GB2210790A

GB2210790A - Two-layer enteric coated pellet

Info

Publication number: GB2210790A
Application number: GB8820169A
Authority: GB
Inventors: Liang Dongkang; He Zhenning; Peng Deguang; Lou Weimin
Original assignee: CHEN LI JI CHINESE MEDICINE PH
Current assignee: CHEN LI JI CHINESE MEDICINE PH
Priority date: 1987-09-05
Filing date: 1988-08-25
Publication date: 1989-06-21
Also published as: CN87106202A; GB8820169D0; CN1003978B

Abstract

A tablet or pellet contains a herbal medicine and is formed with an inner layer of herbal composition coated with enteric material soluble in the intestine, and an outer layer of a herbal composition in a gastric-soluble binder, for immediate release.

Description

Two-layer coated pellet and a process for awaking the sane We , Chen LI Jl Chinese medicine Pharuaceutlcal Factory, Guangzhou, of No.194, Belling Road, Gantzhou, China, a pharnaceutical enterprise organized under the Laws of China , do hereby declare the Invention , for which we pray that a patent nay be granted to us , and the aethod by which it is to be perforned, to be particularly described in and by the following statement:: This invention relates to a pellet forn according to traditional recipe of Chinese medicine with its technological Process , particularly to the twolayer coated pellet that dissolves separately in stomach and Intestine and a process for awaking the sane.

Conventional Chtnese recipe pellets ( vater-honey pellets ) include the following processes : choosing ingredients in accordance with prescription, drying. grinding and mixing all drug powders, narking pellets by aixing medical powders with refined honey , finally obtaining pellets with no layer but being coated with charcoal powder. The pellets nade in such a way are disintergrated and dissolved in stomach after oral aduinistration. All coaponents , whether active or inactive or even irritable to stonach , act on stomach initially and then are absorbed. Theoretically , to cure diseases with herbal aedicine i.e., alleviating the syiptois and eradiating primary causes , the site on which the Chinese herbal medicine acts should be considered In addition to correct prescription.Certain drugs are dissolved and absorbed in stomach , while others are In intestine for effective treatment of diseases.

Previously , pellets were prepared In two different types , one is of gastric solubility and the other Is of enteric solubility. This causes repeated processes and incoveniences to patients because they have to take two kinds of pellets for the sane disease.

To overcome the setback as mentioned above , an improvement has been made on the basis of conventional theoretical Chinese iedlcine. A portion of medicinal material is dissolved and absorbed in stomach and another portion is dissolved and absorbed In intestine. Thus the effects of drugs have been improved and side effect reduced.

This invention is a modified Chinese prescription of pellets which has two portions , the inner one and outer one. The inner part is coated with material soluble in intestine , while the outer part is coated with edible binding agent.

The process of this invention is as follows : Crude medicinal materials are divided into two parts according to the sites of their action as defined by the theory of Chinese herbal medicine. One part soluble in stomach Is used as outer layer drug , the other part soluble in intestine is used as inner layer drug. Two parts of the raw material are ground into fine powder, filtered, and well mixed respectively. Refined honey or water is added to inner drug powder to make inner pellet , which is coated with material soluble in intestine and then packaged with outer layer drug powder by edible binding agent.In order to make pellets look fine , taste good, and to be damp-proof, antiseptic , and protective against insects during preservation , routine coating methods for such pellets are used , such as charcoal coating , drying , and polishing to final products. Two layer can be seen on the cross-section of pellet. The outer layer can be stripped.

The schematic diagram 1 indicates the process of two-layer coated oral pellets.

Referring to the diagram 1 , the crude materials , after pretreatments such as purifying , cleaning , slicing , and drying are divided into inner layer drug soluble in intestine and the outer layer drug soluble in stomach. The latter is ground into fine powder , filtered , well mixed ; and sterilized for later use. The inner layer drug goes through the same process and is made into the inner pellet by mixing inner layer drug powder with a certain amount of water and refined honey. After drying , the inner pellet Is suRar-coated with basal powder layer and then with material soluble In intestine until approaching to a certain criterion.

Material soluble in intestine used in such processe includes mixed liquid of lac , cellulose acetate phthalate (CAP), sodium-carboxymethyl cellulose (ChC- Na), acrylic resin etc..

Then , pellets soluble in intestine are put into sugar-coating machine, packaged witii outer layer drug powder by edible binding agent such as gelatinsyrup , refined hoe and water. To keep a good appearance and polishing, conventional Chinese pellets are usually coated ith activated carbon or talc powder , red haltoysite , and Tie Hei ( iron black ). After drying again , the pellets are put into pan for polishing until their surfaces become polished homogeneouly. After being tested for quality , the pellets are packaged according to dosages.

Pellets prepared according to Chinese recipe and processed as described above have following advantages : soluble in stomach and intestine separately, Improved theraputic effects , convenient to use for patients , and siapler process of production.

Exemplified prescription: Technological process of pellet for Invigorating the spleen and replenishing gut.

1. The following ingredients (percentage by weight ) after being ground into fine powder , filtered , well mixed , sterilized and cooled are to be used as outer layer powder.

Astragalus root 4-1296 Pilose asiabell root 4-15% White Peony Root 7-17% Amomum fruit 1-7 - Chinese angelica root Blghead atractylodes rhizoma 5-12% Cinnaaon Park 1-7 *6 2. The following ingredients (perentage by weight ) after being processed as aentioned aboveare made into inner pellets by adding a certain amount of refined honey and water and have them well dried up.

Rhizoma Corydalis 5-13 * Litechi seed 5-10 % N Dried ginger 1-4 % Liquorice 5-12 9f Ledeboriella root 2-7 at; Aucklandia root 2-6 % Psoralea fruit 1-6 tis Red halloysite 7-17 % 3. Inner pellets are put into sugar-coating machine. Gelatin-syrup and basal powder are used for basal powder layer , and mixed liquid of lac and certain amount of talc powder are used for the layer soluble in intestine to.aeet requlreaents of the Public Health Office.

4. Pellets soluble In intestine are put into sugar-coating machine and packaged with defined anount of outer layer powder by binding agent which is composed of appropriate amount of refined honey and water.

5. Activated carbon is used as coating. After drying, pellets are put into pan for polishing until they become pollshed homogeneously.

Pharmaceutical , toxicological and clinical tests have shown that pellets only applied in such a way for inviorating the spleen and replenishing gut have an effective rate of 97.596 compared with two kind of pellets with the sane ingredients as mentioned above produced separately by conventional method, which have an effective rate of less than ae in treatment of chronic colitis and ulcerative colitis. Fibro-colonoscopy was done before and after treataent.

Short- terr cure rate is over 40 %. No side effects are observed. Theraputic effects are-confireed. It is an ideal drug of choice for treatment of chronic and ulcerative colitis.

Claims

1. A pellet made with herbal aedicine based on Chinese recipe, wherein that it has two layers , the inner layer and the outer layer , the forser is coated with material soluble in Intestine , then packaged with outer layer drug soluble in stomach by edible binding agent,

2. A pellet as claimed in claim 1 wherein that ingredients of inner layer drug (% by weight) comprise: Rhinzoma Corydal is 5-13 % Litchi seed Dried ginger 1-4 %6 Liquorice 5-12 % Ledebouriella root 2-7 %6 Aucklandia root 2-6 % Psoralea fruit 1-6 % Red halloysite 7-17 %

3.A pellet as claimed in claim 1 and 2 , wherein that ingredients of outer layer drug (% by weight) comprise: Astragalus root 4-12 % Pilose asiabell root 4-15 % White Peony Root 7-17g6 Anonum fruit 1-7 % Chinese angelica root 1-

4 % Bighead atractylodes rhizoma 5-12 % Cinnamon Park 1-7 % 4. A pellet as claimed in claim 1-3 , wherein that aaterials soluble In intestine comprise mixed liquid of lac , cellulose acetate phthalate (CAP) or sodium carboxymethyl cellulose or acrylic resin.

5. A pellet as claimed in claim 1-4 , wherein that edible binding agents comprise gelatin syrup, refined honey and water.

6.A process for producing the two-layer pellet , wherein that crude medicinal materials are ground into fine powder , filtered , mixed, sterilized and eixed with refined honey or water to form pellets and then dried to produce pellets soluble in intestine ,the pellets are packaged with drug powder coated with material soluble in stomach by edible binding aRents, and then routine methods of coating and dryinR for conventional pellets are used to produce two-layer pellets which dissolved in stomach and intestine separately.

7. A process for producing the two-layer pellet substantially as hereinbefore described with reference to Diagram 1.

8. A two-layer coated pellet produced by the process claimed in any preceding claim.