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Nifuratel compound tablet and preparation method thereof

A nifuratel and composition technology, which is applied in the field of nifuratel composition tablet and preparation thereof, can solve the problem of unsuitability for industrial production and clinical use, slow disintegration of oral tablet, poor adverse reaction effect, etc. problem, to achieve the effect of accurate dose, one-sided smooth and beautiful, and low cost

Active Publication Date: 2013-01-23
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, nifuratel has been listed in dosage forms such as oral tablets, capsules, vaginal tablets and capsules, but at present, various dosage forms have the problems of large side effects, many adverse reactions, relatively poor effects, and low bioavailability. Especially nifuratel oral tablet has the disadvantages of slow disintegration rate, low dissolution rate and poor stability, and is not suitable for industrial production and clinical use

Method used

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  • Nifuratel compound tablet and preparation method thereof
  • Nifuratel compound tablet and preparation method thereof
  • Nifuratel compound tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Nifuratel was used as the raw material to investigate the effects of the dosage of various excipients on the angle of repose, hardness, appearance, disintegration, friability and dissolution of the drug. The dosage of excipients in each prescription is shown in Table 1.

[0035] Sieve the raw materials and auxiliary materials separately, and set aside; Nifuratel, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized starch, croscarmellose sodium, carboxymethyl starch sodium, stearin Magnesium acid was mixed according to the prescription amount, and the angle of repose was measured. After tableting, the hardness, appearance, weight difference, disintegration, friability, and dissolution were measured. The results are shown in Table 2. Among them, the determination methods of hardness, appearance, weight difference, disintegration, friability and dissolution refer to the second appendix of "Chinese Pharmacopoeia" 2005 edition. Appearance: visual i...

Embodiment 2

[0042]Prepare nifuratel granules with prescription 4 of Example 1, take three parts and place them in a weighed flat weighing bottle, respectively place them under the conditions of RH43%, RH59%, and RH70%, place 1, 3, 5 After taking it out, weigh them respectively, investigate the influence of different humidity on the drug, and calculate the moisture absorption rate of the particles. The results are shown in Table 3.

[0043] Table 3 moisture absorption rate test results

[0044] condition

[0045] It can be seen from the results in Table 3 that under the humidity condition of RH70%, the moisture absorption weight gain increases significantly, and under the condition of RH59% humidity, the moisture absorption weight gain does not change significantly. Therefore, the space humidity must be controlled below RH59% during the preparation process.

Embodiment 3

[0046] Embodiment 3: Nifuratel composition tablet of the present invention

[0047]

[0048]

[0049] Preparation method: pass nifuratel, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium and carboxymethyl starch sodium through 80 mesh sieve respectively, and then 2000g of nifuratel, 250g of Mix microcrystalline cellulose, 470g of pregelatinized starch and 128g of croscarmellose sodium evenly, add 1000g of soft material made of 4% hypromellose and 50% ethanol, pass through a 20-mesh sieve to make granules , control the humidity below RH59%, dry the prepared granules at 50-60°C, pass through a 18-mesh sieve, add 224g of sodium carboxymethyl starch and 32g of sodium stearate, mix well, and press with a Φ11mm shallow arc surface die Slices, ready to serve.

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Abstract

The invention belongs to the field of medical preparations and discloses a nifuratel compound tablet and a preparation method thereof. The nifuratel compound tablet disclosed by the invention has the following advantages of high disintegration speed and dissolving rate, excellent stability, exact dosage, convenience to take and carry, easily-obtained raw materials and low cost. The preparation method of the nifuratel compound tablet is simple in operation, easy to control, time-saving, labor-saving and beneficial for large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a nifuratel composition tablet and a preparation method thereof. Background technique [0002] Vaginitis is one of the common diseases in gynecology. It can be caused by different reasons such as candida, vaginal bacteria, vaginal trichomonas, etc. Among them, those caused by bacteria account for about 30% to 35% of vaginitis, and the vaginitis caused by candida accounts for about 30% of vaginitis. 20% to 25%, trichomonas vaginalis accounted for 10%, mixed infection accounted for 15% to 20%. Bacterial vaginosis is a syndrome without vaginal mucosal inflammation caused by a variety of pathogens, mainly anaerobic bacteria mainly Gardnerella, which can lead to upper reproductive tract infection, amnion choriovitis, and premature rupture of membranes , premature birth, postpartum endometritis, infection after cesarean section and total hysterectomy, etc. Vulvovaginal cand...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/30A61K31/422A61K47/38A61P15/02A61P31/02A61P33/02
Inventor 李明杰冯长运刘文文牛洪芬
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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