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Orally disintegrating tablet of 'Shuanghuanglian' and its preparation

A technology of orally disintegrating tablets and Shuanghuanglian, which is applied in pharmaceutical formulas, medical preparations containing active ingredients, and pill delivery, can solve the problems of unstable chemical structure of chlorogenic acid and reduction of chlorogenic acid content, and achieve pharmacological Good effect, rapid onset and convenient storage

Inactive Publication Date: 2005-03-16
张晴龙
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Shuanghuanglian orally disintegrating tablets are composed of honeysuckle, baicalin, and forsythia, and are derived from Shuanghuanglian injection, but many adverse reactions have been found in clinical application of Shuanghuanglian injection (Shizhen Guoyi Guoyao, 1998, Volume Nine, Third Period, 283 pages), caused a lot of pain to the patient; Shuanghuanglian Granules ("The Pharmacopoeia of the People's Republic of China" 2000 edition one 420 pages) in the preparation process takes water decoction, ethanol precipitation extraction method to honeysuckle, forsythia, The chemical structure of chlorogenic acid, the active ingredient of honeysuckle, is unstable. This method reduces the content of chlorogenic acid in honeysuckle during the heating process of water extraction (Chinese Journal of Traditional Chinese Medicine, 1994, volume 9, pp. 545-547), so the Extraction should be carried out by warm soaking method, and forsythia contains hemolytic components, so in the process of alcohol precipitation, alkaline ethanol should be used for precipitation to remove hemolytic components in forsythia (Chinese patent medicine, 1997, fifth period, 46-47 page); the patent search did not find the patent of Shuanghuanglian orally disintegrating tablets

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0125] (1) bulk drug of the present invention is:

[0126] Honeysuckle is 150 grams, Scutellaria is 150 grams, and Forsythia is 300 grams;

[0127] (2) Take honeysuckle, use 6 times, 40% ethanol solution, adjust the pH value to 4 with hydrochloric acid, keep the temperature at 40 ° C, soak for 3 hours, filter, combine the soaking liquid, reclaim the ethanol to the utmost, vacuum concentration and drying, water Dissolve completely, filter, put the filtrate on a D101 macroporous adsorption resin column, wash the column with water until clarification, and then elute with 40% ethanol until no blue fluorescence is detected for fluorescence detection, collect the eluate, and depressurize When concentrated to 50°C, the relative density of the extract is 1.20, add 95% ethanol to the alcohol content of 80%, let it stand for 12 hours, filter, take the supernatant, recover the ethanol to the end, concentrate and dry in vacuum to obtain the effective part of honeysuckle 5.0 grams;

[01...

Embodiment 2

[0134] (1) bulk drug of the present invention is:

[0135] Honeysuckle is 150 grams, Scutellaria is 150 grams, and Forsythia is 300 grams;

[0136] (2) Take honeysuckle, use 8 times, 50% ethanol solution, adjust the pH value to 6 with hydrochloric acid, keep the temperature at 50 ° C, soak for 5 hours, filter, combine the soaking liquid, reclaim ethanol to the utmost, vacuum concentration and drying, water Dissolve completely, filter, put the filtrate on a D101 macroporous adsorption resin column, wash the column with water until clarification, and then elute with 50% ethanol until no blue fluorescence is detected for fluorescence detection, collect the eluate, and depressurize When concentrated to 50°C, the relative density of the extract is 1.30, add 95% ethanol to the alcohol content of 85%, let it stand for 24 hours, filter, take the supernatant, recover the ethanol to the end, concentrate and dry in vacuo, and obtain the effective part of honeysuckle 12.0 grams;

[0137...

Embodiment 3

[0142] (1) bulk drug of the present invention is:

[0143] Honeysuckle is 300 grams, Scutellaria is 300 grams, and Forsythia is 600 grams;

[0144] (2) Take honeysuckle, use 7 times, 45% ethanol solution, adjust the pH value to 5 with hydrochloric acid, keep the temperature at 45 ° C, soak for 4 hours, filter, combine the soaking liquid, reclaim ethanol to the utmost, vacuum concentration and drying, water Dissolve completely, filter, put the filtrate on a D101 macroporous adsorption resin column, wash the column with water until clarification, and then elute with 45% ethanol until no blue fluorescence is detected for fluorescence detection, collect the eluate, and depressurize When concentrated to 50°C, the relative density of the extract is 1.25, add 95% ethanol to the alcohol content of 82%, let it stand for 14 hours, filter, take the supernatant, recover the ethanol to the end, concentrate and dry in vacuo, and obtain the effective part of honeysuckle 21.9 grams;

[0145...

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PUM

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Abstract

The invention discloses an orally disintegrating tablet of 'Shuanghuanglian' and its preparation characterized in that the tablet comprises the significant portions extracted from traditional Chinese medicinal honeysuckle flower, baikal skullcap root, capsule of weeping forsythia and other medical use findings, the invention is also characterized that composite disintegrating tablet containing tetrahydroxy butane is employed, wherein the composite disintegrating tablet is obtained by combining tetrahydroxy butane with low substituted Hydroxypropylmethyl cellulose or sodium carboxymethylstarch or crossbond sodium carboxymethylstarch or insoluble cross bond polyvinylpyrrolidone by a finite proportion, the tetrahydroxy butane has the action of taste rectifying agent, thus reducing the consumption of medicinal findings in the preparation. Pharmacological experiment has shown that the disintegrating tablet has the advantages of quick disintegration, fast effect, and better pharmacological actions.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine pharmacy, and in particular relates to a Shuanghuanglian orally disintegrating tablet and a preparation method thereof. Background technique [0002] Orally disintegrating tablets are a new pharmaceutical preparation, which can be absorbed through the sublingual mucosa and directly enter the blood, effectively avoiding the first-pass effect, so the dosage is small, safe and has a rapid effect. Although it is an oral preparation, it can achieve the effect of an injection preparation. Therefore, it is gradually becoming a hot spot in the field of pharmaceutical companies and research and development. The dosage form is mainly to choose a suitable fast disintegrating agent, and the tablet made of it has a certain hardness and a certain degree of porosity. When taking it, it does not need water to assist swallowing, and it can quickly disintegrate into fine particles in the mouth...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61P11/04A61P31/12
Inventor 张晴龙
Owner 张晴龙
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