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Iron sucrose injection and preparation method thereof

A technology of iron sucrose and injection, applied in the field of medicine, can solve the problems such as the research on the bioequivalence of the unseen preparations, the complex process of repeated adsorption by activated carbon, and the reduction of the detection rate of visible foreign matter, and achieves the convenience of industrialized production operation, The effect of improved sterility assurance level and short production cycle

Inactive Publication Date: 2016-11-23
HARVEST PHARMA HUNAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patent CN201310298423.1 discloses a kind of iron sucrose injection and its preparation method. The prescription of the product is the same as that of the original research prescription. The detection rate of visible foreign matter is reduced through repeated adsorption of activated carbon, and the thermal stability of the preparation has also been improved to a certain extent. However, the activated carbon The process of repeated adsorption is relatively complicated, and the final product can only withstand the terminal sterilization of the residual probability method (115℃×30min, F0≈8), and cannot be sterilized by the overkill method, and the level of sterility assurance is relatively low
[0006] Chinese patent CN200610021229.9 discloses a sterile iron sucrose powder injection and its preparation method. The product is prepared by spraying and drying the medicinal liquid and subpackaging in the aseptic subpackaging room. The level is low, and there is no study on the bioequivalence of the preparation in the patent
[0007] Chinese patent CN200510094323.2 discloses an iron sucrose injection for treating iron deficiency anemia and its preparation method. The sterilization method used in the product may be sterile filtration, steam sterilization for 15-60 minutes or boiling for 15-60 minutes. F of the aforementioned flow-through steam sterilization and poaching process 0 Values ​​are less than 8, in principle, the review agency will not approve

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  • Iron sucrose injection and preparation method thereof
  • Iron sucrose injection and preparation method thereof
  • Iron sucrose injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] formula:

[0038]

[0039] Preparation steps:

[0040] 1) Add 80% of the total amount of water for injection into the preparation tank, adjust the water temperature to 15°C-30°C, add the prescribed amount of sodium gluconate and sucrose in sequence, and stir to dissolve;

[0041] 2) Add the benzyl alcohol of prescription quantity, stir and mix evenly;

[0042] 3) Continue to add the main active ingredient iron sucrose in the prescribed amount, and stir until completely dissolved;

[0043] 4) Slowly add 1M sodium hydroxide solution or 1M hydrochloric acid solution, adjust the pH of the solution to 10.5-11.1, and mix well;

[0044]5) Add water for injection to the full amount.

[0045] The injection obtained in step 5) is sterilized and filtered with two-stage 0.22um hydrophilic polyvinylidene fluoride filters, collected in a buffer tank, filled into glass ampoules with about 5ml / bottle, and sealed; The intermediate product is transferred to the product sterilizer,...

Embodiment 2

[0048] Thermodynamic stability evaluation of iron sucrose injection

[0049] The filling intermediate product prepared in Example 1 (before sterilization) and appropriate amount of commercially available products were divided into 6 groups, wherein 1 group was not subjected to terminal moist heat sterilization, and the remaining 5 groups were respectively sterilized at 115°C×30min, 121°C×12min, 121°C. ℃×15min, 121℃×30min and 121℃×60min for moist heat sterilization, the above 6 groups of sample numbers are S2-1, S2-2, S2-3, S2-4, S2-5 and S2-6 respectively. After the sterilization, the molecular weight of iron sucrose in different samples was determined by referring to the method recorded in the monograph "Iron Sucrose Injection" of the United States Pharmacopoeia USP36-NF31.

[0050] The specific experimental results are shown in Table 1

[0051] Table 1. Detection results of iron sucrose molecular weight under different sterilization conditions

[0052]

[0053] The abov...

Embodiment 3

[0055] The prescription and process refer to the above example 1, the only difference is that the first type of stabilizer sodium gluconate in the prescription is adjusted to an equal amount of zinc gluconate or calcium gluconate to prepare two batches of samples; or, the prescription and process refer to The above Example 1 is only different in that the second type of stabilizer sucrose in the prescription is adjusted to use equal amounts of maltose and lactose to prepare two batches of samples.

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Abstract

The invention provides an iron sucrose injection, comprising iron sucrose, a stabilizer, a bacteriostat, an acid-base regulator and water for injection; the thermal stability of the iron sucrose injection preparation has been significantly improved, and the overkill method can be adopted Compared with terminal sterilization by residual probability method, especially the preparation produced by aseptic production process, the sterility assurance level of the product has been significantly improved by carrying out terminal sterilization. On the other hand, the present invention provides a preparation method of iron sucrose injection, which has a simple preparation process, does not need to repeatedly add activated carbon for adsorption, is convenient for industrial production operation, has a short production cycle and low energy consumption.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an iron sucrose injection and a preparation method thereof. Background technique [0002] Iron sucrose injection is a sterile, polynuclear iron hydroxide-sucrose complex solution for intravenous injection, and is the oldest intravenous iron supplement. Iron sucrose is prepared by the complexation of ferric hydroxide colloid and sucrose. It is a water-soluble complex of ferric hydroxide and sucrose. The iron contained in it is in a non-ionic state with an average molecular weight of 34000-60000Da. Since it was launched in Switzerland in 1950, it has been sold in 68 countries and regions around the world. It is suitable for patients who need intravenous iron therapy because the effect of oral iron is not good, such as patients who cannot tolerate oral iron; patients who do not absorb oral iron well. [0003] The iron sucrose injection currently on the market in China, the Unit...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7016A61K33/26A61K47/48A61K47/26A61K47/12A61P7/06
CPCA61K9/08A61K9/0019A61K31/7016A61K33/26A61K47/12A61K47/26
Inventor 袁金桥李海龙刘芳洁
Owner HARVEST PHARMA HUNAN CO LTD
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