Traditional Chinese medicine double-layer patch for treating dental ulcer and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine double-layer patch for treating dental ulcer and a preparation method thereof. The double-layer patch contains 18-22mg of abelmoschus manihot total flavone extract, the weight of the double-layer patch is only 64-84mg, the diameter of the double-layer patch is 7mm, and the thickness of the double-layer patch is 1.5-1.7 mm. Compared with 240 clinical contrast test results of existing patented authorized large-dose patches (the weight of each patch is 130 mg, and the patch contains 40 mg of abelmoschus manihot total flavone extract), it shows that compared with the large-dose patches (the diameter is 8 mm, and the thickness is 2.3-2.5 mm), the small-dose patch is light in foreign body sensation on the ulcer surface, good in patient compliance, high in compliance and 67.50% in ulcer healing rate; the patch is superior to a large-dose patch (62.50%); the results of 480 III-stage clinical tests carried out by adopting the small-dose patch show that the total effective rate of the small-dose patch on the clinical curative effect of dental ulcer (heart and spleen heat accumulation syndrome) is 61.28% and is remarkably superior to that of a blank control group (P is less than 0.01).

Description

Technical field: [0001] The invention relates to a preparation containing total flavonoids extract from hollyhock flowers, in particular to a traditional Chinese medicine double-layer patch for treating oral ulcers—a total flavonoids from hollyhock flowers oral patch, which is used for treating oral ulcers. [0002] The invention also relates to a preparation method of the total flavonoids of hollyhock flower oral patch. Background technique: [0003] The hollyhock flower has been recorded in the medical books of all dynasties in my country. Its medicinal use has a long history, and its folk use is also very common. It was first recorded in "Jiayou Materia Medica": "The smell of the flower is sweet, cold, slippery, and non-toxic. It is mainly used for urination and diarrhea. For the treatment of various malignant sores and pus without acne for a long time, it will heal immediately after applying it at the end, and it is an essential medicine for sores, disappearing carbuncles...

AI Technical Summary

Problems solved by technology

[0004] During the clinical application of the patented large-dose patch (ZL200710113698.8, oral patch with total flavonoids from Calendula officinalis) (130mg tablet weight, containing 40mg total flavonoids extract from hollyhock flowers), two dosage specifications, large and small, are required for clinical application. The results of the dose-exploratory clinical comparison test of 240 cases conducted by the two showed that the subjects reported that the large-dose patch with a tablet weight of 130mg, a diameter of 8mm, and a thickness of 2.3-2.5mm had a relatively strong foreign body sensation when pasted on the oral ulcer mucosa. Strong (the excipients in the patch, carbomer and hypromellose, have swelling effect when exposed to water), so the compliance is poor, and the dose is reduced by half. The small-dose patch with a thickness of 1.5-1.7 mm was pasted on the oral ulcer mucosa, and the foreign body sensation was not obvious, and the compliance of the subjects was improved

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