Xingui dogwood-ginger dropping pill as well as preparation method and quality detection method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparation. The invention provides a dripping pill containing radix angelicae sinensis, fructus corni and ginger as well as a preparation method and a quality detection method of the dripping pill. The dripping pill is prepared from the following raw materials in parts by weight: 10 to 20 parts of xanthoceras sorbifolia bunge, 10 to 20 parts of semen ziziphi spinosae, 8 to 15 parts of rhizoma chuanxiong, 8 to 15 parts of radix angelicae sinensis, 5 to 10 parts of rhizoma zingiberis and 5 to 10 parts of fructus evodiae. According to the preparation process of the dripping pill for cornus officinalis, provided by the invention, the extraction mode, the extraction solvent and the extraction time of the medicinal materials, dripping parameters of the dripping pill and the like are determined, so that effective components in the medicinal materials can be better extracted, and the purity, the dissolution rate and the extraction rate of the effective components are improved; the utilization rate of the medicinal materials and the absorption rate of effective components in the medicinal materials are improved; the prepared dropping pill is round and neat in appearance, moderate in hardness and not easy to adhere.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and in particular to a Wen Gui Yu Jiang Dripping Pill, its preparation method, and its quality testing method. Background Technology

[0002] Wen Gui Yu Jiang Di Wan is composed of six herbs: *Vernicia fordii*, *Ziziphus jujuba* seed, *Ligusticum chuanxiong*, *Angelica sinensis*, dried ginger, and *Evodia rutaecarpa*. Wen Gui Yu Jiang Tang targets various pain syndromes caused by wind-dampness obstruction, cold stagnation and blood stasis, and blood deficiency and malnourishment. Its formulation follows the principle of "eliminating pathogens while supporting the body's resistance, warming and invigorating the body while nourishing blood." The principal herb is *Vernicia fordii*, which directly dispels wind-dampness from the muscles and bones, and promotes joint mobility. The assistant herbs are *Ligusticum chuanxiong*, *Angelica sinensis*, and *Ziziphus jujuba* seed, which assist the principal herb in promoting blood circulation and relieving joint pain and headaches, nourishing blood and tendons, alleviating muscle pain caused by blood deficiency, and also promoting blood circulation. The adjuvant herbs are dried ginger and *Evodia rutaecarpa*, which warm the middle and lower burners, directly eliminating cold pathogens from the middle burner and uterus, working together with the principal herb to relieve abdominal pain and dysmenorrhea. The formula works synergistically to dispel wind and dampness, disperse cold and dampness, invigorate blood circulation, and nourish qi and blood. By dispelling wind and dampness, dispersing cold and dampness, clearing blood stasis, and replenishing blood deficiency, it can unblock the meridians and nourish qi and blood. Therefore, it is suitable for rheumatic joint pain, muscle pain, abdominal pain, dysmenorrhea, headache and eye pain, etc., reflecting the treatment principle of "treating pain by clearing the meridians and nourishing blood while clearing the meridians".

[0003] The Wen Gui Yu Jiang formula is rich in volatile components. Compared to traditional decoctions, its active ingredients are easily volatilized during the decoction process, but they can be directly absorbed into the bloodstream to exert their therapeutic effects after oral administration. Furthermore, the slow dissolution rate of the drugs in the decoction results in low bioavailability. Therefore, this invention aims to provide a method for preparing Wen Gui Yu Jiang dripping pills, addressing the above problems through dosage form improvement. Among the medicinal materials in the Wen Gui Yu Jiang formula, the main active ingredients in *Xanthoceras sorbifolium* are saponins; in *Ziziphus jujuba*, the main active ingredients are flavonoids and saponins; in *Ligusticum chuanxiong*, the main active ingredients are organic acids; in *Angelica sinensis*, the main active ingredients are ferulic acid and other volatile components; in dried ginger, the main active ingredient is volatile ginger oil; and in *Evodia rutaecarpa*, the main active ingredients are volatile oils, flavonoids, and alkaloids. The active ingredients of these six herbs have significantly different properties. Therefore, the extraction and purification processes of the medicinal materials during the preparation of the dripping pills greatly affect the transfer rate of different active ingredients, directly impacting the efficacy of the pills.

[0004] In addition, although quality control methods for Wen Gui Yu Jiang Dripping Pills have been established, there are currently no relevant quality testing methods for Wen Gui Yu Jiang Dripping Pills. Summary of the Invention

[0005] The purpose of this invention is to provide a Wen Gui Yu Jiang dripping pill, its preparation method and quality testing method, which broadens the dosage form of Wen Gui Yu Jiang preparations and helps to improve the quality of Wen Gui Yu Jiang preparations.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a Wen Gui Yu Jiang Dripping Pill, which is prepared from the following raw materials in parts by weight: 10-20 parts of *Vernicia fordii* fruit, 10-20 parts of *Ziziphus jujuba* seed, 8-15 parts of *Ligusticum chuanxiong* rhizome, 8-15 parts of *Angelica sinensis* root, 5-10 parts of dried ginger, and 5-10 parts of *Evodia rutaecarpa* fruit.

[0007] Preferably, the *Sapindus mukorossi* fruit, *Ziziphus jujuba* seed, *Ligusticum chuanxiong* rhizome, *Angelica sinensis* root, and dried ginger are all traditional Chinese medicine decoction pieces.

[0008] This invention also provides a method for preparing Wen Gui Yu Jiang Dripping Pills, comprising the following steps: (1) Press the sliced ​​fruit of *Vernicia fordii* and the sliced ​​fruit of *Ziziphus jujuba* to obtain *Vernicia fordii* oil and *Ziziphus jujuba* oil respectively; (2) Mix the sliced ​​chuanxiong, sliced ​​danggui, sliced ​​dried ginger and sliced ​​wuzhuyu, add water and steam distill to obtain mixed volatile oil; (3) Mix the *Sapindus mukorossi* oil, jujube seed oil and mixed volatile oil, add the matrix and stir in a water bath until melted and uniform; (4) The molten medicinal liquid is dripped, the droplets are collected, dried, and the Wen Gui Yu Jiang Droplets are made.

[0009] Preferably, the amount of water used in step (2) is 8 to 12 times the total mass of the chuanxiong slices, angelica slices, dried ginger slices and evodia, and the steam distillation time is 4 to 5 hours.

[0010] Preferably, the matrix in step (3) is a mixture of PEG4000 and PEG6000, the mass ratio of the mixture of PEG4000 and PEG6000 is 3~4:1, the amount of the matrix is ​​3~5 times the total mass of the *Sapindus mukorossi* oil, jujube seed oil and mixed volatile oil, and the temperature of the water bath is 80~90℃.

[0011] Preferably, the coolant temperature during the dripping process in step (4) is 6~14℃, the dripping distance is 4~8cm, and the dripping speed is 25~35 drops / min.

[0012] This invention also provides a quality testing method for Wen Gui Yu Jiang Dripping Pills, comprising the following steps: (1) Cut the Wen Gui Yu Jiang Di Wan into small pieces to obtain the sample to be tested; (2) Take the sample to be tested and perform GC-MS analysis; (3) Take the sample to be tested and perform qualitative and quantitative analysis of the volatile oil components.

[0013] As a preferred method, the method of cutting in step (1) is to cut the Wen Gui Yu Jiang Di Wan into small pieces with a size of 0.5~1.5mm.

[0014] As a preferred embodiment, the GC-MS analysis conditions in step (2) are as follows: using an Agilent HP-5 column (30 mm x 0.25 mm x 0.25 μm), with He as the carrier gas; carrier gas flow rate of 0.8-1.2 ml / min, injection volume of 0.8-1.2 μL, split ratio of 9-11:1, injection port temperature of 220-240℃, initial column temperature of 55-65℃, holding for 1-3 min, then increasing to 175-185℃ at 4-6℃ / min, holding for 1-3 min, then increasing to 240-260℃ at 8-12℃ / min, holding for 1-3 min; Mass spectrometry detection was performed using an electron impaction source (EI) with ion energy of 60–80 eV, ion source temperature of 220–240 °C, quadrupole temperature of 145–155 °C, TIO scan mass range of m / z 50–500, and solvent delay time of 1–3 min.

[0015] Preferably, the qualitative and quantitative analysis in step (3) uses the NIST11 standard database, and the relative content is determined by the peak area normalization method.

[0016] The preparation process of Wen Gui Yu Jiang Dripping Pills provided by this invention determines the extraction method, extraction solvent, extraction time, and dripping parameters of the medicinal materials, which can better extract the effective components from the medicinal materials, improve the purity, dissolution and extraction rate of the effective components, and thus improve the utilization rate of the medicinal materials and the absorption rate of the effective components in the medicinal materials; the prepared dripping pills are round, moderately soft and hard, and not easy to stick together.

[0017] The Wengui Yujiang Dripping Pills provided by this invention exhibit highly dispersed active ingredients within the pills, improving their solubility. The pills have a short dissolution time, resulting in rapid dissolution of the active ingredients, thereby enhancing the body's bioavailability and enabling the drug to exert its maximum effect.

[0018] The quality testing method for Wenguiyujiang Dripping Pills provided by this invention employs optimized solution preparation and instrumental detection methods to qualitatively and quantitatively detect the main active ingredients contained in the drug. The GC-MS analysis method established in this invention has high stability and accurate results, ensuring the quality stability of the components in the dripping pills. Attached Figure Description

[0019] Figure 1 The total ion chromatogram of volatile oil components in Example 1 is shown below. Figure 2 The total ion chromatogram of volatile oil components in Example 2 is shown below. Figure 3 The total ion chromatogram of volatile oil components in Example 3 is shown below. Figure 4 The total ion chromatogram of volatile oil components in Example 4 is shown below. Figure 5 The total ion chromatogram of volatile oil components in Example 5 is shown below. Figure 6 The image shows the total ion chromatogram of the volatile oil components in Example 6. Detailed Implementation

[0020] This invention provides a Wen Gui Yu Jiang Dripping Pill, which is prepared from the following raw materials in parts by weight: 10-20 parts of *Vernicia fordii* fruit, 10-20 parts of *Ziziphus jujuba* seed, 8-15 parts of *Ligusticum chuanxiong* rhizome, 8-15 parts of *Angelica sinensis* root, 5-10 parts of dried ginger, and 5-10 parts of *Evodia rutaecarpa* fruit.

[0021] In this invention, the Wen Gui Yu Jiang Dripping Pill is preferably prepared from the following raw materials in parts by weight: 15 parts of *Vernicia fordii*, 5 parts of *Ziziphus jujuba* seed, 10 parts of *Ligusticum chuanxiong*, 10 parts of *Angelica sinensis*, 8 parts of dried ginger, and 8 parts of *Evodia rutaecarpa*.

[0022] In this invention, the *Sapindus mukorossi* fruit, *Ziziphus jujuba* seed, *Ligusticum chuanxiong* rhizome, *Angelica sinensis* root, and dried ginger are all traditional Chinese medicine decoction pieces.

[0023] This invention also provides a method for preparing Wen Gui Yu Jiang Dripping Pills, comprising the following steps: (1) Press the sliced ​​fruit of *Vernicia fordii* and the sliced ​​fruit of *Ziziphus jujuba* to obtain *Vernicia fordii* oil and *Ziziphus jujuba* oil respectively; (2) Mix the sliced ​​chuanxiong, sliced ​​danggui, sliced ​​dried ginger and sliced ​​wuzhuyu, add water and steam distill to obtain mixed volatile oil; (3) Mix the *Sapindus mukorossi* oil, jujube seed oil and mixed volatile oil, add the matrix and stir in a water bath until melted and uniform; (4) The molten medicinal liquid is dripped, the droplets are collected, dried, and the Wen Gui Yu Jiang Droplets are made.

[0024] In this invention, the amount of water used in step (2) is preferably 8 to 12 times the total mass of the chuanxiong slices, angelica slices, dried ginger slices and evodia, and more preferably 10 times. The steam distillation time is preferably 4 to 5 hours, and more preferably 4.5 hours.

[0025] In this invention, the matrix in step (3) is preferably a mixture of PEG4000 and PEG6000, the mass ratio of the mixture of PEG4000 and PEG6000 is preferably 3~4:1, more preferably 3.5:1, the amount of the matrix is ​​preferably 3~5 times the total mass of the *Sapindus mukorossi* oil, jujube seed oil and mixed volatile oil, more preferably 4 times, and the temperature of the water bath is preferably 80~90℃, more preferably 85℃.

[0026] In this invention, the temperature of the coolant during the dripping process in step (4) is preferably 6~14℃, more preferably 10℃, the dripping distance is preferably 4~8cm, more preferably 6cm, and the dripping speed is preferably 25~35 drops / min, more preferably 30 drops / min.

[0027] This invention also provides a quality testing method for Wen Gui Yu Jiang Dripping Pills, comprising the following steps: (1) Cut the Wen Gui Yu Jiang Di Wan into small pieces to obtain the sample to be tested; (2) Take the sample to be tested and perform GC-MS analysis; (3) Take the sample to be tested and perform qualitative and quantitative analysis of the volatile oil components.

[0028] In this invention, the method of cutting in step (1) is to cut the Wen Gui Yu Jiang Di Wan into small pieces with a size of 0.5~1.5mm, more preferably 1mm.

[0029] In this invention, the preferred conditions for GC-MS analysis in step (2) are: using an Agilent HP-5 column (30 mm x 0.25 mm x 0.25 μm), with He as the preferred carrier gas; carrier gas flow rate of 0.8-1.2 ml / min, injection volume of 0.8-1.2 μL, split ratio of 9-11:1, injection port temperature of 220-240℃, initial column temperature of 55-65℃, holding for 1-3 min, then increasing to 175-185℃ at 4-6℃ / min, holding for 1-3 min, then increasing to 240-260℃ at 8-12℃ / min, holding for 1-3 min; more preferably: carrier gas flow rate of 1 ml / min, injection volume of 1 μL, split ratio of 10:1, injection port temperature of 230℃, initial column temperature of 60℃, holding for 2 min, then increasing to 180℃ at 5℃ / min, holding for 2 min, then increasing to 250℃ at 10℃ / min. ℃, keep for 2 minutes

[0030] The mass spectrometry detection uses an electron impaction source (EI) with an ion energy of 60–80 eV, an ion source temperature of 220–240 °C, a quadrupole temperature of 145–155 °C, and a TIO scan mass range of m / z 50–500, which is further preferred; or an ion energy of 70 eV, an ion source temperature of 230 °C, a quadrupole temperature of 150 °C, a TIO scan mass range of m / z 50–500, and a solvent delay time preferably of 1–3 min, which is further preferred of 2 min.

[0031] In this invention, the qualitative and quantitative analysis in step (3) preferably uses the NIST11 standard database, and the relative content is determined according to the peak area normalization method.

[0032] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0033] Instruments and materials

[0034] 1. Instruments: GC-MS system type 7890-5977B (Agilent Technologies), electronic analytical balance type BSA224S-CW (Sartorius Scientific Instruments Co., Ltd.), and the volatile oil determination method 2204 of the Chinese Pharmacopoeia 2025 edition.

[0035] 2. Materials: The processed medicinal slices of *Vernicia fordii*, *Ziziphus jujuba*, *Ligusticum chuanxiong*, *Angelica sinensis*, dried ginger, and *Evodia rutaecarpa* all come from reputable medicinal slice companies.

[0036] Example 1

[0037] (1) Take 20g of *Vernicia fordii* slices and 15g of *Ziziphus jujuba* seed slices respectively and press them to obtain *Vernicia fordii* oil and *Ziziphus jujuba* seed oil; (2) Take 15g of Ligusticum chuanxiong slices, 15g of Angelica sinensis slices, 6g of dried ginger slices and 6g of Evodia rutaecarpa slices, add 12 times the weight of water, and steam distill for 4 hours to obtain mixed volatile oil; (3) Mix appropriate amounts of *Sapindus mukorossi* oil, jujube seed oil and mixed volatile oil, add 5 times the weight of matrix, and stir until melted and uniform under 90°C water bath heating. The matrix is ​​a mixture of PEG4000 and PEG6000 with a weight ratio of 4:1. (4) Add the molten medicine liquid to the dropper for dripping. The temperature of the coolant is 8°C, the dripping distance is 5cm, and the dripping speed is 10 drops / min. Collect the droppers, dry them, and make the Wengui Yujiang preparation droppers.

[0038] (5) Preparation of test solution by GC-MS: Take 2.0g of Wenguiyujiang Dripping Pills, cut them into pieces, and you will get the solution.

[0039] Example 2

[0040] (1) Take 15g of *Vernicia fordii* slices and 15g of *Ziziphus jujuba* seed slices respectively and press them to obtain *Vernicia fordii* oil and *Ziziphus jujuba* seed oil; (2) Take 15g of Ligusticum chuanxiong slices, 15g of Angelica sinensis slices, 6g of dried ginger slices and 6g of Evodia rutaecarpa slices, add 10 times the weight of water, and steam distill for 4 hours to obtain mixed volatile oil; (3) Mix appropriate amounts of *Sapindus mukorossi* oil, jujube seed oil and mixed volatile oil, add 5 times the weight of matrix, and stir until melted and uniform under 80°C water bath heating. The matrix is ​​a mixture of PEG4000 and PEG6000 with a weight ratio of 4:1. (4) Add the molten medicine liquid to the dropper for dripping. The temperature of the coolant is 8°C, the dripping distance is 5cm, and the dripping speed is 10 drops / min. Collect the droppers, dry them, and make the Wengui Yujiang preparation droppers.

[0041] (5) Preparation of test solution by GC-MS: Take 2.0g of Wenguiyujiang Dripping Pills, cut them into pieces, and you will get the solution.

[0042] Example 3

[0043] (1) Take 10g of *Vernicia fordii* slices and 15g of *Ziziphus jujuba* seed slices respectively and press them to obtain *Vernicia fordii* oil and *Ziziphus jujuba* seed oil; (2) Take 15g of Ligusticum chuanxiong slices, 15g of Angelica sinensis slices, 6g of dried ginger slices and 6g of Evodia rutaecarpa slices, add 8 times the weight of water, and steam distill for 4 hours to obtain mixed volatile oil; (3) Mix appropriate amounts of *Sapindus mukorossi* oil, jujube seed oil and mixed volatile oil, add 5 times the weight of matrix, and stir until melted and uniform under water bath heating at 85°C. The matrix is ​​a mixture of PEG4000 and PEG6000 with a weight ratio of 4:1. (4) Add the molten medicine liquid to the dropper for dripping. The temperature of the coolant is 8°C, the dripping distance is 5cm, and the dripping speed is 10 drops / min. Collect the droppers, dry them, and make the Wengui Yujiang preparation droppers.

[0044] (5) Preparation of test solution by GC-MS: Take 2.0g of Wenguiyujiang Dripping Pills, cut them into pieces, and you will get the solution; Example 4 (1) Take 20g of *Vernicia fordii* slices and 10g of *Ziziphus jujuba* seed slices respectively and press them to obtain *Vernicia fordii* oil and *Ziziphus jujuba* seed oil; (2) Take 15g of Ligusticum chuanxiong slices, 15g of Angelica sinensis slices, 6g of dried ginger slices and 6g of Evodia rutaecarpa slices, add 10 times the weight of water, and steam distill for 5 hours to obtain mixed volatile oil; (3) Mix appropriate amounts of *Sapindus mukorossi* oil, jujube seed oil and mixed volatile oil, add 5 times the weight of matrix, and stir until melted and uniform under water bath heating at 85°C. The matrix is ​​a mixture of PEG4000 and PEG6000 with a weight ratio of 4:1. (4) Add the molten medicine liquid to the dropper for dripping. The temperature of the coolant is 8°C, the dripping distance is 5cm, and the dripping speed is 10 drops / min. Collect the droppers, dry them, and make the Wengui Yujiang preparation droppers.

[0045] (5) Preparation of test solution by GC-MS: Take 2.0g of Wenguiyujiang Dripping Pills, cut them into pieces, and you will get the solution; Example 5 (1) Take 20g of *Vernicia fordii* slices and 20g of *Ziziphus jujuba* seed slices respectively and press them to obtain *Vernicia fordii* oil and *Ziziphus jujuba* seed oil; (2) Take 15g of Ligusticum chuanxiong slices, 15g of Angelica sinensis slices, 6g of dried ginger slices and 6g of Evodia rutaecarpa slices, add 12 times the weight of water, and steam distill for 5 hours to obtain mixed volatile oil; (3) Mix appropriate amounts of *Sapindus mukorossi* oil, jujube seed oil and mixed volatile oil, add 5 times the weight of matrix, and stir until melted and uniform under water bath heating at 85°C. The matrix is ​​a mixture of PEG4000 and PEG6000 with a weight ratio of 4:1. (4) Add the molten medicine liquid to the dropper for dripping. The temperature of the coolant is 8°C, the dripping distance is 5cm, and the dripping speed is 10 drops / min. Collect the droppers, dry them, and make the Wengui Yujiang preparation droppers.

[0046] (5) Preparation of test solution by GC-MS: Take 2.0g of Wenguiyujiang Dripping Pills, cut them into pieces, and you will get the solution; Example 6 (1) Take 15g of *Vernicia fordii* and jujube seed slices and press them to obtain jujube seed oil; (2) Take 15g of Ligusticum chuanxiong slices, 15g of Angelica sinensis slices, 6g of dried ginger slices and 6g of Evodia rutaecarpa slices, add 8 times the weight of water, and steam distill for 5 hours to obtain mixed volatile oil; (3) Mix an appropriate amount of jujube seed oil and mixed volatile oil, add 5 times the weight of matrix, and stir until melted and uniform under water bath heating at 85°C. The matrix is ​​a mixture of PEG4000 and PEG6000 with a weight ratio of 4:1. (4) Add the molten medicine liquid to the dropper for dripping. The temperature of the coolant is 8°C, the dripping distance is 5cm, and the dripping speed is 10 drops / min. Collect the droppers, dry them, and make the Wengui Yujiang preparation droppers.

[0047] (5) Preparation of test solution by GC-MS: Take 2.0g of Wenguiyujiang Dripping Pills, cut them into pieces, and you will get the solution; Experimental Example: Quality Testing of Ginger and Cornus officinalis Droplets (1) Take the GC-MS prepared in Examples 1 to 6 to prepare test solutions, and perform GC-MS analysis and qualitative and quantitative analysis respectively.

[0048] (2) GC-MS analysis conditions

[0049] An Agilent HP-5 column (30 mm x 0.25 mm x 0.25 μm) was used with He as the carrier gas. The carrier gas flow rate was 1.0 mL / min, the injection volume was 1 μL, the split ratio was 10:1, and the injection port temperature was 230 °C. The temperature program was used (initial column temperature 60 °C, hold for 2 min, then increase to 180 °C at 5 °C / min, hold for 2 min, then increase to 250 °C at 10 °C / min, hold for 2 min). Mass spectrometry detection was performed using an electron impaction source (EI), with an ion energy of 70 eV, an ion source temperature of 230 °C, a quadrupole temperature of 150 °C, a TIO scan mass range of m / z 50–500, and a solvent delay time of 2 min.

[0050] (3) Qualitative and quantitative analysis

[0051] The volatile oil components in Wenguiyujiang Dripping Pills were qualitatively studied using the NIST11 standard database and relevant literature, and their relative contents were determined by peak area normalization method.

[0052] (4) The measurement results are shown in Table 1.

[0053] Table 1. Relative percentage content of each component in the volatile oil

[0054] (5) The test results are shown in Figures 1-6 .

[0055] As can be seen from the above embodiments, the present invention provides a Wen Gui Yu Jiang Dripping Pill, its preparation method, and its quality testing method, which is prepared from raw materials comprising the following parts by weight: 10-20 parts of *Xanthoceras sorbifolium*, 10-20 parts of *Ziziphus jujuba* seed, 8-15 parts of *Ligusticum chuanxiong*, 8-15 parts of *Angelica sinensis*, 5-10 parts of dried ginger, and 5-10 parts of *Evodia rutaecarpa*. The preparation process of the Wen Gui Yu Jiang Dripping Pill provided by the present invention determines the extraction method, extraction solvent, extraction time, and dripping parameters of the medicinal materials, which can better extract the effective components from the medicinal materials, improve the purity, dissolution rate, and extraction rate of the effective components, thereby improving the utilization rate of the medicinal materials and the absorption rate of the effective components in the medicinal materials; the prepared dripping pills are round, of moderate hardness, and not prone to sticking together.

[0056] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. Wen Guji Jiang dripping pills, characterized in that, It is prepared from raw materials including the following weight parts: Xanthoceras sorbifolia Bunge 10~20 parts, Zizyphus jujuba Mill. var. spinosa (Bunge) Hu 10~20 parts, Ligusticum chuanxiong Hort. 8~15 parts, Angelica sinensis (Oliv.) Diels 8~15 parts, Zingiber officinale Roscoe 5~10 parts and Evodia rutaecarpa (Juss.) Benth. 5~10 parts.

2. The Wen Gujiang dripping pills according to claim 1, characterized in that, The Xanthoceras sorbifolia Bunge, Zizyphus jujuba Mill. var. spinosa (Bunge) Hu, Ligusticum chuanxiong Hort. and Zingiber officinale Roscoe are all traditional Chinese medicine decoction pieces.

3. The preparation method of the Evodia rutaecarpa ginger dripping pills of claim 1 or 2, characterized in that, It comprises the following steps: (1) separately squeeze Xanthoceras sorbifolia Bunge decoction pieces and Zizyphus jujuba Mill. var. spinosa (Bunge) Hu decoction pieces to obtain Xanthoceras sorbifolia Bunge oil and Zizyphus jujuba Mill. var. spinosa (Bunge) Hu oil; (2) mix Ligusticum chuanxiong Hort. decoction pieces, Angelica sinensis (Oliv.) Diels decoction pieces, Zingiber officinale Roscoe decoction pieces and Evodia rutaecarpa (Juss.) Benth., and then steam distill after adding water to obtain mixed volatile oil; (3) mix Xanthoceras sorbifolia Bunge oil, Zizyphus jujuba Mill. var. spinosa (Bunge) Hu oil and mixed volatile oil, and then stir to melt uniformly under water bath heating after adding matrix; (4) drop the melted medicinal liquid, collect the drop pills, dry and prepare the Wen Gu Li Ji Jiang drop pills.

4. The production method according to claim 3, characterized by, The water in step (2) is used in an amount of 8~12 times the total mass of Ligusticum chuanxiong Hort. decoction pieces, Angelica sinensis (Oliv.) Diels decoction pieces, Zingiber officinale Roscoe decoction pieces and Evodia rutaecarpa (Juss.) Benth., and the steam distillation time is 4~5 h.

5. The preparation method according to claim 3, characterized in that, The matrix in step (3) is a mixture of PEG4000 and PEG6000, the mass ratio of the mixture of PEG4000 and PEG6000 is 3~4:1, the amount of the matrix is 3~5 times the total mass of Xanthoceras sorbifolia Bunge oil, Zizyphus jujuba Mill. var. spinosa (Bunge) Hu oil and mixed volatile oil, and the temperature of the water bath is 80~90℃.

6. The preparation method according to claim 3, characterized in that, The cooling agent temperature is 6~14℃, the drop distance is 4~8 cm and the drop speed is 25~35 drops / min during the dropping in step (4).

7. The quality detection method of the Wen Guji Jiang dripping pills of claim 1 or 2, characterized in that, It comprises the following steps: (1) cut the Wen Gu Li Ji Jiang drop pills to obtain the sample to be tested; (2) take the sample to be tested for GC-MS analysis; (3) take the sample to be tested for qualitative and quantitative analysis of volatile oil components.

8. The quality detection method according to claim 7, characterized in that, The method for cutting in step (1) is to cut the Wen Gu Li Ji Jiang drop pills into small pieces with a size of 0.5~1.5 mm.

9. The quality detection method according to claim 7, wherein The GC-MS analysis conditions in step (2) are as follows: Agilent HP-5 chromatographic column (30 mm x 0.25 mm 0.25 μm) is adopted, He is used as carrier gas, carrier gas flow rate is 0.8~1.2 ml / min, sample injection amount is 0.8~1.2 μL, split ratio is 9~11:1, sample injection port temperature is 220~240℃, initial column temperature is 55~65℃, holding for 1~3 min, then increasing to 175~185℃ at a rate of 4~6℃ / min, holding for 1~3 min, then increasing to 240~260 ℃ at a rate of 8~12 ℃ / min, holding for 1~3 min; Mass spectrometry detection adopts electron impaction source (El), ion energy is 60~80 eV, ion source temperature is 220~240 ℃, quadrupole rod temperature is 145~155 ℃, TIO scanning mass range is m / z 50~500, and solvent delay time is 1~3 min.

10. The quality detection method of claim 7, wherein, The NIST11 standard database is used for qualitative and quantitative analysis in step (3), and the relative content is determined according to peak area normalization method.

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