CN111228233A - Coating composition for preparing perhexiline enteric-coated tablets and application thereof - Google Patents
Coating composition for preparing perhexiline enteric-coated tablets and application thereof Download PDFInfo
- Publication number
- CN111228233A CN111228233A CN202010165390.3A CN202010165390A CN111228233A CN 111228233 A CN111228233 A CN 111228233A CN 202010165390 A CN202010165390 A CN 202010165390A CN 111228233 A CN111228233 A CN 111228233A
- Authority
- CN
- China
- Prior art keywords
- parts
- polymer
- plasticizer
- pigment
- coating composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2893—Tablet coating processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medical Informatics (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Preparation (AREA)
- Vascular Medicine (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Urology & Nephrology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Heart & Thoracic Surgery (AREA)
- Inorganic Chemistry (AREA)
- Cardiology (AREA)
Abstract
The invention discloses a coating composition for preparing perhexiline enteric-coated tablets and application thereof, wherein the coating composition is prepared from the following raw materials in parts by weight: 10 parts of polymer, 1-5 parts of plasticizer, 1-10 parts of anti-sticking agent and 1-10 parts of pigment. The enteric-coated tablet obtained by the invention does not disintegrate under the acidic condition of human gastric juice, rapidly disintegrates under the weak acid and weak alkaline condition of human intestinal juice, and the drug release position can be at different intestinal positions. Compared with the conventional film-coated tablet, the film-coated tablet avoids adverse reactions such as stomach discomfort and the like caused by disintegration of the film-coated tablet in the stomach and certain stomach-sensitive patients, and improves the compliance and the safety of the patients.
Description
(I) technical field
The invention relates to a pharmaceutical composition of a traditional Chinese medicine preparation and a preparation method thereof, in particular to a coating composition of perhexiline enteric-coated tablets and a preparation method and application thereof.
(II) background of the invention
The prescription of the Guanxinning tablet is salvia miltiorrhiza and ligusticum wallichii, and the Guanxinning tablet has the effects of promoting blood circulation to remove blood stasis and dredging collaterals and nourishing heart and has definite curative effect. The perhexiline tablet has the characteristic of fast disintegration, so that the medicine of a patient is completely dissolved and released in the stomach in a short time after the perhexiline tablet is taken, the effect is very fast, certain adverse reactions are brought, particularly for patients with diseases or sensitive stomach, and the fast release and the effect of the medicine bring certain stimulation to the stomach, so that stomach discomfort or slight pain is caused. In the fourth phase clinical trial after the new medicine is on the market, about 1 percent of the subjects react, and the perhexiline tablet occasionally has the adverse reaction of stomach pain or discomfort, and particularly after the perhexiline tablet is taken on an empty stomach, the adverse reaction is more obvious.
Disclosure of the invention
The invention provides a coating composition of perhexiline enteric-coated tablets which is more beneficial to patients to take and a preparation method thereof aiming at the adverse reaction phenomenon of stomach discomfort or slight pain after the patients with stomach diseases or stomach sensitivity take perhexiline tablets (film coated tablets), so as to meet the medication requirements of the patients.
The technical scheme adopted by the invention is as follows:
the invention provides a coating composition for preparing perhexiline enteric-coated tablets, which consists of the following raw materials in parts by weight: 10 parts of polymer, 1-5 parts of plasticizer, 1-10 parts of anti-sticking agent and 1-10 parts of pigment; the polymer is a copolymer mixed by two or three of methacrylic acid, ethyl acrylate, methyl methacrylate or methyl acrylate in equal weight ratio; the plasticizer is triethyl citrate or polyethylene glycol 6000; the anti-sticking agent is talcum powder; the pigment is one of titanium dioxide or ferric oxide or a mixture of the titanium dioxide and the ferric oxide in a mass ratio of 2: 1.
Further, the polymer is one of the following: (1) a copolymer in which methacrylic acid and ethyl acrylate are mixed in a mass ratio of 1: 1; (2) a copolymer in which methacrylic acid and methyl methacrylate are mixed in a mass ratio of 1: 1; (3) methacrylic acid, methyl acrylate and methyl methacrylate were mixed at a mass ratio of 1:1: 1.
Further, the coating composition is prepared from the following raw materials in parts by weight: 10 parts of polymer, 1-2 parts of plasticizer, 2.5-5 parts of anti-sticking agent and 4-8 parts of pigment.
Furthermore, the coating composition is composed of the following raw materials in a weight ratio: (1) 10 parts of polymer, 1 part of plasticizer, 2.5 parts of anti-sticking agent and 5 parts of pigment; the polymer is a copolymer mixed by methacrylic acid and ethyl acrylate copolymer in a mass ratio of 1: 1; the plasticizer is polyethylene glycol (6000); the anti-sticking agent is talcum powder; the pigment is prepared from the following components in percentage by mass: 1 titanium dioxide and iron oxide; (2) 10 parts of polymer, 2 parts of plasticizer, 4 parts of anti-sticking agent and 6 parts of pigment; the polymer is a copolymer mixed by methacrylic acid and methyl methacrylate in a mass ratio of 1: 1; the plasticizer is triethyl citrate; the anti-sticking agent is talcum powder; the pigment is prepared from the following components in percentage by mass: 1 titanium dioxide and iron oxide; (3) 10 parts of polymer, 2 parts of plasticizer, 4 parts of anti-sticking agent and 7 parts of pigment; the polymer is a copolymer mixed by methacrylic acid, methyl acrylate and methyl methacrylate in a mass ratio of 1:1:1, and the plasticizer is triethyl citrate; the anti-sticking agent is talcum powder; the pigment is prepared from the following components in percentage by mass: 1 titanium dioxide and iron oxide.
The invention also provides an application of the coating composition in coating perhexiline enteric-coated tablets, and the application method comprises the following steps: mixing the polymer, the plasticizer, the anti-sticking agent and the pigment according to the formula amount, adding the solution to prepare a coating solution, and coating the perhexiline tablet core by adopting the coating solution; the solution is water or ethanol water solution with volume concentration of 95 percent; the ratio of the solution to the total amount of the coating composition is 0.8-15:1, wherein the ratio of water to the total amount of the coating composition is 0.8-2:1, and the ratio of the 95% ethanol aqueous solution with volume concentration to the total amount of the coating composition is 7-15: 1.
Further, the perhexiline tablet core is prepared from salvia miltiorrhiza decoction pieces and ligusticum wallichii decoction pieces in a mass ratio of 1: 1-9, and the specific method comprises the following steps:
(1) mixing salvia miltiorrhiza decoction pieces and ligusticum wallichii decoction pieces according to a mass ratio of 1: 1-9, adding 6-12 times of water of the total raw materials, extracting at 90-100 ℃, and concentrating the extracting solution at 40-70 ℃ to obtain a concentrated solution with the density of 1.20-1.30; taking the concentrated solution, adding industrial alcohol with the ethanol content of 90-98 percent to carry out alcohol precipitation so that the alcohol content of alcohol precipitation supernatant reaches 70-80 percent; concentrating the supernatant at 40-70 ℃ to obtain an extract with the density of 1.25-1.35;
(2) adding the extract obtained in the step (1) into pharmaceutic adjuvant to granulate to obtain granules, and tabletting the granules to obtain a tablet core; the pharmaceutical auxiliary materials comprise a diluent, a disintegrating agent and a lubricant, wherein the mass of the diluent is 10-30% of that of the tablet core, the mass of the disintegrating agent is 5-15% of that of the tablet core, and the mass of the lubricant is 0.5-1.5% of that of the tablet core; the diluent is one or a mixture of calcium sulfate, calcium hydrophosphate or starch; the disintegrant is one or more of crospovidone, croscarmellose sodium or sodium carboxymethyl starch; the lubricant is one or more of silicon dioxide, magnesium stearate or talcum powder.
Furthermore, the mass ratio of the salvia miltiorrhiza decoction pieces to the ligusticum wallichii decoction pieces in the step (1) is 1: 1.
Further, the extraction times in the step (2) are 3 times, the first time is to add 8 times of the total raw materials for water extraction for 2 hours, and the second time and the third time are to add 6 times of the total raw materials for water extraction for 1.5 hours; concentrating the extracting solution and concentrating the supernatant under reduced pressure at 50-60 ℃; the alcohol content of the alcohol precipitation supernatant was 75%.
Further, in the step (3), the diluent is calcium sulfate; the disintegrating agent is one or a mixture of two of crospovidone and croscarmellose sodium in a mass ratio of 1: 2; the lubricant is one or a mixture of two of silicon dioxide and magnesium stearate in a mass ratio of 1-2: 1.
Compared with the prior art, the invention has the following beneficial effects: according to a disintegration time limit inspection method in the fourth department of Chinese pharmacopoeia, the perhexiline enteric-coated tablet prepared by the coating composition is inspected in a hydrochloric acid solution for 2 hours, and has no crack, disintegration or softening phenomena, namely, the perhexiline enteric-coated tablet does not disintegrate under the condition of human gastric juice and the retention time period of the perhexiline enteric-coated tablet in the stomach; when the tablets are checked in phosphate buffer (pH6.8), the tablets are totally disintegrated within 20 minutes, which indicates that the perhexiline enteric-coated tablets can be rapidly disintegrated and released in the intestinal tract and take effect. And the perhexiline enteric-coated tablets can be released at different parts of the intestinal tract according to the use of different types of enteric-coated polymer materials, and for some patients with stomach diseases or sensitive stomach, the perhexiline enteric-coated tablets can avoid adverse reactions of stomach discomfort or pain caused by the disintegration and dissolution of common film-coated tablets in the stomach, bring a better medicine selection for the patients and meet the medicine requirements of the patients.
(IV) detailed description of the preferred embodiments
The invention will be further described with reference to specific examples, but the scope of the invention is not limited thereto:
the salvia miltiorrhiza decoction pieces and the ligusticum wallichii decoction pieces are purchased from Shanghai medicinal material limited company.
Example 1:
(1) preparing a tablet core: extracting Saviae Miltiorrhizae radix decoction pieces and rhizoma Ligustici Chuanxiong decoction pieces with water at 100 deg.C for 3 times, adding 8 times of total amount of the raw materials for the first time, extracting for 2 hr, adding 6 times of total amount of the raw materials for the second and third times, extracting for 1.5 hr, mixing extractive solutions, and concentrating under reduced pressure at 60 deg.C to obtain concentrated solution with density of 1.22; adding industrial alcohol with 95% ethanol content into the concentrated solution, precipitating with ethanol to make the ethanol content of the supernatant reach 75%, and concentrating the supernatant at 60 deg.C under reduced pressure to obtain extract with density of 1.30; and (3) adding 468g of calcium sulfate and 240g of crospovidone into 4000g of the extract, performing one-step granulation and drying by using a fluidized bed to obtain granules, adding 120g of crospovidone, 36g of magnesium stearate and 105g of calcium sulfate, fully and uniformly mixing, and tabletting to obtain 10000 tablets (specification: 0.36g of each tablet).
(2) Coating liquid: 180g of methacrylic acid and ethyl acrylate (mass ratio is 1:1) copolymer, 18g of polyethylene glycol (6000), 45g of talcum powder, 90g of titanium dioxide and ferric oxide mixture according to the mass ratio is added into 2667g of 95% ethanol aqueous solution, and the mixture is uniformly mixed to prepare 3000g of organic coating solution.
And coating the tablet core with an enteric coating layer by taking the organic coating solution, wherein the weight gain of the enteric coating is 9.25 percent of the mass of the tablet core. The medicine releasing part is duodenum and lower intestinal tract.
(3) Checking disintegration time limit: according to a disintegration time limit inspection method in the four parts of Chinese pharmacopoeia, the phenomena of cracking, disintegration or softening do not occur after 2 hours of inspection in a hydrochloric acid solution; examination was carried out in a phosphate buffer (pH6.8) and the total disintegration was carried out within 15 minutes.
Example 2:
(1) preparing a tablet core: extracting Saviae Miltiorrhizae radix decoction pieces and rhizoma Ligustici Chuanxiong decoction pieces with water at 90 deg.C for 3 times, adding 8 times of total amount of the raw materials for the first time, extracting for 2 hr, adding 6 times of total amount of the raw materials for the second and third times, extracting for 1.5 hr, mixing extractive solutions, and concentrating under reduced pressure at 60 deg.C to obtain concentrated solution with density of 1.23; adding industrial alcohol with 95% ethanol content into the concentrated solution, precipitating with ethanol to make the ethanol content of the supernatant reach 75%, and concentrating the supernatant at 60 deg.C under reduced pressure to obtain extract with density of 1.30; and (3) adding 468g of calcium sulfate and 240g of croscarmellose sodium into 4000g of the extract, performing one-step granulation and drying by using a fluidized bed to obtain granules, adding 120g of croscarmellose sodium, 18g of silicon dioxide, 18g of magnesium stearate and 95g of calcium sulfate, fully and uniformly mixing, and tabletting to obtain 10000 tablets (specification: 0.36g of each tablet).
(2) Coating liquid: 180g of methacrylic acid and methyl methacrylate (mass ratio is 1:1) copolymer, 36g of triethyl citrate, 72g of talcum powder, 72g of titanium dioxide and 36g of ferric oxide are taken, 604g of purified water is added, and the mixture is uniformly mixed to prepare 1000g of aqueous dispersion coating liquid.
And coating the tablet core with an enteric coating layer by taking the aqueous dispersion coating solution, wherein the weight of the enteric coating is 11 percent of the mass of the tablet core. The drug release parts are jejunum and ileum.
(3) Checking disintegration time limit: according to a disintegration time limit inspection method in the four parts of Chinese pharmacopoeia, the phenomena of cracking, disintegration or softening do not occur after 2 hours of inspection in a hydrochloric acid solution; examination was carried out in a phosphate buffer (pH6.8) and the total disintegration was carried out within 20 minutes.
Example 3:
(1) preparing a tablet core: extracting Saviae Miltiorrhizae radix decoction pieces and rhizoma Ligustici Chuanxiong decoction pieces 8.89kg respectively with water at 100 deg.C for 3 times, adding 8 times of total amount of the raw materials for the first time, extracting for 2 hr, adding 6 times of total amount of the raw materials for the second and third times, extracting for 1.5 hr, mixing extractive solutions, and concentrating under reduced pressure at 60 deg.C to obtain concentrated solution with density of 1.25; adding industrial alcohol with 93% ethanol content into the concentrated solution, precipitating with ethanol until the ethanol content of the supernatant reaches 75%, and concentrating the supernatant at 60 deg.C under reduced pressure to obtain extract with density of 1.30; and adding 468g of calcium bicarbonate and 240g of croscarmellose sodium into 4000g of the extract, performing fluidized bed one-step granulation and drying to obtain granules, adding 120g of crospovidone, 36g of silicon dioxide, 18g of magnesium stearate and 110g of calcium sulfate, fully and uniformly mixing, and tabletting to obtain 10000 tablets (specification: 0.36g of each tablet).
(2) Coating liquid: 180g of methacrylic acid, methyl acrylate and methyl methacrylate (mass ratio is 1:1:1) copolymer, 36g of triethyl citrate, 72g of talcum powder, 84g of titanium dioxide and 42g of ferric oxide are added with 2568g of 95% ethanol aqueous solution and evenly mixed to prepare 3000g of organic coating solution.
And coating the tablet core with an enteric coating layer by taking the organic coating solution, wherein the weight gain of the enteric coating is 12 percent of the mass of the tablet core. The medicine releasing part is near colon.
(3) Checking disintegration time limit: according to a disintegration time limit inspection method in the four parts of Chinese pharmacopoeia, the phenomena of cracking, disintegration or softening do not occur after 2 hours of inspection in a hydrochloric acid solution; examination was carried out in a phosphate buffer (pH6.8) and the total disintegration was carried out within 20 minutes.
Claims (10)
1. A coating composition for preparing perhexiline enteric-coated tablets is characterized by comprising the following raw materials in parts by weight: 10 parts of polymer, 1-5 parts of plasticizer, 1-10 parts of anti-sticking agent and 1-10 parts of pigment; the polymer is a copolymer mixed by two or three of methacrylic acid, ethyl acrylate, methyl methacrylate or methyl acrylate in equal weight ratio; the plasticizer is triethyl citrate or polyethylene glycol 6000; the anti-sticking agent is talcum powder; the pigment is one of titanium dioxide or ferric oxide or a mixture of the titanium dioxide and the ferric oxide in a mass ratio of 2: 1.
2. The coating composition of claim 1, wherein said polymer is one of the following: (1) a copolymer in which methacrylic acid and ethyl acrylate are mixed in a mass ratio of 1: 1; (2) a copolymer in which methacrylic acid and methyl methacrylate are mixed in a mass ratio of 1: 1; (3) methacrylic acid, methyl acrylate and methyl methacrylate were mixed at a mass ratio of 1:1: 1.
3. The coating composition of claim 1, wherein the coating composition comprises the following raw materials in parts by weight: 10 parts of polymer, 1-2 parts of plasticizer, 2.5-5 parts of anti-sticking agent and 4-8 parts of pigment.
4. The coating composition of claim 1, wherein the coating composition comprises one of the following materials in parts by weight: (1) 10 parts of polymer, 1 part of plasticizer, 2.5 parts of anti-sticking agent and 5 parts of pigment; the polymer is a copolymer mixed by methacrylic acid and ethyl acrylate copolymer in a mass ratio of 1: 1; the plasticizer is polyethylene glycol 6000; the anti-sticking agent is talcum powder; the pigment is prepared from the following components in percentage by mass: 1 titanium dioxide and iron oxide; (2) 10 parts of polymer, 2 parts of plasticizer, 4 parts of anti-sticking agent and 6 parts of pigment; the polymer is a copolymer mixed by methacrylic acid and methyl methacrylate in a mass ratio of 1: 1; the plasticizer is triethyl citrate; the anti-sticking agent is talcum powder; the pigment is prepared from the following components in percentage by mass: 1 titanium dioxide and iron oxide; (3) 10 parts of polymer, 2 parts of plasticizer, 4 parts of anti-sticking agent and 7 parts of pigment; the polymer is a copolymer mixed by methacrylic acid, methyl acrylate and methyl methacrylate in a mass ratio of 1:1:1, and the plasticizer is triethyl citrate; the anti-sticking agent is talcum powder; the pigment is prepared from the following components in percentage by mass: 1 titanium dioxide and iron oxide.
5. Use of the coating composition of claim 1 in coated perhexiline enteric tablets.
6. The application according to claim 5, characterized in that the method of application is: mixing the polymer, the plasticizer, the anti-sticking agent and the pigment according to the formula amount, adding the solution to prepare a coating solution, and coating the perhexiline tablet core by adopting the coating solution; the solution is water or ethanol water solution with volume concentration of 95 percent; the ratio of the solution to the total amount of the coating composition is 0.8-15: 1.
7. The use according to claim 6, wherein the perhexiline core is prepared by a process comprising:
(1) mixing salvia miltiorrhiza decoction pieces and ligusticum wallichii decoction pieces according to a mass ratio of 1: 1-9, adding 6-12 times of water of the total raw materials, extracting at 90-100 ℃, and concentrating the extracting solution at 40-70 ℃ to obtain a concentrated solution with the density of 1.20-1.30; taking the concentrated solution, adding industrial alcohol with the ethanol content of 90-98 percent to carry out alcohol precipitation so that the alcohol content of alcohol precipitation supernatant reaches 70-80 percent; concentrating the supernatant at 40-70 ℃ to obtain an extract with the density of 1.25-1.35;
(2) adding the extract obtained in the step (1) into pharmaceutic adjuvant to granulate to obtain granules, and tabletting the granules to obtain a tablet core; the pharmaceutical auxiliary materials comprise a diluent, a disintegrating agent and a lubricant, wherein the mass of the diluent is 10-30% of that of the tablet core, the mass of the disintegrating agent is 5-15% of that of the tablet core, and the mass of the lubricant is 0.5-1.5% of that of the tablet core; the diluent is one or a mixture of calcium sulfate, calcium hydrophosphate or starch; the disintegrant is one or more of crospovidone, croscarmellose sodium or sodium carboxymethyl starch; the lubricant is one or more of silicon dioxide, magnesium stearate or talcum powder.
8. The use as claimed in claim 7, wherein the mass ratio of the salvia miltiorrhiza decoction pieces to the ligusticum wallichii decoction pieces in the step (1) is 1: 1.
9. The use as claimed in claim 7, wherein in step (2), the number of times of extraction is 3, the first time is 2 hours of water extraction with an amount of 8 times of the total raw materials, and the second and third times are 1.5 hours of water extraction with an amount of 6 times of the total raw materials; concentrating the extracting solution and concentrating the supernatant under reduced pressure at 50-60 ℃; the alcohol content of the alcohol precipitation supernatant was 75%.
10. The use of claim 7, wherein in step (3), the diluent is calcium sulfate; the disintegrating agent is one or a mixture of two of crospovidone and croscarmellose sodium in a mass ratio of 1: 2; the lubricant is one or a mixture of two of silicon dioxide and magnesium stearate in a mass ratio of 1-2: 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010165390.3A CN111228233A (en) | 2020-03-11 | 2020-03-11 | Coating composition for preparing perhexiline enteric-coated tablets and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010165390.3A CN111228233A (en) | 2020-03-11 | 2020-03-11 | Coating composition for preparing perhexiline enteric-coated tablets and application thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN111228233A true CN111228233A (en) | 2020-06-05 |
Family
ID=70876864
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010165390.3A Pending CN111228233A (en) | 2020-03-11 | 2020-03-11 | Coating composition for preparing perhexiline enteric-coated tablets and application thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN111228233A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100998648A (en) * | 2007-01-05 | 2007-07-18 | 北京汉典中西药研究开发中心 | Method for preparing compound red-rooted salvia enteric tablet |
| CN102920662A (en) * | 2011-08-08 | 2013-02-13 | 丽珠医药集团股份有限公司 | Famciclovir sustained-release pellet, preparation method and application thereof |
| CN103156814A (en) * | 2011-12-09 | 2013-06-19 | 四川科伦药物研究有限公司 | Azithromycin enteric composition and preparation method |
| CN104940168A (en) * | 2015-07-06 | 2015-09-30 | 合肥华方医药科技有限公司 | Dextrorotation lansoprazole diphasic spansule preparation and preparing method thereof |
-
2020
- 2020-03-11 CN CN202010165390.3A patent/CN111228233A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100998648A (en) * | 2007-01-05 | 2007-07-18 | 北京汉典中西药研究开发中心 | Method for preparing compound red-rooted salvia enteric tablet |
| CN102920662A (en) * | 2011-08-08 | 2013-02-13 | 丽珠医药集团股份有限公司 | Famciclovir sustained-release pellet, preparation method and application thereof |
| CN103156814A (en) * | 2011-12-09 | 2013-06-19 | 四川科伦药物研究有限公司 | Azithromycin enteric composition and preparation method |
| CN104940168A (en) * | 2015-07-06 | 2015-09-30 | 合肥华方医药科技有限公司 | Dextrorotation lansoprazole diphasic spansule preparation and preparing method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 张翠英: "丹参川芎对药及其组方冠心宁制剂治疗心脑血管疾病的研究进展", 《中成药》 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA2993183A1 (en) | Pridopidine base formulations and their use | |
| CN103301084B (en) | Berberine hydrochloride tablet and preparation method thereof | |
| CN103893246A (en) | General flavanone capsule of desmodium styracifolium and preparation method and application thereof | |
| CN101628002B (en) | Micronized composition containing Levonorgestrel | |
| CN109568284B (en) | Tenofovir alafenamide enteric-coated tablet and preparation method thereof | |
| CN112315934B (en) | Preparation process of pulsatilla saponin B4 enteric-coated tablet | |
| CN111228233A (en) | Coating composition for preparing perhexiline enteric-coated tablets and application thereof | |
| CN115531463B (en) | Traditional Chinese medicine for treating hyperlipidemia | |
| CN103908535A (en) | Enteric capsule containing andrographolide | |
| WO2021168930A1 (en) | Tablet of remdesivir and preparation method therefor | |
| CN100586446C (en) | Compound herba sophorae alopecuroide active region group and its colon location preparation | |
| CN114392249B (en) | Enteric-coated pellet and powder direct compression tablet of polysaccharide-iron compound | |
| CN101244068B (en) | Hemsleyadin sustained-release preparation | |
| CN103655585A (en) | Gastrodin controlled release preparation and preparation method thereof | |
| CN103301074B (en) | Diammonium glycyrrhizinate enteric-coated pellet as well as preparation method and preparation thereof | |
| CN103816466A (en) | Traditional Chinese medicine composition for treating chest stuffiness and pains as well as preparation and preparation method thereof | |
| CN101780094B (en) | Slow-release preparation of cucurbitacin | |
| CN116870120B (en) | Traditional Chinese medicine composition for treating hyperplasia of mammary glands and preparation method and application thereof | |
| WO2024140984A1 (en) | Controlled release tablet of loxoprofen sodium, preparation method, and use | |
| CN102824327A (en) | Medicinal composition of agomelatine-containing enteric-coated tablets | |
| CN107158095A (en) | Yellow enteric administration composition of one kind three and preparation method thereof | |
| CN105663063A (en) | Compound pellet of diammonium glycyrrhizinate and entecavir and preparation method of compound pellet | |
| CN100388922C (en) | Chinese medicinal preparation for treating sorethroat, aphtha and its preparation method | |
| CN101121014A (en) | Enteric coated traditional Chinese medicine preparation for intestine-stabling and anti-diarrheal | |
| CN102210755B (en) | Chinese medicinal composition as well as preparation and application thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20200605 |