Adapalene and hydrochloric clindamycin compound gel preparation and preparation method thereof
A technology of clindamycin hydrochloride and compound gel, which is applied in the direction of medical formula, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of difficult to obtain hydrogel preparations and unsatisfactory therapeutic effects , The stability of the preparation is not high, etc., to achieve broad application and market prospects, significant therapeutic effect, and convenient administration
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Embodiment 1
[0036] The preparation of embodiment 1 compound gel of the present invention
[0037] Table 1 shows the amount of raw and auxiliary materials used in the preparation examples I-III of the compound gel preparation of the present invention.
[0038] Table 1 prepares the used raw material of embodiment I-III and auxiliary material formula
[0039]
preparation Embodiment I
[0041] (1) prepare bulk drug and adjuvant by the preparation embodiment 1 in table 1;
[0042] (2) Preparation of gel matrix:
[0043] Take a 10L container, add 50g Carbomer 940, 5g disodium edetate, 10g methylparaben, 400g 1,2-propanediol, 16g poloxamer 188 into the container, add 2075.5g deionized water, stir until a uniform jelly-like matrix is formed. A 0.2 g / ml triethanolamine solution was prepared, and the remaining amount of 1,2-propanediol and 20 g of ethylene glycol phenyl ether were mixed. The jelly matrix, 0.2 g / ml triethanolamine solution, poloxamer 188 aqueous solution, 1,2-propanediol and ethylene glycol phenyl ether mixture, and deionized water were sterilized by heating at 121° C. for 20 minutes. Remove, cool, and set aside.
[0044] (3) Add bulk drug: dissolve 50g clindamycin hydrochloride with 375.1g deionized water under aseptic conditions, dissolve 5g adapalene with the above-mentioned sterilized good 1,2-propanediol and ethylene glycol phenyl ether mi...
Embodiment 2
[0046] The stability research of embodiment 2 compound gel preparations of the present invention
[0047] The stability investigation data of this product (batch number: 20040204) is shown in Table 2.
[0048] Table 2 Adapalene hydrochloride clindamycin compound gel stability test results
[0049]
[0050] As can be seen from the 36-month stability test results of the compound preparation of the present invention, each quality index meets the standard requirements, and there is no obvious change. Stability study data show that the quality of the preparation is stable within the validity period.
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