CN113230222B - High-stability blood lipid-lowering pharmaceutical preparation and preparation method thereof - Google Patents
High-stability blood lipid-lowering pharmaceutical preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a lipid-lowering medicinal preparation, which comprises the following raw materials: 6-7 parts of atorvastatin calcium, 15-25 parts of lactose, 35-43 parts of microcrystalline cellulose, 15-30 parts of calcium silicate, 0-1 part of meglumine, 3-8 parts of croscarmellose sodium, 1-3 parts of hydroxypropyl cellulose, 800.2-0.8 part of polysorbate, 0.1-0.6 part of magnesium stearate and 4-5 parts of a film coating premix (gastric soluble type). According to the invention, the raw materials are subjected to the aid of the gaps of lactose in an atorvastatin calcium tablet in a ball milling manner, and the lactose is an auxiliary material with good water solubility, so that the solubility of atorvastatin calcium can be increased; meanwhile, calcium carbonate is replaced by calcium silicate auxiliary materials in the formula, the auxiliary materials can provide better alkaline conditions for raw materials, are easy to disperse and not easy to layer, and the mixing uniformity of the product is ensured and the stability of the product is improved; in the invention, a small amount of meglumine is added into the prescription to further improve the stability of the atorvastatin calcium tablet in the storage process, thereby ensuring the medication safety.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a high-stability lipid-lowering pharmaceutical preparation and a preparation method thereof.
Background
Atorvastatin calcium was developed by wara-lambert (now incorporated into pyroxene) in the united states and approved by the FDA for marketing at 12 months 1996 in specifications of 10mg, 20mg and 40mg, under the trade name "Lipitor", as a third generation new statin drug for the treatment of hypercholesterolemia and coronary heart disease. Approved by the European Union in 9 th 1997, approved in Japan in 3 rd 2000, and marketed in China in 5 th year in the same year, with specifications of 20mg and 40mg, under the trade name "Lipitor". In 2007, the U.S. FDA approved new 5 indications of atorvastatin for non-fatal cardiac infarction, stroke, cardiac surgery, heart failure and heart disease chest pain.
Atorvastatin calcium tablets are used for treating hypercholesterolemia patients with primary hypercholesterolemia. Including patients with familial hypercholesterolemia (hetero type) or combined hyperlipidemia (type IIa and IIb corresponding to Fredrickson's classification), use of the product can treat elevated Total Cholesterol (TC), elevated low density lipoprotein cholesterol (LDL-C), elevated apolipoprotein B (apo B) and elevated Triglycerides (TG) if the therapeutic effects of diet therapy and other non-drug therapies are not satisfactory. In homozygous familial hypercholesterolemia, atorvastatin can be used in combination with other lipid lowering therapies (such as LDL plasma dialysis) or alone (when no other treatment is available) to lower TC and LDL-C. Coronary heart disease or coronary heart disease (such as diabetes, symptomatic atherosclerosis disease, etc.) with hypercholesterolemia or mixed dyslipidemia, and the product is suitable for: reducing the risk of non-fatal myocardial infarction, reducing the risk of fatal and non-fatal stroke, reducing the risk of revascularization, reducing the risk of hospitalization due to congestive heart failure, and reducing the risk of angina pectoris.
The modern living standard is improved, so that the life style and diet of people are improved, and the incidence rate of hyperlipidemia is increased. Hyperlipidemia is a disease caused by disorder of fat metabolism in the body, and the disease can cause various diseases and also can be a hidden killer which is harmful to human health. Atorvastatin calcium as an HMG-CoA reductase inhibitor occupies a very important position in reducing blood fat, and has a plurality of advantages compared with other statins. The blood fat reducing effect is strong, the adverse reaction is less, and the atorvastatin calcium can be well tolerated.
However, atorvastatin calcium has poor stability, is sensitive to wet, hot and acid conditions, and is easy to degrade particularly under the condition of low pH.
Chinese patent CN1630510A discloses that atorvastatin calcium tablets are prepared by wet granulation, and calcium carbonate is used as a stabilizer in the formula to provide an alkaline environment for the tablets and improve the stability of the drug.
Chinese patent CN106491554B discloses a preparation method of atorvastatin calcium tablets, wherein wet granulation is adopted, the dosage of calcium carbonate is 22 parts, and the calcium carbonate is added as a stabilizing agent, but the problem of the rise of related substances in the storage process cannot be solved.
Therefore, how to prepare the atorvastatin calcium tablet into a product with better dissolution and higher stability is a main problem to be solved by the technical field of medicine.
Disclosure of Invention
The invention aims to provide a high-stability lipid-lowering pharmaceutical preparation and a preparation method thereof.
The blood lipid reducing medicinal preparation provided by the invention comprises the following raw materials in parts by mass: 6-7 parts of atorvastatin calcium, 15-25 parts of lactose, 35-43 parts of microcrystalline cellulose, 15-30 parts of calcium silicate, 0-1 part of meglumine, 3-8 parts of croscarmellose sodium, 1-3 parts of hydroxypropyl cellulose, 800.2-0.8 part of polysorbate, 0.1-0.6 part of magnesium stearate and 4-5 parts of a film coating premix (gastric soluble type);
specifically, the lipid-lowering medicinal preparation comprises the following raw materials in parts by mass: 6.7 parts of atorvastatin calcium, 22 parts of lactose, 39.4 parts of microcrystalline cellulose, 22 parts of calcium silicate, 6 parts of croscarmellose sodium, 3 parts of hydroxypropyl cellulose, 800.4 parts of polysorbate, 0.5 part of magnesium stearate and 4 parts of a film coating premix (gastric soluble type);
or, the lipid-lowering medicinal preparation comprises the following raw materials in parts by mass: 6.7 parts of atorvastatin calcium, 22 parts of lactose, 41.4 parts of microcrystalline cellulose, 22 parts of calcium silicate, 4 parts of croscarmellose sodium, 3 parts of hydroxypropyl cellulose, 800.4 parts of polysorbate, 0.5 part of magnesium stearate and 4 parts of a film coating premix (gastric soluble type);
or, the lipid-lowering medicinal preparation comprises the following raw materials in parts by mass: 6.7 parts of atorvastatin calcium, 22 parts of lactose, 39.4 parts of microcrystalline cellulose, 21 parts of calcium silicate, 1 part of meglumine, 6 parts of croscarmellose sodium, 3 parts of hydroxypropyl cellulose, 800.4 parts of polysorbate, 0.5 part of magnesium stearate and 4 parts of a film-coated premix (gastric-soluble type);
specifically, the blood lipid lowering medicine comprises the following raw materials in parts by mass: 6.7 parts of atorvastatin calcium, 22 parts of lactose, 39.4 parts of microcrystalline cellulose, 21.9 parts of calcium silicate, 0.1 part of meglumine, 6 parts of croscarmellose sodium, 3 parts of hydroxypropyl cellulose, 800.4 parts of polysorbate, 0.5 part of magnesium stearate and 4 parts of a film coating premix (gastric soluble);
specifically, the blood lipid lowering medicine comprises the following raw materials in parts by mass: 6.7 parts of atorvastatin calcium, 22 parts of lactose, 39.4 parts of microcrystalline cellulose, 21.5 parts of calcium silicate, 0.5 part of meglumine, 6 parts of croscarmellose sodium, 3 parts of hydroxypropyl cellulose, 800.4 parts of polysorbate, 0.5 part of magnesium stearate and 4 parts of a film-coated premix (gastric-soluble).
The lipid-lowering medicinal preparation is prepared by the method comprising the following steps:
1) ball milling atorvastatin calcium and lactose for 2 hours to obtain premixed powder 1;
2) respectively sieving microcrystalline cellulose, calcium silicate, croscarmellose sodium and magnesium stearate with a 60-mesh sieve for later use;
3) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing binder;
4) sequentially adding the premixed powder 1, microcrystalline cellulose, calcium silicate and croscarmellose sodium into a wet mixing granulator, setting a stirring speed of 280rpm and a shearing speed of 1500rpm, mixing for 5min, adding a prepared adhesive for wet granulation, granulating for 3min, performing fluidized bed drying, adding magnesium stearate, uniformly mixing, and tabletting;
5) preparing a film coating premix (gastric-soluble type) YS-1-7040 into coating solution with a mass concentration of 13% by using purified water, and coating the prepared tablet to obtain the tablet.
The method can further comprise the operations of sieving meglumine by a 60-mesh sieve in the step 2) and adding the meglumine after adding the croscarmellose sodium in the step 4).
The weight increment of the coating is controlled between 2% and 4%.
According to the invention, the raw materials are subjected to the aid of the gaps of lactose in an atorvastatin calcium tablet in a ball milling manner, and the lactose is an auxiliary material with good water solubility, so that the solubility of atorvastatin calcium can be increased;
meanwhile, calcium carbonate is replaced by calcium silicate auxiliary materials in the formula, the auxiliary materials can provide better alkaline conditions for raw materials, are easy to disperse and not easy to layer, and the mixing uniformity of the product is ensured and the stability of the product is improved;
in the invention, a small amount of meglumine is added into the prescription to further improve the stability of the atorvastatin calcium tablet in the storage process, so that the medication safety is ensured, and the process is favorable for improving the production efficiency and is convenient for commercial production.
Detailed Description
The present invention will be described below with reference to specific examples, but the present invention is not limited thereto.
The experimental methods used in the following examples are all conventional methods unless otherwise specified; reagents, materials and the like used in the following examples are commercially available unless otherwise specified.
Example 1 preparation of 1000 tablets of atorvastatin calcium 20mg
The atorvastatin calcium tablet 1000 tablets with specification of 20mg comprises 20g of atorvastatin calcium, 66g of lactose, 118.3g of microcrystalline cellulose, 66g of calcium silicate, 18g of croscarmellose sodium, 9g of hydroxypropyl cellulose, 1.2g of polysorbate 80, 1.5g of magnesium stearate and 12g of film coating premix (gastric dissolution type);
the preparation process comprises the following steps:
1) ball milling atorvastatin calcium and lactose for 2 hours to obtain premixed powder 1;
2) respectively sieving microcrystalline cellulose, calcium silicate, croscarmellose sodium and magnesium stearate with 60 mesh sieve;
3) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing binder;
4) sequentially adding the premixed powder 1, microcrystalline cellulose, calcium silicate and croscarmellose sodium into a wet mixing granulator, setting the stirring speed at 280rpm and the shearing speed at 1500rpm, mixing for 5min, adding a prepared adhesive for wet granulation for 3min, performing fluidized bed drying, adding magnesium stearate, uniformly mixing, and tabletting;
5) preparing a film coating premix (gastric-soluble type) YS-1-7040 into coating solution with a mass concentration of 13% by using purified water, and coating the prepared tablet to obtain the tablet.
The weight increment of the coating is controlled between 2 percent and 4 percent.
Example 2:
the atorvastatin calcium tablet 1000 tablets with specification of 20mg comprises 20g of atorvastatin calcium, 66g of lactose, 124.3g of microcrystalline cellulose, 66g of calcium silicate, 12g of croscarmellose sodium, 9g of hydroxypropyl cellulose, 1.2g of polysorbate 80, 1.5g of magnesium stearate and 12g of film coating premix (gastric dissolution type);
the preparation method is the same as that of the embodiment 1.
Example 3:
the atorvastatin calcium tablet comprises, by weight, 20g of atorvastatin calcium, 66g of lactose, 118.2g of microcrystalline cellulose, 63g of calcium silicate, 3g of meglumine, 18.0g of croscarmellose sodium, 9g of hydroxypropyl cellulose, 1.2g of polysorbate 80, 1.5g of magnesium stearate and 12g of a film-coating premix (gastric-soluble type);
the preparation method comprises the following steps:
1) ball milling atorvastatin calcium and lactose for 2 hours to obtain premixed powder 1;
2) respectively sieving microcrystalline cellulose, calcium silicate, croscarmellose sodium, magnesium stearate and meglumine with a 60-mesh sieve for later use;
3) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing binder;
4) sequentially adding the premixed powder 1, microcrystalline cellulose, calcium silicate, croscarmellose sodium and meglumine into a wet mixing granulator at a stirring speed of 280rpm and a shearing speed of 1500rpm for 5min, adding a prepared adhesive for wet granulation for 3min, performing fluidized bed drying, adding magnesium stearate, uniformly mixing, and tabletting;
5) preparing a film coating premix (gastric-soluble type) YS-1-7040 into coating solution with a mass concentration of 13% by using purified water, and coating the prepared tablet to obtain the tablet.
The weight increment of the coating is controlled between 2 percent and 4 percent.
Example 4:
the atorvastatin calcium tablet 1000 tablets with specification of 20mg comprises 20g of atorvastatin calcium, 66g of lactose, 118.3g of microcrystalline cellulose, 65.7g of calcium silicate, 0.3g of meglumine, 18.0g of croscarmellose sodium, 9g of hydroxypropyl cellulose, 1.2g of polysorbate 80, 1.5g of magnesium stearate and 12g of film coating premix (gastric soluble type);
the preparation method comprises the following steps:
1) ball milling atorvastatin calcium and lactose for 2 hours to obtain premixed powder 1;
2) respectively sieving microcrystalline cellulose, calcium silicate, croscarmellose sodium, magnesium stearate and meglumine with a 60-mesh sieve for later use;
3) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing binder;
4) sequentially adding the premixed powder 1, microcrystalline cellulose, calcium silicate, croscarmellose sodium and meglumine into a wet mixing granulator at a stirring speed of 280rpm and a shearing speed of 1500rpm for 5min, adding a prepared adhesive for wet granulation for 3min, performing fluidized bed drying, adding magnesium stearate, uniformly mixing, and tabletting;
5) preparing a film coating premix (gastric-soluble type) YS-1-7040 into coating solution with a mass concentration of 13% by using purified water, and coating the prepared tablet to obtain the tablet.
The weight increment of the coating is controlled between 2 percent and 4 percent.
Example 5
The preparation method of the atorvastatin calcium tablet 1000 with specification of 20mg comprises the same preparation method as example 4, wherein the preparation method comprises the following steps of weighing raw materials, namely, 20g of atorvastatin calcium, 66g of lactose, 118.3g of microcrystalline cellulose, 64.5g of calcium silicate, 1.5g of meglumine, 18.0g of croscarmellose sodium, 9g of hydroxypropyl cellulose, 1.2g of polysorbate 80, 1.5g of magnesium stearate and 12g of film-coated premix (gastric-coated premix).
Comparative example 1 preparation of 1000 atorvastatin calcium tablets of 20mg
The atorvastatin calcium tablet 1000 tablets with specification of 20mg comprises 20g of atorvastatin calcium, 66g of lactose, 118.3g of microcrystalline cellulose, 66g of calcium carbonate, 18.0g of croscarmellose sodium, 9g of hydroxypropyl cellulose, 1.2g of polysorbate 80, 1.5g of magnesium stearate and 12g of film coating premix (gastric soluble);
the preparation process comprises the following steps:
1) respectively sieving microcrystalline cellulose, calcium carbonate, croscarmellose sodium and magnesium stearate with a 60-mesh sieve for later use;
2) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing binder;
3) sequentially adding the raw materials, microcrystalline cellulose, calcium carbonate and croscarmellose sodium into a wet mixing granulator, mixing for 5min, adding the prepared adhesive for wet granulation for 3min, performing fluidized bed drying, adding magnesium stearate, mixing uniformly, and tabletting;
4) preparing a film coating premix (gastric-soluble type) YS-1-7040 into coating solution with a mass concentration of 13% by using purified water, and coating the prepared tablet to obtain the tablet. The weight increment of the coating is controlled between 2 percent and 4 percent.
Comparative example 2
The calcium carbonate in comparative example 1 was added, and the other components were the same as in the preparation method
The preparation process of 1000 atorvastatin calcium tablets with specification of 20mg comprises the following raw materials, by weight, 20g of atorvastatin calcium, 66g of lactose, 83.3g of microcrystalline cellulose, 101g of calcium carbonate, 18.0g of croscarmellose sodium, 9g of hydroxypropyl cellulose, 1.2g of polysorbate 80, 1.5g of magnesium stearate and 12g of film coating premix (gastric soluble type):
1) respectively sieving microcrystalline cellulose, calcium carbonate, croscarmellose sodium and magnesium stearate with a 60-mesh sieve for later use;
2) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing binder;
3) sequentially adding the raw materials, microcrystalline cellulose, calcium carbonate and croscarmellose sodium into a wet mixing granulator, mixing for 5min, adding the prepared adhesive for wet granulation for 3min, performing fluidized bed drying, adding magnesium stearate, mixing uniformly, and tabletting;
4) preparing a film coating premix (gastric-soluble type) YS-1-7040 into coating solution with a mass concentration of 13% by using purified water, and coating the prepared tablet to obtain the tablet. The weight increment of the coating is controlled between 2 percent and 4 percent.
Comparative examples 3,
The atorvastatin calcium and the lactose in the comparative example 1 are subjected to ball milling, and because the lactose is loose and porous, the combination of the lactose and the raw materials is increased by the ball milling to improve the dissolution speed; other components and preparation method are the same.
The atorvastatin calcium tablet 1000 tablets with specification of 20mg comprises 20g of atorvastatin calcium, 66g of lactose, 118.3g of microcrystalline cellulose, 66g of calcium carbonate, 18.0g of croscarmellose sodium, 9g of hydroxypropyl cellulose, 1.2g of polysorbate 80, 1.5g of magnesium stearate and 12g of film coating premix (gastric soluble type), and the preparation process comprises the following steps:
1) ball milling atorvastatin calcium and lactose for 2 hours to obtain premixed powder 1;
2) respectively sieving microcrystalline cellulose, calcium carbonate, croscarmellose sodium and magnesium stearate with a 60-mesh sieve for later use;
3) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing binder;
4) sequentially adding the premixed powder 1, microcrystalline cellulose, calcium carbonate and croscarmellose sodium into a wet mixing granulator, mixing for 5min, adding a prepared adhesive, performing wet granulation for 3min, performing fluidized bed drying, adding magnesium stearate, uniformly mixing, and tabletting;
5) preparing a film coating premix (gastric-soluble type) YS-1-7040 into coating solution with a mass concentration of 13% by using purified water, and coating the prepared tablet to obtain the tablet. The weight increment of the coating is controlled between 2 percent and 4 percent.
Comparative examples 4,
The atorvastatin calcium tablet 1000 with specification of 20mg uses the weight of each raw material, 20g of atorvastatin calcium, 66g of lactose, 118.3g of microcrystalline cellulose, 66g of calcium silicate, 18g of croscarmellose sodium, 9g of hydroxypropyl cellulose, 1.2g of polysorbate 80, 1.5g of magnesium stearate and 12g of film coating premix (gastric soluble type).
The preparation process comprises the following steps:
1) respectively sieving microcrystalline cellulose, calcium carbonate, croscarmellose sodium and magnesium stearate with a 60-mesh sieve for later use;
2) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing into binder.
3) Sequentially adding the raw materials, microcrystalline cellulose, calcium carbonate and croscarmellose sodium into a wet mixing granulator, mixing for 5min, adding the prepared adhesive for wet granulation for 3min, performing fluidized bed drying, adding magnesium stearate, mixing uniformly, and tabletting;
4) preparing a film coating premix (gastric-soluble type) YS-1-7040 into a coating solution with a mass concentration of 13% by using purified water, and coating the prepared tablet to obtain the tablet. The weight increment of the coating is controlled between 2 percent and 4 percent.
The products prepared in the above examples 1-6 and comparative examples 1-4 were examined for their dissolution curves, and the effect of the changes in the respective formulations on the in vitro dissolution of the product was determined, with the following specific results:
TABLE 1 summary of dissolution measurements
The atorvastatin calcium tablets prepared in examples 1 to 6 and examples 1 to 4 were subjected to the influence factor test, and the contents and related substances of the atorvastatin calcium tablets were compared between 0 day and 30 days under the conditions of high temperature of 60 ℃, high humidity RH of 90% and illumination of 5000Lux, as shown in Table 2.
TABLE 2
From above experimental results, because calcium silicate not only can improve alkaline environment for the product, simultaneously because this auxiliary material is novel auxiliary material, have pore structure, but be different from other porous auxiliary materials, this auxiliary material has bulky macropore in the unique petal crystal structure formation granule, can be with the medicine cladding in porous, avoid illumination and oxidation etc. to the influence of raw materials, in addition, because lactose is loose porous form, consider to improve the speed of dissolving out through the combination that ball-milling increased lactose and raw materials, moreover, the stability of product has further been increased through adding minute amount meglumine.
Claims (3)
1. A lipid-lowering pharmaceutical preparation is prepared by the following raw materials in parts by mass:
the raw materials comprise the following substances in parts by mass: 6.7 parts of atorvastatin calcium, 22 parts of lactose, 39.4 parts of microcrystalline cellulose, 21 parts of calcium silicate, 1 part of meglumine, 6 parts of croscarmellose sodium, 3 parts of hydroxypropyl cellulose, 800.4 parts of polysorbate, 0.5 part of magnesium stearate and 4 parts of a gastric-soluble film coating premix; or
The lipid-lowering medicine comprises the following raw materials in parts by mass: 6.7 parts of atorvastatin calcium, 22 parts of lactose, 39.4 parts of microcrystalline cellulose, 21.9 parts of calcium silicate, 0.1 part of meglumine, 6 parts of croscarmellose sodium, 3 parts of hydroxypropyl cellulose, 800.4 parts of polysorbate, 0.5 part of magnesium stearate and 4 parts of gastric-soluble film coating premix; or
The lipid-lowering medicine comprises the following raw materials in parts by mass: 6.7 parts of atorvastatin calcium, 22 parts of lactose, 39.4 parts of microcrystalline cellulose, 21.5 parts of calcium silicate, 0.5 part of meglumine, 6 parts of croscarmellose sodium, 3 parts of hydroxypropyl cellulose, 800.4 parts of polysorbate, 0.5 part of magnesium stearate and 4 parts of gastric-soluble film coating premix;
the preparation method of the lipid-lowering medicinal preparation comprises the following steps:
1) ball milling atorvastatin calcium and lactose for 2 hours to obtain premixed powder 1;
2) respectively sieving microcrystalline cellulose, calcium silicate, croscarmellose sodium and magnesium stearate with a 60-mesh sieve for later use;
3) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing binder;
4) sequentially adding the premixed powder 1, microcrystalline cellulose, calcium silicate and croscarmellose sodium into a wet mixing granulator, setting a stirring speed of 280rpm and a shearing speed of 1500rpm, mixing for 5min, adding a prepared adhesive for wet granulation, granulating for 3min, performing fluidized bed drying, adding magnesium stearate, uniformly mixing, and tabletting;
5) preparing a coating solution with the mass concentration of 13% by using purified water for a gastric-soluble film coating premix YS-1-7040, and coating the prepared tablet to obtain the tablet;
the method also comprises the operations of sieving meglumine by a 60-mesh sieve in the step 2) and adding the meglumine after adding the croscarmellose sodium in the step 4).
2. A process for preparing the lipid-lowering pharmaceutical formulation of claim 1, comprising the steps of:
1) ball milling atorvastatin calcium and lactose for 2 hours to obtain premixed powder 1;
2) respectively sieving microcrystalline cellulose, calcium silicate, croscarmellose sodium and magnesium stearate with a 60-mesh sieve for later use;
3) weighing hydroxypropyl methylcellulose and polysorbate 80, adding into purified water, stirring for 40min, and preparing binder;
4) sequentially adding the premixed powder 1, microcrystalline cellulose, calcium silicate and croscarmellose sodium into a wet mixing granulator, setting a stirring speed of 280rpm and a shearing speed of 1500rpm, mixing for 5min, adding a prepared adhesive for wet granulation, granulating for 3min, performing fluidized bed drying, adding magnesium stearate, uniformly mixing, and tabletting;
5) preparing a coating solution with the mass concentration of 13% by using purified water for a gastric-soluble film coating premix YS-1-7040, and coating the prepared tablet to obtain the tablet;
the method also comprises the operations of sieving meglumine by a 60-mesh sieve in the step 2) and adding the meglumine after adding the croscarmellose sodium in the step 4).
3. The method of claim 2, wherein: the weight increment of the coating is controlled between 2% and 4%.
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| CN202110294134.9A CN113230222B (en) | 2021-03-19 | 2021-03-19 | High-stability blood lipid-lowering pharmaceutical preparation and preparation method thereof |
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| CN202110294134.9A CN113230222B (en) | 2021-03-19 | 2021-03-19 | High-stability blood lipid-lowering pharmaceutical preparation and preparation method thereof |
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| CN113230222B true CN113230222B (en) | 2021-12-17 |
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