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Emulsion type ointment

An emulsifying, ointment technology, applied in the directions of ointment delivery, emulsion delivery, oil/fat/wax inactive ingredients, etc., can solve the problems of difficulty in ensuring the safety of clinical use of preparations, and difficulty in determining the quality control standards of excipients, and achieves a high level of improvement. Penetration, low cost and strong product stability

Inactive Publication Date: 2013-04-03
SOUTHEAST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] (3) It is difficult to determine the quality control standards of excipients that meet the pharmaceutical requirements
The quality control of excipients determines the stability of product quality to a certain extent. Although every excipient in the prescription can meet the national standard, it is difficult to understand the types of excipients added and their interaction, so it is difficult to ensure the stability of the preparation. Quality and safety for clinical use

Method used

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  • Emulsion type ointment
  • Emulsion type ointment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Mixed system of soybean oil and water, sodium alginate powder, calcium salt solution (calcium phosphate, calcium chloride, calcium carbonate, etc. are all acceptable), distilled water, Tween system:

[0017] Add 30%wt emulsifier Tween of the finished ointment to the soybean oil and water mixed system, dissolve sodium alginate in the water phase of the oil-water mixed system, and the added amount shall not be less than 1%wt and not more than 5% by weight of the finished ointment. %wt, stirring at a speed of not less than 500 rpm for more than 30 minutes, and finally adding calcium salt solution dropwise in an amount of not less than 0.5% and not more than 8% of the weight of the finished ointment, that is, an ointment preparation is made. The consistency and viscosity (ηc) of the emulsified ointment are tested to be not less than 3.18mPa.s, and the water loss rate test shows that the water loss rate of the emulsified ointment for 5 hours is not higher than 6.73%wt. And t...

Embodiment 2

[0019] Sesame oil, water mixed system, sodium alginate powder, glutaraldehyde, Siban system:

[0020] In the sesame oil and water mixed system, add 1%wt of the emulsifier Span of the finished ointment, dissolve sodium alginate in the oil-water mixed system, and the added amount is not less than 0.5%wt and not more than 5%wt of the weight of the finished ointment solution, stirred at a speed of not less than 500 rev / s for more than 30 minutes, and finally added dropwise glutaraldehyde solution, and the amount of glutaraldehyde added dropwise accounted for not less than 0.5% and not more than 8% of the weight ratio of the finished ointment, that is, the prepared into ointment preparations. It is found through testing that the consistency and viscosity (ηc) of the emulsified ointment are not lower than 3.18mPa.s, and the water loss rate test shows that the water loss rate of the emulsified ointment is not higher than 6.73%wt within 5 hours. The emulsified ointment was co-culture...

Embodiment 3

[0022] Liquid paraffin, water mixed system, potassium alginate powder, chitosan, AOT system:

[0023]In the liquid paraffin and water mixed system, add 3%wt emulsifier AOT of the finished ointment, dissolve sodium alginate in the oil-water mixed system, and the proportion of the added amount to the weight of the finished ointment is not less than 0.5%wt and not more than 5%wt Solution, stirred at a speed of not less than 500 rev / s for more than 30 minutes, and finally added dropwise chitosan solution, the amount of chitosan added dropwise accounted for not less than 0.5% and not more than 10% by weight of the finished ointment, that is Made into an ointment preparation. It is found through testing that the consistency and viscosity (ηc) of the emulsified ointment are not lower than 3.18mPa.s, and the water loss rate test shows that the water loss rate of the emulsified ointment is not higher than 6.73%wt within 5 hours. The emulsified ointment was co-cultured with the cells, ...

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Abstract

The invention relates to an emulsion type ointment which comprises alginic acid and salts thereof, an emulsifier, a cross-linking agent, an oil-based agent and a water-based agent, wherein the oil-based agent accounts for 10%-85% by weight of the emulsion type ointment, the alginic acid and the salts thereof account for not more than 7% by weight of the emulsion type ointment, the emulsifier accounts for not lower than 1% and not higher than 30% by weight of the emulsion type ointment, and weight ratio of the cross-linking agent to the alginic acid and the salts thereof is not lower than 1:10and not higher than 5:1, and the remaining is the water-based agent. Materials adopted for the ointment have low price and can be obtained easily, the preparation route is simple, and the product hasstrong stability and is stable without layer separation when standing at 30 DEG C for one year.

Description

1. Technical field [0001] The invention belongs to the technical field of preparation of pharmaceutical dosage forms, in particular to an emulsified ointment pharmaceutical dosage form. The ointment can be used for oil-water mixed drug system, or creaming of oil-soluble drug system. 2. Background technology [0002] Ointment is a paste-like external preparation with appropriate consistency that is prepared by adding drugs to a suitable base and can be easily applied to the skin, mucous membrane, or wound surface. The general matrix requires lubrication and no irritation, suitable consistency, easy to apply; stable properties, no compatibility changes with the main drugs; water absorption, can absorb wound secretions; does not hinder the normal function of the skin, has good drug release performance, and is easy to wash In addition, do not stain clothes. It is suitable for acute and chronic skin lesions such as thickened epidermis, burns, ulcers, keratosis, and chapped skin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K47/36A61K47/44
Inventor 王婷何农跃
Owner SOUTHEAST UNIV