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Tauroursodeoxycholic acid capsule and preparation method thereof

A technology of tauroursodeoxycholic acid and capsules, which can be used in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve problems such as large gaps and fast dissolution rates

Active Publication Date: 2015-03-25
YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since capsules using columnar compressed powders have been sold on the market, their dissolution curves and dissolution behaviors are in line with the absorption laws of the human body. However, the dissolution behavior of existing capsules is quite different from that of columnar compressed powders, especially in The dissolution rate in the early stage is too fast compared with the product of the original research company

Method used

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  • Tauroursodeoxycholic acid capsule and preparation method thereof
  • Tauroursodeoxycholic acid capsule and preparation method thereof
  • Tauroursodeoxycholic acid capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Effect of Capsule Contents on Dissolution Behavior

[0027] The composition of the pre-test sample capsule contents is

[0028]

[0029] Preparation Process:

[0030] ① Pass taurursodeoxycholic acid and other auxiliary materials through an 80-mesh sieve, and set aside.

[0031] ②Precisely weigh the prescribed amount of tauroursodeoxycholic acid, starch, lactose, microcrystalline cellulose, and magnesium stearate, first mix the excipients except the main drug evenly, and then mix the main drug with the premixed excipients uniform.

[0032] ③Put the mixed material in the capsule filling machine, and adjust the filling capacity for capsule filling.

[0033] ④ Intermediate detection, determination of dissolution curve, calculation of f2 factor.

[0034] Using the above prescription process to prepare small test samples, the prepared samples are compared with commercially available products for dissolution, the results are shown in figure 1 . It can be se...

Embodiment 2

[0035] Example 2: Effect of Binder on Dissolution Behavior

[0036] Table 2: The composition of the sample capsule contents is:

[0037]

[0038] Binder 1 was ethyl cellulose and Binder 2 was 10% starch slurry.

[0039] The above prescriptions 21-25 are prepared into finished products, and the preparation process is as follows:

[0040] (1) Raw material pretreatment: Tauroursodeoxycholic acid is passed through an 80-mesh sieve or crushed and passed through an 80-mesh sieve;

[0041] (2) Recipe: receive and pass the inspection of tauroursodeoxycholic acid (calculated as dihydrate), starch, lactose, microcrystalline cellulose, binders (hypromellose, etc.), magnesium stearate, Highly substituted hydroxypropyl cellulose, weighed according to the batch prescription.

[0042] (3) Preparation of the adhesive: according to the composition of the adhesive prescription, slowly add high-substituted hydroxypropyl cellulose into 30 parts of vigorously stirred purified water, mix well...

Embodiment 3

[0053] Embodiment 3: the influence of stabilizer on dissolution behavior

[0054] Table 3 Composition of Sample Capsule Contents

[0055]

[0056] Stabilizer 1 is glyceryl behenate, and stabilizer 2 is ethyl cellulose.

[0057] The method in the above-mentioned prescription reference example 2 was prepared into capsules, and the dissolution test was carried out under the same conditions as the original research capsules, and the second method of appendix XC of the second part of the Pharmacopoeia of the 2010 edition was used for water and pH5.5 phosphate buffer. The dissolution test, the experimental results are as follows image 3 , Figure 4 shown.

[0058] Result analysis:

[0059] A. From image 3 It can be seen that the curves of prescription 31 and prescription 33 are relatively close, indicating that small-scale changes in the amount of excipients have little impact on the dissolution behavior and do not have a significant impact.

[0060] B. Compared with the ...

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Abstract

The invention discloses a tauroursodeoxycholic acid capsule and a preparation method thereof. The prescription of the tauroursodeoxycholic acid capsule is prepared from the following raw materials by weight: 220-280g of tauroursodeoxycholic acid, 22-28g of starch, 25-35g of lactose, 5-7g of microcrystalline cellulose, 1-2g of hydroxypropyl methylcellulose, 1-2g of magnesium stearate and 2-5g of hydroxy propyl cellulose. Through different proportions of the prescription, a proper adhesive, a stabilizer and a disintegrating agent are adopted, so that the dissolution behavior of the prepared capsule preparation is equivalent to or the same as that of a columnar compression powder capsule.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a tauroursodeoxycholic acid capsule and a preparation method thereof. Background technique [0002] In recent years, the incidence of gallstones and cholecystitis has gradually increased. It is about 10% for adults in my country, and even as high as 15% for middle-aged women. Common gallstones are cholesterol stones and pigment stones and their mixed stones. Surgical therapy and stone-dissolving therapy are commonly used clinically. Surgical therapy not only increases the suffering of patients, but also easily causes complications or serious consequences. Commonly used drugs for stone-dissolving therapy include chenodeoxycholic acid (CDCA), ursodeoxycholic acid (UDCA), and hyodeoxycholic acid. CDCA has many side effects, such as diarrhea and liver damage. The stone-dissolving effect of UDCA is better than that of CDCA, and the side effects are much smaller,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/575A61K47/38A61P1/16
Inventor 李元波黄兴悦袁瑜张学建陈龙虎罗敏王颖
Owner YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD
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