Ketoprofen and prilocaine nano-emulsified gel preparation and preparation method thereof
A technology of emulsified gel and prilocaine, which is applied in the field of medicine, can solve problems such as the inability to ensure stable drug effect, fluctuation of drug release rate, poor cold and heat resistance, etc., to improve safety, ease of operation, and stable release rate , Increase the effect of heat and cold resistance
Active Publication Date: 2022-05-27
NEOFORM BIOPHARMACEUTICAL LTD
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Problems solved by technology
[0003] has the following problems: 1. Ethanol accounts for about 50%, used to dissolve insoluble drugs and improve drug penetration
[0005]1. Ordinary gel systems suffer from harsh storage conditions due to poor cold and heat resistance
[0006]2. Ketoprofen photo-instability caused by harsh storage conditions
[0007]3. There are large fluctuations in the drug release rate per unit time, which cannot guarantee a stable drug effect
Method used
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Effect test
Embodiment 1
[0035] Prilocaine and ketoprofen were weighed and mixed at 1:1 (w / w), and heated in a 60° C. water bath to prepare a clear oily complex, which was a drug phase.
Embodiment 2
[0037]Prilocaine and ketoprofen were weighed and mixed at 1:1 (w / w), and heated in a water bath at 70° C. to prepare a clear oily complex, which was a drug phase.
Embodiment 3
[0039] Prilocaine and ketoprofen were weighed and mixed at a ratio of 2:1 (w / w), and heated in a water bath at 60° C. to prepare a clear oily complex, which was a drug phase.
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Abstract
The invention discloses a nano emulsified gel preparation of ketoprofen and prilocaine and a preparation method of the nano emulsified gel preparation. The pharmaceutical composition comprises a medicine phase, a water phase matrix and a surfactant, wherein the medicine phase in the system is a compound of ketoprofen and prilocaine in a molten state; and the water-phase matrix is a water-soluble high polymer material. According to the nano-emulsified gel, the heat resistance and cold resistance of a gel system are improved, and the product can be conveniently circulated and stored around the world and used after being uncovered; the light stability of the product is superior to that of Fastone by utilizing the protection effect of the nano delivery system on the medicine, so that the product is convenient to store and use; compared with commercially available fasaston, the nano-emulsified gel has the advantages that the in-vitro release rate is stable, burst release of the medicine is avoided, the total release amount can be increased, and the stable medicine effect can be maintained for a long time; the prescription does not need ethanol, so that skin irritation caused by ethanol is avoided, and the effectiveness of the product is improved. In addition, the safety and operability of the production process can be improved.
Description
Technical field: [0001] The invention belongs to the field of medicine, in particular to a nano-emulsion gel preparation of ketoprofen and prilocaine and a preparation method thereof. Background technique: [0002] Antipyretic, analgesic and anti-inflammatory drugs (NSAIDs) are the first-line drugs for the treatment of chronic pain such as rheumatoid arthritis and osteoarthritis. Analgesic mechanism: 1. Inhibition of prostaglandin synthesis; 2. Inhibition of lymphocyte activity and T lymphocyte differentiation, reducing stimulation of afferent nerve endings; 3. Directly acting on nociceptors to prevent the formation and release of analgesic substances. Commonly used topical NSAIDs for local analgesia include ketoprofen, diclofenac sodium and piroxicam. Listed in Italy Menarini Pharmaceutical Industry United Co., Ltd. (OTC) was included in the 24th batch of reference preparations in China, and is currently the most widely used ketoprofen gel in clinical practice. The ind...
Claims
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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/192A61K31/167A61K9/06A61K47/32A61K47/10A61P29/00A61P19/02
CPCA61K31/192A61K31/167A61K9/06A61K47/32A61K47/10A61K9/0014A61P29/00A61P19/02A61K2300/00Y02A50/30
Inventor 苏钰清郑乾隆黄晓燕
Owner NEOFORM BIOPHARMACEUTICAL LTD
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