Stable pharmaceutical preparation containing thymosin 1 derivatives
A technology of thymosin and its derivatives, applied in the field of pharmaceutical preparations, can solve problems such as increased use by doctors and patients, increased manufacturing costs, and decreased content and activity
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Embodiment 1
[0041] Weigh a certain proportion of disodium hydrogen phosphate and sodium dihydrogen phosphate and dissolve it in freshly prepared water for injection, adjust the pH of the solution to about 3.0, 5.0, 7.0, 10.0 with phosphoric acid or sodium hydroxide, and then add 0.1% activated carbon to set Incubate in a 60℃ water bath for 15 minutes and filter while hot to remove the carbon. Take the additional filtrate and place it in an ice bath to cool to below 15℃. Weigh the prescription amount (1.6mg / ml) of PEG Thymosin 1 and stir slowly to dissolve it and use phosphoric acid or hydrogen. Sodium oxide adjusts the pH of the drug solution to about 3.0, 5.0, 7.0, 10.0, and finally the drug solution is filtered with a 0.22 μm microporous membrane, divided into packages, filled with nitrogen, and stoppered and capped. The samples were placed at 25°C and 40°C to investigate their stability. The inspection indicators were properties, related substances, content and turbidity. The results are...
Embodiment 2
[0045] Weigh a certain proportion of disodium hydrogen phosphate and sodium dihydrogen phosphate and dissolve it in freshly prepared water for injection, adjust the pH of the solution to about 7.0 with phosphoric acid or sodium hydroxide, then add 0.1% activated carbon and place it in a 60°C water bath for 15 minutes. Filter and remove the carbon while hot, take the additional filtrate and place it in an ice bath to cool to below 15°C, add 0.2% L-glutathione, weigh the prescription amount (1.6mg / ml) of PEG thymosin 1, and stir slowly to dissolve it The pH of the drug solution is adjusted to about 7.0 with phosphoric acid or sodium hydroxide. Finally, the drug solution is filtered with a 0.22 μm microporous filter membrane, divided, filled with nitrogen, and stoppered and capped. The samples were placed at 25°C and 40°C to investigate their stability. The inspection indicators were properties, related substances, content and turbidity. The results are shown in Table 2.
[0046] Ta...
Embodiment 3
[0050] Weigh a certain proportion of disodium hydrogen phosphate and sodium dihydrogen phosphate and dissolve it in freshly prepared water for injection, adjust the pH of the solution to about 7.0 with phosphoric acid or sodium hydroxide, then add 0.1% activated carbon and place it in a 60°C water bath for 15 minutes. Filter and remove the carbon while hot, take the additional filtrate and place it in an ice bath to cool to below 15°C, add 0.2% L-glutathione and 0.05% poloxamer 188, weigh the prescription amount (1.6mg / ml) of PEG Thymosin 1, slowly stir to dissolve it and adjust the pH of the drug solution to about 7.0 with phosphoric acid or sodium hydroxide. Finally, the drug solution is filtered with a 0.22μm microporous membrane, packed, filled with nitrogen, stoppered, and capped. The samples were placed at 25°C and 40°C to investigate their stability. The inspected indicators were properties, related substances, content and turbidity. The results are shown in Table 3.
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Abstract
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