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Propranolol hydrochloride submicron emulsion gel and preparation method and application thereof

A technology of propranolol hydrochloride and propranolol hydrochloride is applied in the field of propranolol hydrochloride sub-microemulsion gel and preparation thereof, and can solve problems such as adverse effects, need to be strengthened, low blood sugar and the like, and achieve no skin irritating effect

Active Publication Date: 2016-03-30
WUHAN CONFORM PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, oral propranolol may cause side effects such as hypotension, hypoglycemia, bradycardia, etc., especially with potential adverse effects on the nervous system of infants and young children.
At present, the technical means of propranolol skin administration has attracted widespread attention, and it has been found that in the preparation process of propranolol hydrochloride gel or cream, the increase of the concentration of propranolol hydrochloride will make the preparation product Viscosity drops significantly, and matrix flocculation or delamination occurs, which cannot meet the needs of clinical drug stability
Therefore, research on propranolol hydrochloride topical preparations still needs to be strengthened

Method used

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  • Propranolol hydrochloride submicron emulsion gel and preparation method and application thereof
  • Propranolol hydrochloride submicron emulsion gel and preparation method and application thereof
  • Propranolol hydrochloride submicron emulsion gel and preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0085] The influence of surfactants on the formation of submicron emulsion was investigated by single factor investigation method

[0086] The inventors of the present invention, according to the preliminary experimental results of component selection, designed 9 different prescription compositions as shown in Table 1 below. First mix the oil with the penetration enhancer oxybenzone, then add the crude drug propranolol hydrochloride, and stir until the drug is completely dissolved to form a uniform oil phase. Dissolve surfactant, co-surfactant in water as water phase. Then after the oil phase and the water phase are mixed, use a high-speed shear emulsifier to shear 6min at 8000rpm to form a rough emulsion, observe whether there is stratification or precipitation in the rough emulsion, the size and number of oil droplets floating on the surface of the rough emulsion, and the sample Perform high-speed centrifugation experiments to observe its stability. Propranolol hydrochlori...

Embodiment 2

[0112] Preparation of Propranolol Hydrochloride Submicroemulsion Gel

[0113] prescription:

[0114]

[0115] Preparation method:

[0116] (1) Soybean oil and oxybenzone were mixed so as to obtain a first mixture.

[0117] (2) dissolving propranolol hydrochloride in the first mixture, so as to obtain a second mixture containing propranolol hydrochloride oily phase.

[0118] (3) Poloxamer, propylene glycol, and glycerin were dissolved in water to obtain a third mixture forming an aqueous phase.

[0119] (4) The second mixture and the third mixture were mixed, sheared with a high-shear emulsifier, and sheared at 8000 rpm for 6 minutes, so as to obtain the fourth mixture containing crude propranolol hydrochloride.

[0120] (5) Use a high-pressure homogenizer to homogenize the coarse milk of the fourth mixture, and circulate and homogenize it 8 times under a pressure of 800 bar, so as to obtain the fifth mixture containing the propranolol hydrochloride submicroemulsion pharm...

Embodiment 3

[0140] Effect of the dosage of pH regulator triethanolamine on the prescription

[0141] Using the method of Example 2, in the swelling step of the gel matrix with water, the amount of the pH regulator triethanolamine is adjusted so that the pH values ​​of the gel matrix are respectively pH4.5, pH5.0, pH5.5, pH6.0, pH 7.0, the rest of the prescription and preparation method are the same as in Example 2, and 5 samples are prepared, which are compared with the sample of pH 6.5 in Example 2.

[0142] The above 6 different propranolol hydrochloride submicroemulsion gel samples were stored at 40°C and a relative humidity of 75% for 3 months, and the appearance, particle size, pH value and content of the submicroemulsion gel were regularly checked. The results showed that the pH5.5, pH6.0, and pH6.5 formulations were all stable, with no significant changes in appearance, particle size, pH value, and drug content, while the formulations of pH4.5, pH5.0, and pH7.0 The longer the stor...

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Abstract

The invention discloses propranolol hydrochloride submicron emulsion gel and a preparation method and application thereof. The propranolol hydrochloride submicron emulsion gel comprises propranolol hydrochloride and pharmaceutical acceptable medicinal excipients, wherein the medicinal excipients comprise oil, a surfactant, a cosurfactant, a penetration enhancer, a gel substrate, a pH conditioning agent and the balance water. The propranolol hydrochloride submicron emulsion gel can efficiently deliver the propranolol hydrochloride to skin tissue to enable drugs to be released slowly, skin targeted drug delivery treatment on superficial infantile hemangioma is achieved, and the problems that for an existing drug, the curative effect is low, the side effect is large, and the transdermal absorption ratio is low are effectively solved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically, the invention relates to propranolol hydrochloride submicroemulsion gel and its preparation method and application. Background technique [0002] Infantile hemangioma is a common benign tumor caused by endothelial cell proliferation. The incidence of neonatal hemangioma is about 1.1% to 2.6%. Although most hemangiomas can regress spontaneously, the regression period is long and may last for 5 to 7 years. About 20% of hemangiomas cannot regress naturally, and various complications may occur, such as ulcers, bleeding, infection, etc. Hemangiomas occurring in special parts, such as the periorbital, glottis, and perineum, are likely to cause dysfunction, growth and development restriction, and even life-threatening in severe cases, bringing great pain to children. Treat early and aggressively. The current treatment methods for infantile hemangioma mainly include c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/138A61K47/38A61K47/10A61P35/00
Inventor 蔡育周小顺牟东升贺容丽李进张伟
Owner WUHAN CONFORM PHARMA CO LTD
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