Preparation and quality control method of traditional Chinese medicine granules for treating hyperplasia of mammary glands
By optimizing the preparation method of Chinese medicine granules, the problems of poor compliance and storage stability of Chinese medicine decoctions were solved, the drug extraction rate and molding effect were improved, and better efficacy and patient experience were achieved.
Patent Information
- Application Number
- CN202510927792.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-07
- Publication Date
- 2025-10-17
AI Technical Summary
Existing traditional Chinese medicine decoctions for treating breast hyperplasia have problems such as poor compliance, loss of active ingredients, poor storage stability and molding defects. The rosmarinic acid extraction rate is low under the traditional decoction process, and the granules take a long time to dissolve.
Optimize the preparation method of Chinese medicine granules, including medicinal material pretreatment, extraction, extract preparation and granulation processes, use vacuum decompression concentration and dextrin mixing, establish the identification method of Scrophularia ningpoensis and Fritillaria thunbergii, and ensure efficacy and quality control.
It improves the drug extraction rate, enhances the efficacy, improves the patient's taking experience, improves the molding effect and storage stability of the granules, and ensures the quality reliability of the product.
Smart Images
Figure CN120789199A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of traditional Chinese medicine preparation, in particular to a preparation and quality control method of a traditional Chinese medicine granule for treating breast hyperplasia. BACKGROUND
[0002] Breast hyperplasia is a kind of breast structure disorder disease caused by different degrees of breast parenchyma and interstitial hyperplasia and incomplete involution, and its incidence rate in middle-aged women is very high, accounting for more than 90% of breast diseases, and it is closely related to breast cancer. The clinical manifestations of the disease are breast lumps, pain, irregular menstruation and other symptoms, and the main causes of the disease are periodic disorder of estrogen and progesterone levels and stimulation of high expression of estrogen on breast tissue.
[0003] At present, the treatment of breast hyperplasia mainly relies on hormone drugs and surgical treatment. For example, tamoxifen can be used for premenopausal and postmenopausal women, but long-term use has risks of endometrial cancer, venous thromboembolism and cataract; surgical treatment cannot fundamentally solve the problem and will affect the appearance.
[0004] Traditional Chinese medicine classifies breast hyperplasia as "rubi", and believes that its pathogenesis is related to liver qi stagnation, spleen deficiency and dampness, blood stasis and phlegm accumulation. Traditional Chinese medicine compounds and their active ingredients can exert synergistic effects on breast hyperplasia through multiple pathways and multiple targets, and have good efficacy and low toxicity and side effects. Xiaopi Decoction is optimized based on the experience of Wuhan No. 3 Hospital, and the previous animal experiments show that it can reduce the diameter of the rat breast, regulate the content of various hormones in the serum, and also achieve therapeutic effect by affecting the expression level of related proteins.
[0005] However, the existing traditional Chinese medicine decoction for treating breast hyperplasia has many problems, such as poor compliance, an average dosage of 200 mL per day and obvious bitterness; loss of active ingredients, the extraction rate of rosmarinic acid under the traditional decoction process is only 58%-62%; poor storage stability, precipitation occurs after 72 hours of storage at 25℃; and existing granule forming defects, the granule melting time is >5 minutes when the extract and auxiliary material ratio is 1:1. SUMMARY
[0006] In view of the deficiencies of the prior art, the present application provides a preparation and quality control method of a traditional Chinese medicine granule for treating breast hyperplasia, which solves the problems raised in the background art.
[0007] To achieve the above purpose, the present application realizes the following technical scheme: a preparation method of a traditional Chinese medicine granule for treating breast hyperplasia, which comprises the following specific steps: Pre-preparation: weigh 55-65g raw malt, 8-12g raw oyster, 8-12g Fritillaria thunbergii, 13-17g selfheal, 6-10g white mustard, 2-4g trifoliate mushroom, 8-12g salvia miltiorrhiza, 4-6g kelp, 8-12g turmeric, 4-6g Scrophularia ningpoensis, and pre-treat the medicinal materials; Extraction; After soaking the pretreated medicinal materials in 10 times water for 1 hour, perform the first decoction, filter and separate the first medicinal liquid and the medicinal residue, decoct the medicinal residue for the second time, filter and separate the second medicinal liquid and the medicinal residue, combine the medicinal liquids obtained by the two filtrations, use the filtrate for later use, and discard the medicinal residue; Extract preparation: placing the combined medicinal liquid in a vacuum decompression concentration tank to concentrate to obtain the Chinese medicine extract; Granulation: Take the Chinese medicine extract and dextrin and mix them in proportion, add them into a 16-mesh sieve granulator to granulate, place the granules in a 60°C hot air circulation oven and dry them for 2 hours, take them out and sieve them with a 10-mesh sieve to remove fine powder and undissolved particles, and obtain Xiaopi granules.
[0008] A further improvement of the technical solution of the present invention is that the pretreatment of the prepared Chinese medicinal materials includes: Soak raw oysters, kelp, Fritillaria thunbergii, Curcuma aromatica, and Scrophularia ningpoensis for 60 minutes until fully swollen. Store white mustard seeds and raw malt separately to prevent loss. Store Scrophularia ningpoensis, Trillium gracile, and Prunella vulgaris in a sealed container to prevent deliquescence.
[0009] A further improvement of the technical solution of the present invention is that the first decoction and the second decoction in the extraction include the following specific settings: First decoction: add 10 times the amount of water to the soaked herbs and boil for 45 minutes; Second decoction: add 10 times the amount of water to the residue filtered and separated after the first decoction and decoct for 45 minutes.
[0010] A further improvement of the technical solution of the present invention is that: in the preparation of the extract, the environment of the vacuum decompression concentration tank is set to: 60° C., vacuum degree -0.08 MPa for concentration; The relative density of the concentrated Chinese medicinal extract obtained in the extract preparation is: 1.16 at 80°C.
[0011] A further improvement of the technical solution of the present invention is that: in the granulation, the Chinese medicine extract and dextrin are mixed at a ratio of 6.19 g and 10 g.
[0012] A further improvement of the technical solution of the present invention is that the pre-preparation further comprises: Weigh 60 g of raw malt, 10 g of raw oyster, 10 g of Fritillaria thunbergii, 15 g of Prunella vulgaris, 8 g of white mustard seeds, 3 g of Trillium scabra, 10 g of Salvia miltiorrhiza, 5 g of Kelp, 10 g of Curcuma aromatica, and 5 g of Scrophularia ningpoensis for medicinal material pretreatment.
[0013] The application also provides a quality control method, which comprises Scrophularia ningpoensis identification and Fritillaria thunbergii Miq. The Scrophularia ningpoensis identification comprises: Cancel the habit of particles 5g, add methanol 20mL, ultrasonic 30 minutes, filter, evaporate the filtrate, add 1mL methanol to the residue to dissolve, as the test solution; Another Scrophularia ningpoensis control drug 1g is added with methanol 20mL, ultrasonic 30 minutes, filter, evaporate the filtrate, add 1mL methanol to the residue to dissolve, and the control drug solution is prepared; Take habarogosine control 1mg, add methanol 1mL as control solution; Take 10ul of test solution, control solution and control drug solution, and point on the same silica gel G plate, develop, take out, air dry, spray with 5% vanillin sulfuric acid solution, heat at 100 DEG C until the color spot is clear, and complete the Scrophularia ningpoensis identification.
[0014] Observe the color spot in the corresponding position of the test chromatogram and the control chromatogram under sunlight.
[0015] The further improvement of the technical scheme of the application is that the Fritillaria thunbergii Miq. Cancel the habit of particles 5g, add methanol 20mL, ultrasonic 30 minutes, filter, evaporate the filtrate, add 1mL methanol to the residue to dissolve, as the test solution; Take habarogosine control 1mg, add methanol 1mL as control solution; Take 10ul of test solution, control solution and control drug solution, and point on the same silica gel G plate, develop, take out, air dry, spray with 5% vanillin sulfuric acid solution, heat at 100 DEG C until the color spot is clear, and complete the Scrophularia ningpoensis identification. Observe the color spot in the corresponding position of the test chromatogram and the control chromatogram under sunlight.
[0016] The further improvement of the technical scheme of the application is that the Scrophularia ningpoensis identification comprises that the developing agent is chloroform:methanol:water=12:4:1.
[0017] The further improvement of the technical scheme of the application is that the Fritillaria thunbergii Miq.
[0018] Advantages Compared with the prior art, the advantages of the present application are: by optimizing the extraction process, the extraction rate of the medicine is improved, which helps to enhance the efficacy of Xiaopi granules; The optimal ratio of extract and dextrin is determined, which significantly improves the yield and molding effect of the granules, and facilitates patient use and storage; The identification method of Scrophularia ningpoensis and Fritillaria thunbergii Miq is established, which can effectively control the quality of Xiaopi granules and ensure the stability and reliability of the product; After being made into granules, the patient is more convenient to take, the taste and compliance are better, which is conducive to clinical application and promotion. BRIEF DESCRIPTION OF DRAWINGS
[0019] Figure 1 It is a flowchart for preparing the traditional Chinese medicine granules for treating breast hyperplasia; Figure 2 It is a TLC identification spectrum of Scrophularia ningpoensis of the present application; Figure 3 It is a TLC identification spectrum of Fritillaria thunbergii Miq of the present application. DETAILED DESCRIPTION
[0020] Various exemplary embodiments, features, and aspects of the present application will be described in detail below with reference to the accompanying drawings. The same reference numbers in the drawings represent functionally the same or similar elements. Although various aspects of the embodiments are shown in the drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
[0021] The word "exemplary" is used herein in the sense of being an example, instance, or illustration. Any implementation described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other implementations.
[0022] In addition, in order to better illustrate the present application, numerous specific details are given in the specific embodiments below. Those skilled in the art should understand that the present application can also be implemented without certain specific details. In some examples, methods, means, elements well known to those skilled in the art are not described in detail, in order to highlight the main idea of the present application.
[0023] The present application provides a preparation method of traditional Chinese medicine granules for treating breast hyperplasia, the preparation method comprising the following specific steps: Preparation; after weighing 55-65g of raw malt, 8-12g of raw oyster, 8-12g of Fritillaria thunbergii Miq, 13-17g of Prunella vulgaris, 6-10g of white mustard seed, 2-4g of mountain bitterling, 8-12g of Salvia miltiorrhiza, 4-6g of Laminaria japonica, 8-12g of Curcuma zedoary, 4-6g of Scrophularia ningpoensis, the medicinal materials are pretreated; Extraction; soak the pre-processed medicinal materials with 10 times water for 1 hour, then perform the first decoction, filter and separate the first medicinal liquid from the residue, decoct the residue for the second time, filter and separate the second medicinal liquid from the residue, combine the two filtered medicinal liquids, and reserve the filtrate for later use, and discard the residue; Extraction; soak the pre-processed medicinal materials with 10 times water for 1 hour, then perform the first decoction, filter and separate the first medicinal liquid from the residue, decoct the residue for the second time, filter and separate the second medicinal liquid from the residue, combine the two filtered medicinal liquids, and reserve the filtrate for later use, and discard the residue; Granulation; mix the Chinese medicinal extract with dextrin according to a certain proportion, add a 16-mesh granulator to granulate, place the granules in a 60℃ hot air circulation oven to dry for 2 hours, take out the granules, sieve them with a 10-mesh sieve, remove the fine powder and unsolved granules, and obtain the Xiaopi granules.
[0024] The pre-preparation of the Chinese medicinal materials includes the following steps: Soak the raw oyster, kelp, Zhejiang fritillary, turmeric, and Chinese foxglove for 60 minutes, and make them fully swell, separately store the white mustard seed and raw malt to prevent loss, and seal the Chinese foxglove, mountain yam, and prunella vulgaris to prevent deliquescence.
[0025] The first decoction and the second decoction in the extraction process include the following specific settings: First decoction; decoct the soaked medicinal materials with 10 times water for 45 minutes; Second decoction; decoct the residue separated by filtering after the first decoction with 10 times water for 45 minutes.
[0026] In the extraction process, the vacuum and reduced pressure concentration tank is set to an environment of 60℃ and a vacuum degree of-0.08 MPa for concentration. In the extraction process, the relative density of the Chinese medicinal extract obtained by concentration is 1.16 at 80℃.
[0027] In the granulation process, the Chinese medicinal extract and dextrin are mixed at a ratio of 6.19 g to 10 g.
[0028] The pre-preparation also includes the following steps: Weigh 60 g of raw malt, 10 g of raw oyster, 10 g of Zhebei, 15 g of prunella vulgaris, 8 g of white mustard seed, 3 g of mountain yam, 10 g of salvia miltiorrhiza, 5 g of kelp, 10 g of turmeric, and 5 g of Chinese foxglove, and perform the pre-treatment of the medicinal materials.
[0029] The present application also provides a quality control method, which includes Chinese foxglove identification and Zhebei identification. The Chinese foxglove identification includes the following steps: Add 20 mL of methanol to 5 g of Xiaopi granules, and ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 1 mL of methanol to obtain a test solution; Separately take 1 g of Chinese foxglove control medicinal materials, add 20 mL of methanol, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 1 mL of methanol to obtain a control medicinal material solution; Separately take 1 mg of haraeanoside control, add 1 mL of methanol to obtain a control solution. Take 10 μL of the test solution, the control solution and the control drug solution respectively, and spot them on the same silica gel G plate. Develop, take out and air dry them in turn with chloroform-methanol-water as the developing agent. Spray with 5% vanillin sulfuric acid solution, heat at 100°C until the color spots are clear, and complete the identification of Scrophularia ningpoensis.
[0030] Observe the color spots in the test sample chromatogram corresponding to the control sample chromatogram under sunlight.
[0031] The results are shown in the following table. Figure 2
[0032] The identification of Fritillaria includes: Take 10 g of granules, add 2 mL of concentrated ammonia test solution, 20 mL of chloroform, and heat to reflux for 1 hour. Filter, evaporate the filtrate to dryness, dissolve the residue in 2 mL of ethyl acetate, and take 2 g of the control drug of Fritillaria thunbergii Miq. to prepare a control drug solution as the test sample solution. Take fritilline and peimine as the control samples, add ethyl acetate to prepare a mixed solution containing 2 mg of fritilline and peimine per 1 mL of ethyl acetate, and prepare a control drug solution. Take the test sample solution, the control sample solution and the control drug solution and spot them on the same silica gel G plate. After spotting, place the thin layer plate in ammonia vapor for 3 minutes, develop in a double-tank developing cylinder, put the developing agent of ethyl acetate-concentrated ammonia in one tank, and put the same volume of concentrated ammonia test solution in the other tank, develop with a developing distance of 8 cm. After drying the developed thin layer plate at 105°C for 5 minutes, spray with a mixed solution of dilute bismuth potassium iodide solution-2% hydrochloric acid ethanol solution, and then spray with sodium nitrite solution. Observe the color spots in the test sample chromatogram corresponding to the control sample chromatogram under sunlight.
[0033] The results are shown in the following table. Figure 2
[0034] The developing agent for the identification of Scrophularia ningpoensis is chloroform:methanol:water=12:4:1.
[0035] In the identification of Fritillaria thunbergii Miq., the developing agent is ethyl acetate:concentrated ammonia=100:1, and the mixing ratio of dilute bismuth potassium iodide solution-2% hydrochloric acid ethanol solution is 1:1.
[0036] Example 1. This example is aimed at the amount of raw malt in the granules of traditional Chinese medicine. The amount of 55-65 parts of raw malt mentioned above is explored, and specifically: Test group one: medicinal materials: take 120 g of raw malt, 10 g of raw oyster, 10 g of Fritillaria thunbergii Miq., 15 g of Prunella vulgaris L., 8 g of white mustard seed, 3 g of Ophiocordyceps sinensis, 10 g of Salvia miltiorrhiza Bunge, 5 g of Laminaria japonica, 10 g of Curcuma zedoary, and 5 g of Scrophularia ningpoensis. Test group two, medicinal materials: take 60g of raw malt, 10g of raw oyster, 10g of Zhejiang fritillary, 15g of spirea, 8g of white mustard seed, 3g of mountain cordyceps, 10g of salvia miltiorrhiza, 5g of laminaria japonica, 10g of curcuma, and 5g of radix scrophulariae; Test group three, medicinal materials: take 30g of raw malt, 10g of raw oyster, 10g of Zhebei mother, 15g of spirea, 8g of white mustard seed, 3g of mountain cordyceps, 10g of salvia miltiorrhiza, 5g of laminaria japonica, 10g of curcuma, and 5g of radix scrophulariae.
[0037] Test group one, test group two, and test group three are prepared according to the preparation process disclosed above, including: pre-preparation; after taking 55-65g of raw malt, 8-12g of raw oyster, 8-12g of Zhebei mother, 13-17g of spirea, 6-10g of white mustard seed, 2-4g of mountain cordyceps, 8-12g of salvia miltiorrhiza, 4-6g of laminaria japonica, 8-12g of curcuma, and 4-6g of radix scrophulariae, the medicinal materials are pretreated; Extraction; after soaking the pretreated medicinal materials with 10 times water for 1 hour, the first decoction is carried out, the first medicinal liquid and dregs are separated by filtration, the dregs are subjected to the second decoction, the second medicinal liquid and dregs are separated by filtration, the medicinal liquids obtained by two times of filtration are combined, and the filtrate is ready for use, and the dregs are discarded; Extraction; after soaking the pretreated medicinal materials with 10 times water for 1 hour, the first decoction is carried out, the first medicinal liquid and dregs are separated by filtration, the dregs are subjected to the second decoction, the second medicinal liquid and dregs are separated by filtration, the medicinal liquids obtained by two times of filtration are combined, and the filtrate is ready for use, and the dregs are discarded; Granulation; the traditional Chinese medicine extract and dextrin are mixed in proportion, granulated in a 16-mesh sieve granulator, dried in a 60°C hot air circulation oven for 2 hours, and then sieved with a 10-mesh sieve to remove fine powder and unsolved particles to obtain the Xiaopi granules.
[0038] According to The test group one, test group two, and test group three are prepared according to the following scheme: Take 6g of granules, measure the complete melting time according to the Granules General Rule of Chinese Pharmacopoeia, and the result is qualified if the complete melting time is ≤3min, and measure the moisture content according to the requirements of Chinese Pharmacopoeia, and the result is qualified if the moisture content is ≤8%, and observe the uniformity, caking, and color difference of the granules, and the results are as follows: Item Amount of malt (g) Yield of granules (%) Dissolution time (min) Moisture (%) Appearance evaluation Test group 1 120 85±2 4.5±0.3 6.5±0.2 Slightly adhered, color slightly dark Test group 2 60 92±1 2.8±0.2 5.8±0.1 Uniform, no caking Test group 3 30 78±3 5.2±0.4 7.0±0.3 Loose, uneven granules As can be seen from the above, the granule yield of 60g of malt is the highest, which is 92%, and the melting time is the shortest, which is 2.8min, meeting the requirements of the pharmacopoeia and having the best molding effect; the extract viscosity of 120g of malt increases due to the high malt starch content, resulting in granule adhesion and prolonged melting time; the extract viscosity of 30g of malt is insufficient, resulting in loose granules, low yield, and poor melting performance. When the malt dosage is 60g, the granule yield and molding effect are the best, and it is recommended as the standard dosage of malt for preparing Xiaopi granules.
[0039] Embodiment 2, this embodiment is directed to the extraction process of Xiaopi granules in traditional Chinese medicine granules, specifically: select water addition (A), decoction time (B), decoction times (C) as three factors, use L9(34) orthogonal table, with water addition 8 / 10 / 12 times, decoction time 30 / 45 / 60 min, decoction times 1 / 2 / 3 times as variables, carry out orthogonal test, with rosmarinic acid, harabein and extract yield comprehensive score as index, determine the best extraction process A1B3C2, that is, 10 times the amount of water decoction 2 times, 45 minutes each time.
[0040] Embodiment 3, this embodiment is directed to the mixing ratio of auxiliary material dextrin and traditional Chinese medicine extract in granule forming process.
[0041] This embodiment establishes the following groups of tests, such as test group A, the mass ratio of dextrin to extract is 1:1, the extract amount is 6.19g, and the dextrin amount is 6.19g; test group B, the mass ratio of dextrin to extract is 1:1.5, the extract amount is 6.19g, and the dextrin amount is 9.285g; test group C, the mass ratio of dextrin to extract is 1:2, the extract amount is 6.19g, and the dextrin amount is 12.38g; test group D, the mass ratio of dextrin to extract is 1:3, the extract amount is 6.19g, and the dextrin amount is 18.57g.
[0042] According to the above steps, add 16 mesh screen granulator to granulate, place the granules in a 60°C hot air circulation oven for drying for 2 hours, take out and sieve with a 10 mesh sieve to remove fine powder and unsolved granules, and obtain Xiaopi granules.
[0043] According to , take 1g of granules, according to the method in Chinese Pharmacopoeia 2020 edition, that is, 37°C water bath, stirring speed 50r / min, record the complete dissolution time and molding state, the results are shown in the following table: Item Yield (%) Dissolution time (min) Moldability evaluation Group A 82±1.5 5.2±0.3 Adhered, dissolution slow Group B 89±1.2 3.5±0.2 Slightly adhered Group C 94±0.8 2.8±0.1 Uniform granules, fast dissolution Group D 93±1.0 2.5±0.2 Good flowability but easy to absorb moisture Obviously, the critical value is 1:2, which meets the requirements of yield >90% and dissolution time <3min, although group D dissolves faster, but the hygroscopicity increases and the stability decreases, which does not meet the long-term storage requirements.
[0044] It should be noted that in this paper, relational terms such as first and second are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "contain" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or equipment including a series of elements not only includes those elements, but also includes other elements not explicitly listed or inherent to such process, method, article or equipment.
[0045] While embodiments of the present application have been shown and described, it is to be understood that the embodiments described are merely divergences of the principles and spirit of the present application and that numerous modifications, changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the present application as defined by the appended claims and their equivalents.
Claims
1. A method for preparing a Chinese medicine granule for treating breast hyperplasia, characterized in that: The preparation method comprises the following specific steps: Pre-preparation: weigh 55-65g raw malt, 8-12g raw oyster, 8-12g Fritillaria thunbergii, 13-17g selfheal, 6-10g white mustard, 2-4g trifoliate mushroom, 8-12g salvia miltiorrhiza, 4-6g kelp, 8-12g turmeric, 4-6g Scrophularia ningpoensis, and pre-treat the medicinal materials; Extraction; After soaking the pretreated medicinal materials in 10 times water for 1 hour, perform the first decoction, filter and separate the first medicinal liquid and the medicinal residue, decoct the medicinal residue for the second time, filter and separate the second medicinal liquid and the medicinal residue, combine the medicinal liquids obtained by the two filtrations, use the filtrate for later use, and discard the medicinal residue; Extract preparation: placing the combined medicinal liquid in a vacuum decompression concentration tank to concentrate to obtain the Chinese medicine extract; Granulation: Take the Chinese medicine extract and dextrin and mix them in proportion, add them into a 16-mesh sieve granulator to granulate, place the granules in a 60°C hot air circulation oven and dry them for 2 hours, take them out and sieve them with a 10-mesh sieve to remove fine powder and undissolved particles, and obtain Xiaopi granules.
2. A method for preparing a Chinese medicine granule for treating breast hyperplasia according to claim 1, characterized in that: The pre-treatment of the prepared Chinese medicinal materials includes: Soak raw oysters, kelp, Fritillaria thunbergii, Curcuma aromatica, and Scrophularia ningpoensis for 60 minutes until fully swollen. Store white mustard seeds and raw malt separately to prevent loss. Store Scrophularia ningpoensis, Trillium gracile, and Prunella vulgaris in a sealed container to prevent deliquescence.
3. A method for preparing a Chinese medicine granule for treating mammary hyperplasia according to claim 1, characterized in that: The first decoction and the second decoction in the extraction include the following specific settings: First decoction: add 10 times the amount of water to the soaked herbs and boil for 45 minutes; Second decoction: add 10 times the amount of water to the residue filtered and separated after the first decoction and decoct for 45 minutes.
4. The method for preparing a Chinese medicine granule for treating mammary hyperplasia according to claim 1, wherein: The vacuum decompression concentration tank environment in the extract preparation is set to: 60°C, vacuum degree -0.08MPa; The relative density of the concentrated Chinese medicinal extract obtained in the extract preparation is: 1.16 at 80°C.
5. The method for preparing a Chinese medicine granule for treating mammary hyperplasia according to claim 1, wherein: In the granulation, the Chinese medicinal extract and dextrin are mixed at a ratio of 6.19 g and 10 g.
6. The method for preparing a Chinese medicine granule for treating mammary hyperplasia according to claim 1, wherein: The pre-preparation also includes: Weigh 60 g of raw malt, 10 g of raw oyster, 10 g of Fritillaria thunbergii, 15 g of Prunella vulgaris, 8 g of white mustard seeds, 3 g of Trillium scabra, 10 g of Salvia miltiorrhiza, 5 g of Kelp, 10 g of Curcuma aromatica, and 5 g of Scrophularia ningpoensis for medicinal material pretreatment.
7. A quality control method according to claim 1, applied to the method for preparing the Chinese medicine granules according to any one of claims 1 to 5, characterized in that: The control method includes identification of Scrophulariaceae and identification of Fritillaria thunbergii; The identification of Scrophularia ningpoensis comprises: 5 g of Canpi granules were added with 20 mL of methanol, ultrasonicated for 30 minutes, filtered, the filtrate was evaporated to dryness, and the residue was dissolved in 1 mL of methanol to prepare the test solution; Take 1 g of Scrophularia ningpoensis as a control medicinal material, add 20 mL of methanol, sonicate for 30 minutes, filter, evaporate the filtrate to dryness, and dissolve the residue in 1 mL of methanol to prepare a control medicinal material solution; Then take 1 mg of harpaoside reference substance and add 1 mL of methanol as reference substance solution; 10 μL each of the test solution, reference solution, and reference medicinal material solution were aspirated and spotted on the same silica gel G plate. Developed with chloroform-methanol-water as the developing solvent, the plates were removed and dried in sequence. The plates were then sprayed with 5% vanillin sulfuric acid solution and heated at 100°C until the spots were clearly colored. Observe the color spots in the chromatogram of the test sample at the corresponding positions in the chromatogram of the reference sample under daylight.
8. A quality control method according to claim 7, characterized in that: The identification of Fritillaria comprises: To 10 g of Cancellu Pi Granules, add 2 mL of concentrated ammonia test solution and 20 mL of chloroform, heat and reflux for 1 hour, filter, evaporate the filtrate to dryness, add 2 mL of ethyl acetate to dissolve the residue, and take 2 g of Fritillaria thunbergii control medicinal material to prepare a control medicinal material solution as the test solution; Take flavonoids A and flavonoids B as reference solution, add ethyl acetate to make a mixed solution containing 2 mg of flavonoids A and 2 mg of flavonoids B per 1 mL of ethyl acetate, and make a reference medicinal solution; Pipette the test solution, reference solution, and reference medicinal material solution onto the same silica gel G plate. After spotting, fumigate the plate with ammonia vapor for 3 minutes and develop it in a double-slot developing cylinder, with one slot containing ethyl acetate-concentrated ammonia and the other slot containing the same volume of concentrated ammonia test solution. Develop the plate with a spread of 8 cm. Bake the plate at 105°C for 5 minutes, then spray it with a mixed solvent of dilute potassium bismuth iodide test solution and 2% hydrochloric acid in ethanol, and then spray it with sodium nitrite test solution. Observe the color spots in the chromatogram of the test sample at the corresponding positions in the chromatogram of the reference sample under daylight.
9. A quality control method according to claim 7, characterized in that: The developing solvent in the identification of Scrophularia ningpoensis is chloroform:methanol:water=12:4:
1.
10. A quality control method according to claim 7, characterized in that: In the identification of Fritillaria thunbergii, the developing agent is ethyl acetate:concentrated ammonia=100:1, and the mixing ratio of dilute potassium bismuth iodide test solution-2% hydrochloric acid ethanol solution is 1:1.