05% oxalate tetraacetic acid to the ultrafiltrate, adjust the pH to 7.0 according to the content of gastrodin, and after the intermediate product is qualified, the liquid is filtered and filled in an ampoule at a temperature of 108° C. Sterilize in a water bath for 30 minutes, inspect with light, and the clarity is 98%, and pack to obtain the finished product of gastrodin injection.
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