Pharmaceutical composition containing danazol and application thereof

A composition, the technology of danazol, which is applied in the field of pharmaceutical composition containing danazol and its preparation, can solve the problems affecting the effectiveness and safety, reducing the compliance of patients taking medicine, and the low content of danazol, and achieves Improve the safety of use, simplify the clinical drug regimen, and facilitate swallowing

Active Publication Date: 2020-08-28
HEILONGJIANG UNIV OF CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the composition contains a large amount of surfactants with solubilizing properties and hydrophilic excipients. On the one hand, the content of danazol is low, and repeated medication is required, which greatly reduces the patient's medication compliance.
On the other hand, the application of a large number of excipients still has potential problems such as the compatibility of raw materials and excipients, the stability of preparations, and the control of impurity limits, which directly affect the effectiveness and safety.

Method used

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  • Pharmaceutical composition containing danazol and application thereof
  • Pharmaceutical composition containing danazol and application thereof
  • Pharmaceutical composition containing danazol and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0034] Examples 1-3 Preparation of Orally Disintegrating Tablets of Danazol

[0035] The composition of danazol oral disintegrating tablet is shown in Table 1, and its preparation method is as follows:

[0036] Pass danazol through a 100-mesh sieve, and other excipients through an 80-mesh sieve; weigh the prescription amount of danazol, mix with the prescription amount of lecithin, sodium lauryl sulfate, sodium carboxymethyl starch, colloidal silicon dioxide, Cross-linked polyvinyl pyrrolidone XL-10 (inside), moistened with 45% ethanol to make soft material; add the above mixture, lactose, low-substituted hydroxypropyl methylcellulose, cross-linked polyvinyl pyrrolidone XL-10 ( outside), mix well, moisten with 45% ethanol to make soft material, granulate; pass through a 40-mesh sieve; add magnesium stearate in the prescribed amount, and press into tablets.

[0037] Table 1 embodiment 1-3 danazol tablet composition

[0038] Composition (mg) Example 1 Example 2 ...

Embodiment 4-6

[0039] Examples 4-6 Tablet Properties and Dissolution Investigation

[0040] 1. Tablet performance investigation

[0041] The properties of the tablets of Examples 1-3 were investigated, and the results are shown in Table 2.

[0042] Table 2 Examples 1-3 Tablet Properties

[0043]

[0044]

[0045] It can be seen from the results in Table 2 that, compared with Example 3, the tablets prepared in Example 1-2 have uniform particles, good fluidity, smooth surface without cracks, and significantly improved hardness and friability. It is not prone to chipping, capping or cracking, and can completely disintegrate in 45s.

[0046] 2. Dissolution determination

[0047]Take this product, according to the dissolution and release determination method (general rule 0931 second method), use 0.1mol / L hydrochloric acid solution-isopropanol (3:2) 1000mL as the dissolution medium, the rotation speed is 80 revolutions per minute, after At 30 minutes, take 25 mL of solution and filter...

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PUM

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Abstract

The invention relates to a solid pharmaceutical composition containing danazol. The solid pharmaceutical composition comprises the following components in percentage by weight: 70-99% of danazol and 1-10% of a pharmaceutically acceptable carrier. The pharmaceutically acceptable carrier is optionally selected from any one or a combination of a diluent, a lubricant, an adhesive, a disintegrating agent and a glidant. By scientifically screening and optimizing the formula of the solid pharmaceutical composition, firstly, the content of danazol is increased, a clinical medication scheme is simplified, and the medication compliance of a patient is remarkably improved; 2, the hardness and friability of the tablet are obviously improved, and the product quality is improved; 3, potential problems of impurity limit control and the like possibly caused by auxiliary materials are remarkably reduced, and the use safety of the medicine is improved; and 4, the dissolution rate of the drug is improved, so that the danazol can be absorbed by a human body to the maximum extent.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition containing danazol, a preparation method and an application thereof. Background technique [0002] Endometriosis refers to the growth of the endometrium (including glands and stroma) in other tissues other than the endometrium covered by the uterine cavity, clinically manifested as ovarian cysts, dysmenorrhea and infertility, etc. seriously affect the quality of life of patients. For women of childbearing age, conservative surgery is the most common method for the treatment of ovarian endometriosis, but the recurrence rate of the disease after surgery is increasing year by year, including the recurrence of lesions and symptoms. According to literature statistics, the recurrence rate of endometriosis after conservative surgery is 8%-10%, the recurrence rate of 2 years after surgery is about 20%, and the cumulative recur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/26A61K47/04A61K31/58A61P15/00
CPCA61K9/0056A61K9/2009A61K9/2018A61K9/2054A61K31/58A61P15/00
Inventor 韩亚光韩亚鹏朱小琳
Owner HEILONGJIANG UNIV OF CHINESE MEDICINE
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