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Production technology of gelatin hard empty capsule

A technology of hollow capsules and production process, which is applied in the direction of capsule transportation, medical preparations of non-active ingredients, inorganic non-effective ingredients, etc. It can solve the problems of low-temperature brittleness, low drying efficiency of dipping glue, and many production processes, etc., and achieve good results. Workability and viscosity, good biodegradability, and the effect of avoiding low temperature embrittlement

Active Publication Date: 2019-12-06
上海东海制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are still the following problems: 1) there are many production processes, and the drying efficiency of dipping in glue is low, and the prepared capsules are difficult to have both high and low temperature resistance and antibacterial properties, and are not suitable for large-scale industrial production; 2) gelatin as a basic material is hydrophilic Better, low viscosity, easy to hang glue when dipping in glue, low yield, prone to low-temperature brittle cracking and high-temperature sticky softening when prepared into finished capsules; 3) The dipping and drying processes cannot be synchronized by processing equipment It leads to low efficiency of dipping and drying, which slows down the processing efficiency of the whole process; and there is waste of glue when dipping glue, which increases the cost of glue preparation

Method used

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  • Production technology of gelatin hard empty capsule
  • Production technology of gelatin hard empty capsule
  • Production technology of gelatin hard empty capsule

Examples

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Effect test

Embodiment 1

[0035] refer to Figure 1-4 As shown, the present embodiment provides a kind of production technology of gelatin hard hollow capsule, comprises the following steps:

[0036] S1. Gelatin modification: In parts by weight, weigh 4 parts of gelatin, add 45 parts of deionized water, stir and heat up to 60°C, keep warm and stir until the gelatin is completely dissolved, and filter and decolorize with activated carbon to obtain a gelatin solution; take 14 parts of phenylalanine Add 2wt% hydrochloric acid solution, heat at 38°C for 25min to obtain the hydrochloric acid solution of phenylalanine; add 10.8mL of 6wt% carbodiimide aqueous solution to the gelatin solution, stir evenly at room temperature, slowly add Hydrochloric acid solution 75mL, continue to stir for 26min to obtain the cross-linked reactant; pour the cross-linked reactant into a plastic mold, keep the thickness of the formed liquid layer less than 1cm, and dry aseptically at 45°C for 22 hours to obtain the crude modifie...

Embodiment 2

[0045] refer to Figure 1-4 As shown, the present embodiment provides a kind of production technology of gelatin hard hollow capsule, comprises the following steps:

[0046] S1. Gelatin modification: in parts by weight, weigh 5 parts of gelatin, add 55 parts of deionized water, stir and heat up to 62°C, heat and stir until the gelatin is completely dissolved, and filter and decolorize with activated carbon to obtain a gelatin solution; take phenylalanine 18 part, add 2wt% hydrochloric acid solution, heat at 40°C for 25min to obtain the hydrochloric acid solution of phenylalanine; Hydrochloric acid solution 76mL, continue to stir for 25min to obtain the cross-linked reactant; pour the cross-linked reactant into a plastic mold, keep the thickness of the formed liquid layer less than 1cm, and dry aseptically at 43°C for 23 hours to obtain the crude modified gelatin; Grinding, ball milling and aseptic drying to obtain the modified gelatin compound.

[0047] The crude modified ge...

Embodiment 3

[0055] refer to Figure 1-4 As shown, the present embodiment provides a kind of production technology of gelatin hard hollow capsule, comprises the following steps:

[0056] S1. Gelatin modification: in parts by weight, weigh 6 parts of gelatin, add 55 parts of deionized water, stir and heat up to 61°C, heat and stir until the gelatin is completely dissolved, and filter and decolorize with activated carbon to obtain a gelatin solution; take phenylalanine 17 Add 2wt% hydrochloric acid solution, heat at 40°C for 25min to obtain the hydrochloric acid solution of phenylalanine; add 12mL of 6wt% carbodiimide aqueous solution to the gelatin solution, stir evenly at room temperature, slowly add the hydrochloric acid of phenylalanine Solution 80mL, continue to stir for 30min to obtain the cross-linked reactant; pour the cross-linked reactant into a plastic mold, keep the thickness of the formed liquid layer less than 1cm, and dry aseptically at 45°C for 24 hours to obtain the crude mo...

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Abstract

The invention discloses a production technology of a gelatin hard empty capsule. The production technology comprises the processes of gelatin modification, dispersion preparation, gelatin dissolution,gelatin dipping and drying, and after-treatment; as for gelatin modification, phenylalanine and gelatin are modified under the effect of a cross-linking agent, and then crushing, ball milling and sterile drying are conducted to obtain a modified gelatin compound; raw materials of a dispersion are obtained through polyethylene glycol, tween-80 and nanometer titania in a ultrasonic dispersion mode,the cavitation effect of ultrasonic waves enables particulates to be impacted violently, the effects of emulsifying homogeneity and removing tiny bubbles are achieved, the water consumption is decreased, and meanwhile, the antibacterial ability of the capsule is improved through the nanometer titania; and after-treatment comprises the steps of capsule billet shell pulling, cutting and arrangement. Raw materials adopted by the production technology are safe and free of toxicity, compared with the prior art, the production technology is more simplified, the gelatin dipping and drying efficiencyis high, the prepared capsule has good resistance to high and low temperatures and the good antibacterial property, and the production technology is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical excipients, in particular to a production process of gelatin hard hollow capsules. Background technique [0002] According to the records of Chinese Pharmacopoeia 2015 Edition IV - Pharmaceutical Excipients, gelatin hollow capsules are hollow hard capsules made of gelatin plus excipients. In terms of properties, this product is in the shape of a cylinder, which is a hard and elastic hollow capsule composed of a cap and a body that can be fitted and locked. The capsule body should be clean, uniform in color, smooth incision, free of deformation and odor. There are three types of this product: transparent (no opacifying agent in both sections), translucent (only one section contains opacifying agent), and opaque (both sections contain opacifying agent). [0003] The existing production process of gelatin hollow capsules is roughly composed of the following processes: sol of medicinal gelati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/42A61K47/18A61K47/10A61K47/26A61K47/02A61J3/07
CPCA61J3/077A61K9/4816A61K9/4825A61K9/4883A61K47/02A61K47/10A61K47/18A61K47/183A61K47/26
Inventor 李煜龙陈贵浩许锐鹏李灼
Owner 上海东海制药股份有限公司
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