JPS5841816A - Compression molding preparation of semicircular cardiotonic agent for chronic disturbance (scrofulosis) of five digestive organs mainly in infant - Google Patents

Abstract

PURPOSE:To obtain the titled drug useful as ''MANBYO KANNOGAN '' or ''KANNOGAN '', by mixing an excipient, a hardness increasing agent and a disintegrating agent as essential components with a mixture of crude drugs for obtaining a cardiotonic agent for the chronic disturbance (scrofulosis) of five digestive organs mainly in infants, compression molding the resultant mixture into a semicircular tablet, and coating the resultant tablet with a silver foil. CONSTITUTION:100pts.wt. mixed crude drug powder for obtaining a cardiotonic agent for the chronic disturbance (scrofulosis) of five digestive organs mainly in infants is mixed with 30-50pts.wt. excipient, particularly lactose, kneaded, dried and pulverized to give a granular material. 100pts.wt. resultant granular material is then mixed with 10-15pts.wt. each hardness increasing agent and disintegrating agent, particularly light silicic acid anhydride and calcium cellulose glycolate, if necessary further a lubricant, etc. under stirring. The resultant mixture is then tableted in a compression molding machine (a tablet machine) having a semicircular mold into a semicircular shape, which is coated with a silver foil to afford a semicircular cardiotonic agent for the chronic disturbance (scrof ulosis) of five digestive organs mainly in infants, having a uniform shape, improved disintegrating property and rapid drug effect in high yield very efficiently and sanitarily.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for producing Gofu cardiotonic medicine known as Banbyou Sensogan or Sensogan by compression molding.

The purpose is to achieve extremely high production efficiency and high yield.
Compression molding of half-moon-shaped Gofu cardiotonic medicine has various advantages such as uniform shape, hygienic production, high disintegration, and rapid medicinal effect.
It is about providing law.

Gofu toxin medicine is known as Banbyou Kan'ōgan or Kan'ōgan, but it was created in 1714 A.D. From the beginning, it was marketed as a half-moon-shaped flat tablet, and as a special shape, it was sold for 260 years.
It has been popular for many years.

This gofu stimulant medicine is mainly composed of animal herbal medicines such as Jacora, Kouou, and Yutan, and plant herbal medicines such as Acacia japonica, saffron, ginseng, and agarwood, and is coated with silver foil to protect the active ingredients. As mentioned above, its shape is a half-moon key, and it is said that maintaining this shape is unavoidable for sales purposes, and this shape is extremely famous. be.

Gofu cardiotonic medicine, which has this unique shape, has been conventionally produced as follows.

First, the prescribed amount of herbal medicine powder is thoroughly mixed, and kneaded by adding kanbai powder as a binder and an appropriate amount of water to this mixed powder, a pill mass with a consistency that can be rolled is made by hand. . This pill mass is then packed into a metal box with a round hole with a diameter of 8 to 10111 mm on one side and squeezed using a manual round maker, resulting in a rod-shaped pill mass that is squeezed out from the round hole. It is cut into columns using a cutting tool with thin wire stretched at equal intervals, divided into prescribed amounts, and rolled into balls.

The formwork is removed from there. Then, the obtained circular object is further pressed to a certain thickness using a pressing tool to make a disk-shaped flattened bowl. Then, when it is still partially dry, it is cut in half with a thin knife to create a half-moon-shaped flat key. After this is sufficiently dried, a small amount of water is added and stirred until the surface of the key is smooth, and after it is sufficiently dried again, it is finished by applying a coating using silver foil.

In addition to this manufacturing method, there is also a method of rolling the raw material into a plate shape and punching it out with semicircular metal, but all of these methods require complicated processes and extremely low productivity. .

This conventional manufacturing method suffers from various drawbacks as follows.

(11) It is an unsanitary manufacturing method for pharmaceuticals because the process is done manually, so people often touch the medicine with their hands.

(2) Since it is a special manufacturing method of rolling and crushing, a large amount of binder is required and the degree of collapse is extremely poor.

(3) Because the slightly elastic pill mass containing water is manually divided into prescription lids, the individual weights of the dried flat keys vary widely, and the weight deviation standard is R7.
c The yield of compatible products is extremely poor.

(4) There is a drawback that it is not possible to produce a uniform shape.

(5) Productivity is extremely low' and costs are high, which is a significant disadvantage.

The present inventor has repeatedly researched various methods for many years in order to improve the conventional method for producing half-moon-shaped Gofu cardiotonic medicine, which has many drawbacks as described above, and has focused on the compression molding method □. After further research into the drawbacks of this method,
We found a manufacturing method that can be molded by compression molding, satisfying various conditions such as making the key collapsible well and having a hardness that allows silver foil to be rubbed onto it, without compromising the basic ingredients and essence. It was.

That is, an excipient, a hardness increaser, and a disintegrant are added as essential components to a herbal medicine mixture for obtaining Gofu cardiotonic medicine, and the mixture is compression-molded into a half-moon-shaped lock using a compression molding machine. He then invented a method for producing half-moon-shaped Gofu cardiotonic drugs by compression molding, which was characterized by coating them with silver foil.

The most significant feature of the manufacturing method of the present invention is that half-moon-shaped locks can be mass-produced using a compression molding machine, but this is made possible by not using a binder like the traditional Kanbai powder. This is because excipients and hardness increasing agents were added instead. On the other hand, a disintegrant is added to ensure that even if these excipients and hardness increasing agents are added, the digestion and absorption in the small intestine will not be reduced.This allows for better disintegration, digestion and absorption than with conventional products. It became like that.

In other words, it became possible to incorporate excipients and hardness increasers only by incorporating disintegrants, and these 8
The combination of these ingredients worked synergistically, making it possible to manufacture the product by compression molding without sacrificing the effectiveness of the basic principles.

Briefly explaining the production method of the present invention, excipients are added to the herbal medicine blended powder, kneaded, dried, and then ground in a grinder to obtain a granular material without grinding. Then, a hardness increaser, a disintegrant, and a lubricant, if necessary, are added to this granular material, stirred and mixed, and the mixture is molded into a half-moon shape. The tablets are compressed into half-moon shapes using a compression molding machine (tablet machine), and then coated with silver foil to form a product.

It is most preferable to use lactose as the excipient in the present invention, and the blending ratio is 30 to 501 parts by weight of lactose per 100 parts by weight of the crude drug blended powder (the proportion is appropriate, and if it is less than 30 parts by weight, it will be difficult to mold; If it exceeds 50 parts by weight, it becomes too hard and the disintegration properties deteriorate.

Furthermore, it is most preferable to use light anhydrous silicic acid as the hardness increasing agent in the present invention, and the mixing ratio thereof is 10 to 10 parts by weight of light anhydrous silicic acid to 100 parts by weight of the above granular material.
15 parts by weight is appropriate; less than 10 parts by weight is too flexible.
If it exceeds 5 parts by weight, it becomes too hard.

Further, as the disintegrating agent in the present invention, cellulose calcium glycolate is most preferable, and its blending ratio is suitably 10 to 15 parts by weight, less than 10 parts by weight, per 100 parts by weight of the above granular material. In this case, disintegration and absorption in the small intestine becomes difficult, and even if 15 parts by weight or more is added, the effect is the same and is meaningless.

Note that the silver foil used in the present invention is free from volatile substances (
For example, talc is coated to prevent volatilization of warm borneol (for example, warm borneol), and talc is generally used as a lubricant that is optionally added in the present invention.

Next, an example of the present invention will be described, but the blending ratio in this example is only one example, and the present invention is not limited by the example.

Example The following crude drug combination powder was prepared.

Asenyaku end 3450g Clove ends 2100g Nine-borneol 12 (E g Agarwood powder 3000g Carrot powder 6000g Ta.

6000 g of polysaccharide was added as an excipient to this herbal medicine mixture, and the mixture was stirred and mixed for 30 minutes using a pony mixer.

Next, 12oOg of beef tallow and 45g of hIIum benzoate.
A fluid solution prepared by dissolving .

This material was further kneaded to make coarse particles.

The coarse particles were dried using an infrared hot air dryer at 40°C for 8 hours. (Loss on drying: 7% or less) The mixture was then crushed and granulated using a Power Mill C impact crusher to obtain a granular material.

To 24,450 g of this granular material were added 8,000 g of light anhydrous silicic acid as a hardness increaser, 3,000 g of calcium cellulose gelcholate as a disintegrant, and 300 g of talc as a lubricant, and the mixture was stirred and mixed using a pony mixer.

The granules prepared in this way are compressed and molded using a rotary tablet machine equipped with a half-moon mold as a compression molding machine, and are made into half-moon tablets with a size of about 20 fl and a tablet weight of 520 η. The lock was pressed into a shaped key.

The obtained key was coated with silver foil using a mixture of 300 g of silver foil and 150 g of purified shellac using a pan specifically designed for silver foil coating, thereby producing a silver half-moon-shaped tablet product.

As can be seen from the above examples, the half-moon-shaped Gofu cardiotonic drug obtained by the production method of the present invention does not require manual labor because it is carried out automatically and mechanically (it is very hygienic compared to the conventional production method). In addition, the combination of disintegrants has a high absorption rate, and rapid medicinal efficacy can be expected.Moreover, the shape is uniform and beautiful, almost passing the weight deviation test, and extremely high yields can be obtained. As a result of the process being significantly streamlined and mechanized, it is possible to achieve extremely high manufacturing efficiency and labor savings, and it has various excellent effects such as being economically advantageous.

Patent applicant: Nippon Pharmaceutical Co., Ltd. 98-

Claims (1)

[Claims] 1. In the crude drug formulation for obtaining Gofu cardiotonic medicine, excipients,
Compression molding of a half-moon-shaped Gofu cardiotonic drug, which is characterized in that it contains a hardness increaser and a disintegrant as essential ingredients, is compression-molded into a half-moon-shaped tablet using a compression molding machine, and is then covered with silver foil. Manufacturing method. 2. The manufacturing method according to claim 1, which uses lactose as an excipient. 8. The manufacturing method according to claim 1 or 2, using light anhydrous silicic acid as a hardness increaser. 4. The manufacturing method according to claim 1, 2, or 3, which uses cellulose calcium glycolate as a disintegrant.