CN101485643B

CN101485643B - Plant hollow capsule

Info

Publication number: CN101485643B
Application number: CN2009101162426A
Authority: CN
Inventors: 刘松林
Original assignee: 刘松林
Current assignee: Anhui Huangshan Capsule Co.,Ltd.
Priority date: 2009-02-25
Filing date: 2009-02-25
Publication date: 2012-01-11
Anticipated expiration: 2029-02-25
Also published as: CN101485643A

Abstract

The invention provides a vegetable hollow capsule, which is prepared by taking cellulose ether as a raw material. The hollow capsule is characterized by comprising the following components in percentage by weight: 80 to 90 percent of carboxymethyl cellulose, 1.5 to 10 percent of curing agent and 1.5 to 10 percent of coagulant aid, wherein the curing agent is selected from one or mixed glue of more than two of vegetable glue, or microbial glue or seaweed glue; and the coagulant aid is selected from potassium citrate or sodium citrate and the like. Just like the gelatin hollow capsule, the preparation of the vegetable hollow capsule also comprises the preparation of glue materials and the processing of capsule shell, and the processing equipment of the gelatin hollow capsule is also used. The capsule has the advantages of bright surface gloss, good fluency, and high rate of capsule filling; moreover, the indexes such as disintegration time limit, friability at different temperatures and the like, meet national standards of the gelatin hollow capsule.

Description

A kind of plant hollow capsule

One, technical field

The present invention relates to the adjuvant that a kind of pharmaceutical preparation is used, specifically a kind of plant hollow capsule with carboxymethyl cellulose processing.

Two, background technology

Capsules is the main adjuvant of processing medicament capsule preparation.The Capsules that uses is at present processed by gelatin mostly.Glue after gelatin elder generation water logging bubble, the swelling, after send the capsule manufacture line to obtain Capsules (softgel shell) through dipping in operations such as gum forming, dry solidification, cooling, cutting.Described glue is exactly the gelatin after the swelling to be dropped into to heat up in the mixing kettle with water, surfactant etc. stir, and after filtering, remove bubble, transferring proportion, obtains sizing material.

The water soluble protein that gelatin is obtained through hydrolysis by the collagen protein in the connective tissues such as the skin of animal, bone, tendon, ligament.Protein is subject to the influence of acid, alkali, and medicated powder acidity or alkalescence that Ruo Qinei fills are stronger, and practice shows; In storage process, although also in the shelf-life, the quality of capsule also seriously descends; Such as sclerosis, embrittlement, easy disintegrating not, serious only remaining a pile powder.In addition, because of the religions belief reason, take like taboos such as Islam, kosher; Epidemic situations such as " bovine spongiform encephalopathy " that occurs in recent years, " foot and mouth disease " again serious impact gelatine capsule agent market.Other feedstock production capsules that exploitation substitutes gelatin have realistic meaning.So have human hydroxypropyl emthylcellulose (HPMC) and polysaccharide to prepare Capsules.But more capsular physicochemical properties of this type such as low temperature friability, not anti-temperature storage etc. still can not be satisfactory more than 30 ℃.

Gelatin is taken from animal, and cellulose ether and polysaccharide for being different from the gelatin Capsules, claim to use the Capsules of cellulose ether and polysaccharide processing to be plant hollow capsule from plant.

Three, summary of the invention

The present invention aims to provide the new plant hollow capsule that a kind of each item physicochemical property all meets the pharmacopeia regulation, and technical problem to be solved is to select suitable cellulose ether composition.

Cellulose ether is be raw material with the native cellulose through chemistry change a social system one type of molding high molecular weight water soluble polymer that narrows, principal item has ion-type such as carboxymethyl cellulose, sulfonic acid ethyl cellulose and nonionic such as methylcellulose (CM), hydroxyethyl-cellulose (HEC) etc.The applicant is through the condition test of system, and in the cellulose ether series of products, choosing carboxymethyl cellulose (CMC) is raw material, and is aided with firming agent and flocculation aid processing plant hollow capsule, and each component has following percentage by weight:

CMC:80～96%, firming agent: 1.5～10%, flocculation aid: 1.5～10%.

Described firming agent is selected from plant gum, like arabic gum or sesbania gum or carrageenan or pectin, and perhaps microbiological gum, like gellan gum or xanthan gum, perhaps one or more epoxy glues in alginate jelly or the agar etc.Preferred carrageenan is or/and arabic gum or/and xanthan gum etc.

Described flocculation aid is selected from potassium citrate or sodium citrate or potassium chloride or calcium chloride.Optimization citric acid acid potassium.

CMC is commonly used to be the anionic cellulose ether for sodium salt, is generated by alkali fiber (native cellulose and finite concentration NaOH solution effects generate) and the reaction of etherifying agent sodium chloroacetate.In the preparation process, can obtain the CMC of different molecular weight, the molecular weight difference only influences the viscosity of CMC solution, and experiment shows that the CMC of different molecular weight all can be used to prepare Capsules.

CMC, firming agent and flocculation aid are the key components of this plant hollow capsule, and be the same with processing gelatin Capsules in addition, also can add food coloring according to actual needs or/and opacifier titanium dioxide etc.

The preparation of this Capsules also comprises the preparation of sizing material and the processing of softgel shell.CMC and water dropped into heated and stirred dissolving back adds firming agent and flocculation aid in the mixing kettle, the after-filtration that stirs, remove bubble, transfer proportion (being CMC concentration), send capsule manufacture line processing softgel shell then.

This Capsules appearance surfaces is glossy, and fluency is good, and probability is high on the capsule shells filling medicated powder, and the user uses percent defective low.And HPMC plant hollow capsule and polysaccharide vegetable Capsules appearance surfaces are lackluster, and fluency is poor, and probability is low on the capsule shells filling medicated powder, and percent defective is high, and particularly HPMC plant hollow capsule surface is poorer.

" 2 000 editions regulation Capsuleses of Chinese pharmacopoeia disintegration time is 10 minutes, and this capsule only needs 6 minutes, and other two plant capsules generally all need 10-15 minute.

Insulation is 4 hours under the different temperatures.Observe the viscosity degradation percentage rate, the comparative test result sees table 1.

Table 1:

	45℃	50℃-60℃	70℃-80℃
				The CMC plant hollow capsule	0	0	1％
Capsules	Expand and do not dissolve	2％	5％
				The HPMC plant hollow capsule	0	8％	100％
The polysaccharide vegetable Capsules	0	10％	25％

The leftover bits and pieces or the waste product that produce in this explanation CMC production process; Quality does not descend; Can reclaim use repeatedly again, product cost is just low, and other three kinds recovery service property (quality)s are poor; The leftover bits and pieces or the waste product that resemble the HPMC plant hollow capsule just can not reclaim, and this has just improved the cost of product undoubtedly.

Under the different temperatures, preserved three months, the comparative test result sees table 2.

Table 2:

Friability is by " 2 00 editions two Capsules standard operations of Chinese pharmacopoeia; 50 capsules detect with 20 gram counterweights; Crisp broken capsule does not allow to exceed 15; From these four kinds of capsules of result 15--25 ℃ can both be qualified, but CMC plant hollow capsule advantage is more obvious under low temperature and hot conditions.And Capsules is in that " Chinese pharmacopoeia 2 000 editions is clear and definite regulation just, must store (below 20 ℃) in the cool, and the capsule of these other two kinds of explanation requires relatively harshness on temperature.

Four, the specific embodiment

Below the present invention is described in further detail, and provide the specific embodiment.

Embodiment 1, get low viscosity CMC30kg, carrageenan 3kg, potassium citrate 3kg, water 64kg.

Production equipment is identical with former useful manufacturing of gelatin Capsules.Pour CMC and water into reaction pot heated and stirred, dissolving, add firming agent and flocculation aid again, 60 ℃-90 ℃ of the recirculated water water temperatures of reaction pot; Stirred 2-4 hour, fully glue is filtered with 200 purpose filter bags in the dissolving back, and glue is stored in the heat-preserving container; See proportion, regulate gelatin concentration, according to user's demand versicolor food coloring that difference adds; With add a certain amount of opacifier titanium dioxide etc.; Leave standstill insulation and remove bubble again, put into again on the capsule manufacture line, need lettering lettering etc. behind fit through dipping in glue, oven dry, cooling, the demoulding, cutting, fit, check, packing.

Embodiment 2, get medium viscosity (FM ₆) CMC25kg, arabic gum 1.5kg, carrageenan 1kg, potassium citrate 2.5kg, water 70kg.Also can be according to user's demand difference with adding versicolor food coloring and a certain amount of opacifier titanium dioxide etc.Its production method is with embodiment 1.

Embodiment 3, get high viscosity (FH ₆) CMC20kg, xanthan gum 1.5kg, carrageenan 0.5kg, potassium citrate 2kg, water 76kg.Also can be according to user's demand difference adds versicolor food coloring and a certain amount of opacifier titanium dioxide etc.Its production method is with embodiment 1.

Embodiment 4, get extra-high-speed viscosity CMC15kg, carrageenan 1.5kg, potassium citrate 1.5kg, water 82kg also can add versicolor food coloring and a certain amount of opacifier titanium dioxide etc. according to user's demand difference.Its production method is with embodiment 1.

Claims

1. plant hollow capsule; Be to be the Capsules of feedstock production by cellulose ether; It is characterized in that: each component has following percentage by weight: carboxymethyl cellulose 80～90%; Firming agent 1.5～10%, flocculation aid potassium citrate 1.5～10%, described firming agent be selected from carrageenan or/and arabic gum or/and xanthan gum.