Choline fenofibric acid sustained release pellets and preparation method thereof
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A technology for choline fenofibrate and sustained-release pellets, which is applied to sugar-coated pills, pill delivery, pharmaceutical formulations and other directions, can solve problems such as poor effect, harm to human health, low bioavailability and the like, and achieves a preparation method. Simple and easy to operate, reduce irritation, good drug stability
Inactive Publication Date: 2015-03-25
HARBIN SHENGJI PHARMA
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[0006]2. Dietary factors The role of dietary factors in the examination is always complicated in the abdominal cavity. A considerable proportion of hyperlipoproteinemia patients who are hospitalized is closely related to dietary factors
However, the effect of most drugs is not very good, the stability is not high, the bioavailability is low, and most of the drugs have many side effects, which will cause serious harm to human health.
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Embodiment 1
[0035] A kind of fenofibric acid choline sustained-release pellets, comprising drug-containing pellets and a coating layer, the coating layer wraps the drug-containing pellets, and the drug-containing pellets include: 45mg fenofibric acid choline , 100-200mg blank ball core, 100-200mg filler, 25-125mg lubricant, 5-50mg binder, the coating layer includes: 35-175mg Eudragit NE30D, 5-52mg talcum powder.
[0036] The optimal mass ratio of raw materials in the drug-containing pellets is: 45 mg choline fenofibrate, 100 mg blank core, 190 mg filler, 25 mg lubricant, and 10 mg binder.
[0037] The optimal mass ratio of raw materials in the coating layer is: 45mg Eudragit NE30D, 7mg talcum powder.
[0038] The filler is microcrystalline cellulose.
[0039] Described lubricant is talcum powder.
[0040] The binder is hypromellose.
[0041] The coating layer also includes traces of sodium lauryl sulfate or polyethylene glycol.
Embodiment 2
[0043] A preparation method of fenofibric acid choline sustained-release pellets, comprising the following steps:
[0044] Step 1: material preparation: according to the above mass ratio, choline fenofibric acid is pulverized with a pulverizer, and passed through a 100-mesh sieve;
[0045] Step 2: Mixing: Weigh fenofibric acid choline and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make a fine powder of the drug, and take it out for later use;
[0046] Step 3: Preparation of adhesive: Weigh an appropriate amount of hypromellose according to the above mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, and set aside;
[0047] Step 4: Pill making: put the mixed drug fine powder into the feeding tank of the centrifugal pellet machine, put the adhesive into the liquid supply tank, put the blank pellet core into the pot, turn on the machine...
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Abstract
The invention provides choline fenofibric acid sustained release pellets. The choline fenofibric acid sustained release pellets comprise medicine-containing pellets and coating layers, wherein the medicine-containing pellets are coated with the coating layers; the medicine-containing pellets comprise 45mg of choline fenofibric acid, 100-200mg of hollow cores, 100-200mg of filling agents, 25-125mg of lubricating agents and 5-50mg of bonding agents; the coating layers comprise 35-175mg of Eudragit NE30D and 5-52mg of talcum powder. A preparation method of the choline fenofibric acid sustained release pellets comprises the following processes: 1. material preparation; 2. mixing; 3. preparation of the bonding agents; 4. preparation of the pellets; 5. preparation of coating agents; 6. coating; 7. filling; 8. aluminium-plastic packaging and preparation of finished products. The choline fenofibric acid sustained release pellets used for reducing blood lipid have the beneficial effects that as the two kinds of advanced technologies, namely novel sustained release preparations and pellet preparations, are adopted, the choline fenofibric acid sustained release pellets have stable treatment effects and higher bioavailability and have the advantages of good medicine stability, convenience in packaging, transportation and storage, and the like. The preparation method of the choline fenofibric acid sustained release pellets is simple and practicable and is suitable for industrial production.
Description
technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, in particular to a fenofibric acid choline sustained-release pellet and a preparation method thereof. Background technique [0002] Hyperlipidemia refers to excessive blood lipid levels, which can directly cause some diseases that seriously endanger human health, such as atherosclerosis, coronary heart disease, pancreatitis, etc. Due to abnormal fat metabolism or operation, one or more lipids in plasma are higher than normal, which is called hyperlipidemia. Lipids that are insoluble or slightly soluble in water must be combined with proteins to exist in the form of lipoproteins. Therefore, hyperlipidemia is often Hyperlipoproteinemia (hyperlipoproteinemia), manifested as hypercholesterolemia, hypertriglyceridemia and so on. [0003] The cause of disease of hyperlipidemia can be divided into two categories basically, namely primary hyperlipidemia and secondary hyperlipi...
Claims
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