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Creatine phosphate sodium oral solid preparation and preparation method thereof

A technology of sodium phosphocreatine phosphate and solid preparation, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations with inactive ingredients, etc. To reduce the loss, improve myocardial ischemia and hypoxia, and achieve good stability

Inactive Publication Date: 2010-06-02
哈尔滨博莱制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problem that if the oral creatine phosphate is produced by the existing technology, there will be loss, and it is unstable under weak acidity, leading to the problem that domestic and foreign pharmaceutical companies cannot produce oral creatine phosphate preparations, and the oral creatine phosphate sodium preparation is provided. Formulation and its preparation method

Method used

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  • Creatine phosphate sodium oral solid preparation and preparation method thereof
  • Creatine phosphate sodium oral solid preparation and preparation method thereof
  • Creatine phosphate sodium oral solid preparation and preparation method thereof

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Experimental program
Comparison scheme
Effect test

specific Embodiment approach 1

[0020] Embodiment 1: Sodium creatine phosphate oral solid preparation of this embodiment is composed of 204-206g of sodium phosphate phosphate, 41-43g of starch, 27-29g of sodium starch glycolate, 59-61g of microcrystalline cellulose and 5 ~7g of absorption enhancer is made into sodium phosphate oral enteric-coated capsule; wherein the absorption enhancer is L-glutamine, sodium lactate, d-potassium hydrogen tartrate or vitamin B 1 .

specific Embodiment approach 2

[0021] Embodiment 2: The difference between this embodiment and Embodiment 1 is that the sodium creatine phosphate oral solid preparation is composed of 205g of sodium creatine phosphate, 42g of starch, 28g of sodium starch glycolate, 60g of microcrystalline cellulose and 6g of The absorption enhancer is made into sodium phosphate creatine oral enteric-coated capsules. Others are the same as the first embodiment.

[0022] Experiment of the protective effect of sodium creatine phosphate oral solid preparation on skeletal muscle in the present embodiment:

[0023] 1. Experimental animals, feeding conditions and grouping

[0024]1.1 45 healthy adult male SD rats, weighing 190-200g;

[0025] 1.2 The rats were raised in large plastic cages, 5 per cage, and the cages were equipped with stainless steel cages, glass suction bottles and stainless steel suction pipes; the room temperature was about 20 °C, and the relative humidity was 55%-75%; the feed was standard mixed rat diet , f...

specific Embodiment approach 3

[0056] Embodiment 3: The method for preparing sodium creatine phosphate oral solid preparation in this embodiment is implemented according to the following steps: 1. Weigh 204-206 g of sodium creatine phosphate, 41-43 g of starch, and 27-29 g of sodium starch glycolate , 59~61g of microcrystalline cellulose and 5~6g of absorbent; 2. Put the weighed starch, sodium starch glycolate and microcrystalline cellulose at 105°C and dry for 1.5h respectively, and then weigh the The sodium phosphate creatine, the absorbent, the dried starch, the dried sodium starch glycolate and the dried microcrystalline cellulose were passed through a 100-mesh sieve respectively; three, the sieved raw materials were added to the Mixing in the mixer for 15min, then filling the hollow enteric-coated capsules according to the average content weight of 0.335±0.02g to obtain sodium creatine phosphate oral enteric-coated capsules; wherein in step 1, the absorption enhancer is L-glutamine, Sodium lactate, pot...

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Abstract

The invention discloses a creatine phosphate sodium oral solid preparation and a preparation method thereof, relating to an oral solid preparation and a preparation method thereof. The invention solves the problem that the existing pharmaceutical factories can not produce the creatine phosphate sodium oral solid preparation at home and abroad. The creatine phosphate sodium oral solid preparation consists of creatine phosphate sodium, starch, carboxymethyl starch sodium, microcrystalline cellulose and absorbefacient. The method comprises the steps of: weighing raw materials, drying and screening, mixing and filling to obtain an enteric capsule. The creatine phosphate sodium oral solid preparation consists of creatine phosphate sodium, absorbefacient, microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose solution, magnesium stearate, acrylic resin II, ethanol, twain-80, castor oil and phthalic acid diethyl ester. The method comprises the steps of: weighing raw materials, screening, preparing wet granule, tabletting, spraying casing liquid to obtain an enteric coated tablet. The invention realizes the preparation of the creatine phosphate sodium oral solid preparation, and can protect cardiac muscle and skeletal muscle.

Description

technical field [0001] The present invention relates to an oral solid preparation and a preparation method thereof. Background technique [0002] The worldwide pharmaceutical preparation of endogenous creatine phosphate is only a dosage form of sodium phosphate creatine powder injection, which is used in cardioplegia during cardiac surgery to protect the myocardium or to treat abnormal myocardial metabolism in ischemic conditions. Because the powder injection requires corresponding medical equipment and solvents, general places other than medical institutions do not have the conditions to use sodium creatine phosphate powder injection anytime and anywhere for injection, and the onset of myocardial disease is generally sudden, so the drug needs A pharmaceutical preparation that can be used directly orally anytime, anywhere. [0003] Exogenous phosphocreatine is distributed in skeletal muscle in addition to cardiac muscle. The current sodium creatine phosphate powder injecti...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K9/28A61K31/664A61K47/38A61P9/00
Inventor 李靖敏许荣臻胡畔陈妍
Owner 哈尔滨博莱制药有限公司
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