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High-concentration bupivacaine multivesicular liposome, and preparation method and liquid distribution system thereof

A multivesicular liposome and liquid preparation system technology, which is applied in liposome delivery, pharmaceutical formula, mixer accessories, etc., can solve the difficulty of increasing aseptic control, multi-liquid aseptic control points, and difficulty in aseptic process, etc. problems, to achieve the effect of being suitable for industrial production, reducing the difficulty of control, and low cost

Pending Publication Date: 2019-08-30
常州吾合生物医药有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, during the synthesis of multivesicular liposomes, how to remove organic solvents and aseptic control is the difficulty of the liquid preparation system
Due to the need for more liquid aseptic control points in the existing preparation system, it is difficult to control the aseptic process
Secondly, in the preparation process, the principle of gas-liquid equilibrium is used, that is, the double emulsion containing organic solvent is mixed with nitrogen to remove the organic solvent. It is necessary to use a nitrogen generator and gas sterile filtration, which will increase the difficulty of aseptic control.

Method used

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  • High-concentration bupivacaine multivesicular liposome, and preparation method and liquid distribution system thereof
  • High-concentration bupivacaine multivesicular liposome, and preparation method and liquid distribution system thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] figure 1 It is a structural schematic diagram of the liquid distribution system of the present invention.

[0033] Such as figure 1 As shown, the present embodiment 1 provides a liquid distribution system, including: a main liquid distribution tank 1, several auxiliary liquid distribution tanks 2 connected to the main liquid distribution tank 1, and heating devices respectively located on the main liquid distribution tank 1 (not shown), air extraction device 3; wherein said heating device is suitable for heating the test solution in the main liquid distribution tank 1; Volatile organic solvents in the liquid.

[0034] Optionally, the main liquid distribution tank is, for example but not limited to, a jacketed liquid distribution tank, and the temperature of the test solution in the tank can be controlled by the temperature of the water in the jacket, that is, the heating device; and the air extraction device includes But not limited to exhaust fans.

[0035]The liqu...

Embodiment 2

[0046] figure 2 It is a process flow diagram of the multivesicular liposome of the present invention.

[0047] On the basis of embodiment 1, see figure 2 , the present embodiment 2 provides a preparation process of multivesicular liposomes, comprising the following steps: step S1, preparing a sterile raw material solution; step S2, primary emulsification, that is, adding an organic solvent to the sterile raw material solution to form Water-in-oil emulsion; step S3, intermediate emulsification, that is, adding the first water phase to the water-in-oil emulsion to form a water-in-oil-in-water double emulsion; step S4, removing the organic solvent; and step S5, replacing the external water of the double emulsion phase, that is, replacing the external water phase in the water-in-oil-in-water double emulsion with the second water phase to obtain the multivesicular liposomes.

[0048] Specifically, the preparation process of Example 2 can be completed through a corresponding liq...

Embodiment 3

[0061] On the basis of Example 2, this Example 3 provides a multivesicular liposome, which is suitable for synthesis by the aforementioned preparation process.

[0062] For the component content and specific preparation process of multivesicular liposomes, please refer to the relevant discussion in Example 2, and details will not be repeated here.

[0063] In addition, the present multivesicular liposome and its preparation process and liquid preparation system also have the following advantages compared with the prior art solutions:

[0064] The first point, the active substances in the prior art scheme are all bupivacaine phosphate, and in the technical scheme of the present application, the active substance adopts bupivacaine hydrochloride, wherein the bupivacaine phosphate is alkalized by bupivacaine hydrochloride Plus phosphoric acid preparation. Because the solubility of the two in ethanol is different, it will further affect the preparation effect of the product; bupiv...

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Abstract

The invention belongs to the technical field of preparations, and specifically relates to a high-concentration bupivacaine multivesicular liposome as well as a preparation method and a liquid distribution system thereof. The liquid distribution system comprises a main liquid distribution tank, a plurality of auxiliary liquid distribution tanks which are arranged in parallel on the main liquid distribution tank, and a heating apparatus and an air exhaust apparatus which are respectively located on the main liquid distribution tank, wherein the heating apparatus is suitable for heating test liquid in the main liquid distribution tank and the air exhaust apparatus is suitable for maintaining vacuum degree in the main liquid distribution tank, thereby allowing extraction of volatile organic solvents from the test liquid; and thus, nitrogen generator and gas sterile filtration are not required while sterility control of gas is not needed, so that, difficulty of control of aseptic process isreduced with aseptic environment in liquid distribution process improved. Therefore, the liquid distribution system is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of preparations, in particular to a high-concentration bupivacaine multivesicular liposome, a preparation process and a liquid preparation system thereof. Background technique [0002] The microstructure of multivesicular liposomes (MVLs) is the aggregation of multiple liposomes into a spherical shape, and each liposome consists of a hydrophobic membrane and an internal aqueous phase. There are many large and small vesicles separated by lipid bilayers inside the multivesicular liposome. This unique structure endows the liposome with strong rigidity. When one of the vesicles ruptures, the drug is only released from the ruptured vesicle, and the intact vesicle remains intact, which reduces the leakage rate of the drug and releases the drug from the liposome without burst release , to achieve slow drug release over a period of one day to several weeks. [0003] However, during the synthesis of multivesicular ...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K47/28A61K31/445B01F13/10B01F15/00B01F15/06
CPCA61K9/1271A61K9/1277A61K47/28A61K31/445B01F33/81B01F35/00B01F35/90B01F2035/99
Inventor 张希
Owner 常州吾合生物医药有限责任公司
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