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Oral solid preparation for treating bladder cancer and preparation method of oral solid preparation

A solid and tablet technology, applied in the direction of non-active ingredient medical preparations, pill delivery, pharmaceutical formulations, etc., can solve the problems that diabetic patients are not suitable for long-term use, complicated process steps, difficult quality control, etc., and achieve good clinical use Value and social benefits, simple preparation process, and the effect of avoiding burst release phenomenon

Inactive Publication Date: 2021-02-26
JIANGSU YAHONG MEDITECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the sugar-coating process is an old preparation process, the process operation steps are complex, time-consuming and labor-intensive, the experience is strong, the quality is difficult to control, and it is difficult to industrialize large-scale production
In addition, because the sugar coating contains a lot of powdered sugar and talcum powder, middle-aged and elderly people and patients with diabetes should not take it for a long time

Method used

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  • Oral solid preparation for treating bladder cancer and preparation method of oral solid preparation
  • Oral solid preparation for treating bladder cancer and preparation method of oral solid preparation
  • Oral solid preparation for treating bladder cancer and preparation method of oral solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] The preparation one of embodiment 1 nitroxyquinoline oral solid tablet core

[0058] In order to obtain a tablet core prescription with a moderate dissolution rate and avoid sudden release, the types and proportions of excipients are selected. Based on the total weight of the tablet core, the weight percentages of various components are shown in Table 1 below.

[0059] The percentage by weight of various components in each prescription of table 1

[0060]

[0061] The preparation method of nitroxyquinoline tablet tablet core:

[0062] (1) according to the above table, take respectively nitroquinoline, filler, disintegrating agent, binding agent and lubricant of each prescription amount;

[0063] (2) 10 mesh sieves are crossed by nitraxine, and 60 mesh sieves are crossed by other components, for subsequent use;

[0064] (3) the binder (starch) of each prescription amount is mixed with the aqueous solution of 5% mass concentration with purified water, for subsequent...

Embodiment 3

[0072] The preparation two of embodiment 3 nitroxyquinoline oral solid tablet core

[0073] Taking the above-mentioned prescription 7 with a moderate release rate as a sample, after the preliminary influencing factor test at 60°C for 10 days (the tablet core was placed in a blast drying oven at 60°C for 10 days), it was found that the tablet could hardly disintegrate. After analysis and research, it is found that the reason may be that the nitroxoquinoline as an ion complexing agent has taken away the magnesium in the magnesium stearate, so that the stearic acid is freed, and the stearic acid with a low melting point and hydrophobicity is at the accelerated test temperature. The water-permeable channels in the sheet are blocked after melting, causing the disintegration rate to decrease. In order to solve the problem of aging of prescriptions containing magnesium stearate, lubricants were screened, and stearic acid was used as a positive control formula (prescription 8) for ver...

Embodiment 5

[0088] Embodiment 5 nitroxyquinoline oral solid tablet core and its preparation

[0089] Based on the total weight of the tablet core, the weight percentages of various components are shown in Table 3 below. Wherein the binder formula ratio is the proportion of solids used, and the binder used in the preparation is an aqueous solution of 5% starch.

[0090]

[0091] Preparation:

[0092] (1) according to the above table, take respectively nitroquinoline, filler, disintegrating agent, binding agent and lubricant of each prescription amount;

[0093] (2) 10 mesh sieves are crossed by nitraxine, and 60 mesh sieves are crossed by other components, for subsequent use;

[0094] (3) The binder (starch or hypromellose) is prepared into an aqueous solution of 5% mass concentration with purified water for subsequent use;

[0095] (4) Nitroxine, filler (lactose, starch, microcrystalline cellulose) and disintegrant (hydroxypropyl cellulose) of each prescription amount are put into t...

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Abstract

The invention relates to an oral solid preparation for treating bladder cancer and a preparation method of the oral solid preparation. Specifically, the invention provides a nitrohydroxyquinoline oralsolid tablet which contains nitrohydroxyquinoline as an active ingredient, a filler, a binder, a disintegrating agent, a lubricant and an optional coating agent. The oral solid tablet containing thenitrohydroxyquinolinone is moderate in dissolution rate, capable of avoiding burst release, moisture-proof, impermeable, good in stability, safe, effective, convenient to take and high in patient compliance, the preparation process is suitable for industrial mass production, and the oral solid tablet has good clinical use value and social benefits.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oral solid preparation for treating bladder cancer and a preparation method thereof. Background technique [0002] Bladder cancer is one of the malignant tumors that seriously threaten human health and is the most common malignant tumor of the urinary system. According to the data disclosed in the 2018 edition of "Bladder Cancer Diagnosis and Treatment Standards", the incidence of bladder cancer worldwide: the incidence rate ranks 11th among all malignant tumors, and the male incidence rate is 9.0 / 100,000, ranking 7th among male malignant tumors 2.2 / 100,000 for women, ranking after tenth for women; the death rate ranks the thirteenth among all tumors, the male and female mortality rates are 3.2 / 100,000 and 0.9 / 100,000, and the mortality rate is the highest among men Malignant tumors ranked 9th. According to statistics from the National Cancer Registry Center, the i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/26A61K47/36A61K47/38A61K47/12A61K47/20A61K47/22A61K47/02A61K47/10A61K31/47A61P35/00
CPCA61K9/2013A61K9/2018A61K9/2059A61K9/2054A61K9/2095A61K9/2893A61K9/2886A61K9/2813A61K9/2853A61K9/2866A61K9/282A61K31/47A61P35/00A61K31/4706A61K9/284Y02A50/30A61K9/0053A61K9/2826
Inventor 刘江华郭玉申申帅朱伟
Owner JIANGSU YAHONG MEDITECH CO LTD
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