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CN-121987849-A - Filling composition for small-bore cycloolefin injection tube and preparation method thereof

CN121987849ACN 121987849 ACN121987849 ACN 121987849ACN-121987849-A

Abstract

The application provides a filling composition suitable for a cycloolefin injection tube with a small inner diameter and a preparation method thereof. Wherein the filling composition comprises crosslinked hyaluronate gel and microspheres, the shearing viscosity of the filling composition is 0.8-1.5 ten thousand mPa.s at the frequency of 0.1Hz, the cohesion is 20-60mg/mL, and the particle size of the microspheres is 10-70 mu m. The filling composition of the application is uniformly dispersed, and has good filling and supporting effects when being injected into deep parts of bones and skin by selecting specific cohesive force and viscosity. The filling composition can be used for the cycloolefin injection tube with the small inner diameter, reduces the flow resistance of liquid medicine in the injection tube, and improves the uniformity and the efficiency of filling. The cycloolefin injection tube with the thin inner diameter is better in material quality, free from the risk of leaching of leachables of the long-term implant, and more slender in inner diameter, higher in injection precision and higher in end.

Inventors

  • ZHAO TONGTONG
  • CHEN YI
  • YAO JIAJIE
  • DONG LIANGRUN
  • TANG HAO
  • SU YANG

Assignees

  • 华熙生物科技(海南)有限公司

Dates

Publication Date
20260508
Application Date
20241107

Claims (9)

  1. 1. A filling composition suitable for use in a fine bore cycloolefin injection tube comprising a crosslinked hyaluronate gel and microspheres, wherein the filling composition has a shear viscosity of 0.8 to 1.5 mPa-s at a frequency of 0.1Hz, a cohesion of 20 to 60mg/ml and the microspheres have a particle size of 10 to 70 μm.
  2. 2. The filled composition of claim 1, wherein the microspheres are selected from one or more of hydroxyapatite microspheres, polycaprolactone microspheres, polylactic acid microspheres, cross-linked hyaluronate microspheres, bioactive glass microspheres, composite calcium phosphate microspheres, polymethyl methacrylate microspheres, polyglycolic acid microspheres, polysaccharide and protein complex microspheres.
  3. 3. The filling composition according to claim 1 or 2, wherein in the filling composition the content of hyaluronate in the crosslinked hyaluronate gel is 5-50mg/ml and the content of microspheres is 100-600mg/ml.
  4. 4. A potting formulation comprising a cyclic olefin syringe and the potting composition of any one of claims 1-3 potted in the cyclic olefin syringe.
  5. 5. The potting formulation of claim 4, wherein the cyclic olefin syringe has an inner diameter of 6.6mm or less and a length of 30mm or more.
  6. 6. The potting formulation of claim 4 or 5, wherein the cyclic olefin syringe further comprises pharmaceutically or medically acceptable excipients and/or active ingredients.
  7. 7. A method for preparing the potting formulation of any one of claims 4-6, comprising the steps of: Premixing the crosslinked hyaluronate gel and the microspheres, Stirring the premixed materials until the materials are uniformly mixed to obtain the filling composition; the well-mixed filling composition is filled into cycloolefin injection tubes.
  8. 8. The production method according to claim 7, wherein the stirring is performed in a manner including revolution and rotation.
  9. 9. A production method as claimed in claim 8, wherein the revolution speed is 500-1000r/min, the rotation speed is 160-300r/min, and the stirring time is 100-600s.

Description

Filling composition for small-bore cycloolefin injection tube and preparation method thereof Technical Field The application belongs to the technical field of medicines, and particularly relates to a filling composition for a cycloolefin injection tube with a small inner diameter and a preparation method thereof. Background In the biomedical field, medical fillers are a common medical means, which are mainly aimed at improving the appearance of human faces or body parts or repairing tissue functions. Among these, gels and microspheres are two commonly used medical filling materials. However, in practical applications, the preparation and application of the medical filler composition face a number of challenges, such as uniformity of mixing, and filling of high viscosity drugs, which are important technical challenges. The compositions of the prior art medical fillers present some problems in preparation and application. First, because of the need for clinical current use, the operation is complex, increasing the burden of the clinician, and also easily causing poor filler effect or adverse reaction due to improper operation. For the filling of gel/microsphere compositions with high strength, high viscosity and high cohesion, manual or semi-automatic filling modes are generally adopted in the prior art, and the overall effect of filling is limited. Secondly, leachable residues of the glass tube can influence the purity and quality of the liquid medicine, certain potential safety hazards exist, the inner diameter of the glass tube is thick under the same specification, and the injection precision is limited. In addition, the high viscosity characteristic makes it easy for bubble and layering to appear in the filling process of thin internal diameter syringe to influence homogeneity and stability of liquid medicine. Finally, the existing filling process is relatively difficult for injection tubes made of cycloolefin polymers with small inner diameter and large length-diameter ratio, especially for high-viscosity and easily dehydrated and dried thick liquid medicine, and the problems of uneven filling, insufficient filling amount, bubbles, layering and the like easily occur, so that the quality and effect of the filling agent are affected. Therefore, how to develop a novel filler composition with high viscosity, high strength, high cohesion, no bubbles, uniform mixing and no layering, and how to optimize the filling process to ensure bubble-free and layering-free liquid medicine in the storage and to accurately inject is a major problem facing the current industry and technology. Disclosure of Invention Aiming at the problems existing in the prior art, the application provides a filling composition suitable for a cycloolefin injection tube with a small inner diameter and a preparation method thereof. In particular, the application relates to the following aspects: 1. A filling composition suitable for use in a fine bore cycloolefin injection tube comprising a crosslinked hyaluronate gel and microspheres, wherein the filling composition has a shear viscosity of 0.5 to 1.5 mPa-s at a frequency of 0.1Hz, a cohesion of 20 to 60mg/ml and the microspheres have a particle size of 10 to 70 μm. 2. The potting composition of item 1, wherein the microspheres are selected from one or more of hydroxyapatite microspheres, polycaprolactone microspheres, polylactic acid microspheres, crosslinked hyaluronate microspheres, bioactive glass microspheres, composite calcium phosphate microspheres, polymethyl methacrylate microspheres, polyglycolic acid microspheres, polysaccharide and protein complex microspheres. 3. The potting composition according to item 1 or 2, wherein the content of hyaluronate in the crosslinked hyaluronate gel is 5-50mg/ml and the content of microspheres is 100-600mg/ml in the potting composition. 4. A potting formulation comprising a cyclic olefin syringe and the potting composition of any one of items 1-3 potted in the cyclic olefin syringe. 5. The potting formulation of item 4, wherein the cyclic olefin syringe has an inner diameter of 6.6mm or less and a length of 30mm or more. 6. The potting formulation of item 4 or 5, wherein the cycloolefin syringe further comprises pharmaceutically or medically acceptable excipients and/or active ingredients. 7. A method for preparing the potting formulation of any one of claims 4-6, comprising the steps of: Premixing the crosslinked hyaluronate gel and the microspheres, Stirring the premixed materials until the materials are uniformly mixed to obtain the filling composition; And filling the uniformly mixed filling composition into a cycloolefin injection tube. 8. The production method according to item 7, wherein the stirring is performed in a manner including revolution and rotation. 9. The production method according to item 8, wherein the revolution speed is 500 to 1000r/min, the rotation speed is 160 to 300r/min, and the stirring time is 100 to 600s. The benefic