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Pravastatin sodium enteric-coated tablet and preparation method thereof

A technology of pravastatin sodium and enteric-coated tablets, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, coatings, etc., which can solve the problem of poor fluidity and compressibility of raw materials, reduction of adverse reactions, and difficulty in meeting direct compression requirements Process requirements and other issues to achieve the effect of improving poor fluidity, high bioavailability, and uniform release

Pending Publication Date: 2020-10-23
浙江诺得药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to overcome the problems that pravastatin sodium is unstable under acidic conditions, is prone to conversion in gastric acid, and the fluidity and compressibility of raw materials are poor, and it is difficult to meet the requirements of direct compression technology, the object of the present invention is to provide a general Vastatin sodium enteric-coated tablet, the enteric-coated tablet is composed of a tablet core and an outer enteric coating, no isolation layer is required between the tablet core and the enteric coating layer, the production efficiency is improved, the dissolution rate and bioavailability are high, The therapeutic effect is good, and the adverse reactions are significantly reduced

Method used

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  • Pravastatin sodium enteric-coated tablet and preparation method thereof
  • Pravastatin sodium enteric-coated tablet and preparation method thereof
  • Pravastatin sodium enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 5

[0043] Embodiment 5 stability test

[0044] Take embodiment 1 sample as investigation object, investigate the stability of accelerated test, result is as shown in table 2:

[0045] Table 2

[0046]

Embodiment 6

[0048] Embodiment 6 dissolution test

[0049] Taking the sample of Example 1 as the object of investigation, investigate the dissolution curves of the gained pravastatin sodium enteric-coated tablets of the present invention and commercially available pravastatin sodium tablets (trade name: Pravastatin), the results are shown in figure 1 .

Embodiment 7

[0050] Embodiment 7 pharmacokinetic test

[0051] Take embodiment 1 sample as object of investigation, investigate gained pravastatin sodium enteric-coated tablet of the present invention and commercially available pravastatin sodium tablet (trade name: pravastatin) pharmacokinetic test, the results are as follows:

[0052] Test preparation: Pravastatin sodium enteric-coated tablets obtained in Example 1 (specification: 10 mg / tablet);

[0053] Reference drug: purchase Sino-US Shanghai Bristol-Myers Squibb Pharmaceutical Co., Ltd. (Pulagu, specification: 10mg / tablet);

[0054] Select 20 healthy male subjects, aged (23.2±1.2) years old, body mass (65.3±5.2) kg, height (172.3±5.2) cm, all subjects were asked about medical history and physical examination before the experiment, electrocardiogram , chest X-ray, liver function, kidney function, blood routine, urine routine examination and mental state were all normal. The subjects did not take other drugs 2 weeks before and during...

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Abstract

The invention provides a pravastatin sodium enteric-coated tablet and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The enteric-coated tablet is prepared by adopting a direct tabletting method and comprises a tablet core and an outer enteric coating layer; the tablet core comprises pravastatin sodium and pharmaceutically acceptable auxiliary materials; and the weight of the enteric layer is increased by 2.0-10.0%. A filling agent is an equal-mass mixture of mannitol, microcrystalline cellulose and sodium alginate, and the stability of the pravastatin sodium can be better improved compared with single use of mannitol. The disintegrating agent is a mixture of any one of dry starch, low-substituted cellulose, croscarmellose sodium, sodium carboxymethyl starch and povidone and magnesium aluminum silicate, and the mass ratio is 3:1 to 4:1. The stability of the pravastatin sodium under the acidic condition is improved, and the absorptivity of the pravastatin sodium in the intestinal tract environment is promoted. According to the invention, the main medicinal amount is reduced, toxic and side effects are reduced, the bioavailability in the intestinal tract is better improved, and the property is stable in the storage period.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pravastatin sodium enteric-coated tablet and a preparation method thereof. Background technique [0002] Pravastatin sodium, also known as Pavading, pravastatin, is a white crystalline powder chemical, chemical name 1,2,6,7,8,8a-hexahydro-2-methyl-8-( 2-Methylbutyryloxy)-1-naphthalene-3',5',6-trihydroxyheptanoic acid sodium salt, molecular formula C 23 h 36 NaO 7 , Soluble in water and methanol, soluble in absolute ethanol, melting point 171.2 ~ 173 ℃. The chemical formula is as follows: [0003] [0004] Pravastatin sodium is a competitive inhibitor of 3-hydroxy 3-methylglutaryl coenzyme A reductase (HMG-CoA reductase), which catalyzes the conversion of HMG-CoA to formazan in the initial stage of cholesterol biosynthesis. Valonate is the rate-limiting enzyme and, therefore, reversibly inhibits HMG-CoA reductase, thereby inhibiting cholesterol bios...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K9/20A61K47/26A61K47/38A61K47/36A61K47/32A61K47/02A61K47/44A61K31/22A61P3/06
CPCA61K9/2018A61K9/2054A61K9/205A61K9/2059A61K9/2027A61K9/2009A61K9/2095A61K9/282A61K9/2846A61K31/22A61P3/06
Inventor 何招燚梁雷殷学治
Owner 浙江诺得药业有限公司
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