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Sustained release preparation composition

A composition and compound technology, applied in the directions of drug combinations, anesthetics, anti-inflammatory agents, etc., can solve the problems of oil separation risk and oxidation, and achieve the effects of easy administration, improved oil retention, and improved discoloration problems.

Pending Publication Date: 2022-07-19
NANJING DELOVA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because castor oil contains unsaturated fatty chains, there may be a risk of oxidation during storage. In addition, due to the high proportion of castor oil, there may be a risk of oil separation as the storage time prolongs

Method used

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  • Sustained release preparation composition
  • Sustained release preparation composition
  • Sustained release preparation composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0128] Effect of Stabilizers on Appearance of Compositions

[0129] Prepare compositions containing different gelling factors as shown in Table 1-1 to Table 1-3, and place them at room temperature for a long time for 20 months. The change in appearance color of the composition was examined.

[0130] Table 1-1 Appearance color of the composition with glycerol monostearate as gelling factor after long-term storage

[0131]

[0132] Table 1-2 Appearance color of compositions with stearin as gelling factor after long-term storage

[0133]

[0134] Table 1-3 Appearance color of compositions with glyceryl behenate as gelling factor after long-term storage

[0135]

[0136] The present invention unexpectedly finds that the color of the oil-gel preparation containing only fatty acid glycerides as a gelling factor becomes darker to varying degrees during the long-term sample retention process, and the composition adding a stabilizer (such as SPC, HSPC) is placed for a long t...

Embodiment 2

[0138] Oil retention study of the composition

[0139] Pharmaceutical compositions containing different ratios of gelling factors were prepared according to each ingredient shown in Tables 2-1 to 2-9 below. 0.5 g of the pharmaceutical composition was weighed, placed in a centrifuge tube, centrifuged at different speeds, and the centrifuge tube was inverted after centrifugation to observe the oil separation of the composition.

[0140] Table 2-1 Study on oil retention of oil gel compositions without stabilizers

[0141]

[0142] Table 2-2 Comparison of oil retention of oil-gel compositions after adding stabilizer

[0143]

[0144] Table 2-3 Study on the oil retention of the oil-gel composition by the amount of stabilizer

[0145]

[0146] Table 2-4 Study on the oil retention of the oil gel composition by the amount of stabilizer

[0147]

[0148]

[0149] Table 2-5 Study on the oil retention of the oil gel composition by the amount of stabilizer

[0150]

...

Embodiment 3

[0161] Viscosity measurement of oil-gel compositions

[0162] Pharmaceutical compositions containing different amounts of stabilizers and organic solvents were prepared according to Tables 3-1 to 3-3. Mix the raw and auxiliary materials in the table at 70°C, stir while heating until a transparent and homogeneous solution is formed, and cool to room temperature to form a solid gel-like substance. Subsequently, the viscosity of the pharmaceutical composition was measured by a shaft method using a viscometer equipped with a No. 14 rotor, the detection temperature was 30° C. and the rotation speed was 10 rpm. The viscosity detection results are shown in Tables 3-1 to 3-3 below.

[0163] Table 3-1 Viscosity results of pharmaceutical compositions without stabilizers

[0164]

[0165] Table 3-2 Viscosity results of pharmaceutical compositions containing different stabilizers

[0166]

[0167] 3-3 Viscosity results of pharmaceutical compositions containing different amounts of...

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Abstract

The invention relates to a pharmaceutical composition. The pharmaceutical composition comprises liquid oil, a pharmaceutically acceptable gelator, a pharmaceutically acceptable stabilizer and a pharmaceutically active ingredient. The pharmaceutical composition is especially suitable for development of pharmaceutical preparations with anesthesia and analgesic activity, and has more advantages compared with other sustained-release analgesic systems, for example, release of analgesic active ingredients is continuous and stable, injection administration can be achieved, the pharmaceutical composition is suitable for stable and convenient local administration, patient tolerance is good, and side effects are few.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a sustained-release preparation composition and a preparation method and application thereof. Background technique [0002] Postoperative pain is acute pain that occurs immediately after surgery, usually lasting no more than 3 to 7 days, and may develop into chronic pain if it cannot be adequately controlled in the initial state. At present, the commonly used clinical treatment method is to use an analgesic pump for treatment, but the drugs contained in the analgesic pump are mostly opioid analgesics and some auxiliary analgesics such as tramadol, etc. 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] The use of local anesthetics to treat postoperative pain can avoid the above-mentioned adverse reactions, but local anesth...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K47/14A61K47/24A61K47/28A61K47/44A61K45/00A61P23/02A61P29/00
CPCA61K9/06A61K47/44A61K47/14A61K47/28A61K47/24A61K45/00A61K9/0024A61K9/0014A61P29/00A61P23/02A61K31/445A61K45/06A61K31/5415A61K31/573A61K31/355A61K31/407A61K9/0021A61K31/21A61K31/56A61K31/661
Inventor 李玲武曲嵇元欣王青松
Owner NANJING DELOVA BIOTECH CO LTD
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