Compound polyethylene glycol (3350) electrolyte oral liquid and preparation process thereof
By designing a compound polyethylene glycol electrolyte oral liquid containing polyethylene glycol 3350, sodium bicarbonate, sodium chloride, potassium chloride, sucralose and flavor, and using a specific preparation process, the problems of complex preparation and large volume in the prior art were solved, and the process was simplified and convenient to use were achieved.
Patent Information
- Application Number
- CN202411420510.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-12
- Publication Date
- 2025-03-18
AI Technical Summary
The existing polyethylene glycol electrolyte oral liquid has problems such as complex preparation, large volume of administration and increased discomfort in clinical use, which is difficult to meet the needs of patients.
The prescription design of a compound polyethylene glycol (3350) electrolyte oral liquid is adopted, including polyethylene glycol 3350, sodium bicarbonate, sodium chloride, potassium chloride, sucralose and flavors. Through specific preparation processes and the screening of flavors, a concentrated solution is formed, which simplifies the preparation process and improves the convenience of taking.
It has achieved simplification of the preparation process, reduced the volume of taking, improved the quality stability and convenience of use of the product, and met the use needs of patients.
Smart Images
Figure CN119632916A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to a prescription design and a preparation process of a compound polyethylene glycol (3350) electrolyte oral solution, belonging to the field of medicine. Background Art
[0002] Compound polyethylene glycol (3350) electrolyte oral solution is a compound preparation with polyethylene glycol as the main ingredient. It was developed by Norgine BV of the Netherlands. It was approved in the UK in 500ml in May 2011, and in May 2016, a 25ml direct-taken sachet was added. Both are approved for marketing as over-the-counter drugs. The 500ml specification is used to treat chronic constipation; the 25ml specification is used to treat ① constipation in adolescents and adults aged 12 years and above; ② fecal impaction, that is, intractable constipation with hard fecal accumulation in the rectum and / or colon.
[0003] The approved polyethylene glycol dosage forms are mainly powders, oral solutions, etc. Powders need to be prepared during clinical use, and patient compliance is poor. Oral solutions have low concentrations and require patients to take a large amount, which increases discomfort. Therefore, how to provide a polyethylene glycol electrolyte oral solution with a simple preparation process, small dosage volume, stable quality, and convenient administration has become a technical problem that needs to be solved in this field. Summary of the invention
[0004] The technical problem to be solved by the present invention is to provide a polyethylene glycol electrolyte oral solution with simple preparation process, small dosage volume, stable quality and convenient administration and a preparation method thereof.
[0005] A compound polyethylene glycol (3350) electrolyte oral solution, comprising the following ingredients: a mixture of 525 g / L polyethylene glycol 3350, 7.14 g / L sodium bicarbonate, 14.03 g / L sodium chloride, 2.00 g / L potassium chloride, 0.5 g to 1.5 g / L sucralose, 1.0 g to 3 g / L flavor and purified water.
[0006] Screen different types of flavors, including but not limited to strawberry flavor, peach flavor, mixed fruit flavor, bubble hall flavor, grapefruit flavor, sweet orange flavor and other water-soluble flavors, and select flavoring agents that are easily accepted by most people as the flavoring agents of this prescription.
[0007] Select sweeteners in different dosages and screen out the dosage that is easily accepted by most people as the flavor corrector for this prescription.
[0008] This product is a concentrated solution, and the growth of microorganisms is inhibited. In order to ensure that the microbial load of the product is at a low level in the initial state, in addition to controlling the microbial limits of raw and auxiliary materials, the present invention boils the process water with industrial steam for 15 minutes and then cools it to 60°C before use.
[0009] The order of feeding materials in the preparation process of the present invention is: weigh the prescribed amount of sodium chloride, potassium chloride, sodium bicarbonate and sucralose into a preparation tank, add 70% of the prescribed amount of purified water, and stir to dissolve.
[0010] Weigh the prescribed amount of polyethylene glycol 3350, slowly add it into the solution, and stir to dissolve.
[0011] Cool the solution to 35-40°C, weigh the prescribed amount of flavor, add it to the above solution, and stir evenly.
[0012] Add remaining water and make up to volume by weight. BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Figure 1 : Preparation process flow chart. DETAILED DESCRIPTION
[0014] Weigh 75% of the prescription amount of purified water, sodium chloride, potassium chloride, sodium bicarbonate, sucralose, and polyethylene glycol 3350 for later use. Figure 1 .
[0015] Add 61.50 kg (75% of the prescribed amount) of purified water into the preparation tank, open the interlayer steam, and control the solution temperature at about 50°C.
[0016] Start stirring at a speed of 53 rpm, add 2.106 kg of sodium chloride, 0.301 kg of potassium chloride, 1.070 kg of sodium bicarbonate, and 0.075 kg of sucralose in sequence, and stir for 20 minutes to dissolve the raw materials.
[0017] Add 79.793 kg of polyethylene glycol 3350 into the preparation tank in three portions and stir at 50°C until the solution is basically clear.
[0018] Weigh 20.50 kg of purified water (remaining 25% of the prescription amount), add it to the preparation tank to make up to volume, continue stirring for 30 minutes, and the solution should be clear.
[0019] The solution was cooled to 35-40°C, 0.150 kg of sweet orange essence was added, and the stirring was continued in an open circulation for 15 min. The intermediate was sampled and sent for inspection.
[0020] filter.
[0021] A triple cartridge filter is used, the filter element is made of polyethersulfone, the pore size is 0.45um, the size is 10 inches, the filtration pressure is 0.10~0.40Mpa, the filter element is used once, and the drug solution before, during and after filtration is taken to check the properties, pH, content and microbial limit, and the filtration time is recorded.
[0022] The storage time limit of the buffer tank was investigated. The filtered drug solution was stored in the buffer tank. Samples were taken at 0h, 8h and 24h to test the properties, pH, content, polyethylene glycol 3350 content and microbial limits.
[0023] Filling.
[0024] The theoretical filling volume is 25ml / bag, and the filling volume is controlled at 25.5-26.5ml. During the filling process, 10 bags are taken continuously every 10 minutes to determine the filling volume. (Weighing method, specifically determined according to the specific weight of the adjusted filling volume).
[0025] Packaging: 30 bags / box.
Claims
1. A compound polyethylene glycol (3350) electrolyte oral solution, comprising the following ingredients: a mixture of 525 g / L polyethylene glycol 3350, 7.14 g / L sodium bicarbonate, 14.03 g / L sodium chloride, 2.00 g / L potassium chloride, 0.5 g to 1.5 g / L sucralose, 1.0 g to 3 g / L flavor and purified water.
2. The purified water according to claim 1 is prepared by heating the purified water to boiling and then cooling it to 60° C. for standby use.
3. The flavor according to claim 1, including but not limited to water-soluble flavors such as strawberry flavor, peach flavor, mixed fruit flavor, bubble hall flavor, grapefruit flavor, sweet orange flavor.
4. According to claim 1, it is characterized in that A mixture comprising the following ingredients: polyethylene glycol 3350525 g / L, sodium bicarbonate 7.14 g / L, sodium chloride 14.03 g / L, potassium chloride 2.00 g / L, sucralose 0.5 g / L, flavor 1.0 g / L and purified water.
5. According to claim 1, it is characterized in that A mixture comprising the following ingredients: polyethylene glycol 3350525 g / L, sodium bicarbonate 7.14 g / L, sodium chloride 14.03 g / L, potassium chloride 2.00 g / L, sucralose 1.0 g / L, flavor 1.0 g / L and purified water.
6. According to claim 1, it is characterized in that A mixture comprising the following ingredients: polyethylene glycol 3350525 g / L, sodium bicarbonate 7.14 g / L, sodium chloride 14.03 g / L, potassium chloride 2.00 g / L, sucralose 1.5 g / L, flavor 1.0 g / L and purified water.
7. According to claim 1, it is characterized in that A mixture comprising the following ingredients: polyethylene glycol 3350525 g / L, sodium bicarbonate 7.14 g / L, sodium chloride 14.03 g / L, potassium chloride 2.00 g / L, sucralose 1.0 g / L, flavor 1.0 g / L and purified water.
8. According to claim 1, it is characterized in that A mixture comprising the following ingredients: polyethylene glycol 3350525 g / L, sodium bicarbonate 7.14 g / L, sodium chloride 14.03 g / L, potassium chloride 2.00 g / L, sucralose 1.0 g / L, flavor 2.0 g / L and purified water.
9. According to claim 1, it is characterized in that A mixture comprising the following ingredients: 3350525 g / L polyethylene glycol, 7.14 g / L sodium bicarbonate, 14.03 g / L sodium chloride, 2.00 g / L potassium chloride, 1.0 g / L sucralose, 3.0 g / L flavor and purified water.
10. According to claims 1 and 2, the dissolution temperature of each raw material is 50-60°C.