Search

CN-122005872-A - Placebo of bitter wine soup powder, preparation method thereof and simulation degree evaluation method

CN122005872ACN 122005872 ACN122005872 ACN 122005872ACN-122005872-A

Abstract

The invention provides a placebo of bitter liquor soup powder, which is prepared from the following raw materials, by weight, 2, 080-3, 120 parts of a filler, 60-90 parts of a clouding agent, 0.0704-0.1056 part of a pigment, 40-60 parts of a tackifier, 107.2-160.8 parts of a taste auxiliary material, 44.2-66.3 parts of a smell auxiliary material and 67.84-101.76 parts of a foaming agent. The invention also provides a preparation method and a simulation degree evaluation method of the placebo of the bitter wine Shang Fenji. The invention screens out the percolation process as the best extraction process through a radioactive oral mucosa animal experiment, further carries out systematic optimization on the extraction-freeze-drying-flavoring process, successfully prepares the 'temporary instant formula' bitter liquor Shang Fenji, and develops the high-simulation placebo based on the multidimensional sensory characteristics of bitter liquor soup powder such as shape, color, smell, taste and the like. The evaluation method of the invention respectively evaluates the similarity of the powder, dissolution behavior and solution appearance of the placebo, synchronously imitates the three states, improves the solubility of the crude drug powder and the placebo respectively through freeze-drying protective agent and micronization to make the crude drug powder and the placebo similar, and has special appearance and physicochemical properties of the solution after the dissolution of the crude drug, thus carrying out simulation optimization.

Inventors

  • HUANG HAOZHOU
  • ZHANG DINGKUN
  • ZHENG CHUAN
  • FENG JIAMIN
  • YOU FENGMING
  • XIE XINGLIANG

Assignees

  • 成都中医药大学

Dates

Publication Date
20260512
Application Date
20260214

Claims (10)

  1. 1. The placebo of the bitter wine soup powder is characterized by being prepared from the following raw materials in parts by weight: Filling agent 2,080-3,120 parts, clouding agent 60-90 parts, pigment 0.0704-0.1056 parts, adhesion promoter 40-60 parts, taste auxiliary material 107.2-160.8 parts, smell auxiliary material 44.2-66.3 parts and foaming agent 67.84-101.76 parts; the bulking agent comprises one or two of mannitol and maltodextrin, the clouding agent comprises soybean lecithin, the pigment comprises one or two of lemon yellow and sunset yellow, the adhesion promoter comprises acacia, the taste auxiliary material comprises one or more of salt, monosodium glutamate, acetic acid powder and mogroside, the taste auxiliary material comprises one or more of acetic acid, peppermint essence and orange essence, and the foaming agent comprises tween 80.
  2. 2. The placebo for bitter wine Shang Fenji according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 2600 parts of filler, 75 parts of turbid agent, 0.088 part of pigment, 50 parts of adhesion promoter, 134 parts of taste auxiliary material, 55.25 parts of odor auxiliary material and 84.8 parts of foaming agent; The filler comprises mannitol and maltodextrin, the turbid agent comprises soybean lecithin, the pigment comprises lemon yellow and sunset yellow, the adhesion promoter comprises Arabic gum, the taste auxiliary material comprises a mixture of salt, monosodium glutamate, acetic acid powder and mogroside, the smell auxiliary material comprises a mixture of acetic acid, mint essence and orange essence, and the foaming agent comprises tween 80.
  3. 3. The placebo for bitter wine Shang Fenji according to claim 2, which is characterized by being prepared from the following raw materials in parts by weight: 84.8 parts of tween, 1040.3448 parts of mannitol, 1560.5172 parts of maltodextrin, 54mg of salt, 66 parts of acetic acid powder, 9mg of monosodium glutamate, 0.07 part of lemon yellow pigment, 0.018 part of sunset yellow pigment, 75 parts of soybean lecithin, 50 parts of Arabic gum, 30 parts of mint essence, 20 parts of orange essence, 5 parts of mogroside and 5.25 parts of acetic acid.
  4. 4. The placebo for bitter wine Shang Fenji according to any one of claims 1-3, wherein the preparation method of bitter wine Shang Fenji comprises the following steps: a. Weighing raw materials in weight ratio, wherein each 4g of purified pinellia corresponds to 12ml of rice vinegar and 35ml of egg white; b. adding rice vinegar into purified pinellia tuber, soaking, percolating with a percolation method, and collecting percolate; c. mixing the percolate with ovum gallus Domesticus album, filtering, lyophilizing to obtain lyophilized powder, and adding correctant accounting for 1.8% -2.4% of the total amount of the lyophilized powder.
  5. 5. The placebo for bitter liquor Shang Fenji according to claim 4, wherein in the process for preparing bitter liquor Shang Fenji, Pulverizing the purified pinellia tuber in the step a into coarse powder, coarse powder and medium powder; b, soaking for 0.5-2.0h, soaking for 6-36h, and percolating at a flow rate of 1 mL/min-3 mL/min seed kg; c, adding a freeze-drying protective agent in the freeze-drying process, wherein the freeze-drying protective agent comprises mannitol, sucrose, glucose or trehalose, and the dosage of the freeze-drying protective agent is 2.5-10%; The freeze-drying condition in the step C is that pre-frozen at-80 ℃ for 6 h, and then dried at the vacuum degree of 20-Pa and the cold trap temperature of-50 ℃ for 24-h; The flavoring agent in the step c is a composition of mint essence, orange essence and mogroside, and the weight ratio of the composition is as follows: 0.6-1.4 parts of mint essence, 0.6-1.4 parts of orange essence and 0.3-0.4 part of momordica glycoside; Preferably, the flavoring agent is a composition of peppermint essence and orange essence, and the weight ratio of the flavoring agent is as follows: 1.2 parts of mint essence, 0.8 part of orange essence and 0.3 part of mogroside.
  6. 6. The placebo for bitter liquor Shang Fenji, wherein in the process for preparing bitter liquor Shang Fenji, A, crushing the purified pinellia tuber in the step a into medium powder; b, soaking time is 1h, soaking time is 18h, and percolating flow rate is 2.0 mL/min and kg; c, adding a freeze-drying protective agent in the freeze-drying process, wherein the freeze-drying protective agent is mannitol, and the dosage of the freeze-drying protective agent is 5%.
  7. 7. A process for preparing a placebo for bitter wine Shang Fenji according to any one of claims 1 to 5, comprising the steps of: Weighing filler and solution turbid agent, grinding in mortar, mixing, adding pigment, taste adjuvant and smell adjuvant solution, mixing, adding viscosity increaser and foaming agent, grinding, sieving with No. five sieve (80 mesh, pore size 180 μm), and sieving with No. six sieve to obtain powder of at least 95%.
  8. 8. The method for preparing a placebo for bitter wine Shang Fenji according to claim 6, comprising the steps of: Adding Tween 80 with a prescription amount into a mortar, grinding uniformly, adding mannitol, salt, acetic acid, monosodium glutamate and mogroside with a prescription amount, grinding uniformly, adding lemon yellow pigment and sunset yellow pigment with a prescription amount, grinding uniformly, adding soybean lecithin, acacia and maltodextrin with a prescription amount into the mortar, grinding uniformly, drying at 105 ℃ for 30min, cooling, adding acetic acid, peppermint essence and orange essence with a prescription amount into the mortar, grinding uniformly, and sieving with a No. six sieve to obtain placebo powder.
  9. 9. A placebo simulation degree evaluation method for bitter liquor soup powder is characterized in that a headspace solid-phase microextraction-gas chromatography-mass spectrometry (HS-SPME-GC-MS), an electronic tongue, a color difference meter, a powder characteristic tester and a viscometer are adopted to analyze the multi-dimensional characteristics of 'shape, color, smell and quality' of bitter liquor Shang Fenji.
  10. 10. The method for evaluating the placebo degree of simulation of bitter liquor Shang Fenji according to claim 8, comprising the steps of: a. The method comprises the steps of carrying out volunteer evaluation by adopting a Likett scale, wherein evaluation indexes comprise powder color, powder smell, solution color, solution smell, clarity and solution taste, and the judgment standards comprise similarity threshold value, score >6 score, which indicates high similarity, calculating an included angle cosine (cos) value by using PyCharm 2022.2 software, wherein the closer the cos value is to 1, the higher the similarity is; b. instrument evaluation including The preparation characteristic similarity comprises repose angle, dispersity, clarity, viscosity and foamability; Smell similarity, namely evaluating and distinguishing smell of the sample in a powder state by using an electronic nose; taste similarity, namely evaluating and distinguishing the taste of the sample in a solution state by using an electronic tongue; Color similarity, namely adopting a color difference meter similarity evaluation method; c. And comparing the placebo with the bitter liquor powder standard to obtain a simulation result.

Description

Placebo of bitter wine soup powder, preparation method thereof and simulation degree evaluation method Technical Field The invention relates to a placebo of bitter liquor soup powder, a preparation method and a simulation degree evaluation method thereof. Background Bitter wine soup is a classical prescription for treating sore throat in traditional Chinese medicine, and is derived from Shang Han Lun. Exhibit unique advantages in the treatment of radioactive oral mucositis. Wherein bitter wine (rice vinegar) has effects of astringing and detumescence, eliminating phlegm and resolving masses of pinellia tuber, clearing dryness and promoting granulation, and the three medicines are combined together to play roles of healing sore and promoting granulation, clearing heat and resolving phlegm, and can effectively relieve mucosa swelling and pain and promote ulcer healing. In recent years, the country is greatly pushing the development of classical prescriptions, and the role of traditional Chinese medicine in supporting treatment of tumor radiotherapy is also receiving attention, which is an important opportunity for modern research of bitter liquor soup. However, the prescription still faces the problems of insufficient key information examination, inconvenient use of traditional dosage forms and lack of high-simulation placebo for restricting clinical science evaluation, and needs to promote standardization, dosage form improvement and evaluation system construction through systematic research. The traditional Chinese medicine decoction has unique color, smell and taste, and without highly similar placebo, subjects and researchers are extremely prone to breaking blind, so that expected effects and observer bias are caused, and scientificity and reliability of test results are seriously influenced (Shao Jingyuan, etc., research progress of a traditional Chinese medicine placebo manufacturing process and an evaluation method, medicine evaluation research, volume 46, 5 th phase 2023, 5 th month). The bitter liquor soup is used as a traditional menstruation prescription, has obvious appearance, color and smell characteristics, and the preparation of a placebo with consistent sense is a necessary condition for realizing random, double-blind and placebo control (RCT) design. Disclosure of Invention The invention provides a placebo of bitter wine soup powder, a preparation method and a simulation degree evaluation method thereof. The invention provides a placebo of bitter wine soup powder, which is prepared from the following raw materials in parts by weight: Filling agent 2,080-3,120 parts, clouding agent 60-90 parts, pigment 0.0704-0.1056 parts, adhesion promoter 40-60 parts, taste auxiliary material 107.2-160.8 parts, smell auxiliary material 44.2-66.3 parts and foaming agent 67.84-101.76 parts; the bulking agent comprises one or two of mannitol and maltodextrin, the clouding agent comprises soybean lecithin, the pigment comprises one or two of lemon yellow and sunset yellow, the adhesion promoter comprises acacia, the taste auxiliary material comprises one or more of salt, monosodium glutamate, acetic acid powder and mogroside, the taste auxiliary material comprises one or more of acetic acid, peppermint essence and orange essence, and the foaming agent comprises tween 80. Preferably, the feed additive is prepared from the following raw materials in parts by weight: 2600 parts of filler, 75 parts of turbid agent, 0.088 part of pigment, 50 parts of adhesion promoter, 134 parts of taste auxiliary material, 55.25 parts of odor auxiliary material and 84.8 parts of foaming agent; The filler comprises mannitol and maltodextrin, the turbid agent comprises soybean lecithin, the pigment comprises lemon yellow and sunset yellow, the adhesion promoter comprises Arabic gum, the taste auxiliary material comprises a mixture of salt, monosodium glutamate, acetic acid powder and mogroside, the smell auxiliary material comprises a mixture of acetic acid, mint essence and orange essence, and the foaming agent comprises tween 80. Further preferably, the feed additive is prepared from the following raw materials in parts by weight: 84.8 parts of tween, 1040.3448 parts of mannitol, 1560.5172 parts of maltodextrin, 54mg of salt, 66 parts of acetic acid powder, 9mg of monosodium glutamate, 0.07 part of lemon yellow pigment, 0.018 part of sunset yellow pigment, 75 parts of soybean lecithin, 50 parts of Arabic gum, 30 parts of mint essence, 20 parts of orange essence, 5 parts of mogroside and 5.25 parts of acetic acid. The preparation method of the bitter wine Shang Fenji comprises the following steps: a. Weighing raw materials in weight ratio, wherein each 4g of purified pinellia corresponds to 12ml of rice vinegar and 35ml of egg white; b. adding rice vinegar into purified pinellia tuber, soaking, percolating with a percolation method, and collecting percolate; c. mixing the percolate with ovum gallus Domesticus album, filtering, lyoph