Polyethylene glycol electrolyte oral liquid and preparation method thereof

Abstract

The invention relates to polyethylene glycol electrolyte oral liquid and belongs to the field of medicine. The polyethylene glycol electrolyte oral liquid comprises polyethylene glycol, sodium bicarbonate, sodium chloride and potassium chloride. The polyethylene glycol electrolyte oral liquid has the advantages that the oral liquid is a solution and does not contain any preservative, patients can take the oral liquid directly without preparation, and the oral liquid is convenient to take and safe; the oral liquid is a concentrated preparation, required dosage is small, only 25 mL of the oral liquid is required for treating constipation, 50 mL is required for gut purge, adverse reaction like nausea and abdominal distension are avoided, and patient compliance is high.

Description

technical field [0001] The invention relates to a polyethylene glycol electrolyte oral liquid, which belongs to the field of medicine. Background technique [0002] Polyethylene glycol (Polyethylene Glycol, PEG) is a long-chain polymer polymerized by ethylene oxide, which has the effect of laxative and bowel cleansing. Diol 4000 and 3350. After it enters the body orally, it can form hydrogen bonds with water molecules to keep the water in the colon, increase the water content of the stool and soften the stool, restore the volume and weight of the stool to normal, and promote the final completion of defecation, thereby improving the symptoms of constipation; , because its mechanism of action is a physical action, it is extremely inert to the gastrointestinal tract, and its toxicity is small (the LD50 value of rats reaches 11600mg / Kg). Taking polyethylene glycol in large doses not only still shows higher safety, but also It can also flush and lavage the intestinal tract, so ...

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Problems solved by technology

[0004] The above listed powders all have the following problems that are difficult to overcome: 1) in the production and storage process, they are easy to absorb moisture and agglomerate; 3) The particle size of each ingredient is small, and the powder is easily adsorbed on the composite film, so it is not easy to dump completely during use; 4) During clinical application, patients need to prepare by themselves according to requirements, which is inconvenient to use , and personal preparation is often difficult to strictly follow the requirements in the instructions (especially for the grasp of the water volume and water temperature used in the preparation process), resulting in the quality can not be guaranteed, and the difference in clinical curative effect is large, sometimes causing serious adverse reactions

[0005] In the prior art, the commercially available polyethylene glycol-electrolyte oral solution is the same as the polyethylene glycol-electrolyte oral solution disclosed in the patent CN1850112B, which solves the problem that patients need to prepare themselves in the clinical application of the powder, and improves the convenience of use. and quality controllability, but still have the following problems: 1) the oral liquid is a dilute solution of polyethylene glycol-electrolyte, and the concentration of polyethylene glycol is below 0.06g / mL, and the patient takes a large amount (2000ml- 4000ml), greatly increased the pain of the patient, made the compliance of the patient to take the medicine poor, and the product packaging volume was large, and storage and transportation were inconvenient; 2) in the last step of the preparation process, the packaged product was placed in boiling water at 100° or heat sterilization in water vapor, which will partially decompose sodium bicarbonate and cause the instability of oral liquid components, and the preparation process is loaded down with trivial details, and production cost is higher; 3) described oral liquid contains sulfate, and this salt is high Osmotic saline solution will stimulate intestinal peristalsis and enhance defecation, causing serious adverse reactions such as diarrhea

And the added amount of preservatives in the above-mentioned patented products has exceeded the total daily intake allowed by the human body

Because preservatives are added to the polyethylene glycol solution, the risk of adverse reactions to polyethylene glycol electrolyte oral liquid will increase, and it is not suitable for children, especially when the amount of preservatives added exceeds the total daily intake allowed by the human body. Ingestion can cause serious harm to the human body

[0007] In addition, the concentrated polyethylene glycol electrolyte oral liquid also has the following technical problems: 1) Difficult to prepare: due to the large concentration of polyethylene glycol in the prescription and the need to add a large amount of electrolytes, it will affect the solubility of polyethylene glycol, resulting in Polyethylene glycol or electrolytes cannot be completely dissolved, and it is difficult to prepare a uniform and stable solution during the preparation process; 2) It is difficult to ensure the stability of the highly concentrated oral liquid during storage, and it is easy to cause solute precipitation, stratification, etc. Phenomenon

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