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Catalpol nasal drops as well as preparation method and application thereof

A technology of nasal drops and catalpol, which is applied in the directions of blood diseases, pharmaceutical formulations, extracellular fluid diseases, etc., can solve the problem that patients cannot arrive at the hospital in time, and achieves reduction in the number of neuronal cell apoptosis in the cortex and stable storage properties. , good safety effect

Active Publication Date: 2022-04-15
SOUTHWEST UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

During this period, the vast majority of patients cannot arrive at the hospital in time.

Method used

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  • Catalpol nasal drops as well as preparation method and application thereof
  • Catalpol nasal drops as well as preparation method and application thereof
  • Catalpol nasal drops as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1, Zichun nasal drop prescription screening

[0043] Due to the rich vascular system and the highly permeable structure in the nasal membrane in the nasal cavity, intranasal administration can achieve rapid onset of effect. However, there are two major obstacles to intranasal absorption of drugs, one is the low membrane permeability of polar drugs, and the other is that the drug is quickly cleared due to the mucociliary clearance, so adding safe and effective thickeners and absorption enhancers will can solve this problem to a large extent.

[0044]The pH value of nasal mucus can affect the action of solution bacterial enzymes and ciliary movement. The pH value of the normal nasal secretion fluid of adults is 5.5-6.5. When it is alkaline, it is easy to cause acute non-infectious inflammation. Exercise can cause bacterial infection. In addition, the previous experiments of the research group showed that catalpol is unstable to acid and alkali, so this part ...

Embodiment 2

[0084] Embodiment 2, the preparation technology and formula of Zichun nasal drops

[0085] According to the research of Example 1, the final concentration of each component of Zichun nasal drops is as follows, specifically shown in Table 6:

[0086] Table 6. Formula of catalpol nasal drops

[0087]

[0088] The specific preparation process is as follows: accurately weigh an appropriate amount of catalpol extract, prepare a catalpol solution with physiological saline, and prepare it as solution A, and reserve it for later use. Accurately weigh 0.1g of carbomer, add 50mL of normal saline to dissolve in a water bath at 40°C, and leave it at room temperature for several hours until the carbomer solution is observed to have no white core by naked eyes, and the swelling is complete, which is solution B. Add water-soluble azone to solution B and stir well, then add solution A and mix well again, adjust the pH value to 6.5-7.0 with phosphate buffer, set the volume to 100mL, and st...

Embodiment 3

[0090] Embodiment 3, the stability evaluation of catalpol nasal drops

[0091] Prepare catalpol nasal drop sample solution according to the prescription of embodiment 2, be divided into 4 parts and seal in test tube, respectively at normal temperature (4 ℃, 25 ± 2 ℃), high temperature 40 ℃, strong light irradiation (illuminance≧5000Lx fluorescent lamp) Preserve under the condition, in the 1st week, the 2nd week, the 3rd week, the 4th week get the solution and dilute to 1mg / mL respectively, measure the change of catalpol concentration according to the assay method of embodiment 1, observe the solution clarification situation and the change of pH value. Variety.

[0092] The experimental data was sampled with IBM spss20.0 (SPSS Inc, Chicago, USA) for one-way analysis of variance, and the statistical results were expressed as Mean ± SD. Use GraphpadPrsm5.0 (Graphpad Software, USA) to make statistics and make result graphs.

[0093] The stability test results of catalpol nasal dro...

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Abstract

The invention discloses catalpol nasal drops and a preparation method and application thereof.The catalpol nasal drops are prepared from catalpol, a thickening agent, an absorption enhancer and a pH regulator, the catalpol, the thickening agent and the absorption enhancer are 10 mg / ml, the mass percentage of the thickening agent is 0.1%, the volume percentage of the absorption enhancer is 2.0%, and the pH value is 6.5-7.0; the preparation is stable in storage property under normal-temperature and dark conditions; the absorption is fast through nasal administration, the concentration in brain tissues is obviously higher than that of intravenous administration, and brain targeting is achieved; compared with oral administration and injection administration, the catalpol nasal administration dosage form can also reduce the infarct volume of brain tissues of acute cerebral ischemia patients, and can reduce the number of apoptosis of neuronal cells in a cortical region caused by cerebral ischemia injury, which shows that the catalpol nasal administration dosage form has a remarkable neuroprotective effect on the cerebral cortical region; the catalpol nasal drops have low toxicity to cilia, no obvious nasal cavity irritation is found, and the nasal administration safety is good.

Description

technical field [0001] The present invention relates to the field of traditional Chinese medicine preparations, in particular to a nasal drop whose active ingredient is Zichun, and also to a preparation method and application of Zichun nasal drop. Background technique [0002] Catalpol is one of the active ingredients of the traditional Chinese medicine Rehmannia glutinosa, and it is an iridoid glycoside compound. Modern studies have confirmed that it has neuroprotective effects on brain ischemic injury, Alzheimer's disease (AD) and Parkinson's disease (PD) effect. However, due to the good water solubility of catalpol, it is difficult to penetrate the blood-brain barrier under the general route of administration (such as oral administration and injection), and the bioavailability is not very high, which limits its application and development in the treatment of brain diseases . [0003] Nasal drug delivery system refers to a class of preparations that are absorbed through ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7048A61K47/32A61K47/22A61K47/02A61P7/04A61P25/00A61P9/10
CPCY02A50/30
Inventor 祝慧凤张育华
Owner SOUTHWEST UNIVERSITY
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