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'Huachan'essence coated micropills and its preparation process

A technology of coating micropills and cinobufagin, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve problems such as difficult storage, transportation, prone to allergic reactions, and large vascular irritation. Achieve the effect of overcoming local irritation, good drug stability, and fast absorption

Active Publication Date: 2008-12-10
广东同德药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The types of cinobufacin preparations that have been marketed in China include tablets, oral liquids and injections, but the above-mentioned preparations all have shortcomings and deficiencies in varying degrees
Cinobufagin enteric-coated tablets are easily affected by food and gastrointestinal transit speed, with long disintegration time, slow absorption and low bioavailability
Cinobufacin injection belongs to invasive drug administration, which is inconvenient for patients to use, highly irritating to blood vessels and prone to allergic reactions; it is also difficult to store and transport
Cinobufacin Oral Liquid has a bitter taste, poor taste, difficult for patients to take, high production cost, poor stability, short storage period, and inconvenient transportation and storage

Method used

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  • 'Huachan'essence coated micropills and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Enteric-coated pellet prescription (feeding amount of 200 capsules):

[0035] Cinochansu extract powder 45g

[0036] Dextrin 40g

[0037] water 5g

[0038] Coating solution: prepare the following components into 100ml ethanol solution

[0039] Hydroxypropylmethylcellulose Phthalate HPMCP 6g Triethyl Citrate 0.6g

[0040] Titanium dioxide 0.49g

[0041] After the above three components were mixed uniformly, 70% ethanol was added to prepare 100 ml of coating solution.

[0042] Preparation process: mix cinobufacin extract powder and diluent dextrin evenly; make a soft material from the mixture of binder water, cinobufacafin extract powder and dextrin, put it in an extruder, and extrude it into a cylinder The strip-shaped extrudate is then placed in a spheronizer, spheronized into pellets, placed in a fluidized bed, dried at a temperature of 50°C for 0.5 hours, and then sprayed with a coating solution to obtain a coating Pellets, dried and filled in empty capsules. T...

Embodiment 2

[0044] Enteric-coated pellet prescription (feeding amount of 200 capsules):

[0045] Cinobufacin 40g

[0046] Mannitol: lactose (1:1 weight ratio) mixture 40g

[0047] Hypromellose 0.6g

[0048] Coating solution: prepare the following components into 100ml ethanol solution

[0049] Hydroxypropyl Methyl Cellulose Acetate Succinate HPMCAS 4g

[0050]Triethyl citrate 0.4g

[0051] Talc powder 3g

[0052] After the above three components were mixed uniformly, 65% ethanol was added to prepare 100 ml of coating solution.

[0053] Preparation process: After mixing the cinobufacin extract powder, mannitol and lactose evenly, the binder hydroxypropyl methylcellulose is prepared into a 10% by weight aqueous solution and cinobufacin extract powder, mannitol and lactose The mixture is made of soft material, granulated through 18 sieves, placed in a coating pan, spheronized into pellets, dried with hot air at a temperature of 40°C for 4 hours, and then sprayed with coating solution t...

Embodiment 3

[0055] Enteric-coated pellet prescription (feeding amount of 200 capsules):

[0056] Cinobufacin 42g

[0057] Powdered sugar: starch (1:2 weight ratio) mixture 32g

[0058] Methylcellulose 0.8g

[0059] Coating solution: prepare the following components into 100ml ethanol solution

[0060] Acrylic L100 5g

[0061] Triglyceryl acetate 0.5g

[0062] Magnesium Stearate 2g

[0063] After the above three components were mixed uniformly, 85% ethanol was added to prepare 100 ml of coating solution.

[0064] Preparation process: After mixing the cinobufacin extract powder, sugar powder and starch evenly, the binder methyl cellulose is prepared into an aqueous solution with a weight percentage of 10% and cinobufacin extract powder, sugar powder and starch The soft material made from the mixture is granulated through a 15-mesh sieve, placed in a coating pan, spheronized into pellets, dried with hot air at a temperature of 60°C for 0.5 hours, and then sprayed with a coating solutio...

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Abstract

The invention relates to Cinobufotalin coated pellets for treating tumor and hepatitis B, which comprises Cinobufotalin concrete powder, diluent, bonding agent and coating liquid, wherein the coating liquid is the alcoholic solution of mixture of coating material, plasticizing agent, screening agent or antisticking agent. The invention also discloses the preparing process.

Description

technical field [0001] The invention relates to a coated pellet, in particular to a cinobufacin coated pellet for treating tumors and hepatitis B and a preparation method thereof. Background technique [0002] Toad is a traditional Chinese medicinal material in my country. According to the "Compendium of Materia Medica", toad has a pungent and cool smell and is slightly poisonous. It has the effects of reducing fever, removing dampness, and killing insects. Cinobufacin is an extract of the whole dry skin of Bufo bufo, mainly containing indole alkaloids, which has the functions of clearing away heat and detoxification, relieving pain, diuresis and swelling, removing blood stasis and ulcerating firmness. Modern pharmacological studies have confirmed that cinobufacin has various pharmacological effects such as anti-tumor, immune promotion and anti-viral effects. [0003] Malignant tumors and hepatitis B are high incidences in today's society and seriously threaten human health...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/32A61K35/56A61P35/00A61P31/20A61P1/16A61K35/65
Inventor 谷福根夏敏
Owner 广东同德药业有限公司
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