Overview[1]
Anhydrous calcium hydrogen phosphate is a white, odorless, tasteless powder or crystal, which exists in the form of triclinic crystals. Pharmaceutical grade anhydrous calcium hydrogen phosphate is mainly used as a diluent for hydrophobic drug tablets and capsules. It is both a pharmaceutical excipient and a calcium supplement.
Apply[2] [4]
Anhydrous calcium hydrogen phosphate is used in the preparation of amlodipine besylate tablets.
CN201710713623.7 discloses a preparation process of amlodipine besylate tablets, which includes the following steps: (1) material preparation process: the amlodipine besylate tablets are made of the following raw materials: benzenesulfonic acid Amlodipine, microcrystalline cellulose, starch, anhydrous calcium hydrogen phosphate, sodium carboxymethyl starch, starch paste, medicinal ethanol, magnesium stearate and talc; (2) Pretreatment process of raw and excipients; (3) Weighing and batching process; (4) Wet granulation process; (5) Granulation and general mixing process; (6) Tablet pressing process; (7) Aluminum plastic packaging process; (8) Finished product packaging process. The preparation process of the amlodipine besylate tablets is reasonably designed to normalize and standardize the production process and ensure product quality; the amlodipine besylate tablets prepared by the present invention are effective for essential hypertension and chronic stable angina pectoris variants. Angina pectoris has excellent therapeutic effects.
CN201410071625.7 prepares an injectable calcium phosphate-based bone repair material that can meet clinical minimally invasive repair applications. The material uses calcium phosphate bone cement as the basic system, and the liquid phase uses a weak acid solution of chitosan to improve the effectiveness of CPC. Plasticity and viscoelasticity make bone cement injectable, greatly improving the application range and application comfort of bone cement; the solid phase is biphasic calcium phosphate (TTCP+DCPA) powder, and a certain amount of nectar is added to the solid phase Alcohol and polylactic acid-co-glycolic acid (PLGA) are used as pore-forming agents. While mannitol dissolves in the body, CPC gradually forms a porous structure, while avoiding the osmotic dehydration of cells caused by higher concentrations of mannitol. The different solubilities of mannitol and PLGA are used to make the material have a certain strength in the early stage and gradually form pores in the body, thereby producing an “injectable scaffold material”.
Preparation[1] [3]
A production method of medicinal anhydrous calcium hydrogen phosphate, including the following steps:
(1) Prepare a phosphoric acid solution with a concentration of 15-30%, add it to the reaction kettle, and raise the temperature to 40-50°C;
(2) Prepare calcium carbonate slurry with a concentration of 20-25%, and add it to the reaction kettle at a rate of 1.5-3.5L/min. At the same time, the solution in the reaction kettle is heated to 65-70°C, and continuously heated to 200- Stir at a speed of 250 rpm. Calcium carbonate reacts with the phosphoric acid solution. After adding the calcium carbonate slurry, continue stirring until the pH of the solution is 5.0-5.5. Stop stirring, lower the temperature to 50-60°C, and let it sit for 0.5-1.5 hours to obtain a slurry. 1;
(3) Prepare a concentration of 10-15% milk of lime, add it to the slurry one obtained in step (2) at a rate of 1.0-2.5L/min, stir at a rate of 130-200rpm while adding milk of lime, After the lime milk is added, continue stirring for 15-20 minutes until the pH of the solution is 6.0-7.0, and let it stand for 1-1.5 hours to obtain slurry two;
(4) Perform solid-liquid separation on the slurry two obtained in step (3), recover the solid and dry it to obtain anhydrous calcium hydrogen phosphate.
A preparation method of granular anhydrous calcium hydrogen phosphate, which is characterized by: the specific steps are as follows:
(1) Use calcium carbonate or calcium hydroxide as the calcium source, and adjust its concentration with purified water to obtain a calcium carbonate or calcium hydroxide solution. The concentration of calcium carbonate or calcium hydroxide and purified water is 1:2~4; Adjust the mass concentration of the phosphoric acid solution to 20%~25%, add 1‰~1.5‰ of its mass of magnesium oxide to the phosphoric acid solution; add calcium carbonate or calcium hydroxide solution dropwise to the phosphoric acid solution, and react at room temperature. The stirring speed is set to 200rpm~300rpm. When the pH is neutralized to 3.2~3.8, the heating temperature is raised to 40°C~45°C, and the pH is neutralized to 4.6~4.8. The reaction is completed and the slurry is obtained;
(2) Adjust the pH of the slurry to 6.5~7.0 with a calcium hydroxide solution with a mass concentration of 10%~15%, filter until the calcium hydrogen phosphate water content is 10~15%, and dry it with a pulse air dryer. The steam pressure is maintained at 0.3MPa～0.5MPa, the temperature in the second zone of the drying tube is 80℃～110℃, and the hot blast furnace outlet temperature reaches 220℃～33At 0°C, the weight loss on ignition of the dried material is 7.0% to 8.5%, and anhydrous calcium hydrogen phosphate is made.
Main reference materials
[1] [China invention, China invention authorization] CN201610346346.6 A production method of medicinal anhydrous calcium hydrogen phosphate
[2]CN201710713623.7 Preparation process of amlodipine besylate tablets
[3] [China invention, China invention authorization] CN201710113875.6 Preparation method of granular anhydrous calcium hydrogen phosphate
[4]CN201410071625.7 Preparation method of injectable porous calcium phosphate bone repair material
