Radix paeoniae alba mouth decoction pieces and preparation method thereof
By preparing Bai Shaozui Decoction, the problem of uneven distribution of ingredients of Bai Shaozui Medicinal Materials was solved, and the effect of small particle size, uniform quality and high stability of the decoction was achieved, which was suitable for the needs of the modern Chinese medicine industry.
Patent Information
- Application Number
- CN202411520846.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-29
- Publication Date
- 2025-02-07
AI Technical Summary
The uneven distribution of the internal active ingredients of the white peony medicinal herbs leads to uneven quality and poor stability of the white peony decoction, which in turn affects the clinical efficacy and metastasis rate.
The preparation method of Baishaozui decoction is adopted, including selecting the white peony material at the root head, cutting it into small pieces of particle size of 2-4mm, and drying and sieving to obtain Baishaozui decoction with uniform particle size and stable quality. .
The white peony tablets have smaller particle sizes and more uniform quality, high decoction utilization rate, improved stability and safety, and are suitable for large-scale production and clinical applications.
Smart Images
Figure CN119386086A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of Chinese medicine pieces, in particular to a kind of white peony root Chewing decoction pieces and preparation method thereof. Background Art
[0002] As a traditional Chinese medicine processing method, Fuzhu was first seen in the Yellow Emperor's Classic of Internal Medicine. The original meaning of Fuzhu is to bite the medicine into pieces with the mouth so that it can be decocted and taken. Fuzhu Chinese medicine pieces are widely recorded and used in the medical books of successive dynasties. With the changes of history, according to the social environment, processing technology and development of Chinese medicine in different periods, Fuzhu is defined as a processing method that processes the medicine into madou-sized pieces for decoction and subsequent production.
[0003] As a traditional drug processing method, Fuzhu has been gradually replaced with the development of Chinese medicine processing technology. However, Fuzhu slices made by Fuzhu have unique application advantages. Fuzhu slices have smaller particle size and higher transfer rate than traditional slices. They save medicinal resources and retain some medicinal identification characteristics. They are not easy to cause turbidity of the medicinal solution and have certain advantages and application prospects. Under the guidance of traditional Chinese medicine theory, in order to meet the needs of the modernization of traditional Chinese medicine, the modern development and utilization of traditional Chinese medicine Fuzhu is of great significance to the high-quality development of the traditional Chinese medicine industry.
[0004] White peony root is a perennial herb of the genus Paeoniae in the family Ranunculaceae. However, due to the growth cycle and tissue structure characteristics of white peony medicinal plants, the distribution of its internal active ingredients is uneven. Therefore, when white peony medicinal materials and decoction pieces are formed, the quality will be uneven and unstable, which will lead to differences in efficacy in clinical preparation even with the same dose, and the transfer rate is low. In view of this, the white peony root was developed. The research on chewing herbal slices is of great significance to improving the overall quality of white peony root slices. Summary of the invention
[0005] The present invention aims to provide a kind of Compared with traditional white peony root slices, the chewed decoction slices and their preparation method retain the shape characteristics of traditional white peony root slices while having smaller particle size specifications and uniform size. They have the advantages of high decoction utilization rate and uniform and stable quality, and are convenient for clinical adjustment and packaging and transportation.
[0006] To achieve the above purpose, the present invention provides a white peony root The preparation method of chewable decoction pieces comprises:
[0007] Select white peony root with target diameter;
[0008] Cut the white peony root into small pieces with a particle size of 2-4 mm;
[0009] The white peony root pieces were dried and sieved, and the white peony root pieces with a particle size of 2 to 4 mm after drying were selected. Chew the slices.
[0010] The invention also provides a kind of white peony root White Peony Root The water content of the chewable tablets does not exceed 14%, white peony root The chewable tablets contain no less than 1.6% paeoniflorin and white peony root. The water-soluble extract of the chewable tablets shall not be less than 22.0%.
[0011] Technical effects and advantages of the present invention:
[0012] 1. The present invention simplifies the preparation process, saves drying time, and makes the white peony root Chewing slices can achieve large-scale production without adding other processing steps, thereby improving production efficiency and reducing costs.
[0013] 2. The method for cutting medicinal slices of the present invention retains the effective ingredients of medicinal slices to the greatest extent through drying technology, while also significantly shortening the drying cycle. This innovation not only minimizes the possibility of microbial contamination and oxidation risks in the process of transforming medicinal materials into medicinal slices in terms of time, but its unique cutting process may also be suitable for cutting while fresh, which not only simplifies the complex cross-process flow, but also breaks through the limitations of the appearance of the medicinal slices. Therefore, this cutting method helps to maintain the stability and safety of the drug, extend its shelf life, and reduce the failure or deterioration of medicinal slices due to improper storage.
[0014] 3. White Peony Root The invention of chewing slices is not only the result of technological innovation, but also a kind of inheritance and development of traditional Chinese medicine culture. It reflects the adaptability and innovation of Chinese medicine in modern society, and provides strong support for the modernization and globalization of Chinese medicine.
[0015] Other features and advantages of the present invention will be described in the following description, and partly become obvious from the description, or be understood by implementing the present invention. The purpose and other advantages of the present invention can be realized and obtained by the structures pointed out in the description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Figure 1 White Peony Root Flow chart of the method for preparing chewable tablets;
[0017] Figure 2 White Peony Root Sample picture of chewable tablets (2-4 mm);
[0018] Figure 3 This is a sample picture of traditional white peony root slices;
[0019] Figure 4 15 batches of white peony root Fingerprints of chewed medicinal pieces (2-4 mm) and traditional medicinal pieces and standard decoctions;
[0020] Figure 5 White Peony Root Microscopic identification of chewed decoction pieces and traditional white peony root decoction pieces. DETAILED DESCRIPTION
[0021] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0022] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change of the proportion relationship or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the effects and purposes that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. The change or adjustment of their relative relationship should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.
[0023] Example 1
[0024] A white peony root Preparation method of chewing tablets, such as Figure 1 As shown, the method comprises the following steps:
[0025] 1. Pretreatment: Select some white peony roots with a root diameter of about 2 cm, remove impurities, and wash with water.
[0026] 2. Softening: Soak the clean white peony root obtained in step 1 in an appropriate amount of water for 1 hour, seal it in a plastic bag and soften it for 18 hours until the water content of the white peony root is 50%.
[0027] 3. Cut the softened white peony root obtained in step 2 into 2-3 mm thick slices, and then cut the thick slices into small pieces with a particle size of 2-4 mm in a wet state.
[0028] 4. Drying: Dry the white peony root pieces obtained in step 3 in a hot air drying oven at 45° C. for 6 hours to obtain dry white peony root pieces.
[0029] 5. Sieve: Pass the dried white peony root pieces through a 4mm sieve, but not through a 2mm sieve, to obtain white peony root with a particle size of 2 to 4mm. Chew the slices.
[0030] For the white peony root obtained in Example 1 The chewing tablets meet the relevant standards and the following experiments were conducted:
[0031] 1. White Peony Root in Example 1 Evaluation of fingerprints of chewed medicinal pieces and standard decoctions of traditional medicinal pieces
[0032] 1.1 Chromatographic conditions
[0033] Aglient ZORBAX SB-C18 chromatographic column (4.6mm×250mm, 5m), mobile phase was acetonitrile (A)-0.1% phosphoric acid solution (B), gradient elution (0-5min, 5%A→9%A; 5-8min, 9%A→15%A; 8-23min, 15%A→25%A, 23-28min, 25%A→35%A, 28-35min, 35%A→90%A); flow rate was 1.0ml / min, column temperature was 30°C, injection volume was 10μl, detection wavelengths were 257nm (1-12.85min), 230nm (12.85-35min).
[0034] 1.2 Preparation of reference solution
[0035] Accurately weigh appropriate amounts of reference substances such as gallic acid, oxidized paeoniflorin, catechin, paeoniflorin, paeoniflorin, galloylpeoniflorin, and benzoylpeoniflorin, respectively, place them in 10 ml volumetric flasks, add 70% methanol to dissolve and dilute to the scale to obtain a mixed reference substance solution of a certain mass concentration.
[0036] 1.3 Example and Comparative Example Test Solution Prepared from White Peony Root Pieces
[0037] in accordance with" According to the requirements of the Technical Requirements for Preparation of Jue Decoction Pieces (Trial), 15 batches of white peony root materials were collected as shown in Table 1, and white peony root F1-F15 were prepared using the preparation process of Example 1 and the traditional process. The samples of chewed decoction pieces and the traditional decoction pieces of white peony root from S1 to S15, such as Figure 2 and 3 Take the white peony root prepared in Example 1 100g of each of the decoction pieces and traditional decoction pieces, add 7 times the amount of water to soak for 30min, decoct and extract for 1h, filter while hot, add 6 times the amount of water to the residue, decoct for 40min, combine the two filtrates, concentrate and fix the volume to 500mL, and obtain a decoction with a concentration of 0.2g / mL. Take 1mL, dilute with dilute ethanol to 10mL, shake well, and let stand for 20min.
[0038] Among them, the traditional preparation method of medicinal slices is: take white peony root medicinal material, soak it in water for 1 hour, then steam it for 18 hours to soften the medicinal material, and then cut it into traditional white peony root medicinal slices with a thickness of 2 to 3 mm, and dry it.
[0039] Table 1 Sample source information
[0040]
[0041]
[0042] 1.4 White Peony Root Prepared in Example 1 Establishment of fingerprints of chewed and traditional medicinal pieces and identification of common peaks
[0043] The white peony root prepared in Example 1 The test sample solutions of the chewed decoction pieces and the traditional decoction pieces were prepared according to the method under "1.3", tested under the chromatographic conditions of "1.1", and the chromatograms were recorded. The chromatogram results were then sequentially imported into the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System (2012 Edition)" software developed by the State Pharmacopoeia Committee for analysis. S1 was used as the reference spectrum, the "median method" was used, the time width was set to 0.1min, and multi-point correction and full-spectrum peak matching were performed on each characteristic spectrum chromatographic peak to generate a control spectrum (R), and the white peony root in Example 1 was established. Fingerprints of chewed medicinal pieces and traditional medicinal pieces. Eight main common peaks were identified in the fingerprints of chewed and traditional medicinal pieces (the total area of the main common peaks accounted for more than 80% of the total peak area of the samples). The results are as follows: Figure 4 shown.
[0044] The white peony root in Example 1 The fingerprints of chewed decoction pieces and traditional decoction pieces were compared with the retention time of each chromatographic peak in the chromatogram of the mixed reference substance, and peak 1 was identified as gallic acid, peak 2 as oxidized paeoniflorin, peak 3 as catechin, peak 4 as paeoniflorin, peak 5 as paeoniflorin, peak 6 as galloylpeoniflorin, peak 7 as 1,2,3,4,6-O-pentagalloylglucose, and peak 8 as benzoylpeoniflorin.
[0045] 1.5 Similarity evaluation
[0046] Taking the control spectrum R as reference, 15 batches of white peony root prepared in Example 1 were The similarity between the characteristic maps of the chewed pieces and the traditional pieces was calculated, and it was found that the similarity of the pieces of the corresponding batches was small. The results can be seen in Table 2, indicating that the traditional pieces of white peony root, The main peak groups of the chewing slice samples are similar overall, and the two have good similarity.
[0047] Table 2 Traditional herbal medicine pieces of white peony root, Similarity analysis results of chewed decoction pieces samples
[0048]
[0049]
[0050] 1.6 White Peony Root Prepared in Example 1 Determination of 7 ingredients in chewed pieces and standard decoctions of traditional pieces
[0051] Take the white peony root prepared in Example 1 For decoction pieces and traditional decoction pieces, prepare the test sample solution according to item "1.3" and determine it according to the chromatographic conditions under item "1.1". Calculate the decoction of traditional decoction pieces of white peony root, The content and transfer rate of each component in the decoction of chewing slices are shown in Table 3 below. There are significant differences in the contents of six components, including gallic acid, oxidized paeoniflorin, catechins, paeoniflorin, paeoniflorin, and galloylated paeoniflorin, between chewed slices and traditional slices, and the contents are higher than those in traditional slices.
[0052] 1.7 White Peony Root Prepared in Example 1 Determination of the transfer rates of seven components in chewed medicinal pieces and standard decoctions of traditional medicinal pieces
[0053] Take the white peony root prepared in Example 1 For decoction pieces and traditional decoction pieces, prepare the test sample solution according to item "1.3" and determine it according to the chromatographic conditions under item "1.1". Calculate the transfer rate of traditional decoction pieces of white peony root, decoction of white peony root, according to the transfer rate = the amount of index component in the standard decoction / the amount of index component in the decoction piece × 100%. The transfer rate of each component in the decoction of the chewing slices is shown in Table 3 below. There are significant differences in the transfer rates of six components, including gallic acid, oxidized paeoniflorin, catechins, paeoniflorin, gallylpaeoniflorin, and benzoylpaeoniflorin, between chewed decoction pieces and traditional decoction pieces, and the transfer rates are higher than those of traditional decoction pieces.
[0054] 1.8 White Peony Root Prepared in Example 1 Stability determination of seven ingredients in chewed and traditional herbal medicine slices
[0055] White Peony Root Prepared According to Example 1 Chew the tablets For the stability study of chewable slices, the test solution was prepared according to the method steps under "1.3", and the samples were tested at 0, 2, 4, 8, 12, and 24 hours. The chewing tablets (average value of 15 groups) were prepared three times in parallel, the contents of the seven components were determined and the content stability was calculated. The calculation formula is as follows.
[0056]
[0057] Where S represents the standard deviation, represents the average value, n=3, x i Represents the value of the i-th number.
[0058] The results show that the RSD of the peak area of each component is 2.08%, 2.68%, 1.33%, 1.12%, 0.31%, 1.87%, and 2.59%, respectively, all below 3%, indicating that the white peony root prepared by the present invention is The chewable tablets have good stability.
[0059] 1.9 White Peony Root Prepared in Example 1 Determination of the yield of paste from chewed and traditional medicinal pieces
[0060] According to the decoction method under "1.3", accurately measure the white peony root of Example 1 25 mL of the decoction pieces and the standard decoction of traditional decoction pieces were placed in an evaporating dish that had been dried to a constant weight, evaporated to dryness in a water bath, dried at 105°C for 3 hours, cooled in a desiccator for 30 minutes, and then quickly and accurately weighed. Two parallel portions were prepared to calculate the paste rate (average value of 15 groups). The data are shown in Table 3. As can be seen from Table 3, the white peony root prepared by the present invention There is a significant difference in the rate of paste production of standard decoction between chewed decoction pieces and traditional decoction pieces. Chewing herbal slices has a higher yield of paste than traditional herbal slices.
[0061] 2.0 White Peony Root Prepared in Example 1 Comprehensive scoring and equivalence evaluation of chewed and traditional herbal pieces
[0062] The contents and the yields of the ingredients of 15 groups of white peony root slices prepared in Example 1 and 15 groups of traditional slices were calculated, and the corresponding entropy values were calculated according to the contents and yields of the ingredients, and the corresponding weights were calculated according to the corresponding entropy values. Finally, the comprehensive scores were obtained according to the weights. The results are shown in Table 3. Chewing the equivalent amount of the traditional pieces of medicine can give 1g of white peony root Chewing the medicinal piece is approximately equal to 1.05g of traditional medicinal piece of white peony root.
[0063] Table 3 White Peony Root Comparison of various indicators between chewed decoction pieces and traditional decoction pieces
[0064]
[0065]
[0066] 2. White Peony Root Prepared in Example 1 Microscopic identification of chewed and traditional medicinal pieces
[0067] By preparing the white peony root of Example 1 The results of observation of the traditional white peony root slices and powder were as follows: Figure 5 Among them, A- traditional herbal medicine gelatinized starch granule agglomerate; B- traditional herbal medicine calcium oxalate cluster crystal; C- traditional herbal medicine catheter; D- traditional herbal medicine fiber; a- Chewing the gelatinized starch granules; b- Calcium oxalate cluster crystals; c- Chewing tablet catheter; d- Its microscopic identification characteristics are summarized as follows: Example 1 prepared white peony root The chewed decoction pieces and the traditional decoction pieces of white peony root are both yellow-white, with many gelatinized starch granules. Among them, the calcium oxalate clusters of both are mainly present in the thin-walled cells, showing an orderly arrangement. In addition, they both have the structural characteristics of reticulated vessels and long spindle-shaped fibers. Under microscopic observation, the identification characteristics of chewed decoction pieces and traditional white peony root pieces are consistent, which can provide a certain basis for their physical and chemical identification.
[0068] 3. White Peony Root Prepared in Example 1 Determination of water-soluble extracts from chewable tablets
[0069] Refer to the "hot immersion method" under the item [Extract] of White Peony Root Pieces in the 2020 edition of the "Chinese Pharmacopoeia" for determination. Take about 2g of the test sample, weigh it accurately, put it in a 250ml conical flask, accurately add 100ml of water, seal it, weigh it, let it stand for 1h, connect the reflux condenser, heat it to boiling, and keep it at a slight boil for 1h. After cooling, remove the conical flask, seal it, weigh it again, make up the lost weight with water, shake it well, filter it with a drying filter, accurately measure 25ml of the filtrate, put it in an evaporating dish that has been dried to constant weight, evaporate it to dryness on a water bath, dry it at 105℃ for 3 hours, cool it in a desiccator for 30min, and quickly weigh it accurately. Calculate the content (%) of water-soluble extracts in the test sample based on the dry product. The specific test results are shown in Table 4. The measured results of the extracts of 15 batches of white peony root slices ranged from 22.34% to 34.30%, with an average of 28.48%. The extracts of white peony root slices in the 2020 edition of the Chinese Pharmacopoeia are stipulated to be no less than 22.0% for the same medicinal materials. 80% of the average is 22.8%, which is rounded to 22.0%. Therefore, it is stipulated that the extracts of white peony root slices shall not be less than 22.0%, which is consistent with the 2020 edition of the Chinese Pharmacopoeia.
[0070] Table 4 Results of water-soluble extracts of 15 batches of white peony root slices in Example 1
[0071]
[0072]
[0073] 4. White Peony Root Prepared in Example 1 Determination of moisture content in chewable tablets
[0074] The moisture determination was carried out in accordance with the second method of 0832 of the fourth general rules of the 2020 edition of the Chinese Pharmacopoeia. Take 2-5g of the test sample, spread it flat in a flat weighing bottle dried to constant weight, with a thickness of no more than 5mm, and the loose test sample should not exceed 10mm. Weigh it accurately, open the bottle cap and dry it at 100-105℃ for 5h, cover the bottle cap, move it to the dryer, let it cool for 30min, weigh it accurately, and then dry it at the above temperature for 1h, let it cool, and weigh it again until the difference between two consecutive weighings does not exceed 5mg. Calculate the water content (%) in the test sample based on the lost weight. The specific results are shown in Table 5. The moisture content of 15 batches of white peony furuzui slices ranged from 3.8% to 7.9%, with an average of 6.08%, indicating that furuzui slices are easy to dry. The moisture content under the white peony slices item of the 2020 edition of the Chinese Pharmacopoeia is the same as that of the medicinal materials, not exceeding 14.0%. According to the actual measurement results of moisture content of 15 batches of White Peony Root Slices, it is consistent with the 2020 edition of the "Chinese Pharmacopoeia".
[0075] Table 5: Moisture content of 15 batches of white peony root slices in Example 1
[0076]
[0077] The invention also provides a kind of white peony root White Peony Root The water content of the chewable tablets shall not exceed 14%. The particle size of the chewed pieces is 2-4 mm. Calculated from the dried product of the chewed slices, containing paeoniflorin (C 23 H 28 O 11 ) shall not be less than 1.6%. , White Peony Root The water-soluble extract of chewable tablets shall not be less than 22.0%.
[0078] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.
Claims
1. A white peony root The method for preparing the chewable tablets is characterized in that: include: Select white peony root with target diameter; Cut the white peony root into small pieces with a particle size of 2-4 mm; The white peony root pieces were dried and sieved, and the white peony root pieces with a particle size of 2 to 4 mm after drying were selected. Chew the slices.
2. The method according to claim 1, characterized in that: The target diameter is 1-3 cm.
3. The method according to claim 1, characterized in that: Before cutting the white peony root into small pieces with a particle size of 2-4 mm, the method further comprises: The white peony root is subjected to impurity removal and cleaning treatment; The cleaned white peony root medicinal material is placed in water for soaking, and the softened white peony root medicinal material is obtained by sealing and softening.
4. The method according to claim 3, characterized in that: The soaking time is 0.5-2h.
5. The method according to claim 3, characterized in that: The softening time is 15-20h.
6. The method according to claim 3, characterized in that: The water content of the softened white peony root is 45% to 60%.
7. The method according to claim 3, characterized in that: The method of cutting the white peony root medicinal material into white peony root small pieces with a particle size of 2-4 mm comprises: cutting the softened white peony root medicinal material into 2-3 mm thick slices, and then cutting the thick slices into white peony root small pieces with a particle size of 2-4 mm.
8. The method according to claim 1, characterized in that: The drying conditions include: drying in a drying oven at a temperature of 45-55° C. for 4-8 hours.
9. The method according to claim 1, characterized in that: The screening process comprises: using a 4 mm sieve and a 2 mm sieve in sequence, and treating the white peony root pieces that pass through the 4 mm sieve but fail to pass through the 2 mm sieve as white peony root pieces. Chew the slices.
10. White Peony Root prepared by the method according to any one of claims 1 to 9 The chewable tablet is characterized in that: White Peony Root The water content of the chewable tablets does not exceed 14%, white peony root The chewable tablets contain no less than 1.6% paeoniflorin and white peony root. The water-soluble extract of the chewable tablets shall not be less than 22.0%.