Sustained-release glucose preparation for treating glycogen storage diseases

Abstract

The invention provides a sustained-release glucose preparation for treating glycogen storage diseases and a preparation method thereof, belonging to the field of medicinal preparations. The sustained-release glucose preparation is composed of two parts, i.e., a glucose pill core and a film coating and prepared from glucose monohydrate, microcrystalline cellulose, ethyl cellulose, hydroxypropyl cellulose, triethyl citrate, ethanol and purified water by using a modern preparation technology. Results of release-rate determination experiments prove that the sustained-release glucose preparation provided by the invention has good sustained-release performance and can be gradually and slowly released within 6 h; the release rates of sustained-release glucose preparations prepared according to three different prescriptions are 40 to 70% within 6 h; so the sustained-release glucose preparation can replace raw core starch and be used for treatment of glycogen storage diseases.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and provides a glucose sustained-release preparation for treating glycogen accumulation disease and a preparation method thereof. Background technique [0002] Glycogen storage disease (GSD) is a kind of glycogen metabolism disorder disease caused by congenital enzyme defects, most of which are autosomal recessive, and the onset varies with races. At present, glycogen storage disease is still a rare disease. In view of the complex disease classification caused by the difference in the type of enzyme deficiency, there is no accurate statistical data on its incidence in various countries. According to European data, the prevalence of this disease in Europe is The incidence rate is about 1 / 20000~1 / 25000. [0003] Glycogen is a high-molecular polysaccharide composed of glucose units. It is mainly stored in the liver and muscle as backup energy. The normal liver and muscle contain about 4% ...

AI Technical Summary

Problems solved by technology

[0008] However, although the raw cornstarch treatment method has low treatment cost, its taking method has many defects: 1) the number of taking is many, no less than 4 times a day, generally between two meals, especially at night at 3 o'clock in the morning 2) taking conditions are harsh, must eat "raw" cornstarch, boiled starch or cornmeal porridge is not acceptable, must be taken with cold water, even in winter also need to use cold water, many patients are difficult to accept; 3) taking large doses, Raw cornstarch expands in volume after being ingested with cold water, and it is very difficult for children to take a therapeutic amount of starch at one time; 4) Poor tolerance, often intolerable to the digestive system of young children, easily leading to diarrhea; 5) Poor compliance, long-term medication is required, but The way of taking medicine is complicated, which will bring a lot of inconvenience to daily life; 6) The quality of commercially available raw cornstarch varies greatly, resulting in a large deviation in therapeutic effect; the patient's dosage

[0009] In summary, although raw cornstarch therapy has the advantage of low cost, its inherent defects greatly limit its use, and there is an urgent need for a new preparation that can replace the therapy in clinical practice. A glucose sustained-release preparation for the treatment of glycogen accumulation disease of the present invention That is, by maintaining the continuous and slow release of glucose, the blood sugar of the child can be maintained within the normal range, and the excessive fluctuation of blood sugar can be avoided to achieve the purpose of treatment.

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