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Atropine sulfate eye drops as well as preparation method and application thereof

The technology of atropine sulfate and eye drops is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, and drug combinations, etc., and can solve the problems of the impact of patients' life and study, the short duration of drug efficacy, and the easy flow into the lacrimal sac for absorption, etc. Achieve the effects of increasing bioadhesion, reducing drug absorption, and simple and feasible preparation process

Pending Publication Date: 2021-08-17
南京恒道医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] When 1% atropine sulfate eye drops are used clinically, the bioavailability is low, the duration of drug effect is short, and it is easy to flow into the lacrimal sac for absorption. The concentration of 1% atropine sulfate eye drops is relatively high, and there are side effects such as mydriasis and blurred vision. , will affect the life and study of patients, and cannot be used as a routine clinical long-term medication for the treatment of myopia

Method used

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  • Atropine sulfate eye drops as well as preparation method and application thereof
  • Atropine sulfate eye drops as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1~4

[0024] Table 1: Embodiment 1 ~ 4 eye drops formulation table

[0025]

Embodiment 1

[0026] Embodiment 1 preparation process

[0027] Step 1) Take an appropriate amount of water for injection to dissolve the prescribed amount of polycarbophil, stir to make the swelling complete, and sterilize at 121°C for 15 minutes for later use;

[0028] Step 2) Take another appropriate amount of water for injection to dissolve edetate disodium, boric acid, sodium borate, sodium chloride, benzalkonium chloride, add atropine sulfate to dissolve, filter, then add to the excipient solution obtained in step 1) and mix well; Use hydrochloric acid or sodium hydroxide to adjust the pH value to 3.5~6.5;

[0029] Step 3) Add water for injection to make up the volume so that the concentration of atropine sulfate in the eye drops is 0.01 mg / ml, and pack it separately to obtain the product. The obtained eye drops have a pH value of 3.5-6.0, an osmolality of 321 mOsm / kg, and a viscosity of 6800 cps.

Embodiment 2

[0030] Embodiment 2 preparation technology

[0031] Step 1) Take an appropriate amount of water for injection to dissolve the prescribed amount of polycarbophil, stir to make the swelling complete, and sterilize at 121°C for 15 minutes for later use;

[0032] Step 2) Take another appropriate amount of water for injection to dissolve edetate disodium, boric acid, sodium borate, sodium chloride, benzalkonium chloride, add atropine sulfate to dissolve, filter, then add to the excipient solution obtained in step 1) and mix well; Use hydrochloric acid or sodium hydroxide to adjust the pH value to 3.5~6.0;

[0033] Step 3) Add water for injection to make up the volume so that the concentration of atropine sulfate in the eye drops is 0.01 mg / ml, and pack it separately to obtain the product. The obtained eye drops have a pH value of 3.5-6.0, an osmolality of 298 mOsm / kg, and a viscosity of 7200 cps.

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Abstract

The invention relates to atropine sulfate eye drops as well as a preparation method and application thereof. The atropine sulfate injection comprises atropine sulfate and a drug release system, also comprises an auxiliary material and / or water for injection, and is characterized by comprising the following components: 0.001-0.2 percent (w / v) of atropine sulfate, a tackifier, an osmotic pressure regulator, a metal chelating agent, a preservative, a pH regulator and water for injection. Thickening agents such as polycarbophil, hydroxypropyl methylcellulose and polyvinylpyrrolidone are used as adhesive polymers, so that the retention time of the medicine in eyes is prolonged, the bioavailability of the medicine in the eyes is improved, the irritation to the eyes is small and the absorption of the lacrimal sac to the medicine can be reduced; According to the technical scheme, the side effects of atropine can be relieved, including pupil enlargement, unclear vision of near objects, photophobia, conjunctivitis and dermatitis. The medicine is mainly suitable for treating and preventing transient myopia (NITM) induced by close-range work and controlling myopia progress.

Description

technical field [0001] The invention relates to the field of ophthalmic preparations, in particular to atropine sulfate eye drops and a preparation method and application thereof. Background technique [0002] Atropine sulphate, an anticholinergic, is used in dilated pupil refraction, cycloplegia, and depressive therapy in the treatment of amblyopia. Atropine sulfate blocks the M-choline receptors, thereby relaxing the pupillary sphincter and ciliary muscle to form pupil dilation; the ciliary muscle relaxes and tightens the suspensory ligament to flatten the lens, reducing its diopter and causing accommodative paralysis. It is clinically used for mydriasis and cycloplegia, reducing transient myopia caused by close work, and controlling the progression of myopia. [0003] In 1960, the U.S. FDA approved 1% atropine sulfate eye drops to go on the market. The indications were cycloplegia, mydriasis, and the treatment of amblyopia in healthy eyes. In 1976, Japan approved 1% atr...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/46A61K47/32A61K47/36A61K47/38A61P27/02A61P27/10A61P29/00
CPCA61K31/46A61K9/0048A61K9/08A61K47/32A61K47/38A61K47/36A61P27/10A61P27/02A61P29/00
Inventor 陶义华韦燕凌岫泉
Owner 南京恒道医药科技股份有限公司
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