A kind of compound methoxyphenamine capsule and preparation method thereof

Abstract

A compound methoxyphenamine capsule applied in the field of pharmaceutical preparations and a preparation method thereof, comprising main ingredients and auxiliary materials, the main ingredients including methoxyphenamine hydrochloride, narcodine, aminophylline, and chlorpheniramine maleate Allergen; Adjuvant includes diluent, disintegrating agent, lubricant, antioxidant, surfactant and other adjuvants, and described diluent is magnesium oxide; Described diluent magnesium oxide consumption is 0.1-5 times of main agent amount 0.1-4.5 times of the main drug amount of the described thinner magnesium oxide dosage; 0.5-3.5 times of the main drug amount of the described thinner magnesium oxide dosage; 0.7-3.0 times; described diluent magnesia consumption is 1.2-1.5 times of the main agent amount. The invention uses magnesium oxide with moisture-proof effect as a diluent, together with disintegrants, lubricants, antioxidants, surfactants and other auxiliary materials to significantly reduce the moisture absorption and improve the stability of the preparation, and use the dry granulation process to solve the problem of disintegration. Solve the problem of slowness to ensure the release characteristics of the formulation.

Description

technical field [0001] The invention relates to a compound methoxyphenamine capsule in the field of pharmaceutical preparations and a preparation method thereof. Background technique [0002] Asthma is a common respiratory disease. It is a chronic disease caused by various causes such as allergies, circulatory system or lung congestion, bronchial edema, kidney or heart disease, and central nervous system excitement. The main symptoms include dyspnea, wheezing, etc. , cough, etc., have been recognized as one of the four persistent diseases by the world medical community. According to World Health Organization (WHO) estimates, there are nearly 300 million people with asthma in the world. With the global air pollution and environmental deterioration, the morbidity and mortality of asthma are increasing year by year. [0003] Compound methoxyphenamine capsules are formulated with four drugs with different properties: aminophylline, methoxyphenamine hydrochloride, narcotine and...

AI Technical Summary

Problems solved by technology

[0004] At present, due to the strong hygroscopicity of methoxyphenamine hydrochloride in domestically produced compound methoxyphenamine capsules, aminophylline will be degraded into theophylline and diethylamine when conditions such as moisture and temperature change, resulting in unstable capsule quality, such as: The shell softens, the content changes color, the dissolution rate slows down, the content decreases, and the related substances increase and many other quality problems; as a capsule containing four medicinal ingredients, its main drug accounts for a high proportion of the entire preparation, and its fluidity is poor. In the production process, it is easy to appear that the loading amount is unstable or even exceeds the limit, resulting in the occurrence of quality problems; the ratio of high-dose drug aminophylline (25mg) and low-dose chlorpheniramine maleate (2mg) in the capsule is very different, exceeding 10 times, it is very prone to uneven mixing, resulting in unqualified content uniformity

Great troubles to production and use

[0005] Chinese patent 200410065967.4 discloses the preparation method of oral solid preparations containing methoxyphenamine, narcotine, aminophylline, and chlorpheniramine maleate. This patent protects the commonly used auxiliary materials with moisture-proof effect in the field of pharmacy. Claim 1 proposes to use glyceryl behenate, stearic acid, cetyl alcohol, stearyl alcohol, etc. as fillers, and using one or more of these auxiliary materials will directly lead to noscapine and aminophylline etc. The release slows down, and claim 8 mentions that lactose is used as a diluent, and aminophylline and lactose will undergo a Maillard reaction, which will cause the preparation to change color and be incompatible, resulting in extreme instability. Therefore, this claim has obvious defect

In addition, the patent example pointed out that in the high-temperature accelerated test, no degradation products were detected in its self-made preparations and commercially available domestic capsules at 0 days, which did not conform to the actual situation. Since the analytical method used in this patent is not suitable for the inspection of this preparation, the results are not representative

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