Calcitriol liquid hard capsule, method for preparing same and application of calcitriol liquid hard capsule
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A liquid hard capsule, calcitriol technology, which is applied in the directions of capsule delivery, bone diseases, pharmaceutical formulations, etc., can solve problems such as poor solubility, and achieve the effects of simple method, excellent solubility and stability, and simple preparation method.
Inactive Publication Date: 2017-11-21
SINOPHARM CHUANKANG PHARMACEUTICAL CO LTD
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[0013] The first object of the present invention is to provide a calcitriol liquid hard capsule, which is made of an oily base, and the active ingredients are directly dissolved in the oily liquid and filled in the hard capsule, which overcomes the problem of poor drug solubility, In order to cla
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Embodiment 1
[0039] The preparation method of calcitriol liquid hard capsule is as follows:
[0040] 1) Ingredients: 0.25mg of calcitriol, 160g of medium-chain fatty acid triglyceride, 16mg of dibutylhydroxytoluene, 16mg of butylhydroxyanisole, 1000 gelatin capsules;
[0041] 2) Stir and dissolve medium-chain fatty acid triglycerides, dibutyl hydroxytoluene, and butyl hydroxyanisole in a stirring tank for 20 minutes, then add calcitriol and continue stirring for 120 minutes until the dissolution is complete, vacuumize and degas, and pour it into a hard In the capsule shell, and encapsulate the pharmaceutical coating material at the capsule's sleeve.
Embodiment 2
[0043] The preparation method of calcitriol liquid hard capsule is as follows:
[0045] 2) After stirring and dissolving coconut oil, dibutyl hydroxytoluene and butyl hydroxyanisole in a stirring tank, add calcitriol and continue stirring to dissolve completely, vacuumize and degas, infuse in the hard capsule shell, and place in the capsule The sheathing part of the bag is encapsulated with a medicinal coating material.
Embodiment 3
[0047] The preparation method of calcitriol liquid hard capsule is as follows:
[0049] 2) After stirring and dissolving castor oil, dibutyl hydroxytoluene and butyl hydroxyanisole in a stirring tank for 30 minutes, add calcitriol and continue stirring for 100 minutes until the dissolution is complete, vacuumize and degas, pour into the hard capsule shell, And encapsulate the medicinal coating material at the joint of the capsule.
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Abstract
The invention provides a calcitriol liquid hard capsule, a method for preparing the same and application of the calcitriol liquid hard capsule. Every 1000 calcitriol liquid hard capsules comprise 0.25-0.5 mg of calcitriol, 140-170 g of oil-based matrixes and 25-40 mg of antioxidants. The method includes mixing the antioxidants and the oil-based matrixes with one another to obtain first mixtures; stirring and dissolving the first mixtures and then adding the calcitriol into the first mixtures to obtain second mixtures; continuing to stir and dissolve the second mixtures and then vacuumizing and degassing the second mixtures; filling hard capsule shells with the mixtures to obtain the calcitriol liquid hard capsule. The calcitriol liquid hard capsule, the method and the application have the advantages that the calcitriol liquid hard capsule can be effectively applied to treating post-menopause and senile osteoporosis, chronic renal failure and the like; the content uniformity of the calcitriol liquid hard capsule which is a medicine can be improved, the calcitriol liquid hard capsule is good in stability, long in quality guarantee period, high in bioavailability, low in cost and convenient to administer, and accordingly the calcitriol liquid hard capsule, the method and the application have obvious merits.
Description
technical field [0001] The invention relates to the field of calcitriol capsule manufacture, in particular to a calcitriol liquid hard capsule and a preparation method and application thereof. Background technique [0002] Osteoporosis is a systemic skeletal disease of multiple causes, characterized by decreased bone strength and increased risk of fracture. Osteoporosis and the fractures it causes rank seventh among current common diseases, seriously threatening the health of middle-aged and elderly people, and becoming a global public health problem. By 2050, it is estimated that the incidence of osteoporosis in my country's population will rise from 6.6% (1997) to 13.6%. The serious clinical consequence of osteoporosis is fracture. The incidence of osteoporosis in the elderly over 60 years old is as high as 55%, and the incidence of fracture is about 10%. The resulting complications lead to death within 1 year, and more than 50% of the survivors cannot walk or have mobil...
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