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Pain-relieving and anti-inflammatory compound sustained-release preparation

A sustained-release preparation and technology of sustained-release preparations, applied in the direction of anti-inflammatory agents, non-central analgesics, anesthetics, etc., can solve the problems of uncertain effect strength and analgesic time, and reduce intravascular puncture and accidental acupuncture risk, ease of administration, and number of needle sticks avoided

Active Publication Date: 2021-11-09
JIANGSU KANGHE BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although local anesthetics are mixed with many drugs for clinical analgesia, except for glucocorticoids, the strength of action and analgesic time are uncertain, and they have not been clinically adopted or recommended (see "Day Surgery, Anesthesiology Society, Chinese Medical Association") post-analgesia expert consensus")

Method used

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  • Pain-relieving and anti-inflammatory compound sustained-release preparation
  • Pain-relieving and anti-inflammatory compound sustained-release preparation
  • Pain-relieving and anti-inflammatory compound sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Preparation of Compositions of Poloxamer 407 and Poloxamer 188

[0039] According to Table 1, slowly add the weighed Poloxamer 407 and Poloxamer 188 into 0.1mol / L KH7.0 pH7.0 2 PO 4 In the buffer solution (room temperature), shake gently, avoid vigorous stirring, until it is completely dissolved. It appears as a colorless transparent liquid at room temperature.

[0040] Put the dissolved colorless transparent liquid into a water bath incubator to measure the viscosity at different temperatures. Do three parallel experiments.

[0041] Table 1

[0042]

[0043] During the measurement process, as the viscosity increases, the model of the viscometer probe is constantly adjusted so that the opening angle is between 30% and 70%, which is convenient for obtaining relatively accurate viscosity results. The data shows that as the temperature continues to rise, High, the viscosity of the composition gradually increases, and finally reaches a semi-solid state. For the compo...

Embodiment 2

[0049] Prepare pain-relieving and anti-inflammatory compound sustained-release preparation of the present invention (without cosolvent)

[0050] According to Table 3, slowly add the weighed poloxamers 407 and 188 into 0.1mol / L KH7.4 pH7.4 2 PO 4 In the buffer solution (room temperature), shake gently, avoid vigorous stirring, until it is completely dissolved. It appears as a colorless transparent liquid at room temperature. Add different concentrations of ropivacaine and meloxicam into the solution, heat to 80-90°C to mix, stir for 30 minutes, cool down to 2-8°C, subpackage, and sterilize at 121°C for 12 minutes.

[0051] table 3

[0052]

[0053] After measurement, the sterilized preparations of ropivacaine and meloxicam under different concentrations, the higher the concentration of main drug, the lower the viscosity of the preparation. At the same time, 8% and 4% ropivacaine, 0.24% and 0.12% At the concentration of meloxicam, after the formulation was left standing a...

Embodiment 3

[0055] Prepare pain-relieving and anti-inflammatory compound sustained-release preparation (containing cosolvent) of the present invention

[0056] According to Table 4, slowly add poloxamer 407 and 188 which have been weighed respectively into 0.1mol / L KH with pH7.4 2 PO 4 In the buffer solution (PB), shake gently, mix well, divide into 16 parts on average, and mark them as experiments 1-16 in turn, and then place the 16 parts of preparations in a water bath at 90°C for 10 minutes and heat the weighed merlot Add four preparations of oxicam, ropivacaine and DMSO, use PB to make up the volume to the required volume; continue to heat and stir for 10 minutes to make it evenly mixed, then cool down to 2-8°C, subpackage, and extinguish at 121°C. Bacteria 12min. Among them, the concentration of DMSO was 10-20%, ropivacaine 4%, and meloxicam 0.12%, and the orthogonal test was carried out. (the stated content is the mass percent content)

[0057] Table 4

[0058]

[0059]

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Abstract

The invention provides a pain-relieving and anti-inflammatory compound sustained-release preparation, which comprises a local anesthetic, a non-steroidal anti-inflammatory drug and a sustained-release preparation consisting of poloxamer 407 and poloxamer 188. The pain-relieving and anti-inflammatory compound sustained-release preparation disclosed by the invention is a non-opioid analgesic, is a dual-effect combined product composed of the local anesthetic and the low-dose non-steroidal anti-inflammatory drug, is specially used for treating postoperative pain and inflammation at an operative site through single administration, and has obvious advantages in efficacy, wherein the non-steroidal anti-inflammatory drug not only has an anti-inflammatory effect, but also can inhibit the formation of an acid environment and normalize the pH value, so that the permeation effect of the local anesthetic is recovered and enhanced, and the drug effect is as long as 4-5 days.

Description

technical field [0001] The invention relates to a compound sustained-release pharmaceutical preparation with analgesic and anti-inflammatory effects. Background technique [0002] The number of surgeries and surgical populations in my country are increasing year by year, and the demand for related drugs is showing a trend of rapid growth. Reducing opioid abuse is a general trend, but most patients still use a lot of opioids for postoperative pain. There is an urgent clinical need for safe, effective, and non-addiction-free medications to reduce opioid use and improve the recovery experience. [0003] Regional anesthesia is considered an adjunct to multimodal analgesic regimens. The duration of action and method of administration of local anesthetics available on the market have deficiencies. The status and demand of long-acting local anesthetics in domestic and foreign guidelines are increasingly prominent. At present, there is no long-acting analgesic product of local a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K9/06A61K31/167A61K31/18A61K31/192A61K31/196A61K31/245A61K31/365A61K31/405A61K31/445A61K31/4453A61K31/5415A61K31/616A61K31/635A61K47/10A61P23/02A61P29/00
CPCA61K45/06A61K31/445A61K31/167A61K31/245A61K31/4453A61K31/5415A61K31/616A61K31/405A61K31/192A61K31/196A61K31/18A61K31/365A61K31/635A61K47/10A61K9/06A61P23/02A61P29/00A61K2300/00
Inventor 钟正明张勇秦小强
Owner JIANGSU KANGHE BIOLOGICAL PHARMA
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