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Sustained release preparation composition

A composition and drug technology, applied in the directions of drug combinations, active ingredients of heterocyclic compounds, anti-inflammatory agents, etc., can solve problems such as no statistical differences, and achieve good drug safety and tolerance, and good oil retention. , Ease of administration

Pending Publication Date: 2021-12-24
NANJING DELOVA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently It has entered phase III clinical trials, but the clinical results did not show a statistical difference compared with bupivacaine solution

Method used

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  • Sustained release preparation composition
  • Sustained release preparation composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0112] Critical Gel Concentration of Several Gelation Factors

[0113] Prepare prescriptions containing different proportions of gelling factor, stand at room temperature for 12 hours, turn the vial upside down, observe the flow of the preparation in the vial, and screen the critical gel concentration for gelation. The results are shown in Table 1-1 and Table 1. -2 and Tables 1-3. The gelling factors tested included fatty acids, fatty alcohols, single fatty acid glycerides and mixed fatty acid glycerides, and sterols, wherein single fatty acid glycerides were esterified from the same fatty acid and glycerol, while mixed fatty acid glycerides were formed from different fatty acids Formed by esterification with glycerol. During the implementation of the present invention, it is unexpectedly found that when the fatty acid carbon chain is less than 12 carbon atoms, the ability of the gelling factor to aggregate with each other is weak, and it is impossible to form a three-dimensi...

Embodiment 2

[0133] Oil gel composition containing different proportions of gelling factors

[0134] Pharmaceutical compositions containing gelatin factors in different proportions were prepared according to each ingredient shown in the following Table 2-1. First, dissolve meloxicam in N-methylpyrrolidone to prepare a 50 mg / g concentrated solution of meloxicam, add ropivacaine and gel factor to liquid oil, benzyl alcohol, and meloxicam at 70°C In the oxicam solution, stir while heating until a transparent and uniform solution is formed, and cool to room temperature to form a solid gel-like substance.

[0135] table 2-1

[0136]

Embodiment 3

[0138] Study on Oil-holding Property of Oleo-gel

[0139] Weigh a certain amount of the pharmaceutical composition from Example 2, place it in a centrifuge tube, and centrifuge at a speed of 9000 rpm for 15 minutes. After centrifugation, turn the centrifuge tube upside down for about 40 minutes, drain the centrifuged oil, and calculate the oil according to the following formula: The oil retention of the gel, the results are shown in Table 3-1.

[0140]

[0141] m 1 is the mass (g) of the centrifuge tube;

[0142] m 2 is the mass (g) of the centrifuge tube and the oil-gel system;

[0143] m 3 is the mass (g) of the centrifuge tube and the precipitate after centrifugation;

[0144] x is the mass fraction of glyceride in the oil gel.

[0145] Table 3-1

[0146]

[0147] Oil retention is one of the indicators for evaluating the structural stability of oil gels. In order to ensure the solidification ability of the gel factor to liquid oil and prevent the phenomenon of li...

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PUM

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Abstract

The invention relates to a pharmaceutical composition which comprises liquid oil and at least one pharmaceutically acceptable gelator. The composition is semi-solid at normal temperature, can be directly used as a medicine storage cavern at the administration part, is convenient for clinical administration, is small in irritation, and has good medication safety and tolerance. The composition is especially suitable for development of pharmaceutical preparations with anesthesia and analgesic activity, has more advantages compared with other slow-release analgesic systems, is continuous and stable in release of analgesic active ingredients, can be used for injection administration, is suitable for stable and convenient local administration, and is good in patient tolerance and few in side effects.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a sustained-release preparation composition, a preparation method and application thereof. Background technique [0002] Postoperative pain is acute pain that occurs immediately after surgery and usually lasts no more than 3 to 7 days. If it cannot be adequately controlled in the initial state, it may develop into chronic pain. At present, the commonly used clinical treatment method is to use analgesic pump for treatment, but the drugs contained in the analgesic pump are mostly opioid analgesics and some auxiliary analgesics such as tramadol. Although the curative effect is good, it is also accompanied by A series of side effects such as respiratory depression, nausea and vomiting, hypotension and potential addiction. [0003] Using local anesthetics to treat postoperative pain can avoid the above-mentioned adverse reactions, but local anesthetics usually h...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K47/44A61K47/10A61K47/14A61K47/12A61K47/26A61K47/28A61K45/00A61K31/635A61K31/445A61P29/00
CPCA61K9/06A61K9/0014A61K9/0019A61K47/44A61K47/10A61K47/14A61K47/12A61K47/26A61K47/28A61K45/00A61K31/635A61K31/445A61P29/00A61K2300/00
Inventor 王青松武曲邹丽敏嵇元欣
Owner NANJING DELOVA BIOTECH CO LTD
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