Alkaline drug enteric preparation and preparation method thereof

An enteric-coated preparation and alkaline technology, which is applied in the field of enteric-coated preparations of alkaline drugs and their preparation, can solve problems such as being uneconomical and inconvenient, affecting the curative effect and application, affecting the gastric digestion and absorption function, etc., and achieving good compliance , stable and long-lasting effect in the body

Inactive Publication Date: 2008-06-04
李大鹏
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Alkaline pH regulators such as sodium bicarbonate ordinary tablets have achieved good curative effect in long-term clinical application, but there are always problems that affect the curative effect and application
① There is gastric acid in the stomach, and when taking alkaline drugs orally, the drug first undergoes an acid-base neutralization reaction with gastric acid, consuming part of the drug and causing drug loss; ② Reduces the amount of gastric acid and affects the normal digestion and absorption function of the stomach; ③ Due to the interaction with gastric acid, small doses of carbonic acid Alkaline pH regulators such as sodium bicarbonate ordinary tablets cannot achieve the therapeutic purpose of effectively alkalizing body fluids or urine; ④After patients take alkaline pH regulators such as sodium bicarbonate ordinary tablets, the pH in the body has a strong difference in pH; ⑤Alkaline substances It reacts with gastric acid to generate heat, and its reaction products cause stomach discomfort, especially sodium bicarbonate can be quickly dissolved and released in the patient's stomach, and directly reacts with gastric acid to produce CO 2 Gas, causing hiccups, gastrointestinal inflation, gastric distension and other adverse reactions, and even gastric cramps and other symptoms, patients with severe gastric ulcers are more likely to cause gastric perforation ("Clinical Medication Instructions", "New Pharmacology" 15th edition), However, patients need to take it several times a day, and the length of the treatment cycle is different. If the time is longer, this adver

Method used

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  • Alkaline drug enteric preparation and preparation method thereof
  • Alkaline drug enteric preparation and preparation method thereof
  • Alkaline drug enteric preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1: sodium bicarbonate enteric-coated tablet

[0036] Prescription: 1000 tablets

[0037]

[0038] Preparation process: crush sodium bicarbonate through a 80-mesh sieve, add 10% starch slurry (that is, mix starch and water and heat it) to make a soft material by rapid stirring, granulate with a 14-mesh sieve, and dry in an oven. Set the temperature at 40°C, raise the temperature to 50°C after 1 hour, and dry; the dry granules are sieved through a 12-mesh sieve, added with dry starch and magnesium stearate, and mixed well. Detect the intermediate, and convert the tablet weight into the pharmaceutical core according to the content. According to the prescription, add the hypromellose and polyethylene glycol of the isolation layer into ethanol for soaking and dissolving; After mixing sesame oil, diethyl phthalate and polysorbate 80, the coating operation is carried out. Put the tablets in the coating pot, turn the coating pot and blow hot air to make the tem...

Embodiment 2

[0040] Embodiment 2: sodium bicarbonate enteric-coated tablet

[0041] Prescription: 1000 tablets

[0042]

[0043] Preparation process: crush sodium bicarbonate through an 80-mesh sieve, add 10% starch slurry to make a soft material by rapid stirring, granulate with a 14-mesh sieve, and dry in an oven. The initial temperature of the oven is 40 ° C, and the temperature is raised to Dry at 50°C; sieve the dry granules through a 12-mesh sieve, add dry starch and magnesium stearate and mix well. Detect the intermediate, and convert the tablet weight into the pharmaceutical core according to the content. According to the prescription, add the hypromellose and polyethylene glycol of the isolation layer into ethanol for soaking and dissolving; After mixing sesame oil, diethyl phthalate and polysorbate 80, the coating operation is carried out. Put the tablets in the coating pot, turn the coating pot and blow hot air to make the temperature in the pot reach about 40°C, first spr...

Embodiment 3

[0045] Embodiment 3: sodium bicarbonate enteric-coated tablet

[0046] Prescription: 1000 tablets

[0047]

[0048]

[0049] Preparation process: crush sodium bicarbonate through an 80-mesh sieve, add 10% starch slurry to make a soft material by rapid stirring, granulate with a 14-mesh sieve, and dry in an oven. The initial temperature of the oven is 40 ° C, and the temperature is raised to Dry at 50°C; sieve the dry granules through a 12-mesh sieve, add dry starch and magnesium stearate and mix well. Detect the intermediate, and convert the tablet weight into the pharmaceutical core according to the content. According to the prescription, add the hypromellose and polyethylene glycol of the isolation layer into ethanol for soaking and dissolving; After mixing sesame oil, diethyl phthalate and polysorbate 80, the coating operation is carried out. Put the tablets in the coating pot, turn the coating pot and blow hot air to make the temperature in the pot reach about 40°...

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Abstract

The invention discloses an oral enteric-coated preparation adopting alkalescence PH regulator as medicine active component and an industrial preparation method of the preparation. The alkalescence PH regulator is selected from one of baking soda, KHCO3, sodium carbonate, citric acid, sodium citrate, potassium citrate, potassium sodium hydrogen citrate or a mixture of the substances. The medicine compound of the invention is not released in stomach but in bowel, so as to avoid defects of the existing common oral preparation that is release in stomach and is counteracted with stomach acid to cause loss of the medicine component, hiccup and gastrectasia, etc. Then the medicine effect can be thoroughly performed, and bad reaction can be greatly alleviated and the toleration of the sufferers can be greatly enhanced. In the clinical application, the invention can be used for regulating acid-alkali balance of body, correcting acid body nature, basifying urine liquid, treating metabolic acidosis and gout, etc. diseases.

Description

technical field [0001] The invention relates to an oral enteric-coated preparation containing alkaline medicine and a preparation method thereof. The alkaline medicine refers to an alkaline pH regulator capable of adjusting acidic body fluid or urine to a normal pH range. Background technique [0002] The acid-base balance of human body fluids is one of the three basic balances of the human body (body temperature balance, nutritional balance, and body fluid acid-base balance). Body fluid, also known as extracellular fluid, mainly refers to blood, lymph, and interstitial fluid between organs and tissues. Human organs and systems are surrounded by specific body fluids, which constitute the internal environment of multicellular organisms. Only by maintaining stable body fluids can the body have a stable internal environment. Human body fluids have a certain pH value, which is often expressed by the pH value of blood, urine, saliva, etc., and generally refers to the pH value of...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/28A61K9/48A61K47/32A61K47/34A61K47/38
CPCA61K33/00A61K31/19A61K9/2813A61K33/10A61P1/00A61K2300/00
Inventor 李大鹏任蔚东马美丽
Owner 李大鹏
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