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Pharmaceutical composition of enalapril maleate folic acid and preparation method thereof

A technology of enalapril maleate and prifolic acid, which is applied in the direction of drug combinations, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve problems such as economic loss, decomposition and deterioration, and increase in side effects, so as to ensure safety Use, good stability, and simple process operation

Inactive Publication Date: 2017-07-21
NANJING YOKO PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] (4) Select the appropriate crystal form. Enalapril maleate has polymorphism, which is divided into type I and type II. Although it is reported that the energy of the two crystal forms is similar, the difference is only 0.6kcal and no mol is detected. , but type II is more unstable in film
During the production, storage and use of pharmaceutical preparations, they will decompose and deteriorate due to the influence of various factors, resulting in reduced drug efficacy or increased side effects. Some drugs even produce toxic substances, which may also cause large economic losses.

Method used

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  • Pharmaceutical composition of enalapril maleate folic acid and preparation method thereof
  • Pharmaceutical composition of enalapril maleate folic acid and preparation method thereof
  • Pharmaceutical composition of enalapril maleate folic acid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 Stability of raw materials

[0038] Put the mixed raw materials of enalapril maleate, folic acid, enalapril maleate and folic acid with a weight ratio of 10:1 under the conditions of 60℃ high temperature, humidity RH 92.5% and 4500lx strong light for 10 days. Influencing factor experiments, the results are shown in Table 1.

[0039] Related substance detection method: Waters high performance liquid chromatography e2695-2489 instrument detection, flow rate 2.0mL no detection min, column temperature: 50℃, detection wavelength 215nm, mobile phase A: 0.01mol L potassium dihydrogen phosphate buffer solution is not detected Adjust pH to 2.2, mobile phase B: acetonitrile, gradient elution mobile phase A did not detect the volume ratio of mobile phase B 90:10→70:30→90:10, only the main impurity content is listed in Table 1.

[0040] Table 1 Investigation of the stability of raw materials

[0041]

[0042] It can be seen from Table 1 that enalapril maleate, folic acid and the...

Embodiment 2

[0043] Example 2 Filler screening

[0044] Through the compatibility experiment of starch, lactose monohydrate, lactose anhydrous, microcrystalline cellulose 101, microcrystalline cellulose 102, mannitol and pregelatinized starch, the fillers were screened at high temperature 60℃ and high humidity. Placed for 10 days under RH 92.5% and 4500lx strong light irradiation conditions, the results are shown in Table 2.

[0045] Table 2 Compatibility experiment of filler raw materials

[0046]

[0047]

[0048] It can be seen from Table 2 that when starch, lactose monohydrate, anhydrous lactose, microcrystalline cellulose 101, microcrystalline cellulose 102, mannitol or pregelatinized starch and enalapril maleate folic acid raw materials are in high humidity When placed under RH 92.5% and light conditions for 10 days, there is no significant change in the impurities of dish acid, enalaprilat and enalapridone; but starch, microcrystalline cellulose 101, microcrystalline cellulose 102 or preg...

Embodiment 3

[0049] Example 3 Adhesive Screening

[0050] Through the original and adjuvant compatibility test of povidone K30, hypromellose E5, hydroxypropyl cellulose SL-FP and hypromellose 603, the adhesives were selected at high temperature of 60℃ and high humidity. Placed for 10 days under RH 92.5% and 4500lx strong light irradiation conditions, the results are shown in Table 3.

[0051] Table 3 Compatibility experiment of adhesive raw materials

[0052]

[0053] It can be seen from Table 3 that when povidone K30, hypromellose E5, hydroxypropyl cellulose SL-FP or hypromellose 603 and enalapril maleate folic acid raw materials are at a high temperature of 60℃, When placed under high humidity RH 92.5% and 4500lx light for 10 days, there is no significant change in impurity of betelic acid, enalaprilat and enalapridone, indicating that povidone K30, hypromellose E5, hydroxypropyl Cellulose SL-FP or hypromellose 603 has good compatibility with enalapril maleate folic acid raw materials, and ca...

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Abstract

The invention provides a pharmaceutical composition of enalapril maleate folic acid. The composition comprises enalapril maleate, folic acid, filler, a disintegrant, a binder and a lubricant. The composition is characterized in that the filler is selected from composition, lactose anhydrous or mannitol, the disintegrant is selected from one or more of cross-linked sodium carboxymethylcellulose or low substituted hydroxypropyl cellulose, the binder is selected from povidone K30, hydroxypropyl methyl cellulose E5, hydroxypropyl cellulose SL-FP or hydroxypropyl methylcellulose 603, and the lubricant is selected from talcum powder, sodium stearyl fumarate or glyceryl behenate. The excipients and raw materials selected by the invention have good compatibility, the preparation obtained by dry granulation has good stability, can ensure safe use of drugs in clinical practice, and the technological operation is simple and is suitable for industrial production.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a pharmaceutical composition of enalapril maleate folic acid and a preparation method thereof. Background technique [0002] The spectrum of cardiovascular and cerebrovascular events in China is significantly different from that of the Western population. The annual incidence of stroke in my country is 250 without 100,000, and the annual incidence of cardiovascular events is 50 without 100,000. The incidence of stroke is 5 times that of cardiovascular events. In clinical trials to observe the effect of lowering blood pressure on cardiovascular and cerebrovascular events, the incidence of myocardial infarction was not detected in Chinese hypertensive populations with a ratio of 6-13:1, while in western hypertensive populations, it was about 1:1, suggesting that stroke is The most important cardiovascular and cerebrovascular events in the hypertensive population in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K9/20A61K47/12A61K47/14A61P9/12A61K31/519
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/2054A61K31/519A61K38/05A61K2300/00
Inventor 张烨缪六舒薛峪泉朱素华张峰
Owner NANJING YOKO PHARMA
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