Technological method for preparing sarafloxzcin hydrochloride soluble powder based on solid dispersion technology
A technology of salafloxacin hydrochloride and solid dispersion, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, powder transportation, etc., can solve the problems of poor water solubility of salafloxacin hydrochloride and limited application, etc. To achieve the effect of good dissolution effect, simple process and easy realization
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Embodiment 1
[0029] The preparation of embodiment 1 sarafloxacin hydrochloride solid dispersion
[0030] Mix sarafloxacin hydrochloride and anhydrous glucose (anhydrous glucose passed through a 60-mesh sieve) uniformly at a weight ratio of 1:2-10, put them in a planetary ball mill for ball milling, and obtain a solid dispersion of sarafloxacin hydrochloride.
[0031] Among them, the planetary ball mill uses medium beads with a diameter of 8-10mm and small beads with a diameter of 3-5mm. The weight ratio of the medium beads to the small beads is 16-20:1; the sum of the weight of the medium beads and the small beads: hydrochloric acid salad The sum of the weights of sandstar and anhydrous glucose = 5-6:1; the rotation speed of the planetary ball mill is at least 240 revolutions per minute, and the ball milling time is at least 50 minutes.
[0032] The planetary ball mill used in this embodiment ball-mills the material with medium and small beads in the cup, and the parameters of each specifi...
Embodiment 2
[0035] The preparation of embodiment 2 sarafloxacin hydrochloride soluble powder
[0036] Take the solid dispersion prepared in Example 1, add soluble auxiliary materials therein and mix uniformly to obtain the finished product, and the main drug content in the finished product is 5-20% by weight based on sarafloxacin. In this embodiment, the soluble excipients at least include one of anhydrous glucose passed through a 60-mesh sieve, glucose containing crystal water passed through a 60-mesh sieve, and lactose passed through a 60-mesh sieve. When mixing, you can choose the mixing equipment that meets the requirements according to the actual situation.
[0037] Each test case in this embodiment is prepared by taking the test case with the same serial number as in Example 1. The main drug content of the finished product obtained in each test case is shown in the table below.
[0038] Case number
Embodiment 3
[0039] The solubility detection of embodiment 3 sarafloxacin hydrochloride soluble powder
[0040] According to the veterinary drug quality standard of the Ministry of Agriculture in 2003, the solubility item of sarafloxacin hydrochloride soluble powder is stipulated as follows: take 1.0g of this product, add 50ml of water, and stir to dissolve it all. This method is referred to as detection method A.
[0041] According to the 2010 edition of the "Chinese Veterinary Pharmacopoeia", the quality standard of sarafloxacin hydrochloride soluble powder does not specify the solubility separately, but only stipulates that other inspection items should meet the relevant provisions under the item of soluble powder; at the same time, under the item of usage and dosage According to the regulations, based on the calculation of sarafloxacin, mixed drink, 25-50mg of chicken (calculated as active ingredients) per 1L of water, for 3-5 consecutive days.
[0042] Under the soluble powder item o...
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