Stable interferon microneedle preparation as well as preparation method and application thereof
A technology of microneedle preparation and interferon, which is applied in the field of medicine, can solve the problems of high transportation cost, inconvenient administration, and strict storage conditions of interferon, and achieve high activity, effective maintenance of activity, and reduced use cost
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Embodiment 1
[0053] Example 1 Integrated Dissolving Microneedle of Human Interferon α1b
[0054] This embodiment firstly provides an integrated dissolving microneedle for human interferon α1b, the preparation method of which is as follows:
[0055] 1. Preparation of microneedle matrix solution:
[0056] The microneedle matrix solution was prepared according to the following solid content ratio: 20% CMC, 5% trehalose, and 5% sucrose. Weigh CMC (sodium carboxymethylcellulose, viscosity 800cps, Anhui Shanhe Pharmaceutical Excipients Co., Ltd.) 0.2g, trehalose 0.05g, sucrose 0.05g, add 0.7mL PBS solution (0.01M, pH6.0) solution, After stirring and dissolving, let stand at 0°C for 5 minutes, centrifuge to remove air bubbles, add 0.042mL of 6mg / mL human interferon α1b stock solution, vortex and oscillate to mix, then centrifuge at 4°C to remove air bubbles, and place at 4°C to stand for use . At this time, the concentration of interferon α1b in the solution was 0.252 mg / mL.
[0057] 2. Micro...
Embodiment 4～7、 comparative example 8～12
[0070] Examples 4-7, Comparative Examples 8-12: Integrated dissolving microneedles containing different stabilizers
[0071] According to the preparation method of Example 1, according to the weight percentage of the substances given in Table 2, the microneedles of Examples 4-7 and Comparative Examples 8-12 were prepared and the microneedle integrity, puncture property, needle body color and biological Molecular activity (see Table 2).
[0072] It can be seen from Table 2 that Examples 4-5 and Comparative Examples 8-12 used similar microneedle matrix materials and single-component stabilizers. The microneedles containing calcium glucoheptonate and L-methionine showed different degrees of color change, and did not meet the standard in appearance; the interferon activity of microneedles containing EDTA, arginine and dextran was lower than 80 %; Microneedles containing trehalose and sucrose have good appearance, microneedle penetration and stability. Different microneedle matri...
Embodiment 8
[0075] Example 8: Layered Dissolving Microneedles of Human Interferon α1b
[0076] This embodiment provides a layered dissolving microneedle of human interferon α1b, the preparation method of which is as follows:
[0077] 1. Preparation of needle tip solution:
[0078] The activity results in Examples 2 and 3 show that CMC and PVA can play a role in stabilizing interferon α1b when used as microneedle substrates, so these two materials will be preferred as needle tip substrate materials when making split needles. When layering microneedles, the drying speed of CMC is faster than that of PVA, which is more conducive to stabilizing the active ingredients of the needle tip, so CMC is preferred as the matrix material of the needle tip.
[0079] The microneedle tip solution was prepared according to the following solid content ratio: 5% CMC, 5% trehalose, and 5% sucrose. Weigh 0.05g of CMC, 0.05g of trehalose, 0.05g of sucrose, add 0.85mL of PBS solution (0.01M, pH6.0) solution, s...
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