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Calcium dobesilate dispersible tablet and preparation method thereof

A technology of calcium dobesilate and dispersible tablets, which is applied in the directions of anhydride/acid/halide active ingredients, pill delivery, cardiovascular system diseases, etc., can solve the problems of complex process, large human influence, and long time consuming granulation method. , to achieve the effect of simple method, reduced irradiation time, and small difference in film weight

Inactive Publication Date: 2014-06-25
JIANGSU WANBANG BIOPHARMLS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The granulation method takes a long time, the process is complicated, and the human influence is relatively large. Therefore, finding a method that takes a short time, has a simple process, and is easy to operate has become a problem to be solved in the preparation process of calcium dobesilate dispersible tablets.

Method used

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  • Calcium dobesilate dispersible tablet and preparation method thereof
  • Calcium dobesilate dispersible tablet and preparation method thereof
  • Calcium dobesilate dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Raw material prescription:

[0032] Calcium dobesilate 25 g

[0033] Crospovidone 9 g

[0034] Microcrystalline cellulose 2.25 g

[0035] Lactose 8.525 g

[0036] Magnesium stearate 0.225 g

[0037]

[0038] Makes 100 pieces

[0039] Preparation process: Mix the prescribed amount of crospovidone, microcrystalline cellulose and lactose in equal increments, and then mix the prescribed amount of calcium dobesilate with the above-mentioned mixed powder in equal increments , and finally add the prescribed amount of magnesium stearate and mix well, determine the tablet weight and hardness, and directly compress the tablet to obtain the calcium dobesilate dispersible tablet. The whole preparation process is completed at 25°C.

[0040] Appearance: The calcium dobesilate dispersible tablet prepared by this method is off-white with smooth surface.

[0041] Uniformity of dispersion: Take 6 tablets of the prepared calcium dobesilate dispersible tablets, place them in 10...

Embodiment 2

[0044] Raw material prescription:

[0045] Calcium dobesilate 25 g

[0046] Crospovidone 9 g

[0047] Microcrystalline Cellulose 4.5 g

[0048] Lactose 6.275 g

[0049] Magnesium stearate 0.225 g

[0050]

[0051] Makes 100 pieces

[0052] Preparation process: Mix the prescription amount of crospovidone, microcrystalline cellulose and lactose in equal increments, then mix the prescription amount of calcium dobesilate with the above-mentioned mixed powder in equal increments Finally, add the prescribed amount of magnesium stearate and mix evenly, determine the tablet weight and hardness, and directly compress the tablet to obtain the calcium dobesilate dispersible tablet. The whole preparation process is completed at 25°C.

[0053] Appearance: The calcium dobesilate dispersible tablet prepared by this method is off-white with smooth surface.

[0054] Uniformity of dispersion: Take 6 tablets of the prepared calcium dobesilate dispersible tablets, place them in 100...

Embodiment 3

[0057] Raw material prescription:

[0058] Calcium dobesilate 25 g

[0059] Crospovidone 9 g

[0060] Microcrystalline cellulose 6.75 g

[0061] Lactose 4.025 g

[0062] Magnesium stearate 0.225 g

[0063]

[0064] Makes 100 pieces

[0065] Preparation process: Mix the prescription amount of crospovidone, microcrystalline cellulose and lactose in equal increments, then mix the prescription amount of calcium dobesilate with the above-mentioned mixed powder in equal increments Finally, add the prescribed amount of magnesium stearate and mix evenly, determine the tablet weight and hardness, and directly compress the tablet to obtain the calcium dobesilate dispersible tablet. The whole preparation process is completed at 25°C.

[0066] Appearance: The calcium dobesilate dispersible tablet prepared by this method is off-white with smooth surface.

[0067] Uniformity of dispersion: Take 6 tablets of the prepared calcium dobesilate dispersible tablets, place them in 100ml o...

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Abstract

The present invention discloses a calcium dobesilate dispersible tablet and a preparation method thereof. The calcium dobesilate dispersible tablet contains, by weight, a main drug calcium dobesilate, and auxiliary materials such as 1-42% of cross-linked povidone, 0.5-42% of microcrystalline cellulose, 2-44% of lactose and 0.01-15% of magnesium stearate. According to the present invention, a direct powder tabletting method is adopted to prepare the calcium dobesilate dispersible tablet; the method has characteristics of simple operation, time saving, reduction of times of calcium dobesilate exposed to air and light, and reduction of moisture absorption and light instability; the prepared calcium dobesilate dispersible tablet has a smooth surface morphology, and can be completely disintegrated within 2 min and screened with a 2# sieve, and the dissolution rate of the prepared calcium dobesilate dispersible tablet in water and a dilute hydrochloric acid solution within 5 min can achieve more than 90%; and the preparation method has characteristics of simple preparation process and time saving, and the prepared calcium dobesilate dispersible tablet has characteristics of smooth surface, good dispersion uniformity and high dissolution rate, and is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparation research, in particular to a dispersible tablet of calcium dobesilate used to regulate microcirculation and a preparation method thereof. Background technique [0002] Calcium Dobesilate is a microcirculation regulating drug, which can inhibit hyperpermeability caused by vasoactive substances, such as histamine, 5-hydroxytryptamine, bradykinin, hyaluronidase, and prostaglandins. function, thereby improving the biosynthesis of basement membrane collagen. In European and American countries, calcium dobesilate has been recognized as the only mature product for the prevention and treatment of microvascular circulation disorders, especially diabetic retinopathy. Lesions and various ophthalmic diseases caused by microcirculation disorders, as well as nephrotic proteinuria, nephrotic syndrome and renal failure. [0003] At present, the commonly used dosage forms of calcium dobesilate in clinic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/185A61K47/38A61P9/10A61P9/14A61P27/02A61P13/12
Inventor 胡小艳乔德水高雪芹
Owner JIANGSU WANBANG BIOPHARMLS
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