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Cefotiam hydrochloride/anhydrous sodium carbonate medicinal composition suspension injection and new use thereof

A technology of cefotiam hydrochloride and anhydrous sodium carbonate, which is applied in the field of medicine, can solve the problems of not being able to store for a long time, rapid decomposition of active ingredients, and low bioavailability, and achieve increased drug safety, low price, and simple operation low effect

Inactive Publication Date: 2012-03-07
HAINAN YONGTIAN PHARMA INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, in the process of dissolving, the solution of the drug turns yellow rapidly, and the active ingredient decomposes quickly, so it cannot be stored for a long time after dissolving; in addition, because the anhydrous sodium carbonate is not effectively treated, the product also has relatively serious defects. Reactions, such as severe irritation to the patient, causing vascular pain, thrombophlebitis and other reactions
[0008] At present, the marketed cefotiam hydrochloride powder for injection has been widely used clinically, but it has the disadvantages of poor stability, high related substances, low bioavailability and poor resolubility

Method used

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  • Cefotiam hydrochloride/anhydrous sodium carbonate medicinal composition suspension injection and new use thereof
  • Cefotiam hydrochloride/anhydrous sodium carbonate medicinal composition suspension injection and new use thereof
  • Cefotiam hydrochloride/anhydrous sodium carbonate medicinal composition suspension injection and new use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Preparation of Cefotiam Hydrochloride / Anhydrous Sodium Carbonate Pharmaceutical Composition Suspension Injection

[0037] Prescription (specification 0.25g)

[0038] Cefotiam Hydrochloride 25g

[0039] Anhydrous sodium carbonate 5.12g

[0040] Chitosan 50g

[0041] Polyethylene glycol 6000 8g

[0042] Cholesterol 8g

[0043] Mannitol 12g

[0044] Sodium sulfite 3g

[0045] Preparation Process:

[0046]A Fully dissolve 25g cefotiam hydrochloride in 500ml water for injection to obtain solution 1, fully dissolve 50g chitosan, 8g cholesterol and 8g polyethylene glycol 6000 in 1000ml ethanol to obtain solution 2, put solution 1 and solution 2 Rotate in a colloid mill for 50 minutes to obtain an emulsion;

[0047] B. Add 12g of mannitol, 3g of sodium sulfite and 5.12g of anhydrous sodium carbonate after steaming the emulsion to remove the organic solvent, then add 500ml of water for injection, stir and dissolve evenly, and pack in vials;

[0048] C is freez...

Embodiment 2

[0049] Example 2 Preparation of Suspension Injection of Cefotiam Hydrochloride / Anhydrous Sodium Carbonate Pharmaceutical Composition

[0050] Prescription (specification 0.5g)

[0051] Cefotiam Hydrochloride 50g

[0052] Anhydrous sodium carbonate 10.24g

[0053] Gelatin 170g

[0054] Povidone K15 8g

[0055] Cholesterol 4g

[0056] Polysorbate 80 4g

[0057] Sodium chloride 10g

[0058] Vitamin E 5g

[0059] Preparation Process:

[0060] A 50g cefotiam hydrochloride was fully dissolved in 600ml water for injection to obtain solution 1, 170g gelatin, 8g povidone K15, 4g cholesterol and 4g polysorbate 80 were fully dissolved in 1500ml isopropanol to obtain solution 2, the solution 1 and solution 2 were placed in a colloid mill and rotated for 50 minutes to obtain an emulsion;

[0061] B. Add 10g of sodium chloride, 5g of vitamin E and 10.24g of anhydrous sodium carbonate after steaming the emulsion to remove the organic solvent, then add 300ml of water for injection, s...

Embodiment 3

[0063] Example 3 Preparation of Suspension Injection of Cefotiam Hydrochloride / Anhydrous Sodium Carbonate Pharmaceutical Composition

[0064] Prescription (specification 0.25g)

[0065] Cefotiam Hydrochloride 25g

[0066] Anhydrous sodium carbonate 5.12g

[0067] Polyamino acid 63g

[0068] Povidone K15 3g

[0069] Polysorbate 80 8g

[0070] Lactose 3g

[0071] Sodium sulfite 1g

[0072] Preparation Process:

[0073] A fully dissolve 25g cefotiam hydrochloride in 450ml water for injection to obtain solution 1, fully dissolve 63g polyamino acid, 3g povidone K15 and 8g polysorbate 80 in 500ml water for injection to obtain solution 2, mix solution 1 and solution 2 Place in a colloid mill and rotate for 45 minutes to obtain an emulsion;

[0074] B. Add 3g of lactose, 1g of sodium sulfite and 5.12g of anhydrous sodium carbonate after steaming the emulsion to remove the organic solvent, then add 550ml of water for injection, stir and dissolve evenly, and then pack in vials; ...

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PUM

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Abstract

The invention provides cefotiam hydrochloride / anhydrous sodium carbonate medicinal composition suspension injection and new use thereof. The preparation is prepared from 166 to 282.2 weight parts of biodegrading agent, 6.64 to 26.56 weight parts of emulsifying agent, 9.96 to 26.56 weight parts of stabilizer, 13.28 to 49.8 weight parts of additive, 83 weight parts of cefotiam hydrochloride and 17 weight parts of anhydrous sodium carbonate. The invention further discloses new use of the cefotiam hydrochloride suspension injection for treating subacute thyroiditis in clinic.

Description

field of invention [0001] The invention relates to a cefotiam hydrochloride / anhydrous sodium carbonate pharmaceutical composition suspension injection and a preparation method thereof, and further relates to a new clinical application of the cefotiam hydrochloride suspension to subacute thyroiditis, which belongs to medical technology field. Background technique [0002] Subacute thyroiditis, also known as granulomatous thyroiditis, is a clinically more common thyroid disease. It is different from acute suppurative thyroiditis with a shorter course and lymphocytic thyroiditis with a longer course, so it is called Subacute thyroiditis. It is generally believed to be related to viral infection, and the pathological manifestations include infiltration of lymphocytes and polymorphic leukocytes in the affected follicles, destruction of filter cells, appearance of multinucleated giant cells and formation of granulation tissue, followed by fibrosis. Its clinical incidence rate is...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K31/546A61K47/02A61K47/32A61K47/34A61K47/36A61K47/42A61P31/12
Inventor 陶灵刚
Owner HAINAN YONGTIAN PHARMA INST
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