CN-121987831-A - Placebo matrix composition simulating bitter taste after traditional Chinese medicine decoction, and gargle placebo with taste of large Huang Huanglian and preparation method thereof

CN121987831ACN 121987831 ACN121987831 ACN 121987831ACN-121987831-A

Abstract

The invention provides the use of xanthan gum, soybean lecithin and bittering agents in combination in a placebo matrix for bitter taste after use in a traditional Chinese medicine decoction. The invention provides a placebo matrix composition for simulating the bitter taste of a traditional Chinese medicine decoction, which comprises the following raw materials, by weight, 0.03% -0.04% of a bitter agent, 0.05% -0.2% of xanthan gum and 1.5% -3% of soybean lecithin. The invention also provides a gargle placebo with great flavor Huang Huanglian. Aiming at the defects that the simple addition of the bitter agent can only generate instantaneous bitter taste and the bitter taste is resolved quickly in the prior art, the invention provides a method capable of actively regulating and obviously prolonging the perception duration time of the bitter taste, so that the placebo can realistically reproduce the complete time-intensity curve of ' after-bitter taste of the traditional Chinese medicine decoction ' for a long time after the entry ' so as to avoid blindness breaking of a subject due to the difference of the bitter duration time. The invention breaks through the limitation of traditional solution simulation, aims to provide a new thought for the preparation of the traditional Chinese medicine placebo, further improves the sensory simulation level of the traditional Chinese medicine placebo, and provides a method and a reference for the research and study of similar placebo.

Inventors

HUANG HAOZHOU
ZHANG DINGKUN
ZHENG CHUAN
WU JING
YOU FENGMING
XIE XINGLIANG

Assignees

成都中医药大学

Dates

Publication Date: 20260508
Application Date: 20260227

Claims (10)

1. Use of xanthan gum, soybean lecithin and a bittering agent in combination in a placebo matrix for bitter taste after use in a traditional Chinese medicine decoction.
2. A placebo matrix composition simulating the bitter taste of a traditional Chinese medicine decoction is characterized by comprising the following raw materials in percentage by weight: 0.03 to 0.04 percent of bittering agent, 0.05 to 0.2 percent of xanthan gum and 1.5 to 3 percent of soybean lecithin.
3. The placebo matrix composition for simulating post-decoction bitter taste of traditional Chinese medicine according to claim 2, wherein the decoction comprises the following raw materials in percentage by weight: 0.03 percent of bittering agent, 0.1 percent of xanthan gum and 2.5 percent of soybean lecithin.
4. The placebo matrix composition for simulating post-decoction bitter taste of a traditional Chinese medicine according to claim 2 or 3, wherein said bitter agent is sucrose octaacetate.
5. A gargle placebo of claim Huang Huanglian, which contains a placebo matrix composition simulating the bitter taste of a decoction of a traditional Chinese medicine according to any one of claims 2 to 4.
6. The flavored large Huang Huanglian mouthwash placebo according to claim 5, wherein it contains 1% of the odorant peppermint flavour.
7. The flavored large Huang Huanglian mouthwash placebo according to claim 6, further comprising the coloring agents lemon yellow, caramel color, sunset yellow, in weight percent, of 0.0075% -0.01% lemon yellow, 0.0075% -0.01% caramel color, and 0.0075% -0.005% sunset yellow.
8. The flavored large Huang Huanglian mouthwash placebo of claim 7, further comprising the coloring agents lemon yellow, caramel color, sunset yellow, in weight percent, 0.01% lemon yellow, 0.1% caramel color, and 0.005% sunset yellow.
9. A process for the preparation of a flavored large Huang Huanglian mouthwash placebo according to any one of claims 5 to 8, characterized in that it comprises the following steps: a. pure water is taken, wherein 40 percent of pure water is added into xanthan gum, and the mixture is stirred uniformly to form a network; b. Adding sucrose octaacetate into 60% pure water, dissolving, slowly adding soybean lecithin, stirring to uniformly disperse, stirring at 60 ℃ for 15min to enable the sucrose octaacetate to be encapsulated in a soybean lecithin micelle hydrophobic core, mixing a xanthan gum solution and a soybean lecithin solution, and finally adding pigment and essence to obtain a placebo solution.
10. The method for preparing a flavored large Huang Huanglian mouthwash placebo according to any one of claims 5 to 8, or a flavored large Huang Huanglian mouthwash placebo according to claim 9, wherein the method for preparing a flavored large Huang Huanglian mouthwash is: Soaking radix et rhizoma Rhei, glycyrrhrizae radix and rhizoma Bletillae 10g each in 12 times of water for 30min min, decocting for 30min, filtering, collecting Coptidis rhizoma 10g, decocting for another 30min, filtering with gauze, mixing the filtrates, concentrating, filtering, and concocting.

Description

Placebo matrix composition simulating bitter taste after traditional Chinese medicine decoction, and gargle placebo with taste of large Huang Huanglian and preparation method thereof Technical Field The invention relates to a placebo matrix composition simulating the bitter taste of traditional Chinese medicine decoction, and a gargle placebo with a taste of Huang Huanglian a and a preparation method thereof. Background At present, the registration application of traditional Chinese medicine presents a continuous growth situation, the number of new medicine clinical trials (IND) is increased year by year, and in a traditional Chinese medicine clinical evaluation system, strict random, double-blind and placebo-controlled clinical trials are developed as 'gold standard' for obtaining high-level evidence-based medical evidence. However, the Traditional Chinese medicine preparation has complex components, and the oral dosage form of the Traditional Chinese medicine preparation generally has unique multidimensional sensory attributes such as shape, color, smell, taste, quality and the like, which brings significant challenges for the simulation preparation of a Traditional Chinese Medicine Placebo (TCMP). Traditional placebo multi-focuses on the simulation of single attributes such as color or taste, and it is difficult to systematically reproduce the overall sensory experience of traditional Chinese medicine formulations in terms of characteristic bitter taste duration, etc. Meanwhile, the simulation degree of TCMP directly influences the quality of clinical test, and if the simulation is insufficient, the risk of blindness breaking can be caused. The traditional Chinese medicine decoction has complex components, and the taste (especially bitter) of the traditional Chinese medicine decoction is not only derived from instant feeling in the mouth, but also more often shows persistent 'after-bitter' after swallowing or gargling, which is determined by the slow release of various fat-soluble and small-molecule bitter components. The prior art has focused on how to "mask" or "eliminate" the undesirable bitter taste, such as by cyclodextrin inclusion, ion exchange resin adsorption, or the use of sweeteners, flavoring agents in large quantities. However, the preparation of the traditional Chinese medicine placebo is not only aimed at the liquid medicine with optimized taste, but also needs to simulate the bitter taste of the real liquid medicine realistically. The mechanism of the existence of "after-bitter taste" in bitter taste is relatively complex, and bitter substances of different drugs are different (Tan Chunhua, etc., development of research on bitter mechanism and novel bitter suppressing agent, modern food science and technology, 2025, vol.41, no. 7). In addition, the post-bitter substances are also different among the different bitter drugs (Chen Yan, et al, analysis of bitter metabolites after papaya fruit pulp cutting based on electronic tongue and metabonomics techniques, & gt, southern fruit tree in China). The existing placebo simulation techniques do not have a method to simulate the bitter taste profile, conventional placebo preparation only focused on the simulation of color, appearance and base viscosity, or the addition of a direct small amount of bittering agent to the formulation. However, the method only can generate 'bitter taste in mouth', the bitter taste is resolved rapidly, and the complex time and intensity curve of 'bitter taste in mouth-after-bitter taste is long-lasting' of the real traditional Chinese medicine decoction cannot be reproduced, which easily causes that the subjects pass through the taste difference 'blind breaking' in the clinical test, and the double blind test is disabled. While the mere use of a thickener can slightly delay the taste diffusion, excessive use of the thickener can bring about an unreal sticky and greasy taste. How to realize the controllable slow release of bitter molecules on the premise of not influencing the overall rheological property of the liquid medicine is a key problem to be solved in the field. The addition of the bittering agent into the base solution simulated by the placebo can only generate instant bitter taste, the release of the bitter taste is fast, the fading is fast, the slow release and lasting bitter taste caused by complex components in real decoction cannot be simulated, the subject is easy to break the blindness by the short duration of the bitter taste, most of the placebo bitter taste simulation multi-purpose fat-soluble substance sucrose octaacetate at present, and the slow release effect of a single thickener added to hydrophobic bitter molecules is limited. The flavored rhubarb and coptis heart-purging gargle is derived from the rhubarb and coptis heart-purging decoction of the typhoid fever theory, the original prescription consists of two ingredients of rhubarb and coptis, and the improved prescription is added with liquo