CN-117045613-B - Pharmaceutical composition for treating diabetic peripheral neuropathy and preparation method thereof

Abstract

A process for preparing the medicine composition for treating peripheral neuropathy of diabetes includes such steps as mixing sodium citicoline, adhesive, filler, disintegrant and lubricant to obtain sodium citicoline powder, mixing mecobalamin, adhesive, filler, disintegrant and lubricant to obtain mecobalamin powder, pressing the sodium citicoline powder and mecobalamin powder on dual-layer tablet press to obtain dual-layer tablet, and coating the dual-layer tablet with light-shielding coating agent. According to the pharmaceutical composition for treating diabetic peripheral neuropathy, disclosed by the invention, the citicoline sodium and the mecobalamin are prepared into the double-layer tablet, so that the content uniformity of medicinal components, the distribution uniformity in tablets and the medicinal stability are effectively ensured, the administration times of patients and the intake of auxiliary materials are reduced, and the use compliance of the patients is improved.

Inventors

• CHEN YONGFANG
• YANG XUFENG
• CHEN ZUNSHENG
• SHEN JING
• ZHANG YUFANG
• CAI QIN

Assignees

• 重庆康刻尔制药股份有限公司

Dates

Publication Date

20260512

Application Date

20230830

Claims (3)

1. 1. A preparation method of a pharmaceutical composition for treating diabetic peripheral neuropathy, which is characterized by comprising the following steps: S1) preparing citicoline sodium mixed powder, namely mixing citicoline sodium, an adhesive, a filler, a disintegrating agent and a lubricant to obtain citicoline sodium mixed powder, wherein the adhesive is at least one of sodium carboxymethyl cellulose, hydroxypropyl cellulose, ethyl cellulose and hydroxyethyl cellulose, the filler is at least one of microcrystalline cellulose, mannitol, sorbitol, lactose and corn starch, the disintegrating agent is crospovidone, and the lubricant is any one of magnesium stearate, calcium stearate and sodium stearyl fumarate; S2) preparing mecobalamin mixed powder, namely mixing mecobalamin, an adhesive, a filler, a disintegrating agent and a lubricant to obtain mecobalamin mixed powder, wherein the adhesive is at least one of polyoxyethylene, polyethylene glycol, polyvinyl alcohol and povidone, the filler is mannitol and lactose with a mass ratio of 2:1, the disintegrating agent is sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crosslinked sodium carboxymethyl cellulose or crosslinked povidone, and the lubricant is any one of magnesium stearate, calcium stearate and sodium stearyl fumarate; S3) pressing the citicoline sodium mixed powder in the step S1 and the mecobalamin mixed powder in the step S2 on a double-layer tablet press to obtain a double-layer double-release tablet; S4) coating the double-layer double-release tablet in the step S3 with a shading coating agent.
2. 2. The method for preparing a pharmaceutical composition for treating diabetic peripheral neuropathy according to claim 1, wherein the citicoline sodium layer comprises 50-200 parts by weight of citicoline sodium, 10-100 parts by weight of binder, 50-200 parts by weight of filler, 20-50 parts by weight of disintegrant and 1-10 parts by weight of lubricant.
3. 3. The method for preparing a pharmaceutical composition for treating diabetic peripheral neuropathy according to claim 1 or 2, wherein the mecobalamin layer comprises 0.5-1 part by weight of mecobalamin, 5-10 parts by weight of adhesive, 20-60 parts by weight of filler, 5-30 parts by weight of disintegrant and 0.1-0.3 part by weight of lubricant.

Description

Pharmaceutical composition for treating diabetic peripheral neuropathy and preparation method thereof Technical Field The invention relates to the technical field of medicines, in particular to a pharmaceutical composition for treating diabetic peripheral neuropathy and a preparation method thereof. Background Peripheral Neuropathy (DPN) changes belong to one of the most common chronic complications of diabetes mellitus, and diabetes mellitus patients have symptoms related to peripheral nerve dysfunction, clinically manifested as symmetrical pain and paresthesia, and lower limb symptoms are more visible than upper limbs. The incidence rate is high, and the disease is a high-risk factor for causing diabetic foot ulcers and lower limb amputation, and the disease becomes a main cause of disability and death of diabetic patients. The treatment of peridiabetic lesions is commonly performed with mecobalamin, which repairs damaged nerve tissue by promoting nucleic acid and protein synthesis and cephalin synthesis of lecithin, promoting myelination and axon regeneration. The citicoline sodium tablet can repair nerve cell membrane, increase blood flow perfusion of blood vessel supplying nerve, and improve peripheral nerve pathological injury by synthesizing phosphatidylcholine, and is mainly used for acute craniocerebral trauma and conscious disturbance after brain operation. The two medicines are still applied in different disease fields at present, but researches prove that the combination of the citicoline sodium and the mecobalamin has a synergistic effect on improving the diabetic peripheral neuropathy, and has better treatment effect than the single use of the mecobalamin for treating the diabetic peripheral neuropathy. Therefore, the compound preparation prepared from the two components can reduce the administration frequency and increase the use compliance of patients. Disclosure of Invention The invention aims to provide a pharmaceutical composition for treating diabetic peripheral neuropathy, and the dual-layer tablet pharmaceutical composition prepared from citicoline sodium and mecobalamin solves the problems of uneven drug content and uneven distribution in a composite preparation, and ensures the stability of drug effect. Another object of the present invention is to provide a method for preparing the above pharmaceutical composition. The invention aims at realizing the following technical scheme: A pharmaceutical composition for treating diabetic peripheral neuropathy is characterized by having a double-layer tablet structure, in particular to a citicoline sodium layer and a mecobalamin layer, wherein the citicoline sodium layer comprises citicoline sodium, an adhesive, a filler, a disintegrating agent and a lubricant, and the mecobalamin layer comprises mecobalamin, an adhesive, a filler, a disintegrating agent and a lubricant. Further, in the citicoline sodium layer, the adhesive is at least one of carboxymethylcellulose sodium, hydroxypropyl cellulose, ethylcellulose and hydroxyethyl cellulose, the filler is at least one of microcrystalline cellulose, mannitol, sorbitol, lactose and corn starch, the disintegrating agent is crospovidone, and the lubricant is any one of magnesium stearate, calcium stearate and sodium stearyl fumarate. Further, in the citicoline sodium layer, 50-200 parts by weight of citicoline sodium, 10-100 parts by weight of adhesive, 50-200 parts by weight of filler, 20-50 parts by weight of disintegrant and 1-10 parts by weight of lubricant are calculated. Further, in the mecobalamin layer, the adhesive is at least one of polyoxyethylene, polyethylene glycol, polyvinyl alcohol and povidone, the filler is at least one of microcrystalline cellulose, mannitol, sorbitol, lactose and corn starch, the disintegrating agent is carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, croscarmellose sodium or crospovidone, and the lubricant is any one of magnesium stearate, calcium stearate and sodium stearyl fumarate. Further preferably, the filler is composed of mannitol and lactose in a mass ratio of 2:1. Further preferably, the binder is polyethylene glycol 4000. Further, in the mecobalamin layer, 0.5-1 part by weight of mecobalamin, 5-10 parts by weight of adhesive, 20-60 parts by weight of filler, 5-30 parts by weight of disintegrant and 0.1-0.3 part by weight of lubricant are calculated. The pharmaceutical composition is prepared by mixing citicoline sodium, an adhesive, a filler, a disintegrating agent and a lubricant to obtain citicoline sodium mixed powder, mixing mecobalamin, the adhesive, the filler, the disintegrating agent and the lubricant to obtain mecobalamin mixed powder, pressing the citicoline sodium mixed powder and the mecobalamin mixed powder on a double-layer tablet press to obtain a double-layer double-release tablet, and finally coating by adopting a shading coating agent. Further, when the filler is composed of mannitol and lactose with a mass ratio