Pharmaceutical composition containing Amlodipine besilate and valsartan and preparation method thereof

Abstract

The invention relates to a pharmaceutical composition containing Amlodipine besilate and valsartan and a preparation method thereof. The pharmaceutical composition is prepared from the following ingredients in parts by weight: 5 parts of Amlodipine besilate, 80 parts of valsartan, 60 parts of microcrystalline cellulose, 4.7-13.2 parts of croscarmellose sodium, 4.8 parts of silicon dioxide and 1.6parts of magnesium stearate. The pharmaceutical composition is prepared by using a direct powder compression technique. The invention can reach the dissolution rate of more than 90% by using less disintegrating agent, and has advantages of good stability and faster disintegrating. The preparation method of the invention has simpler production process, reduces the investment of corresponding equipment and plants and saves the production cost; the tablet produced by using direct powder compression technique has faster disintegrating and is helpful to improve the dissolving of pharmaceutical; through detection, the tablet prepared by using the method is dissolved out by more than 90% within 15 min.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition containing amlodipine besylate and valsartan and a preparation method thereof. Background technique [0002] Hypertension is the most common cardiovascular disease and a major public health problem worldwide. In 1991, my country conducted a sample survey of 940,000 people over the age of 15. Statistics show that the prevalence of hypertension in my country has reached 11.26%, which is 25% higher than that in the 10 years from 1979 to 1990. There are more than 130 million hypertensive patients in my country. . Moreover, this upward momentum continues. Statistics also show that the treatment rate of hypertension is 17.4% in urban areas and 5.4% in rural areas; the control rate (systolic blood pressure<140mmHg and diastolic blood pressure<90mmHg after treatment) is only 2.9%. From the above statistics, it can be seen that the prevalence o...

AI Technical Summary

Problems solved by technology

Because crospovidone has extremely strong hygroscopicity, the monolayer tablet stability of prepared valsartan and amlodipine besylate is not good, disintegration and stripping are slow, and preparation method is dry granulation, although this Compared with the wet granulation method, the method has many advantages, but the equipment is expensive and complicated, and the equipment plant investment is large. The stability of the single-layer tablet of valsartan and amlodipine besylate prepared by this method is not good, and the disintegration and dissolution are also difficult. slow

Although its dissolution rate of the prepared tablet can also reach more than 90%, the consumption of crospovidone as disintegrating agent needs to reach more than 15% of the prescription quantity, as seen that its consumption is relatively large

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