Da-chengqi decoction tablet and preparation method thereof

Abstract

The invention provides a Dazheng qi decoction modified tablet and a preparation method thereof. Compared with the decoction of the original prescription, the tablet provided by the invention is convenient to take, and the dosage can be better controlled. The traditional Chinese medicine composition has the effect of increasing gastrointestinal tract propelling function and volume when used clinically, and can be used for treating local intestinal obstruction and constipation.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical preparation technology, specifically to a modified tablet of Da Chengqi Decoction and its preparation method. Background Technology

[0002] Da Cheng Qi Tang is a traditional Chinese medicine formula. It is a purgative, cold in nature, with a strong effect in purging heat accumulation. It is primarily used to treat Yangming bowel obstruction syndrome, characterized by constipation, frequent flatulence, epigastric and abdominal distension, abdominal pain aggravated by pressure, hard upon palpation, and even tidal fever, delirium, profuse sweating of the hands and feet, a yellow, dry, prickly, or scorched and cracked tongue coating, and a deep, forceful pulse; heat accumulation with diarrhea, characterized by undigested food in clear, greenish stools with a foul odor, abdominal pain around the navel, hard palpation with palpable lumps, dry mouth and tongue, and a slippery, forceful pulse; and internal heat excess syndromes such as heat syncope, convulsions, or mania. Clinically, this formula is often used to treat acute simple intestinal obstruction, acute cholecystitis, acute respiratory distress syndrome, crush syndrome, and acute appendicitis.

[0003] Da Chengqi Decoction comes from the Treatise on Cold Damage. Its prescription consists of rhubarb (12g), magnolia bark (24g), immature bitter orange (12g), and mirabilite (9g).

[0004] The method of using Da Cheng Qi Tang is to decoct it in water and take it orally. First decoct Magnolia officinalis and Citrus aurantium, then add Rheum palmatum and Glauber's salt, and take it orally. Take it warm in two divided doses until bowel movement occurs.

[0005] The original prescription is a decoction, and because it is often used to treat acute illnesses, its preparation, storage, and transport are inconvenient. Developing a new formulation that has the same efficacy as the original and is easier to take has significant pharmaceutical and industrial value. Attached Figure Description

[0006] Figure 1 The disintegration time of the obtained tablets was tested. Summary of the Invention

[0007] The purpose of this invention is to provide a modified tablet of Da Cheng Qi Tang, the prescription of which includes the following ingredients in the following amounts: 12-20g of prepared rhubarb; 24-50g of ginger-processed magnolia bark; 11-30g of wheat bran-fried immature bitter orange; 9-20g of Glauber's salt; appropriate amount of dry starch; and 3-9% disintegrant.

[0008] In a preferred embodiment of the present invention, the disintegrant is selected from any one or a combination of crospovidone, sodium carboxymethyl starch, and dry starch.

[0009] In a preferred embodiment of the present invention, the adhesive is selected from water or ethanol or a combination thereof.

[0010] In a preferred embodiment of the present invention, the lubricant is selected from magnesium stearate.

[0011] Another objective of this invention is to provide a method for preparing the modified Da Cheng Qi Tang tablets, comprising the following steps: ① Preparation of the herbal extract: Weigh 24g of Magnolia officinalis and 12g of Citrus aurantium into a beaker, add 250mL of distilled water and soak for 30min; simmer over low heat for 30min, filter through two layers of gauze; add 250mL of distilled water to cover the dregs, heat and simmer for 30min, filter, combine the two filtrates, add Glauber's salt to dissolve, boil and concentrate to 20mL. ② Preparation of rhubarb powder: Weigh 12g of prepared rhubarb, dry at 60℃, and grind into powder. ③ Preparation of granules: Take 12g of rhubarb powder and 10.5g of the herbal extract, add appropriate amount of dry starch and anhydrous ethanol, make into a soft mass, and granulate through a 16-mesh sieve; dry the wet granules at 60℃, and granulate the dry granules through a 16-mesh sieve. ④ Add disintegrant or surfactant, add 1% magnesium stearate, mix well, and compress into tablets using a tableting machine.

[0012] Unless otherwise stated, when this invention relates to percentages between liquids, the percentage is volume / volume percentage; when this invention relates to percentages between liquids and solids, the percentage is volume / weight percentage; when this invention relates to percentages between solids and liquids, the percentage is weight / volume percentage; the remainder is weight / weight percentage.

[0013] Compared with the prior art, the present invention has the following beneficial effects: The present invention develops a new modified tablet of Da Cheng Qi Tang, which is simple to use compared with the decoction and significantly improves the accessibility of medication for patients.

[0014] The preparation method of the tablet composition of the present invention is simple and has low production cost, making it particularly suitable for large-scale industrial production. Detailed Implementation

[0015] The following specific embodiments illustrate the present invention. It should be noted that these specific embodiments are only for further explanation and do not represent a limitation on the scope of protection of the present invention. Non-essential modifications and adjustments made by others based on the present invention still fall within the scope of protection of the present invention.

[0016] The reagents used in the following examples are as follows: prepared rhubarb, ginger-processed magnolia bark, wheat bran-fried immature bitter orange, Glauber's salt, dry starch, crospovidone, sodium carboxymethyl starch, magnesium stearate, ethanol, and purified water.

[0017] The prescription for 6 major Chengqi Decoction tablets consists of: 12g of prepared rhubarb; 24g of ginger-processed magnolia bark; 11g of wheat-fried immature bitter orange; 9g of Glauber's salt; appropriate amount of dry starch; and disintegrant.

[0018] Preparation methods: ① Preparation of herbal extract: Weigh 24g of Magnolia officinalis and 12g of Citrus aurantium into a beaker, add 250mL of distilled water and soak for 30min; simmer over low heat for 30min, filter through two layers of gauze; add 250mL of distilled water to cover the dregs, heat and simmer for 30min, filter, combine the two filtrates, add Glauber's salt to dissolve, boil and concentrate to 20mL. ② Preparation of rhubarb powder: Weigh 12g of cooked rhubarb, dry at 60℃, and grind into powder. ③ Preparation of granules: Take 12g of rhubarb powder and 10.5g of herbal extract, add appropriate amount of dry starch and anhydrous ethanol, make into a soft mass, granulate through a 16-mesh sieve; dry the wet granules at 60℃, and granulate the dry granules through a 16-mesh sieve. ④ Add disintegrant or surfactant, add 1% magnesium stearate, mix well, and compress into tablets using a tableting machine.

[0019] In Experiment 1, a hardness test was conducted. Six tablets from each disintegrant group were taken for hardness testing. The standard tablet weight requirement is 10N~100N, and the average hardness of all three disintegrant groups in this experiment met the requirements.

[0020] Example 1: Disintegration Time Test. Six tablets of each type were selected for disintegration time testing. For traditional Chinese medicine tablets, the general requirement is complete disintegration within 30 minutes. The results show that the disintegration time of all three types of tablets met the requirements.

[0021] Example 1: Weight Variation Limit Test. According to the weight variation limit requirements, the weight variation limit for an average tablet weight below 0.30g is ±7.5%. Dry starch group: weight range 0.1705g ± 0.1705g × 7.5%, i.e., 0.1577g~0.1833g. All 17 tablets met the required range, and the weight variation limit was qualified. Sodium carboxymethyl starch group: weight range 0.1824g ± 0.1824g × 7.5%, i.e., 0.1687g~0.1961g. Two out of 20 tablets exceeded this range, but the requirement that no more than two tablets exceed the weight variation limit was met, and the weight variation limit test was qualified. Crospovidone group: weight range 0.1789g ± 0.1789 × 7.5%, i.e., 0.1655g~0.1923g. All 18 tablets met the required range, and the weight variation limit was qualified. The weight differences of the three groups of tablets all met the requirements and were qualified.

[0022] The above description of specific embodiments of the present invention does not limit the present invention. Those skilled in the art can make various changes or modifications based on the present invention, and as long as they do not depart from the spirit of the present invention, they should all fall within the scope of protection of the claims of the present invention.

Claims

1. A modified tablet form of Da Chengqi Decoction, the prescription of which includes: 12-20g of processed rhubarb; Ginger-processed Magnolia officinalis 24-50g; Stir-fried immature bitter orange (11-30g) with wheat bran; 9-20g of Glauber's salt; Appropriate amount of dry starch; Disintegrant 3-9%.

2. The tablet according to claim 1, characterized in that, The selected disintegrant is any one or a combination of dry starch, crospovidone, sodium carboxymethyl starch; water or ethanol is used as a wetting agent and magnesium stearate is used as a lubricant during the preparation process.

3. The method for preparing tablets according to claims 1-2, comprising the following steps: ① Preparation of Traditional Chinese Medicine Extract: Weigh Magnolia officinalis and Citrus aurantium in a beaker, add distilled water to soak; simmer over low heat, filter through two layers of gauze; add distilled water to cover the dregs, heat and simmer, filter again, combine the two filtrates, add Glauber's salt to dissolve, boil and concentrate. ② Preparation of Rhubarb Powder: Weigh cooked rhubarb, dry at 60℃, and grind into powder. ③ Preparation of Granules: Take rhubarb powder, traditional Chinese medicine extract, add appropriate amount of dry starch and anhydrous ethanol, make into a soft mass, granulate through a 16-mesh sieve; dry wet granules at 40-70℃, and granulate dry granules through a 16-mesh sieve. ④ Add disintegrant or surfactant, add 1% lubricant, mix well, and compress into tablets using a tableting machine.

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