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Vitamin K1 lyophilized oral emulsion and preparation method thereof

A vitamin and freeze-drying technology, used in anti-inflammatory agents, pharmaceutical formulations, emulsion delivery, etc., can solve problems such as limited dosage forms, and achieve the effect of achieving specificity, improving drug compliance and rationality, and good resolubility.

Inactive Publication Date: 2013-09-25
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although tablets are more stable than injections, the dosage form is limited when used in special groups such as neonates or dysphagia

Method used

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  • Vitamin K1 lyophilized oral emulsion and preparation method thereof
  • Vitamin K1 lyophilized oral emulsion and preparation method thereof
  • Vitamin K1 lyophilized oral emulsion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Take 0.5 mg / 2mL as an example to prepare vitamin K1 freeze-dried oral milk, counting 1000 vials.

[0028] 1. Prescription

[0029]

[0030]

[0031] 2. Preparation process:

[0032] Under dark conditions, weigh a certain amount of medium-chain triglycerides, add vitamin K1 according to the prescription ratio, stir and dissolve at room temperature to prepare solution a, keep away from light for later use; the prescription amount of distilled water and the prescription amount of α-cyclodextrin , stir at 60-70°C to dissolve it, continue to stir to prepare solution b; cool solution b to room temperature; under dark conditions, add solution a according to the prescription ratio to obtain mixed solution c; under dark conditions, solution c Disperse in a dispersing machine at 20000r / min for 3-5min; under the condition of avoiding light, place the obtained light yellow emulsion for 4 hours, add the prescribed amount of lactose, stir to dissolve, and fill it after the dis...

Embodiment 2

[0034] Take 0.5 mg / 2mL as an example to prepare vitamin K1 freeze-dried oral milk, counting 1000 vials.

[0035] 1. Prescription

[0036]

[0037] 2. Preparation process:

[0038] Under dark conditions, weigh a certain amount of medium-chain triglycerides, add vitamin K1 according to the prescription ratio, stir and dissolve at room temperature to prepare solution a, keep away from light for later use; the prescription amount of distilled water and the prescription amount of α-cyclodextrin , stir at 60-70°C to dissolve it, continue to stir to prepare solution b; cool solution b to room temperature; under dark conditions, add solution a according to the prescription ratio to obtain mixed solution c; under dark conditions, solution c Disperse in a dispersing machine at 20000r / min for 3-5min; under the condition of avoiding light, place the obtained light yellow emulsion for 4 hours, add the prescribed amount of lactose, stir to dissolve, and fill it after the dissolution is...

Embodiment 3

[0040] Take 0.5 mg / 2mL as an example to prepare vitamin K1 freeze-dried oral milk, counting 1000 vials.

[0041] 1. Prescription

[0042]

[0043] 2. Preparation process:

[0044] Under dark conditions, weigh the prescribed amount of medium-chain triglycerides, add vitamin K1 according to the prescribed ratio, stir and dissolve at room temperature (prepared solution a), and keep away from light for later use; the prescribed amount of distilled water and the prescribed amount of α-ring Dextrin, stir at 60-70°C to dissolve, continue to stir (to prepare solution b); cool solution b to room temperature; under dark conditions, add solution a according to the prescription ratio to obtain mixed solution c; under dark conditions , disperse solution c in a disperser at 20,000r / min for 3-5min; under dark conditions, place the obtained light yellow emulsion for 4h, add lactose in the prescribed amount, stir to dissolve, and fill it after it is completely dissolved. .; After half-tam...

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Abstract

The invention provides a vitamin K1 lyophilized oral emulsion and a preparation method thereof, and relates to the technical field of medicines and medicine manufacture. The emulsion is prepared from the following components in percentage by weight: 0.125-1 percent of vitamin K1, 5 percent of alpha-cyclodextrin, 91.5-92.5 percent of distilled water, 2.5-3.5 percent of medium chain triglyceride, and 0.7 percent of lactose. The vitamin K1 oral bionic emulsion provided by the invention is an orderly single-layer colloid particle shell formed by self-assembly of colloid particles, and is stabilized in the oil-water interface. Compared with an injection, tablets and a traditional emulsion, the vitamin K1 lyophilized oral emulsion has the advantages that a surfactant and an organic solvent which have a sensitization risk do not need to be added in the process, so that adverse reactions are reduced; the preparation method adopting the lyophilization process has the characteristics of stable dynamics and thermodynamics, and the emulsion has good re-dissolubility after 0.1-0.2 percent of NaCl is added; and breast milk is imitated in an all-sided manner from the composition of auxiliaries and preparation and the physicochemical property, so that the new-born specificity of the vitamin K1 lyophilized oral emulsion can be realized.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a freeze-dried oral bionic milk preparation of vitamin K1 for newborns and a preparation method thereof. Background technique: [0002] This product is yellow to orange yellow transparent viscous liquid, odorless or almost odorless, easy to decompose when exposed to light, soluble in chloroform, ether or vegetable oil, slightly soluble in ethanol, insoluble in water. Chemical name: 2-methyl-3-(3,7,11,15-tetramethylhexade-2-enyl)-1,4-naphthoquinone, molecular formula: C31H46O2 molecular weight: 450.71. Its structural formula is as follows: [0003] [0004] Vitamin K1 is an essential substance for the liver to synthesize factors II, VII, IX, and X. When prothrombin in the blood is deficient, blood coagulation will be slowed down. At this time, supplementing an appropriate amount of vitamin K1 can promote the liver to synthesize prothrombin. It plays ...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/122A61K47/40A61P7/04A61P29/00A61P11/08A61P1/06
Inventor 张继稳汪六一李海燕汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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