A pharmaceutical composition containing hepatocyte growth-stimulating factor and its preparation
A technology for hepatocyte growth factor and pharmaceutical preparations, applied in the field of medicine, can solve the problems of research, no pharmaceutical combination, etc., and achieve the effects of simple preparation method, good stability and easy industrial production.
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experiment example 1
[0037] Experimental example 1 Screening of prescription amount of glutathione
[0038] Table 1 Glutathione dosage
[0039]
[0040] Under the packaging conditions of marketed drugs, store the samples prepared from the above prescription at a temperature of (40±2)°C and a relative humidity of 75%±5%, and take samples after 1 month for the following pharmacological tests:
[0041] 1. In vivo experiment
[0042] Test method: Male Wistar rats, weighing 135~190g, underwent 32% liver resection under pentobarbital sodium (4mg / 100g body weight) anesthesia, injected 4ml of normal saline into the abdominal cavity 4~6 hours after the operation, and took 30 hours to remove the liver. The above drugs were fixed in the middle and lower 1 / 3 of the right lobe of the liver, fixed in Bouin's solution, embedded in sections, stained with 6uH.E., and counted for mitosis, as shown in Table 2:
[0043] group number of animals Mitosis multiple control group 8 0.944 ...
experiment example 2 3
[0056] Experimental example 2 Screening of tris-hydrochloric acid buffer
[0057] Numbering hepatocyte growth-stimulating hormone buffer Glutathione water test 1 10g — 0.05 1000ml test 2 10g Adjust pH=6.0 0.05 1000ml test 3 10g — 0.10 1000ml test 4 10g Adjust pH=6.0 0.10 1000ml
[0058] Prepare the injection according to the preparation method of the above-mentioned injection, and store the sample prepared by the above prescription under the conditions of the temperature (40±2)°C and the relative humidity of 75%±5% under the packaging conditions of the marketed drug, 1 Sampling after one month, carry out MTT test, the result is as follows:
[0059]
[0060] Conclusion: It can be known from the above table that the stability of the pharmaceutical composition can be increased when Tris-hydrochloric acid buffer is added.
experiment example 3
[0061] Experimental Example 3 Stability Test of Hepatocyte Growth-promoting Injection
[0062] 1. Experimental drug
[0063] Take respectively 3 batches of medicines prepared by the methods of Example 1 and Example 5.
[0064] 2. Inspection items and methods
[0065] 2.1 Acidity: take a sample of the hepatocyte growth-promoting hormone injection and directly measure it with an acidity meter. As a result, the pH value was 5.0-7.0.
[0066] 2.2 Clarity and color of the solution: Take 5 samples of hepatocyte growth-promoting hormone injection, and check the solution color according to the solution color test method. The sample solutions of each batch are clear and colorless.
[0067] 2.3 Clarity: Take 5 tubes of hepatocyte growth-stimulating hormone, add water to make a 1mg / ml solution, check according to the Chinese Pharmacopoeia, and all meet the requirements.
[0068] 2.4 Determination of content: Determination of polypeptide content by Folin-phenol method.
[0069] 2.5...
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