Compound alpha-ketoacid tablet free of talcum powder and preparation process thereof

Abstract

The invention relates to a compound alpha-ketoacid tablet free of talcum powder and a preparation process thereof. The conventional preparation process is changed without adding the talcum powder; the tablet prepared by the method has good compressibility, attractive appearance, high disintegrating speed, high dissolution rate, high stability in long-term placement and high medicinal safety. Wet granulation is performed separately according to the acidic and alkaline ingredients and the mass balance ratio of main medicines, i.e., a meta-alkaline ingredient, a meta-acidic ingredient and a nearly neutral ingredient are subjected to wet granulation separately, and then mixing, tabletting and coating are performed, so that the direct contact among the ingredients is avoided, long-term stable placement can be realized and the contents of the active ingredients are guaranteed. A disintegrating agent internal and external addition method is adopted in the formula, the content of polyethylene glycol is optimized, and no talcum powder or analogs with ingredients similar to the talcum powder are included in the formula, so that the problems of agglomeration phenomenon and larger viscosity in the granulation process are solved, and the safety in medication is guaranteed.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a compound α-keto acid tablet and a preparation process thereof, in particular to a talc-free compound α-keto acid tablet and a preparation process thereof. Background technique [0002] Chronic kidney disease is a relatively benign disease that develops slowly, but if it is not diagnosed and treated in time, it can lead to the deterioration and progression of the disease or the progression of the disease, developing into chronic renal insufficiency, renal failure, and eventually uremia. At present, its incidence is increasing, and most patients are often unaware of their condition, which seriously endangers human health. [0003] Compound α-ketoacid tablet is a drug with significant curative effect on chronic kidney disease, and it is used to prevent and treat damage caused by protein metabolism disorder caused by chronic renal insufficiency. The drug is designed with the ratio of essenti...

AI Technical Summary

Problems solved by technology

[0006] 1. Since the ingredients of the main ingredient are relatively complex, and the calcium ketoacid component is highly viscous, in the process of mixing wet granulation, when the water contained in the wetting agent is too large, the wetting agent received by the main ingredient will be affected under the premise of uniform mixing. The degree of humidity will be different, resulting in differences in the bulkiness and bulk density of dry granules formed after drying, which will affect the disintegration time and then affect the batch-to-batch variability

[0007] 2. Calcium ketoacid component is highly viscous, and if a little more binder is added, there will be serious agglomeration phenomenon, which cannot be sieved and granulated; the amino acid component is less viscous, and the appearance of adding more or less binder has no obvious change

[0010] Patent 200810224131.2 discloses a method for preparing compound α-ketoacid dispersible tablets. This method is prepared by mixing wet granulation. The drug is unstable during storage, and the content of related substances easily exceeds the standard

[0011] Patent 201110437147 discloses a compound α-ketoacid tablet and its preparation process, which adopts the process of separating the acidic and alkaline components in the main drug and wet granulation. The acidic components only include L-threonine and L-tryptophan The three components of acid and L-tyrosine have very small mass. Compared with the 7 kinds of alkaline components with too large mass, the mass uniformity is very poor. When the two parts are finally mixed, they cannot be mixed evenly

Moreover, its disintegrating agent only adopts internal addition method, and its disintegration is not particularly ideal.

In addition, 10-12mg of talcum powder is added to the prescription, which may have potential carcinogenic effects when taken by patients

[0012] Patent 201010193155 discloses a compound preparation for treating chronic kidney disease and its preparation method. Polyethylene glycol is added to the prescription as an anti-adhesive agent for the calcium ketoacid part, but polyethylene glycol also acts as an adhesive in it. Composition, when the pressure is high in the actual tableting process, the sticking phenomenon will be very serious, and the amount of polyethylene glycol can be appropriately reduced

In addition, the amount of talcum powder in the prescription has reached 33mg. If there is asbestos in the talcum powder, it will expose the problem of drug safety.

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