Pimobendan sustained-release tablets for pet and preparation method thereof
A technology for pimobendan and sustained-release tablets, applied in the field of pimobendan sustained-release tablets for pets and its preparation, can solve the problems of excessive fluctuation of blood drug concentration, great influence on therapeutic effect, and lack of preparation process , to reduce the risk of injury, improve the effect of clinical treatment, and improve palatability
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Embodiment 1
[0021] Party:
[0022]
[0023] Preparation:
[0024] A, firstly prepare the solid dispersion of pimobendan and citric acid, dissolve pimobendan and citric acid in water together, carry out vacuum drying, pulverize the dried solid powder, pass through a 200 mesh sieve, and set aside;
[0025] B, the sieved pimobendan solid dispersion, slow and controlled release auxiliary material, filler, 80% flavoring agent and 30% binder are mixed uniformly;
[0026] C. Add the ethanol / water (30 / 70) solution of the remaining 70% of the adhesive and mix evenly to make a soft material;
[0027] D. Carry out wet granulation of the prepared soft material, dry at 60°C for 1 hour, and granulate;
[0028] E, add lubricant and remaining 20% correctives to the prepared granule and mix evenly;
[0029] F, tablet pressing, finished product.
Embodiment 2
[0030] Embodiment 2 stability test
[0031] 1 Materials and methods
[0032] 1.1 Material test drugs: the pimobendan sustained-release tablets prepared according to Example 1-A, Example 1-B, and Example 1-C respectively; control drugs: according to the patent (CN100546568C, issued on October 7, 2009 Published in Japan) homemade Pimobendan Tablets, the content is 5mg.
[0033] 1.2 Methods Take 25 tablets of the test drug and the control drug respectively, and carry out the accelerated test of the drug for six months according to the "Technical Specifications for Stability Test of Veterinary Drugs (Trial)". Sampling for content determination.
[0034] 2 Test results: See Table 1.
[0035] Table 1 Drug Stability Test Results (n=4)
[0036]
[0037] The results show that the drug stability of the pimobendan sustained-release tablets prepared in Example 1-A, Example 1-B, and Example 1-C is obviously better than that of the reference drug. It shows that the preparation is st...
Embodiment 4
[0038] Example 4 Clinical Trials
[0039] 1. Materials and Methods
[0040] 1.1 Test material
[0041] 1.1.1 Test drug Test drug: Example 1-C, used continuously for seven days; control drug: self-made pimobendan tablets according to the patent (CN100546568C, published on October 7, 2009), with a content of 5 mg.
[0042] 1.1.2 Experimental animals Tianjin Pet Hospital has diagnosed dogs with heart disease, and 80 dogs have been diagnosed with clinical disease in the third and fourth stages of heart disease. The age of onset is 3-10 years old.
[0043] 1.2 Test method: Divide 80 naturally occurring dogs into five groups of I, II, III, IV and V, with 16 dogs in each group. Group I is the infection-free group; Group II is the group treated with low-dose test drugs (2.5mg per kilogram of body weight orally, once a day, for seven consecutive days); Group III was treated with a medium dose of the test drug (5 mg per kg of body weight, once a day, for seven consecutive days); Group...
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