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Atropine sulfate ocular inserts and preparation method thereof

A tropine sulfate and ophthalmic technology, applied in the field of medicine, can solve problems such as low bioavailability, poor drug stability, and difficulty in eye drug delivery systems, and achieve the effects of solving eye discomfort, film transparency, and improving bioavailability

Active Publication Date: 2020-07-03
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the multiple protective mechanisms of the eye and the high sensitivity of the eye, the ocular drug delivery system is very difficult
At the same time, there are many defects in eye drops, such as low bioavailability and poor drug stability.

Method used

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  • Atropine sulfate ocular inserts and preparation method thereof
  • Atropine sulfate ocular inserts and preparation method thereof
  • Atropine sulfate ocular inserts and preparation method thereof

Examples

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preparation example Construction

[0031] The present invention also provides the preparation method of the atropine sulfate eye film described in the above-mentioned technical scheme, comprises the following steps:

[0032] Mixing the film former, water and plasticizer in turn to obtain a slurry;

[0033] Atropine sulfate is added to the slurry, followed by film forming, drying and sterilization to obtain the atropine sulfate ophthalmic film.

[0034] In the present invention, the water is preferably water for injection. In the present invention, there is no special limitation on the dosage of the water for injection, as long as the complete mixing of the film-forming agent and the plasticizer is sufficient.

[0035] In the present invention, the film forming and drying are preferably carried out in a coater, the wet film coating thickness of the coater is preferably 100±20 μm, the coating speed is preferably 10 to 20 rpm, and the drying temperature is preferably 60 ±5°C.

[0036] The present invention has ...

Embodiment 1

[0042] Atropine sulfate 31.5mg (8μg per square centimeter)

[0043] Hydroxypropyl methylcellulose E536g (9mg per square centimeter)

[0044] Glycerin 18g (4.5mg per square centimeter)

[0045] Water for injection 900mL

[0046] Preparation method: Accurately weigh the prescribed amount of hydroxypropyl methylcellulose E536g, add the prescribed amount of water for injection, fully stir, and dissolve for later use; then slowly add the prescribed amount of glycerin and atropine sulfate to the slurry, and stir at 1000rpm for 20 minutes; Get the slurry. Turn on the coater, install the backing material, adjust the coating thickness so that the thickness of the film is about 100±20μm, set the coating speed to 10rpm, evenly coat the slurry on the backing to form a film, dry at 60±5°C, and dry After that, the film is complete, with uniform appearance and good flexibility.

Embodiment 2

[0048]Atropine sulfate 31.5mg (8μg per square centimeter)

[0049] Hydroxypropyl methylcellulose E1536g (9mg per square centimeter)

[0050] Glycerin 18g (4.5mg per square centimeter)

[0051] Water for injection 900mL

[0052] Preparation method: Accurately weigh the prescribed amount of hydroxypropyl methylcellulose E1536g, add the prescribed amount of water for injection, fully stir, and dissolve for later use; then slowly add the prescribed amount of glycerin and atropine sulfate to the slurry, and stir at 1000rpm for 60min; Get the slurry. Turn on the coater, install the backing material, adjust the coating thickness so that the thickness of the film is about 100±20μm, set the coating speed to 20rpm, evenly coat the slurry on the backing to form a film, dry at 60±5°C, and dry Finally, the film is complete, the appearance of the film is uniform, and the flexibility is better than that of Example 1.

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Abstract

The invention provides atropine sulfate ocular inserts and a preparation method thereof, and belongs to the field of medicines. The atropine sulfate ocular inserts provided by the invention takes atropine sulfate as a main drug and takes a rapidly degradable polymer film-forming material as a drug carrier, thus, the problems that an atropine sulfate aqueous solution is poor in stability, common eye drops are easily diluted by tears, the retention time of the common eye drops in eyes is short, the delivery dosage is inaccurate and the like are solved, and the bioavailability of the atropine sulfate in eyes is greatly improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an atropine sulfate ophthalmic film and a preparation method thereof. Background technique [0002] At present, myopia has become a worldwide public health problem. In some Asian countries, such as Singapore, etc., the rate of suffering from myopia is as high as 80-90%. Myopia refers to the fact that parallel rays of light pass through the refractive system of the eyeball and focus in front of the retina in a relaxed state, making the image seen blurred. This disease has a great impact on the learning of teenagers, which will reduce the learning efficiency and achievement. Compared with normal people, they are more prone to symptoms such as fatigue and headache. If the corresponding measures are not taken in time to protect the eyes, it is very likely to cause retinal detachment , can cause blindness in severe cases. [0003] For the treatment of myopia, there are currently c...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K47/38A61K47/32A61K47/10A61K31/46A61P27/10
CPCA61K9/7007A61K9/0048A61K47/38A61K47/32A61K47/10A61K31/46A61P27/10Y02A50/30
Inventor 张宇尹湉苟靖欣何海冰唐星吉木色
Owner SHENYANG PHARMA UNIVERSITY
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