Injection of mannite and glycerol and preparation method thereof

Abstract

The invention discloses injection of mannite and glycerol, which contains mannite, glycerol and water for injection. Furthermore, the invention also discloses a method for preparing the injection, which comprises the following steps: taking the mannite and the glycerol, dissolving into the water for injection, filtering and filling. The injection of the mannite and the glycerol is clinically usedfor treating cerebrovascular diseases, brain trauma, cerebral tumors, intracranial inflammation and the diseases of acute and chronic intracranial hypertension, hydrocephalus and the like caused by other reasons. The injection of the mannite and the glycerol has the functions of lowering the intracranial pressure quickly and eliminating the hydrocephalus and can also avoid death because of acute renal failure caused by the injury of the kidney; the injection of the mannite and the glycerol suppresses the apoptosis of neural cells and achieves the function of protecting the brain; the functionof lowering the intracranial pressure is stable and has long retention time; crystals occurring because of the change of the air temperature or in the processes of storage and transportation are eliminated; and the glycerol is used as a caloric agent and can improve and recover the energy metabolism of the important viscera of the heart, the brain, the kidney and the like during oxygen deficiency. The injection of the mannite and the glycerol is a very effective, stable and safe medicine for promoting urination and removing water clinically.

Description

technical field [0001] The present invention relates to a compound pharmaceutical preparation, especially a kind of mannitol glycerin injection and its preparation method and application Background technique [0002] Intracranial pressure refers to the pressure generated by the contents of the cranial cavity on the wall of the cranial cavity, which is composed of two factors: hydrostatic pressure and vascular dynamic pressure. Since the total volume of the cranial cavity is relatively fixed, the intracranial pressure remains relatively stable. Normal supine intracranial pressure is about 1.33kPa (10mmHg). Intracranial hypertension is called intracranial hypertension when brain tissue swelling; intracranial space-occupying lesions; excessive secretion of cerebrospinal fluid, malabsorption, obstructed circulation, or excessive cerebral blood perfusion lead to intracranial pressure continuously maintained above 2.0kPa (15mmHg). [0003] The clinical manifestations of intracra...

AI Technical Summary

Problems solved by technology

[0005] The main problems of the clinically used 20% mannitol injection are: (1) crystallization-20% mannitol is a supersaturated solution, when the temperature drops below 10°C, crystallization often occurs, and once crystallization occurs, hard to redissolve

The problem of crystallization brings great inconvenience and trouble to clinicians, and there are great hidden dangers in the safety of medication, which brings inconvenience to rescue patients

(2) Since mannitol mainly removes extracellular fluid through hypertonicity to reduce intracranial pressure, and is excreted from the kidney in the prototype, it has greater nephrotoxicity, and it has been confirmed that patients with acute or chronic renal failure are contraindicated for use

[0006] Although the compound mannitol injection (containing 15% mannitol, 5% glucose and 0.45% sodium chloride) solved the problem of mannitol crystallization when it was cold; Acute renal failure due to dose-response relationship cannot be avoided if the frequency of administration is increased

The addition of sodium chloride has the potential to cause electrolyte disturbances

In addition, in the early post-injury period, patients with severe craniocerebral injury should first choose balance solution, and 5% or 10% glucose solution should not be used; for elderly patients with cerebral hemorrhage, they often have diabetes mellitus, these factors limit the clinical use of compound mannitol injection

[0007] As for glycerin-based compound glycerin preparations (such as glycerin sodium chloride injection, glycerol fructose injection), their effects are mild and long-lasting, but the onset of action is slow, so they are not suitable for clinical emergency treatment.

In addition, the glycerol content in the compound glycerin preparation is all 10%. Although 0.9% sodium chloride is added to check and balance the hemolysis of glycerol, hemolysis still occurs clinically.

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