A temperature-sensitive gel damage repair preparation and its application
A temperature-sensitive, damage-repairing technology that can be used in sensory diseases, aerosol delivery, medical preparations with inactive ingredients, etc.
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Embodiment 1
[0062] A kind of preparation formula three containing rHSA / EGF
[0063] In view of the fact that adding glycerol or adding CMC at the same time in Comparative Example 1 and Comparative Example 2 did not significantly improve the stability of the fusion protein, for this reason, glycine plus poloxamer was used as a protein stability and to increase the viscosity of eye drops. The preparation formula excipients, see Table 3 for details.
[0064] Table 3 A formulation three containing rHSA / EGF
[0065]
[0066] Prepare 4ml / bottle×10 bottles of samples. According to the method described in Comparative Example 1, it was placed in an accelerated test box with a temperature of 25°C and a humidity of 70% to accelerate the stability inspection for 14 days, and samples were taken according to time points for appearance inspection, biological activity measurement and protein electrophoresis detection.
[0067] The results are shown in Table 4.
[0068]
[0069] When testing, the...
Embodiment 2
[0079] A kind of thermosensitive type gel formulation formula five
[0080] In order to achieve the goal that the eye drops are in a liquid state at 0-35°C and in a gel state above 35°C (significantly reducing the fluidity of the eye drops), on the basis of formulation 4, the poloxamer 188 and the consumption of poloxamer 407, specifically see Table 6.
[0081] Table 6 Temperature-sensitive gel preparation formula five
[0082] Component No. name Dosage use 1 rHSA / EGF 0.2mg / mL API 2 Glycine 2% stabilizer 3 Poloxamer 188 6% thickener 4 Poloxamer 407 16.5% thickener 5 100mM PB to a final concentration of 10mM buffer
[0083] Prepare 4ml / bottle×10 bottles of samples. According to the method described in Comparative Example 1, it was placed in an accelerated test box with a temperature of 25°C and a humidity of 70% to accelerate the stability inspection for 14 days, and samples were taken according to time points...
Embodiment 3
[0086] A kind of temperature-sensitive gel formulation formulation formulation six
[0087] In order to achieve the goal that the eye drops are in a liquid state at 0-35°C and in a gel state (no fluidity) above 35°C, on the basis of formulation five, further adjusting Poloxamer 188 and Poloxamer For the amount of 407, see Table 7 for details.
[0088] Table 7 temperature-sensitive gel preparation formulation formulation six
[0089] Component No. name Dosage use 1 rHSA / EGF 0.2mg / mL API 2 Glycine 2% stabilizer 3 Poloxamer 188 6% thickener 4 Poloxamer 407 18% thickener 5 100mM PB to a final concentration of 10mM buffer
[0090] Prepare 4ml / bottle×10 bottles of samples. According to the method described in Comparative Example 1, it was placed in an accelerated test box with a temperature of 25°C and a humidity of 70% to accelerate the stability inspection for 14 days, and samples were taken according to time poi...
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