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Clindamycin hydrochloride emulsifiable paste and preparation method thereof

A technology of clindamycin hydrochloride and cream, applied in the directions of ointment delivery, pharmaceutical formulation, emulsion delivery, etc., can solve the problems of easy oxidation, degradation, excessive growth of impurities, etc., and achieves inhibition of hydrolysis process and stable quality , to avoid the effect of the hydrolysis process

Active Publication Date: 2016-03-16
SHANGHAI NEW ASIATIC PHARMA MINHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the use of lecithin as an auxiliary material in this invention technology, the price is relatively expensive, which greatly increases the preparation cost of this product, and lecithin is used in external preparations, some patients cannot accept the smell of this auxiliary material, these reasons are all To a certain extent, a large number of applications of the invention are limited
[0008] What the present invention aims to solve is to address the disadvantages of the external preparations of active ingredients of clindamycin hydrochloride or its derivatives that are currently on the market: the active pharmaceutical ingredients are prone to instability during storage, and are easily oxidized or degraded. , so that the related substances (or called impurities) grow too fast, or produce unacceptable odors and other shortcomings when used, combined with the characteristics of the physical and chemical properties of clindamycin hydrochloride, develop clindamycin hydrochloride cream

Method used

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  • Clindamycin hydrochloride emulsifiable paste and preparation method thereof
  • Clindamycin hydrochloride emulsifiable paste and preparation method thereof
  • Clindamycin hydrochloride emulsifiable paste and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A kind of clindamycin hydrochloride cream, in every 10g clindamycin hydrochloride cream: the weight that contains clindamycin hydrochloride is 0.1g, cetyl alcohol is 0.7g, light liquid paraffin is 1.4g, white vaseline 0.8g of propylene glycol, 0.5g of propylene glycol, 0.8g of Span 60, 5mg of potassium sorbate, 5mg of ethylparaben, 10mg of 2,6-di-tert-butyl p-cresol, 4mg of Pechoin essence, and the rest 10% phosphoric acid solution and purified water.

[0027] The preparation process of the clindamycin hydrochloride cream is as follows: add white petrolatum, the oil phase matrix, into the oil phase pot, heat to 80°C-90°C to melt, add clindamycin hydrochloride to the melted In the white vaseline, continue to add cetyl alcohol, light liquid paraffin and Span 60, 2,6-di-tert-butyl-p-cresol, potassium sorbate and ethylparaben, continue to stir and melt to obtain the oil phase; Stir Pechoin essence, propylene glycol and purified water evenly, use 10% phosphoric acid solutio...

Embodiment 2

[0029] A kind of clindamycin hydrochloride cream, in every 10g clindamycin hydrochloride cream: the weight that contains clindamycin hydrochloride is 0.05g, cetyl alcohol is 1.0g, light liquid paraffin is 1.0g, white vaseline 1.0g for propylene glycol, 0.8g for propylene glycol, 0.6g for Span 60, 2mg for potassium sorbate, 2mg for ethylparaben, 10mg for 2,6-di-tert-butyl p-cresol, 4mg for strawberry essence, and the rest 20% citric acid solution and purified water.

[0030] The preparation process of the clindamycin hydrochloride cream is as follows: add white petrolatum, the oil phase matrix, into the oil phase pot, heat to 80°C-90°C to melt, add clindamycin hydrochloride to the melted In the white vaseline, continue to add cetyl alcohol, light liquid paraffin and Span 60, 2,6-di-tert-butyl-p-cresol, potassium sorbate and ethylparaben, continue to stir and melt to obtain the oil phase; Stir strawberry essence, propylene glycol and purified water evenly, use 20% citric acid s...

Embodiment 3

[0032] A kind of clindamycin hydrochloride cream, in every 10g clindamycin hydrochloride cream: the weight that contains clindamycin hydrochloride is 0.2g, cetyl alcohol is 0.5g, light liquid paraffin is 2.0g, white vaseline 0.5g of propylene glycol, 0.6g of propylene glycol, 1.5g of Span 60, 10mg of potassium sorbate, 10mg of ethyl paraben, 5mg of 2,6-di-tert-butyl p-cresol, 2mg of strawberry essence, and the rest 15% phosphoric acid solution and purified water.

[0033] The preparation process of the clindamycin hydrochloride cream is as follows: add white petrolatum, the oil phase matrix, into the oil phase pot, heat to 80°C-90°C to melt, add clindamycin hydrochloride to the melted In the white vaseline, continue to add cetyl alcohol, light liquid paraffin and Span 60, 2,6-di-tert-butyl-p-cresol, potassium sorbate and ethylparaben, continue to stir and melt to obtain the oil phase; Stir strawberry essence propylene glycol and purified water evenly, use 20% citric acid solu...

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Abstract

The invention discloses a clindamycin hydrochloride emulsifiable paste and a preparation method thereof. The clindamycin hydrochloride emulsifiable paste is composed of clindamycin hydrochloride used as an active component and a pharmaceutical adjuvant. The pharmaceutical adjuvant comprises an oil-phase matrix, a hygroscopic agent, an emulsifier, an antiseptic, essence a pH value conditioning agent and purified water and is characterized in that the oil-phase matrix is a mixture of cetanol, lightweight liquid paraffin and albolene, the hygroscopic agent is propylene glycol, the emulsifier is Span-60, and the antiseptic is a mixture of ethylparaben, potassium sorbate and 2,6-di-t-butyl p-cresol. According to the invention, clindamycin hydrochloride is dispersed in inertial albolene during preparation of the emulsifiable paste, albolene is used for clathration of the raw material clindamycin hydrochloride, so hydrolysis of the raw material is avoided; moreover, the pH value of the prepared emulsifiable paste maintains 3.0 to 4.5, which enables the hydrolysis process of clindamycin to be effectively inhibited.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a clindamycin hydrochloride cream and a preparation method thereof. Background technique [0002] Acne is a chronic inflammatory skin disease of the pilosebaceous unit. It mainly occurs in adolescents and has a great psychological and social impact on adolescents, but it can often be relieved or cured naturally after puberty. The clinical manifestations are characterized by pleomorphic skin lesions such as acne, papules, pustules, and nodules that are prone to occur on the face. [0003] The occurrence of acne is mainly closely related to factors such as excessive sebum secretion, pilosebaceous gland duct blockage, bacterial infection and inflammatory response. After entering puberty, the level of androgen in the human body, especially testosterone, increases rapidly, which promotes the development of sebaceous glands and produces a large amount of sebum. At the same ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/7056A61K47/44A61P17/10A61P31/04A61K47/06
CPCA61K9/0014A61K9/06A61K31/7056A61K47/06
Inventor 曾垂宇商鼎刘红英
Owner SHANGHAI NEW ASIATIC PHARMA MINHANG
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