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Stable vitamin K2 submicron emulsion and preparing method

A vitamin and submicron emulsion technology, which is applied in the direction of pharmaceutical formula, emulsion delivery, medical preparations of non-active ingredients, etc., can solve problems such as inability to market sales, harsh conditions for preparation transportation and storage, and short validity period, and achieve good results. Effect of Sterilization Stability and Freeze-Thaw Stability

Inactive Publication Date: 2016-11-09
SUNGEN BIOSCIENCE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in most parts of China, the winter temperature is below 0°C, and the transportation and storage conditions of the preparation are very harsh.
Although freeze-drying technology can solve such problems to a certain extent, the freeze-drying process is complicated and the cost is high
[0033] (2) Oxidative degradation of drugs
due to vitamin K 2 There are multiple isoprene structures connected to the naphthoquinone nucleus, and the double bond of the first isoprene structure closest to the naphthoquinone nucleus is easily oxidized, and the catalysis of light or metal ions can also promote the oxidation reaction. occurs, the vitamin K 2 After being prepared into a submicron emulsion, its validity period is very short, and the purpose of marketing cannot be achieved

Method used

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  • Stable vitamin K2 submicron emulsion and preparing method
  • Stable vitamin K2 submicron emulsion and preparing method
  • Stable vitamin K2 submicron emulsion and preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Embodiment 1 Vitamin K 2 Submicron emulsion 1 and 2 (without antifreeze and stabilizer)

[0088] Vitamin K 2 The compositions of submicroemulsions 1 and 2 are shown in Table 1.

[0089] Table 1

[0090]

[0091] Preparation:

[0092] Weigh the formula amount of vitamin K 2 , MCT (Medium Chain Fatty Acid Triglycerides), SPC (Soy Lecithin), RH 40 (polyoxyethylene hydrogenated castor oil) or F68 (Pluronic F68) to form the oil phase;

[0093] Pipette the formula amount of sucrose and add an appropriate amount of purified water as the water phase; vacuumize the two phases and fill them with nitrogen, repeat 3 times, heat the two phases to 60 ° C, and wait until the substances in the two phases are completely dissolved. Slowly add the water phase to the oil phase, and continue to stir for 20 minutes to form a uniform milky shape to obtain colostrum; use a microfluidizer to homogenize 4 times at 14000 psi to obtain submicron-level microfluidics with a particle size of...

Embodiment 2

[0096] Embodiment 2 Vitamin K 2 Submicron emulsions 3 and 4 (with antifreeze but without stabilizers)

[0097] Vitamin K 2 The compositions of submicroemulsions 3 and 4 are shown in Table 2.

[0098] Table 2

[0099]

[0100] Preparation:

[0101] Weigh the formula amount of vitamin K 2 , MCT, SPC, RH 40 Or F68 to form the oil phase;

[0102]Pipette the formulated amount of glycerin and sucrose and add an appropriate amount of purified water as the water phase; the two phases are respectively vacuumed and filled with nitrogen, repeated 3 times, and heated to 60°C. After the substances in the two phases are completely dissolved, under the condition of magnetic stirring, slowly add the water phase to the oil phase, continue to stir for 20 minutes, and it becomes uniform milky, and the colostrum is obtained; use a microfluidizer 14000psi to homogenize 4 times Finally, in order to obtain a submicron-level emulsion with a particle size of 80-200nm, add the mixed berry fla...

Embodiment 3

[0105] Embodiment 3 Vitamin K 2 Sterilization stability and freeze-thaw stability of submicroemulsion 1-4

[0106] As described in Example 1 or 2, sterilize under circulating steam at 100°C for 30 minutes, and spray with cold water to rapidly cool the preparation to room temperature to test the sterilization stability of the submicron emulsion, vitamin K 2 The particle size changes before and after the sterilization of submicron emulsion 1-4 are shown in table 3:

[0107] table 3

[0108]

[0109] Wherein, M.D. represents the average particle diameter, and P.I. represents the particle size distribution.

[0110] As can be seen from Table 3, vitamin K 2 The particle size of the submicron emulsion 1-4 remained basically unchanged before and after sterilization, indicating that its sterilization stability was good.

[0111] Take prepared vitamin K 2 Several bottles of submicron emulsion 1-4 were frozen at -20°C for 48 hours, and then placed at 40°C under accelerated condi...

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Abstract

Vitamin K2 submicron emulsion is prepared from, by weight, 0.0005-1% of vitamin K2, 1.0-10% of oil, 0.1-1.2% of phospholipid, 0.5-2.3% of emulgator, 0.5-3.0% of antifreezing agent and water according to the total weight of the vitamin K2 submicron, wherein emulgators except phospholipid can serve as the emulgator in the emulsion. The vitamin K2 submicron emulsion is good in sterilization stability and freeze-thaw stability, and the expected shelf life can reach two years or more.

Description

technical field [0001] The application relates to the field of pharmaceutical preparations, in particular to a stable vitamin K 2 Submicroemulsion and its preparation method and pharmaceutical application of the above submicroemulsion. Background technique [0002] Osteoporosis is a chronic and progressive bone metabolic disorder, the main disease response is the reduction of bone mass in some or even all bones, accompanied by a greater risk of fracture. The vast majority of elderly people and postmenopausal women will suffer from osteoporosis, facing the threat of chronic pain, fractures and even disability, resulting in reduced quality of life and huge costs. [0003] Calcium is an important component of bone. In order to prevent osteoporosis, more and more people begin to pay attention to calcium supplementation. However, scientific research institutions in European and American countries have conducted many large-scale clinical trials on calcium supplementation and hea...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/122A61K47/24A61P7/04A61P19/10A61P19/02A61P35/00A61P9/00
CPCA61K9/1075A61K31/122A61K47/24A61K47/26A61K47/44A61P7/04A61P9/00A61P9/10A61P19/02A61P19/10A61P35/00
Inventor 陈杰鹏段丽丽邱雪莲洪琳陈鸿锐纪烨瑜蔡桂珠陈煜藩胡留松许志锴叶红林黄晓莹
Owner SUNGEN BIOSCIENCE CO LTD
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