JP2021172613A - Method for producing chinese herbal extract preparation - Google Patents

Abstract

To provide a novel method that can improve the disintegration property of a Chinese herbal extract preparation.SOLUTION: The method for producing a Chinese herbal extract preparation of the present invention comprises a step of heating an extract of a crude drug at 70 to 100°C for 1 hour or more, based on the finding that the disintegration property of a Chinese herbal extract preparation can be improved by heat-treating the herbal extract. The method can improve the disintegration property of the Chinese herbal extract preparation. The present invention provides a Chinese herbal extract preparation with improved disintegration.SELECTED DRAWING: Figure 1

Description

The present invention relates to a method for producing a Chinese herbal extract preparation and a method for improving the disintegration property of the Chinese herbal extract preparation.

The Chinese herbal extract preparation contains a Chinese herbal extract extracted and concentrated from the crude drug. As the Chinese herbal extract, a dried extract powder extracted from the crude drug, concentrated, and then powdered by spray drying or the like may be used.

In recent years, there has been an increasing demand for preparations containing a large amount of Chinese herbal extracts. Chinese herbal extract preparations often have a unique taste and odor, and tablets and other easy-to-drink forms are preferred. There is also a demand for miniaturization of tablets and reduction of the number of tablets to be ingested at one time.

Therefore, the development of a formulation in which the proportion of Chinese herbal extract in the formulation is increased and the proportion of additives is reduced is in progress. However, if the proportion of the additive is small, there is a problem that the disintegration property of the preparation is not sufficient.

Patent Document 1 reports a method for producing a plant extract powder, in which a raw material solution containing a plant extract is subjected to a spray drying treatment at a solution temperature of 70 ° C. or lower for the purpose of improving the disintegration property of the solid preparation. ..

JP-A-2018-95563

In order to provide an easy-to-drink Chinese herbal extract preparation, further technology for improving the disintegration property of a preparation having a high proportion of Chinese herbal extract is required.

Therefore, an object of the present invention is to provide a new method capable of improving the disintegration property of a Chinese herbal extract preparation.

As a result of diligent studies to solve the above problems, the present inventors have found that the disintegration property of a Chinese herbal extract preparation can be improved by heat-treating an extract of a crude drug at 70 ° C. or higher. Completed the invention.

The present invention provides a method for producing a Chinese herbal extract preparation, which comprises a step of heating an extract of a crude drug at 70 ° C. or higher.

The present invention also provides a method for improving the disintegration property of a Chinese herbal extract preparation, which comprises a step of heating an extract of a crude drug at 70 ° C. or higher.

Further, the present invention is a Chinese medicine extract preparation produced by a method including a step of heating an extract of a crude drug at 70 ° C. or higher, and is compared with a Chinese medicine extract preparation manufactured by a method not including the heating step. To provide a Chinese herbal extract preparation with improved disintegration.

The present invention provides a method for producing a Chinese herbal extract preparation, which comprises a step of heating an extract of a crude drug at 70 ° C. or higher for 1 hour or longer.

The present invention also provides a method for improving the disintegration property of a Chinese herbal extract preparation, which comprises a step of heating an extract of a crude drug at 70 ° C. or higher for 1 hour or longer.

Further, the present invention is a Chinese herbal extract preparation produced by a method including a step of heating an extract of a crude drug at 70 ° C. or higher for 1 hour or longer, and a Chinese herbal extract produced by a method not including the heating step. Provided is a Chinese herbal extract preparation having improved disintegration property as compared with the preparation.

According to the present invention, even when the blending ratio of the Chinese herbal extract is high, the disintegration property of the Chinese herbal extract preparation can be improved, and an easy-to-drink Chinese herbal extract preparation can be provided.

The figure which shows the disintegration property of the tablet of Bofutsushosan. The figure which shows the disintegration property of the tablet of Kakkonto. The figure which shows the disintegration property of the tablet of shoseiryuto. The figure which shows the disintegration property of the tablet of shakuyakukanzoto. The figure which shows the disintegration property of the tablet of Bofutsushosan. The figure which shows the disintegration property of the tablet of Kakkonto. The figure which shows the disintegration property of the tablet of Kakkonto. The figure which shows the correlation between the solid content concentration of kakkonto and the Brix value.

(Manufacturing method of Chinese herbal extract preparation)
The present invention provides a method for producing a Chinese herbal extract preparation. The production method of the present invention includes a step of heating the extract of the crude drug at 70 ° C. or higher (hereinafter, also referred to as “heating step”).

In the present specification, the Chinese herbal extract preparation contains a Chinese herbal extract powder obtained by drying an extract of a crude drug or the like. The Chinese medicine extract powder is not particularly limited, but for example, Kazetsuseisan, Kakkonto, Shosaikoto, Shakuyakukanzoto, Kakkonto Kagawa Kyushinsho, Otojiyu, Anchusan, Hachimiji Huangmaru, Oshiba Koto, Sho-saiko-to, Saiko-keishi-to, Saiko-kei-shi-to, Orengedoku-to, Orengedoku-to, Toki-shakuyaku-san, Kami-yo-san, Keishi-Kakkonto, Keishi-karyu-bone oyster-to, Mao-to, Wheat Monfuyu, Ginseng, Shirotoraka Ginseng, Inoryo, Hochuekkito, Rokukimikoto, Tsurifujisan, Daiokansoyu, Shosaikoto, Daikenchuto, Gyusha Renkimaru, Ginseng Yoei-to, Sanko-shoshin-to, Saiko-to, Orengedoku-to, Tokikenchu-to, Asako-jinmaru, Mao-bushi-saishin-to, Keishi-ka-shakuyakukan-to, Kakkon-to, Kanso-to, etc. can.

The herbal medicine can be one kind of herbal medicine or a combination of a plurality of herbal medicines usually used for the Chinese herbal extract powder as described above. Herbal medicines include, for example, Asenyaku, Ireisen (Plantago seeds), Uikyo (Plantago seeds), Engosaku (Pillus root), Ougi (Huangya), Ougon (Huangyu), Oubaku (Yellow Kashiwa), Ouhi (Sakurahide), Ouren (Huangren). ), Onji (distant soul), Gajutsu, Kankyo (dry ginger), Kakkon (Kuzune), Kakkou, Karonin, Kanokosou, Kanzo (licorice), Kamitsure, Kikyo (Kikyou), Kikuka (Kikuhana), Kijitsu (Mitsumi), Kyonin (Kyounin) Apricot kernel), Kyokatsu, Kinginka (gold and silver flower), Kujin (bitter), Keigai (荊芥), Keihi (katsura), Gentiana, Kouka (red flower), Kobushi (kabushi), Koubei, Koboku (koboku), Goou, Goshitsu (cow knee), goshuyu (wu 茱萸), goboushi (cow 蒡子), trash (gomiko), psycho (shibahu), saishin (fine spicy), sanshishi (sanjoko), sanshuyu (sansho), sansho (sansho) , Sanzashi (Yamasako), Sandscon (Yamazukon), Sansounin (Apricot kernel), Sanyaku (Yamayaku), Sanna (Yamana), Jio (Jihuang), Zion, Shakuyaku (Crude drug), Jakou, Shouma (Masuma), Shitsurishi, Shazenshi, Shazensou, Shajin (Shukusha (shrinked sand)), Beast gall (including Yutan), Shokyo (ginger), Jiryu (earth dragon), Shini (spicy), Jikoppi (earth bone skin), Sikon, Sexan (Stone 蒜), Sekko (Gypsum), Senega, Senkotsu (Riverbone), Zenko (Maekhu), Senkyu (Kawakyu), Senburi, Soujutsu (Soujou), Souhakuhi (Mulberry bark), Soyo (Suha), Daiou (Daio), Taisou, Takusha (Sawataki), Chikujo, Chikusetsu carrot (Takebushi carrot), Chouji (Choco), Chotokou (Fishing 鈎), Chorei (Inori), Chinpi (Chen skin), Tennansho (Chinese skin) Tennansei), Tougashi (Fuyu Gourd), Touki (Toki), Tounin (Momohito), Tokon, Tochu, Dokkatsu (Solitary), Nantenjitsu, Carrot (Ginseng), Nindou (Shinobu), Baimo, Bakumondou, Hacka (Light load), Hange (half-summer), byakushi, byakushaku, byakujutsu (white 朮), biwayo (枇杷 葉), binrouji (檳榔子), bukuryo (茯 蓓), boxoku (樸 苓), buttonpi (peony skin), maou (mao) (Asakojin), Mokko (Kika), Yokuinin (Yokutojin), Ryugannik (Ryu-eye meat), Ryokyo (Ryokan), Ryukotsu (Ryubone), Ryutan (Ryuji), Rennik (Lotus meat) and Renkyo (Continuous) Etc. can be used.

The crude drug used in the present invention may be the plant itself as a raw material, or may be a processed product obtained by extracting the raw material. In the present specification, the term "processed product" refers to an extract obtained by adding a solvent to a raw material and extracting it, a squeezed liquid obtained after the raw material is squeezed, and a solvent added to the residue after squeezing the raw material. The extract obtained by extracting the above-mentioned extract, and the dry-solidified product obtained by drying these extracts or the pressed liquid are included.

In the production method of the present invention, the extract of the crude drug to be used in the heating step can be any extract known in the art. The extract of the crude drug to be used in the heating step is not only a solution of the extract extracted from the crude drug by an arbitrary extraction method, but also a concentrate of the extract and a powder obtained by drying the concentrate in water. It can be a solution of dissolved lysate or the like.

In the heating step, the extract of the crude drug is heated at 70 ° C. or higher. For example, the herbal extract is heated at 70 ° C-100 ° C, 80 ° C-90 ° C and 85 ° C-95 ° C. The heating temperature of the extract is the temperature of the extract when heated by a heater, a hot water bath, or the like.

In the heating step, the heating time can be adjusted according to the heating temperature, and can be, for example, 1 hour or more. The lower the heating temperature, the longer the heating time, and the higher the heating temperature, the shorter the heating time. For example, the heating time can be 1 hour or longer at 90 ° C., 2 hours or longer and 3 hours or longer at 80 ° C., and 4 hours or longer and 5 hours or longer at 70 ° C. The heating step may be performed with stirring.

In the production method of the present invention, the extract of the crude drug to be used in the heating step can be any extract. For example, it can be an extract produced in a step of extracting the extract from the crude drug (hereinafter, also referred to as “extraction step”) before the heating step. In the extraction step, for example, a method of room temperature extraction or heat extraction using alcohols such as water, methanol and ethanol, or an extraction solvent such as a mixed solvent thereof can be used. If necessary, extraction may be performed under reduced pressure or pressure. Further, as the extract of the crude drug to be used in the heating step, a commercially available extract can also be used. Further, as the extract of the crude drug to be used in the heating step, a solution obtained by dissolving a commercially available extract in a solvent can also be used.

The production method of the present invention may further include a step of concentrating the extract of the crude drug (hereinafter, also referred to as “concentration step”) before the heating step. In the concentration step, for example, a method such as concentration by heat treatment or concentration under reduced pressure can be used. In the concentration step, the extract may be concentrated until the Brix value is about 20% or more, 30% or more, and 40% or more, without particular limitation.

In the present specification, the "Brix value" is a physical quantity used as a sugar content for measuring the sugar content. When 100 g of an aqueous solution containing only 1 g of sucrose as a solute is measured with a Brix refractometer, the Brix value, which is the reading, is 1%. For example, a solution in which 10 g of sucrose is dissolved in 100 g of solution (90 g of water) has a Brix value of 10%. As for the crude drug extract, it is known that the concentration of the crude drug component in the extract corresponds to the Brix value. Therefore, the solid content concentration (mass%) of the crude drug component in the solution can be estimated to be an approximate value by measuring the Brix value of the solution.

For example, Table 1 below shows an example of the correlation between the Brix value and the solid content concentration when the Kakkonto extract powder is dissolved in water. The Brix value is expressed in%, and the solid content concentration is expressed in% by mass.

In FIG. 8, Table 1 above is shown as a graph. When the solid content concentration (%) is taken on the vertical axis and the Brix value (%) is taken on the horizontal axis, it can be seen that the solid content concentration (%) on the vertical axis is proportional to the Brix value (%) on the horizontal axis. In the case of Kakkonto, it is expressed by the formula: solid content concentration (%) = 0.9284 × Brix value (%) + 0.2792. At this time, the coefficient of determination R ² = 0.9985.

Brix values can be measured by devices commonly used in the art, such as saccharimeters, refractometers and densitometers.

The production method of the present invention may further include a step of drying the heat-treated product obtained by the heating step to obtain a Chinese herbal extract powder (hereinafter, also referred to as “drying step”). In the drying step, it can be dried by any method, and any drying method known in the art such as spray drying and freeze drying can be used.

The heating step in the present invention may be carried out after the extraction step or after the extraction step and the concentration step. Moreover, the heating step may be performed before the drying step. For example, in the production method of the present invention, a heating step may be performed after the extraction step and / or the concentration step, and then a drying step may be performed.

The production method of the present invention may further include a step of granulating Chinese herbal extract powder (hereinafter, also referred to as “granulation step”). In the granulation step, for example, wet granulation and dry granulation can be used. As the wet granulation, a fluidized bed granulation method, a kneading granulation method, an extrusion granulation method and the like can be used.

The production method of the present invention may further include a step of locking the Chinese herbal extract powder (hereinafter, also referred to as a “locking step”). In the tableting step, the Chinese herbal extract powder or its granulated product is locked. The Chinese herbal extract powder or granulated product thereof may be tableted after being mixed with a carrier such as an excipient, a binder, a disintegrant, a fluidizing agent and a lubricant. As the tableting method, a direct tableting method in which the Chinese herbal extract powder is tableted without granulation, a granule tableting method in which the Chinese herbal extract powder is tableted after granulation, or the like can be used.

The content of the Chinese herbal extract powder in the Chinese herbal extract preparation can be the content usually used in the art. The content of the Chinese herbal extract powder in the Chinese herbal extract preparation may be, for example, 1 to 99% by weight, 10 to 90% by weight, 20 to 80% by weight, 30 to 70% by weight and 40 to 60% by weight. By using the method of the present invention, even a preparation containing Chinese herbal extract powder at an arbitrary content can be improved in its disintegration property.

The Chinese herbal extract preparation can be a solid preparation. Solid formulations include tablets, pills, capsules, granules, powders and lozenges. Tablets include orally disintegrating tablets, chewable tablets, effervescent tablets, dispersion tablets, dissolution tablets and the like.

In addition to the Chinese herbal extract powder, the Chinese herbal extract preparation may contain an excipient, a binder, a disintegrant, a fluidizing agent, a lubricant and the like, if necessary. Chinese herbal extract preparations include, for example, sugars and sugar alcohols such as lactose, corn starch, maltose and mannitol, starches and starch derivatives such as corn starch, dextrin and pregelatinized starch, cellulose and cellulose derivatives such as crystalline cellulose and hydroxypropyl cellulose, synthetic. It may contain inorganic substances such as aluminum silicate, calcium phosphate, magnesium stearate, calcium stearate and starch.

According to the production method of the present invention, a Chinese herbal extract preparation having good disintegration property can be produced even when the compounding ratio of the Chinese herbal extract is high.

(How to improve disintegration)
The present invention also provides a method for improving the disintegration property of a Chinese herbal extract preparation. The method of the present invention includes a step (heating step) of heating the extract of the crude drug at 70 ° C. or higher.

As used herein, the term "disintegrating" means the susceptibility of a Chinese herbal extract preparation to disintegrate, particularly in a solution, for example, in the oral cavity and / or in the gastrointestinal tract. The disintegration property can be measured as the disintegration time in accordance with the Japanese Pharmacopoeia 6.09 disintegration test method, for example, and can be measured using an apparatus such as NT-400 manufactured by Toyama Sangyo Co., Ltd. In addition, the disintegration of the Chinese herbal extract preparation includes the dissolution, dispersion, or shattering of the Chinese herbal extract preparation. In the present specification, "improving the disintegration property" means that the time until disintegration is shortened and the disintegration rate is increased, and "improving the disintegration property" means that the disintegration property is improved. It means to improve the disintegration property as compared with the Chinese herbal extract preparation produced by the method not including the heating step by the method for improving the disintegration property.

In the method for improving the disintegration property of the present invention, the extract of the crude drug to be subjected to the heating step can be any extract known in the art. The extract of the crude drug to be used in the heating step is obtained by drying not only the solution of the extract extracted from the crude drug by an arbitrary extraction method but also the concentrate of the extract and the concentrate as described above. It can be a solution of a solution obtained by dissolving the powder in water.

In the heating step, the extract of the crude drug is heated at 70 ° C. or higher. For example, the herbal extract is heated at 70 ° C-100 ° C, 80 ° C-90 ° C and 85 ° C-95 ° C. The heating temperature of the extract is the temperature of the extract when heated by a heater, a hot water bath, or the like.

In the heating step, the heating time can be adjusted according to the heating temperature, and can be, for example, 1 hour or more. The lower the heating temperature, the longer the heating time, and the higher the heating temperature, the shorter the heating time. For example, the heating time can be 1 hour or longer at 90 ° C., 2 hours or longer and 3 hours or longer at 80 ° C., and 4 hours or longer and 5 hours or longer at 70 ° C. The heating step may be performed with stirring.

The method of the present invention may further include a step of extracting the extract from the crude drug (extraction step) before the heating step. Further, the method of the present invention may further include a step of concentrating the extract extracted in the extraction step (concentration step) before the heating step. Further, the method of the present invention may further include a step (drying step) of drying the concentrate obtained by the concentration step or the heat-treated product obtained by the heating step to obtain a Chinese herbal extract powder. Further, the method of the present invention may further include a step of granulating the Chinese herbal extract powder (granulation step). Further, the method of the present invention may further include a step of locking the Chinese herbal extract powder (locking step).

According to the method of the present invention, the disintegration property of the Chinese herbal extract preparation can be improved even when the compounding ratio of the Chinese herbal extract is high.

(Chinese extract preparation with improved disintegration)
The present invention also provides a Chinese herbal extract preparation with improved disintegration. The Chinese herbal extract preparation of the present invention is a Chinese herbal extract preparation produced by a method including a step of heating the extract of the crude drug at 70 ° C. or higher (heating step), and is produced by a method not including a heating step. It is a Chinese herbal extract preparation with improved disintegration property as compared with the Chinese herbal extract preparation.

In the present specification, "improved disintegration" is based on the Japanese Pharmacopoeia 6.09 disintegration test method as compared with the Chinese herbal extract preparation produced by a method that does not include the step of heating the extract of the crude drug. It means that the time until collapse when measured by the measuring method is shortened.

The Chinese herbal extract preparation having improved disintegration of the present invention can be produced by the above-mentioned manufacturing method of the Chinese herbal extract preparation. For example, the Chinese herbal extract preparation of the present invention can be produced by performing a heating step after an extraction step and a concentration step of an extract of a crude drug, followed by a drying step, and then a granulation step or a tableting step. can.

In the case of the Chinese medicine extract preparation having improved disintegration property of the present invention, the disintegration rate of the Chinese medicine extract preparation is high even when the compounding ratio of the Chinese medicine extract is high.

Examples are shown below, and embodiments of the present invention will be described in more detail, but the present invention is not limited to the following examples.

(Measurement method of disintegration)
In each of the following examples, the disintegration property of the pharmaceutical product was measured by NT-400 manufactured by Toyama Sangyo Co., Ltd. by a method based on the Japanese Pharmacopoeia 6.09 disintegration test method.

(Concentration under reduced pressure)
In each of the following examples, vacuum concentration was performed by a flash type concentration tester REV-T2 manufactured by Hisaka Works, Ltd.

(Example 1)
The extract powders of Bofutsushosan, Kakkonto, Shoseiryuto and Shakuyakukanzoto were manufactured in-house by extracting, concentrating, sterilizing and spray-drying each crude drug using a general manufacturing method.

The extract powders of Bofutsushosan, Kakkonto, Shoseiryuto and Shakuyakukanzoto were dissolved in purified water at 50 ° C and used as normal products. The Brix value of Bofutsushosan solution was about 23%. The Brix value of the Kakkonto solution was about 20%. The Brix value of the Shoseiryuto solution was about 20%. The Brix value of the shakuyakukanzoto solution was about 25%. For the heated extract solution, heat each extract powder solution with an IH cooking heater at 90 ° C. for 3 hours with stirring, and then purify each heated extract solution to a Brix value of about 20 to 25%, which is the same as that of a normal product. Prepared by diluting with water (heated product).

The heated product and the normal product were freeze-dried and pulverized to obtain an extract powder. Using a manual tabletop tablet molding machine HANDTAB-200 manufactured by Ichihashi Seiki Co., Ltd., which is a mixture of 8 g of extract powder and 2 g of crystalline cellulose, a mortar coated with a lubricant is normally used at the tableting pressure shown in the table below. An uncoated tablet was prepared by single-shot tableting according to the procedure described in 1. The properties of each tablet are shown in Tables 2-9 below. In each table, the properties shown in the table were measured for the two uncoated tablets that were locked at the respective locking pressures. The mass, thickness, hardness and disintegration were measured with one uncoated tablet that was locked at the same tableting pressure.

The disintegration property of Bofutsushosan tablets is shown in Fig. 1, the disintegration property of Kakkonto tablets is shown in Fig. 2, the disintegration property of Shoseiryuto tablets is shown in Fig. 3, and the disintegration property of shakuyakukanzoto tablets is shown. Shown in 4. In each figure, the horizontal axis represents hardness (kgf) and the vertical axis represents decay time (minutes). In all the extract powders, the heated product had improved disintegration property as compared with the normal product. With Bofutsushosan extract powder, the dissolution rate of the heated product was improved to 24 minutes or less. With the Kakkonto extract powder, the dissolution rate of the heated product improved to 72 minutes or less. With the extract powder of shoseiryuto, the dissolution rate of the heated product improved to 103 minutes or less. With the extract powder of shakuyakukanzoto, the dissolution rate of the heated product improved to 52 minutes or less.

(Example 2)
Bofutsushosan was heat-treated in the process of extracting the extract from crude drugs and obtaining the extract powder.

The extract was extracted by mixing 15870 g of water and 1587 g of crude drug (Brix value: about 3%). This was filtered, and the extract was concentrated under reduced pressure at 60 ° C. to obtain a concentrated solution (Brix value: about 18%). The concentrated solution was heated with an IH cooking heater at 90 ° C. for 3 hours with stirring, and then diluted with purified water so that the Brix value became about 25% (heated product). After concentration, the one that was not heat-treated was used as a control (normal product).

The heated product and the normal product were freeze-dried and pulverized to obtain an extract powder. The extract powder and crystalline cellulose were mixed, and in a mortar coated with a lubricant, a single lock was made by a usual method to prepare an uncoated tablet. The properties of each tablet are shown in Tables 10-11 below. In each table, the properties shown in the table were measured for the two uncoated tablets that were locked at the respective locking pressures. The mass, thickness, hardness and disintegration were measured with one uncoated tablet that was locked at the same tableting pressure.

Figure 5 shows the disintegration of Bofutsushosan tablets. In FIG. 5, the horizontal axis represents hardness (kgf) and the vertical axis represents decay time (minutes). As for the extract preparation extracted from the crude drug, the heated product was more disintegrating than the normal product.

(Example 3)
Kakkonto was heat-treated in the process of extracting the extract from crude drugs to obtain extract powder.

The extract was extracted by mixing 15625 g of water and 1562.5 g of crude drug (Brix value: about 4%). This was filtered and the extract was concentrated under reduced pressure at 60 ° C. (Brix value: about 25%). In the group to be heat-treated after concentration, the mixture was heated with an IH heater at 90 ° C. for 2 hours with stirring, and then diluted with purified water so that the original Brix value was 25% (heated product). In addition, the one that was not heat-treated by the IH cooking heater was used as a control (normal product).

The heated product and the normal product were each freeze-dried, pulverized, and sieved to obtain an extract powder. The extract powder and crystalline cellulose were mixed, and in a mortar coated with a lubricant, a single lock was made by a usual method to prepare an uncoated tablet. The properties of each tablet are shown in Tables 12-13 below. In each table, the properties shown in the table were measured for the two uncoated tablets that were locked at the respective locking pressures. The mass, thickness, hardness and disintegration were measured with one uncoated tablet that was locked at the same tableting pressure.

Figure 6 shows the disintegration of Kakkonto tablets. In the figure, the horizontal axis represents hardness (kgf) and the vertical axis represents decay time (minutes). The heated product was more disintegrating than the normal product.

(Example 4)
The extract solution obtained by dissolving the extract powder of kakkonto in purified water was heat-treated at various heating temperatures and times.

In the same manner as in Example 1, the extract powder of kakkonto was dissolved in purified water and then not heat-treated, which was used as a control (normal product). As the heated extract solution, each extract powder was added to purified water at 50 ° C. and the dissolved extract solution was heated. Extract solutions at 70 ° C for 3 hours (IH), 70 ° C for 5 hours (IH), 80 ° C for 3 hours (water bath), 90 ° C for 30 minutes (IH), 90 ° C for 1 hour (IH) and It was heated at 90 ° C. for 3 hours (IH). The sample heated by the IH cooking heater at the time of heating was shown as (IH), and the sample heated by the water bath was shown as (water bath). The extract solution was heated with stirring for the above time, and then diluted with purified water so that the Brix value was the same as that of the normal product. The sample prepared in Example 1 was used as the extract solution heated at 90 ° C. for 3 hours (IH).

In the same manner as in Example 1, the extract solution heated at each temperature and time and the normal product were freeze-dried and pulverized to obtain an extract powder. Using a manual tabletop tablet molding machine HANDTAB-200 manufactured by Ichihashi Seiki Co., Ltd., which is a mixture of 8 g of extract powder and 2 g of crystalline cellulose, a mortar coated with a lubricant is normally used at the tableting pressure shown in the table below. An uncoated tablet was prepared by single-shot tableting according to the procedure described in 1. The properties of each tablet are shown in Tables 14-20 below. In each table, the properties shown in the table were measured for the two uncoated tablets that were locked at the respective locking pressures. The mass, thickness, hardness and disintegration were measured with one uncoated tablet that was locked at the same tableting pressure.

Figure 7 shows the disintegration property of tablets heated at each heating temperature and heating time of Kakkonto. In FIG. 7, the horizontal axis represents hardness (kgf) and the vertical axis represents decay time (minutes).

When heated at 70 ° C. for 3 hours, the solubility was similar to that of the unheated normal product. When heated at 70 ° C. for 5 hours, the disintegration time was faster than that of the normal product, and the disintegration property was improved.

When heated at 80 ° C for 3 hours, the disintegration time was faster than that of the normal product, and the disintegration property was improved.

When heated at 90 ° C. for 30 minutes, it had the same solubility as the unheated normal product. When heated at 90 ° C. for 1 hour, the disintegration time was faster than that of the normal product, and the disintegration property was improved. In addition, when heated at 90 ° C. for 3 hours, the disintegration time was faster than that of the normal product, and the disintegration property was improved.

From the above results, it can be seen that the higher the heating temperature, the better the disintegration property even if the heating time is short. When the heating temperature was 70 ° C, heating for 3 hours was insufficient, but when the heating temperature was 90 ° C, the disintegration property was sufficiently improved by the heating time of 1 hour.

INDUSTRIAL APPLICABILITY The present invention can be suitably used for producing a Chinese herbal extract preparation having a high blending ratio of the Chinese herbal extract.

Claims (6)

A method for producing a Chinese herbal extract preparation, which comprises a step of heating an extract of a crude drug at 70 ° C or higher. A method for improving the disintegration property of a Chinese herbal extract preparation, which comprises a step of heating an extract of a crude drug at 70 ° C or higher. It is a Chinese medicine extract preparation produced by a method including a step of heating the extract of the crude drug at 70 ° C. or higher, and has improved disintegration property as compared with the Chinese medicine extract preparation manufactured by the method not including the heating step. Chinese herbal extract preparation. The method for producing a Chinese herbal extract preparation according to claim 1, wherein the heating step is heated for 1 hour or more. The method for improving the disintegration property of the Chinese herbal extract preparation according to claim 2, wherein the heating step is heated for 1 hour or more. The Chinese herbal extract preparation according to claim 3, wherein the heating step is heated for 1 hour or more.

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