Composition for enhancing drug safety and clinical efficacy of low concentration atropines

A low-concentration atropine technology, applied in the field of compositions and preparations that enhance the safety and clinical efficacy of low-concentration atropine drugs, can solve the problems of instability of the main drug, accompanying adverse reactions and side effects, and reduce repeated medication The number of times, improve the medicinal effect, the effect of extending the shelf life

Inactive Publication Date: 2019-04-26
杭州赫尔斯科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention aims at the low-concentration atropine drug eye drops in the process of preventing and treating adolescents and children's myopia, the safety and clinical curative effect of the low-concentration atropine drug in the solution are affected by the composition of the used composition and present a greater difference. The problem of differences in safety and clinical efficacy, creatively proposed a composition and its preparation method that can enhance the safety and clinical efficacy of low-concentration atropine drugs, especially for eye drops, through a lot of research work, surprisingly found A composition that can enhance the safety and clinical efficacy of low-concentration atropine drug eye drops can effectively solve the instability of the main drug and the safety and accompanying adverse effects of impurity degradation during the use of current low-concentration atropine drug eye drops In addition, it can effectively enhance the clinical efficacy of drugs, give full play to the use of low-concentration atropine drug eye drops in the prevention and treatment of myopia in adolescents and children, improve the safety and efficacy mechanism of drugs, and improve the eyesight and vision of adolescents and children. Physical health provides safety and efficacy guarantee

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  • Composition for enhancing drug safety and clinical efficacy of low concentration atropines
  • Composition for enhancing drug safety and clinical efficacy of low concentration atropines
  • Composition for enhancing drug safety and clinical efficacy of low concentration atropines

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preparation example Construction

[0042] Adopt the following preparation process to prepare the stock solutions of each pharmaceutical composition of the present invention, then study respectively the influence of the composition of the pharmaceutical composition on the safety, stability and curative effect of the low concentration atropine drug eye drop preparation, and the present invention Each pharmaceutical composition was compared with a comparative pharmaceutical composition to study the differences in their influence on the safety, stability and curative effect of the low-concentration atropine drug eye drop formulation.

[0043] Stock solution preparation process: the raw material drug atropine sulfate is added to water for injection to form an aqueous solution with a concentration of 0.01% (w / v); an osmotic pressure buffer is added to the above solution to adjust the osmotic pressure to 310mOsm / L; Thickener, adjust the viscosity to 30mps; finally add acid-base regulator, the total amount is 2.5% (w / v)...

preparation Embodiment 1

[0085] The crude drug atropine sulfate is added to the water for injection, and the concentration is made into an aqueous solution of 0.001% (w / v), sodium chloride is added in the solution, the osmotic pressure is adjusted to be 250mOsm / L, and hypromellose (HPMC) is added , adjust the viscosity to 10mps, add 1.3% (v / v) of phosphate buffer system, and adjust the pH to 3.0 with dilute hydrochloric acid, after mixing evenly, stir thoroughly, according to the relevant requirements of "Chinese Pharmacopoeia 2015 Edition (Part Four)" eye drops , filtered through a 0.22 μm microporous membrane, sterilized, single-dose aseptically subpackaged, and passed the light inspection to obtain sterile low-concentration atropine drug eye drops.

preparation Embodiment 2

[0087] The crude drug atropine sulfate is added to the water for injection, and the concentration is made into an aqueous solution of 2% (w / v), boric acid is added in the solution, and the osmotic pressure is adjusted to be 360mOsm / L, and sodium hyaluronate is added to adjust the viscosity to 26mps. Add 2.3% (v / v) of citrate buffer system, and adjust the pH to 5.0 with dilute hydrochloric acid. Pore ​​membrane filtration, sterilization, single-dose aseptic subpackaging, and light inspection pass, to obtain sterile low-concentration atropine drug eye drops.

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Abstract

The present invention discloses a composition capable of enhancing the drug safety and clinical efficacy of low concentration atropines, and especially when the composition is used in low concentration atropines eye drops, the fact that the composition used in the low concentration atropines eye drops provided by the invention can effectively improve the drug safety of low concentration atropinesby adjusting key quality parameters such as pH, osmotic pressure and viscosity of the eye drops is creatively discovered, especially for improving clinical efficacy, so as to effectively solve the problems in the use of current low-concentration atropines eye drops, such as poor safety, large efficacy differences, unstable main drugs, safety of impurities degradation, concomitant adverse reactionsand other side effects. The composition enhances the clinical efficacy of low concentration atropines eye drops in the prevention and treatment of myopia of adolescents and children and provides a safer and healthier guarantee for the eyesight of adolescents and children, and has a very broad application prospect.

Description

technical field [0001] The invention belongs to the technical field of ophthalmic medication of pharmaceutical preparations, and in particular relates to a composition for enhancing the safety and clinical efficacy of low-concentration atropine drugs and a preparation method thereof. Background technique [0002] According to a survey on the prevention and treatment of myopia in children jointly conducted by China, the United States and Australia, the number of myopia in my country has reached nearly 450 million, and the number of myopia cases ranks first in the world. The incidence of myopia has reached 1.5 times the world average. The rate is as high as 50% to 60%. As the learning pressure of young students in our country continues to increase, the current young people in my country have become the main group of myopia, which has a great impact on their future work, study and life, and has become the top priority of the current disease control work . With the entry of vari...

Claims

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Application Information

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IPC IPC(8): A61K45/00A61K31/46A61K9/08A61K47/02A61K47/10A61K47/38A61K47/36A61K47/04A61K47/12A61K47/32A61K47/26A61P27/10A61P27/02A61P9/10
CPCA61K9/0048A61K9/08A61K31/46A61K45/00A61K47/02A61K47/10A61K47/12A61K47/26A61K47/32A61K47/36A61K47/38A61P9/10A61P27/02A61P27/10
Inventor 李大伟李文龙穆丹华侯宏兵周光大林建华张虹
Owner 杭州赫尔斯科技有限公司
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