JP-7857145-B2 - Solid pharmaceutical composition

Inventors

• 中曽根 美咲

Assignees

• 小林製薬株式会社

Dates

Publication Date

20260512

Application Date

20220408

Priority Date

20210409

Claims (7)

1. A solid pharmaceutical composition comprising (A) Saikatsukaito extract and (B) carmellose salt .
2. The solid pharmaceutical composition according to claim 1, wherein the content of component (A) is 50 to 95% by weight.
3. The solid pharmaceutical composition according to claim 1, wherein the herbal medicine preparation used to extract component (A) contains 3 to 5 parts by weight of ginger per 100 parts by weight of the herbal medicine preparation.
4. The solid pharmaceutical composition according to claim 1, wherein the content of component (B) is 0.5 to 50% by weight in total.
5. The solid pharmaceutical composition according to claim 1, wherein the content of component (B) per 100 parts by weight of component (A) is 1 to 70 parts by weight in total.
6. Furthermore, the solid pharmaceutical composition according to claim 1, comprising (C) starch, lactose, and/or dextrin.
7. A discoloration inhibitor for solid pharmaceutical compositions containing carmellose salt and Saikatsukaito extract.

Description

This invention relates to a solid pharmaceutical composition exhibiting excellent discoloration inhibition. Saikatsukaijito (Asada Family Formula) is a compound formula derived from a combination of Shosaikoto and Kakkonto, with ginseng and jujube removed and gypsum added. Based on the formula's composition and the source's description, it is considered suitable for treating both Taiyang disease and underlying Shaoyang syndrome (Non-Patent Literature 1). In recent years, while research into the mechanisms of disease onset and the development of new drugs and vaccines for unknown infectious diseases such as COVID-19 has been actively pursued, traditional Chinese medicine (Kampo) treatments are also being applied clinically. Among these, Saikatsukaijito has been proposed for use in preventing the progression of mild COVID-19 cases when fever that cannot be managed with Kakkonto or Maoto is present (Non-Patent Literature 2). Journal of Oriental Medicine, Vol. 44, No. 4, 1994, pp. 107-111Weekly Japan Medical News, No. 5008, 2020, p. 44 1. Solid Pharmaceutical Composition The solid pharmaceutical composition of the present invention is characterized by comprising (A) Saikatsukaito extract (hereinafter also referred to as "component (A)") and (B) light anhydrous silicic acid and/or cellulose compound (hereinafter collectively referred to as "component (B)"). The solid pharmaceutical composition of the present invention will be described in detail below. (A) Saikatsukaito extract The solid pharmaceutical composition of the present invention contains Saikatsukaito extract as component (A). Examples of crude drugs that make up Saikatsukaito include the prescriptions of Rokusho, Unyo, or Asada, and in the present invention, any of these prescriptions may be used. The amount of each crude drug in the crude drug formulation used to produce the Saikatsukaijito extract used in this invention is not particularly limited, but in any formulation, the amount of ginger, for example, is 1 to 5 parts by weight per 100 parts by weight of the total crude drug formulation. To further enhance the discoloration suppression, the amount of ginger per 100 parts by weight of the total crude drug formulation is preferably 3 to 5 parts by weight, more preferably 3.5 to 5 parts by weight, and even more preferably 4 to 5 parts by weight. As a preferred example of the crude drug formulation used in the production of the Saikatsukaito extract used in the present invention, from the viewpoint of further enhancing discoloration suppression, the formulation by Asada is preferred. The crude drug formulation used in the production of the Saikatsukaito extract according to Asada's formulation consists of Bupleurum root, Pueraria lobata, Ephedra herb, Cinnamon bark, Scutellaria root, Peony root, Pinellia tuber, Zingiber officinale, Licorice root, and Gypsum. Preferred amounts of these crude drugs include 1.5 to 5 parts by weight of Bupleurum root, 1.25 to 4 parts by weight of Pueraria lobata, 1 to 3 parts by weight of Ephedra herb, 1 to 3 parts by weight of Cinnamon bark, 1 to 3 parts by weight of Scutellaria baicalensis, 1 to 3 parts by weight of Peony root, 1 to 4 parts by weight of Pinellia tuber, 0.5 to 1 part by weight of Zingiber officinale (preferably 0.8 to 1 part by weight, more preferably 0.9 to 1 part by weight), 0.5 to 2 parts by weight of Licorice root, and 2 to 8 parts by weight of Gypsum. Particularly preferred examples include 4 parts by weight of Bupleurum root, 4 parts by weight of Pueraria lobata, 2.5 parts by weight of Ephedra herb, 2 parts by weight of Cinnamon bark, 2 parts by weight of Scutellaria baicalensis, 2 parts by weight of Peony root, 3 parts by weight of Pinellia tuber, 1 part by weight of Zingiber officinale, 1 part by weight of Licorice root, and 6 parts by weight of Gypsum. The Saikatsu Kaijito extract used in this invention can be obtained by extracting the aforementioned herbal medicine formulation using a known method. The method for extracting the herbal medicine formulation can be the same as the conventional method for extracting Saikatsu Kaijito extract. For example, approximately 10 to 20 times the amount of water, preferably 10 to 15 times the amount of water, is added to the herbal medicine formulation, and the mixture is stirred at approximately 80 to 100°C, preferably 95 to 100°C, for approximately 0.5 to 3 hours, preferably 0.5 to 1 hour. After extraction, the solid content is removed by solid-liquid separation such as centrifugation or filtration, and if necessary, the Saikatsu Kaijito extract is obtained by concentration or drying. To obtain the extract of Saikatsukaito as an extract powder, the extract, from which the solid components have been removed, can be concentrated as needed, and then subjected to drying treatments such as spray drying, vacuum concentration drying, or freeze-drying. Furthermore, excipients may be added to the extract as needed during the drying treatment (especially spray dr