A kind of cyclosporine ophthalmic emulsion composition
A cyclosporine and composition technology, applied in the field of cyclosporine ophthalmic emulsion composition, can solve the problems of long-term storage, rapid growth of impurities, rapid decline of cyclosporine content, etc., and achieve good stability, eye Less irritating, improve the effect of treating dry eye syndrome
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Embodiment 1
[0027] Example 1 Cyclosporine eye emulsion
[0028] 1. Preparation of cyclosporine eyes
[0029] Table 1-1 Cyclosporine opulent emulsion prescription
[0030]
[0031]
[0032] Referring to Table 1-1, the aseptic main excipients are weighted, and in the aseptic environment, in a sterile environment, the method of preparing an emulsion, the preparation method is:
[0033] 1. Place a cyclosporine A, the tray 80 is placed in castor oil, dissolved in 65 ° C ~ 70 ° C, and the proof phase is obtained;
[0034] 2. Polyethylene glycol 15 hydroxy stearate and polycarpotafi are dissolved with a moderate purified water, add glycerol, stirred at 65 ° C to 70 ° C, dissolve, and obtain a water phase;
[0035] 3. At 65 ° C ~ 70 ° C, the water is placed under the high shear homogeneous machine, slowly add the oil to the aqueous phase, and the collision is collected;
[0036] 4. Place the late breast in the molar machine, 60 / 600 bar, so that the emulsion is accented six times.
[0037] 5. Adju...
Embodiment 2
[0045] Sugust Example 2 Study on Emulsion Stability of cyclosporine
[0046] 2.1 Study on long-term stability of emulsion of cyclosporine
[0047]Examples 1-1 to 1-4 samples and control Examples 1 to 5 were stored at 30 ° C ± 2 ° C, 40% RH ± 5% RH relative humidity 24 months, and at 0, when the placement process, 3 In a month, 6 months, 12 months, 18 months and 24 months were detected. The content of cyclosporin in the sample and the total mixture of substances were determined by the HPLC method. The results were shown in Table 2-1 and 2-2; The laser scattering particle diameter analyzer detects the average particle diameter of the sample, and the results are shown in Table 2-3; the pH value of the sample is measured using a pH meter, and the results are shown in Table 2-4, and the results are known, in the long-term placement process, embodiments 1-1 to 1-4 Samples and Control Examples 1 to 5 The stability of the sample is more stable, the content and pH are not significantly cha...
Embodiment 3
[0072] Example 3 Hyginity test of cyclosporine opuquence 3.1 blink test
[0073] Take 20 health-free horny rabbits, randomly divided into 10 groups, 2 rabbits, 1 to 4, respectively, inventive examples 1-1 ~ 1-4, 5th Group 6 to 10 is a comparison Example 1 to 5 groups, respectively, for each animal, left eye syntaxial bladder, 0.1ml, 眼 眼 生 生 生 生 生 生 生 生 生 0.1ml . Each time you look at your eyes, it is oppressed, and the eye is passively closed for 5 to 10 seconds. After 20 seconds of the drug, each rabbit records the number of blinks per rabbit, the time is more than 90 seconds. The results are shown in Table 3-1, and the results are known, Group rabbits have averaged 8.4 times / minute; Examples 1-1 to 1-4 groups of rabbits The average blinking range of 4.2 to 6.1 times / minute, compared to the average blink of rabbits in Examples 1 to 5 ranks of 7.3 to 8.6 times / Between minutes; explain the epitheral emulsion of the inventive embodiment of the epoxy to the bunny eye stimulat...
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