A traditional Chinese medicine composition with antiemetic effect and a preparation method thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition with an antiemetic effect and a preparation method thereof. The traditional Chinese medicine composition contains perilla leaf, Coptis chinensis, Amomum villosum, Saussurea lappa, Pinellia ternata, ginger, Chinese yam and honey. The traditional Chinese medicine composition has a good relieving and treating effect on pregnancy vomiting through pharmacological experiments and clinical use verification. The clinical treatment rate of pregnancy vomiting reaches 92.86%, and the traditional Chinese medicine composition can effectively relieve the clinical symptoms of patients, such as nausea and vomiting, dizziness, anorexia, food entering the stomach and then vomiting, and the like. The preparation process is simple, the traditional Chinese medicine composition can be further produced, and has a wide market prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a traditional Chinese medicine composition and its medicinal uses, specifically a traditional Chinese medicine composition with antiemetic effect and its preparation method. Background Technology

[0002] Vomiting is a protective mechanism of the human body that can expel harmful substances ingested in the stomach. However, frequent and violent vomiting can cause a variety of harmful consequences: malnutrition, dehydration, electrolyte imbalance, acid-base imbalance, and even damage to the esophagus and stomach.

[0003] Vomiting is extremely common in clinical practice. It can be caused by functional disorders or organic diseases, mostly due to lesions in the digestive system itself, but can also be caused by diseases outside the digestive system or systemic diseases. Repeated and severe vomiting can lead to gastroesophageal rupture syndrome, resulting in varying degrees of hematemesis, and in severe cases, even esophageal rupture, which is a surgical emergency. Frequent and prolonged vomiting often causes metabolic disorders such as dehydration, alkalosis, and hypokalemia. Unconscious individuals may develop pneumonia or even die from suffocation due to aspiration of vomit.

[0004] Morning sickness, also known as vomiting during pregnancy, is an early pregnancy reaction that occurs during pregnancy. Its cause is unknown but may be related to various factors. The main clinical manifestations are nausea and vomiting, loss of appetite, and lethargy; in severe cases, it can lead to dehydration or acidosis. Mild morning sickness usually does not require treatment and often resolves on its own; severe cases require active treatment to improve vomiting symptoms. 80%–90% of women experience morning sickness in early pregnancy, and 10%–20% of pregnant women experience nausea and vomiting symptoms that may persist until delivery. Summary of the Invention

[0005] One of the objectives of this invention is to provide a traditional Chinese medicine composition for the prevention and treatment of vomiting, wherein the traditional Chinese medicine composition contains perilla leaves, coptis, amomum villosum, costus root, pinellia, ginger, yam, and honey.

[0006] In some embodiments, the traditional Chinese medicine composition contains the following components:

[0007] Perilla leaves 40-100 parts by weight, Coptis chinensis 10-40 parts by weight, Amomum villosum 30-70 parts by weight

[0008] Costus root 20-50 parts by weight, Pinellia ternata 30-60 parts by weight, Ginger 20-50 parts by weight

[0009] 50-100 parts by weight of yam and 50-150 parts by weight of honey.

[0010] In a preferred embodiment, the traditional Chinese medicine composition contains the following components:

[0011] Perilla leaves 50-80 parts by weight, Coptis chinensis 20-35 parts by weight, Amomum villosum 40-65 parts by weight

[0012] 30-40 parts by weight of costus root, 30-40 parts by weight of pinellia tuber, and 30-40 parts by weight of ginger.

[0013] 80-100 parts by weight of yam and 80-120 parts by weight of honey.

[0014] In a preferred embodiment, the traditional Chinese medicine composition contains the following components:

[0015] Perilla leaves 60 parts by weight, Coptis chinensis 25 parts by weight, Amomum villosum 45 parts by weight

[0016] 33 parts by weight of costus root, 33 parts by weight of pinellia tuber, and 33 parts by weight of ginger.

[0017] 80 parts by weight of yam and 100 parts by weight of honey.

[0018] The Pinellia ternata in the above-mentioned traditional Chinese medicine composition is ginger-processed Pinellia ternata.

[0019] A second objective of this invention is to provide a method for preparing the aforementioned traditional Chinese medicine composition, the method comprising the following steps:

[0020] 1) Pass the Coptis chinensis powder through a 20-mesh sieve, dissolve it in hot water at 40-45℃, maintain the temperature, and then filter it through an 80-mesh sieve for later use.

[0021] 2) Add 6-12 times the amount of water to the medicinal materials except for honey, decoct for 50-80 minutes, filter, add 4-8 times the amount of water to the dregs, decoct for 40-60 minutes, filter, combine the filtrates, concentrate at 70-80℃ to a relative density of 1.03-1.07, let stand, take the supernatant, add Coptis chinensis powder extract, concentrate at 70-80℃ to a relative density of 1.17-1.22, cool, and the extract is ready for use;

[0022] 3) Dissolve gelatin in water, then mix CMC-Na, PVP and sorbitol evenly and add them to the gelatin solution. Add 5% ethanol solution to fully swell, then add the ointment from step 2) and honey, stir and fully cross-link and coat it on non-woven fabric, cover with an anti-adhesive film, and dry to obtain the plaster.

[0023] A third objective of this invention is to provide the medicinal use of the above-mentioned traditional Chinese medicine composition, namely, its use in the prevention, relief and / or treatment of vomiting.

[0024] In some embodiments, the vomiting refers to vomiting caused by illness and / or medication.

[0025] In a preferred embodiment, the vomiting refers to vomiting during pregnancy.

[0026] The fourth objective of this invention is to provide a traditional Chinese medicine preparation, which is prepared from the above-mentioned traditional Chinese medicine composition.

[0027] In some embodiments, the traditional Chinese medicine preparation is an oral preparation and / or a topical preparation.

[0028] In some embodiments, the traditional Chinese medicine preparation is a topical preparation.

[0029] In a more preferred embodiment, the traditional Chinese medicine preparation is a topical ointment.

[0030] Compared with the prior art, the present invention has achieved significant technical effects:

[0031] Clinical experience has shown that the traditional Chinese medicine composition of the present invention has a significant antiemetic effect, especially for vomiting during pregnancy. The clinical efficacy rate of the traditional Chinese medicine composition of the present invention is as high as 92.86%, which can effectively relieve and treat vomiting during pregnancy and improve clinical symptoms such as nausea, vomiting, dizziness, loss of appetite, and vomiting immediately after eating. Attached Figure Description

[0032] Figure 1 Statistical analysis of kaolin consumption in rats of each example group;

[0033] Figure 2 Statistical analysis of feed intake in rats of each example group;

[0034] Figure 3 Statistics on water intake of rats in each example group;

[0035] Figure 4 Statistical analysis of weight changes in rats in each example group. Specific Implementation

[0036] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. After reading the present invention, any modifications of the present invention in various equivalent forms by those skilled in the art will fall within the scope defined by the appended claims.

[0037] Example 1: A plaster containing a traditional Chinese medicine composition is prepared, the composition and process of which are as follows:

[0038] 40g perilla leaves, 10g coptis, 30g amomum villosum, 20g costus root, 30g pinellia, 20g ginger, 50g yam, and 50g honey.

[0039] Preparation process: The processing methods for all the above Chinese medicinal materials are as follows:

[0040] 1) Pass the Coptis chinensis powder through a 20-mesh sieve, dissolve it in hot water at 40-45℃, maintain the temperature, and then filter it through an 80-mesh sieve for later use.

[0041] 2) Add 6-12 times the amount of water to the medicinal materials except for honey, decoct for 50-80 minutes, filter, add 4-8 times the amount of water to the dregs, decoct for 40-60 minutes, filter, combine the filtrates, concentrate at 70-80℃ to a relative density of 1.03-1.07, let stand, take the supernatant, add Coptis chinensis powder extract, concentrate at 70-80℃ to a relative density of 1.17-1.22, cool, and the extract is ready for use;

[0042] 3) Dissolve gelatin in water, then mix CMC-Na, PVP and sorbitol evenly and add them to the gelatin solution. Add 5% ethanol solution to fully swell, then add the ointment from step 2) and honey, stir and fully cross-link and coat it on non-woven fabric, cover with an anti-adhesive film, and dry to obtain the plaster.

[0043] Example 2: A plaster containing a traditional Chinese medicine composition is prepared, the composition and process of which are as follows:

[0044] 100g perilla leaves, 40g coptis, 70g amomum, 50g costus root, 60g pinellia, 50g ginger, 100g yam, 150g honey.

[0045] The preparation process is the same as in Example 1.

[0046] Example 3: A plaster containing a traditional Chinese medicine composition is prepared, the composition and process of which are as follows:

[0047] 50g perilla leaves, 20g coptis, 40g amomum, 30g costus root, 30g pinellia, 30g ginger, 80g yam, 80g honey.

[0048] The preparation process is the same as in Example 1.

[0049] Example 4: A plaster containing a traditional Chinese medicine composition is prepared, the composition and process of which are as follows:

[0050] 80g perilla leaves, 35g coptis, 65g amomum villosum, 40g costus root, 40g pinellia, 40g ginger, 100g yam, 120g honey.

[0051] The preparation process is the same as in Example 1.

[0052] Example 5: A plaster containing a traditional Chinese medicine composition is prepared, the composition and process of which are as follows:

[0053] 60g perilla leaves, 25g coptis, 45g amomum villosum, 33g costus root, 33g pinellia, 33g ginger, 80g yam, 100g honey.

[0054] The preparation process is the same as in Example 1.

[0055] Comparative Example 1: A plaster containing a traditional Chinese medicine composition, the composition and process of which are as follows:

[0056] 60g perilla leaves, 25g coptis, 45g amomum, 33g patchouli, 33g pinellia, 33g ginger, 30g dried tangerine peel, 100g honey.

[0057] The preparation process is the same as in Example 1.

[0058] Comparative Example 2: A plaster containing a traditional Chinese medicine composition, the composition and process of which are as follows:

[0059] 15g perilla leaves, 25g coptis, 25g amomum, 55g costus root, 23g pinellia, 55g ginger, 100g yam, 120g honey.

[0060] The preparation process is the same as in Example 1.

[0061] Comparative Example 3: A plaster containing a traditional Chinese medicine composition, the composition and process of which are as follows:

[0062] 60g perilla leaves, 25g coptis, 45g amomum villosum, 15g bamboo shavings, 15g reed rhizome, 33g pinellia, 33g ginger, 100g yam, 100g honey.

[0063] The preparation process is the same as in Example 1.

[0064] Comparative Example 4: A plaster containing a traditional Chinese medicine composition, the composition and process of which are as follows:

[0065] 33g Pinellia ternata, 60g Perilla frutescens stem, 33g dried ginger, 15g cinnamon, 15g cloves, 10g licorice root

[0066] The preparation process is as follows: Boil twice with water, 1.5 hours each time. Combine the decoctions, concentrate to a thick paste, add the honey mentioned above, and mix well. Apply the resulting mixture directly to the skin.

[0067] Comparative Example 5: A plaster containing a traditional Chinese medicine composition, the composition and process of which are as follows:

[0068] 93g perilla leaves, 25g coptis, 45g amomum, 33g costus root, 33g ginger, 80g yam, 100g honey.

[0069] The preparation process is the same as in Example 1.

[0070] Comparative Example 6: A plaster containing a traditional Chinese medicine composition, the composition and process of which are as follows:

[0071] 60g perilla leaves, 25g coptis, 45g amomum villosum, 33g costus root, 33g pinellia, 33g ginger, 80g yam, 100g honey.

[0072] Preparation process: The processing methods for all the above Chinese medicinal materials are as follows:

[0073] 1) Add 6-12 times the amount of water to the medicinal materials except honey, decoct for 50-80 minutes, filter, add 4-8 times the amount of water to the dregs, decoct for 40-60 minutes, filter, combine the filtrates, concentrate at 70-80℃ to a relative density of 1.03-1.07, let stand, take the supernatant, add Coptis chinensis powder extract, concentrate at 70-80℃ to a relative density of 1.17-1.22, cool, and the extract is ready for use;

[0074] 2) Dissolve gelatin in water, then mix CMC-Na, PVP and sorbitol evenly and add them to the gelatin solution. Add water to make it fully swell, then add the ointment from step 2) and honey, stir and fully cross-link and coat it on non-woven fabric, cover with an anti-adhesive film, and dry to obtain the plaster.

[0075] In the preparation method of Comparative Example 6, the content of berberine was significantly lower than that in other examples, and pharmacological experiments also showed that it was less effective in preventing and treating vomiting.

[0076] This invention emphasizes traditional Chinese medicine theory, focusing on the underlying mechanisms and employing a complete set of principal, assistant, and adjuvant herbs. The formula uses the pungent and warm herbs Pinellia ternata and Perilla frutescens as the principal herbs. Pinellia ternata effectively relieves nausea and vomiting, while Perilla frutescens promotes qi circulation and harmonizes the stomach. Together, they act as the principal herbs, exerting their primary effect. The assistant herbs include the bitter and cold herbs Coptis chinensis to purge liver heat, the pungent and warm herbs Aucklandia lappa and Amomum villosum to invigorate the spleen and harmonize the stomach, and the emetic ginger to stop vomiting. The combination of principal and assistant herbs balances the cold and hot properties, harmonizing the liver and stomach. Dioscorea opposita, being neutral in nature, tonifies the spleen and stomach, serving as an adjuvant herb. Honey tonifies the middle jiao and harmonizes the other herbs, acting as an adjuvant and guiding herb. Pharmacological experiments have shown that the combined effects of these herbs significantly improve vomiting and significantly reduce food intake.

[0077] The traditional Chinese medicine composition of the present invention has a significant antiemetic effect, especially for vomiting during pregnancy. The clinical efficacy rate of the traditional Chinese medicine composition of the present invention is as high as 92.86%, which can effectively relieve and treat vomiting during pregnancy and improve clinical symptoms such as nausea, vomiting, dizziness, loss of appetite, and vomiting immediately after eating.

[0078] I. The therapeutic effect of the plaster of the present invention on a rat model of pica.

[0079] Currently, the rat pica model is the internationally preferred vomiting model. The degree of nausea and vomiting can be indirectly observed by monitoring the dosage of kaolin. In this experiment, we will use a cisplatin-induced rat pica model to observe the preventive and therapeutic effects of the formulation in this invention on rat pica, and to preliminarily explore the antiemetic effect of the formulation, providing a basis for clinical medication.

[0080] 1.1 Experimental Materials

[0081] Sprague-Dawley rats, weighing 220 g ± 20 g, were raised for one week before the experiment to adapt to the environment. The animal certificate number was SYXK (Lu) 20180008.

[0082] 1.2 Drugs and Reagents

[0083] Cisplatin for injection, with the national drug approval number H20023461, produced by Qilu Pharmaceutical Co., Ltd. During the experiment, it was diluted with sterile normal saline to a concentration of 0.4 mg / m1; normal saline; and the paste prepared according to the present invention.

[0084] Examples of the present invention: Example 1, 2, 5 and Comparative Example 1-5 were applied to the Shenque acupoint of rats.

[0085] Positive control group: Compound Scopolamine Hydrobromide Patch, produced by Nantong Baiyi Pharmaceutical Co., Ltd., with the national drug approval number H32025500, was applied to the Shenque acupoint of rats.

[0086] 1.3 Model Establishment and Grouping for Drug Administration

[0087] Drug administration: Model group, blank control group, positive control group, Example 1, 2, 5 and Comparative Example 1-5. There were 10 rats in each group. The rats were initially housed individually. The positive control group, Example 1, 2, 5 and Comparative Example 1-5 groups were applied with Jiangxia paste on the Shenque acupoint of rats. After 2 days of adaptation, when no abnormal situation was observed in the rats, kaolin particles were introduced, and the kaolin particles were separated from the feed to make the rats familiar with the presence of kaolin.

[0088] Three days after introducing kaolin, most rats no longer ingested kaolin. One hour after drug administration to the rats, model establishment began. Each group was intraperitoneally injected with cisplatin at a dose of 1.5 ml / 100 g. Among them, the blank group was intraperitoneally injected with normal saline, and the other groups were intraperitoneally injected with cisplatin solution at a concentration of 0.4 mg / ml. The dose of cisplatin was 6 mg / kg. After 72 hours of model establishment, the rats were sacrificed by cervical dislocation.

[0089] 1.4 Detection of Project Indicators and Results

[0090] At 8:30 every day, the indicators of each group were recorded, including the amount of kaolin ingested by rats, the amount of feed ingested, the amount of water drunk, and the changes in body weight, until 72 hours after model establishment.

[0091] 1.5 Data Analysis

[0092] Data were statistically analyzed using GrapPadprsim6.0.

[0093] 1.6 Results and Analysis <……​​​

[0095] On the first day after administration of kaolin, almost all groups of rats ingested kaolin. On the second and third days after administration, the amount of kaolin consumed gradually decreased, and on the third day, almost no rats ate any. After modeling, the amount of kaolin consumed by rats injected with cisplatin increased to varying degrees in all groups. At 24 hours after modeling, the amount of kaolin consumed by the model group was significantly higher than that of the blank control group (P<0.01), indicating a significant difference and successful replication of the cisplatin-induced chemotherapy-induced vomiting model in rats. At 24 hours, the positive control group showed a significant difference compared to the example (P<0.05) and an extremely significant difference compared to Example 5 (P<0.01), consistent with the 24-hour and 48-hour periods. In other words, the positive control group showed a significant difference compared to the example (P<0.05) and an extremely significant difference compared to Example 5 (P<0.01). See Appendix for details. Figure 1 .

[0096] 1.6.2 Statistics on feed intake of rats

[0097] After modeling, the feeding behavior of rats injected with cisplatin remained largely unchanged across the groups, with no statistically significant or highly significant differences between the groups. See attached document for details. Figure 2 .

[0098] 1.6.3 Statistics on water consumption in rats

[0099] After modeling, water intake decreased in all groups of rats, with the most significant decrease observed in the model group after cisplatin injection. The water intake in Examples 1, 2, and 5 was significantly higher than in the other control groups. Further analysis revealed that the water intake in Example 5 group at 24h, 48h, and 72h was significantly different from that in the positive control group. See Appendix for details. Figure 3 .

[0100] 1.6.4 Statistical analysis of rat weight changes

[0101] After modeling, among the rats injected with cisplatin, the model group showed a significant decrease in body weight, which was significantly different from the control group. The other groups showed little change in body weight, and there were no statistically significant differences between them. See Appendix for details. Figure 4 .

[0102] II. Clinical Application

[0103] 1. Materials and Methods

[0104] 1.1 General Information

[0105] Fifty-six patients with morning sickness during pregnancy admitted to our hospital from December 2021 to December 2023 were selected as the study subjects. All were inpatients and were randomly divided into a treatment group (n=28) and a control group (n=28). The mean age of the treatment group was 26.7±5.6 years, and the duration of illness was 8.5±3.4 days. The mean age of the control group was 25.1±8.7 years, and the duration of illness was 7.8±3.2 days. There were no statistically significant differences in general characteristics between the two groups (P>0.05).

[0106] 1.2 Treatment methods

[0107] The control group received routine Western medicine treatment, including fluid replacement and intramuscular sedation, specifically intravenous injection of 100mg vitamin B6 mixed with 5% glucose solution. The total treatment course was 1–2 weeks.

[0108] The treatment group was given an antiemetic ointment (prepared according to the prescription and method described in Example 5 above) applied to the inside of the wrist, changed daily, for a total course of 1 to 2 weeks.

[0109] Both groups received emotional support during treatment to help alleviate patients' anxieties. Patients were advised to rest in bed as much as possible and ensure sufficient sleep. Dietary adjustments were also made, providing patients with easily digestible, nutritious foods that suited their tastes. Patients with more severe conditions were required to fast for one day upon admission.

[0110] 1.3 Efficacy Evaluation Criteria

[0111] 1.3.1 Treatment efficacy rate

[0112] Cured: Vomiting stopped, all symptoms disappeared, and there was no recurrence after stopping the medication.

[0113] Effective: Symptoms such as vomiting are relieved; or symptoms of vomiting are eliminated, but recurrence occurs after discontinuation of medication.

[0114] Ineffective: No improvement was observed in any of the vomiting symptoms.

[0115] Overall effective rate = (number of cured cases + number of effective cases) / total number of cases × 100%.

[0116] 1.3.2 Clinical symptom score

[0117] Symptoms disappearance is 0 points; mild symptoms with little impact on work and life is 1 point; severe symptoms affecting work and life is 2 points; severe symptoms with no improvement is 3 points.

[0118] 1.4 Statistical Methods

[0119] The relevant data were statistically analyzed using SPSS 22.0 software. Quantitative data were expressed as "x±s" and t-tests were used. A p-value < 0.05 was considered statistically significant.

[0120] 2. Results

[0121] 2.1 Clinical efficacy rate

[0122] The total effective rate in the treatment group was 92.86%, which was significantly higher than that in the control group (67.86%).

[0123] Table 1 Comparison of clinical treatment effectiveness rates among different groups

[0124] Group Number of examples (examples) Cured (case) Valid (example) Invalid (example) Overall effectiveness (%) control group 28 8 18 2 92.86 Treatment group 28 2 17 9 67.86

[0125] 2.2 Clinical symptom scores

[0126] After treatment, the clinical symptoms of nausea, vomiting, dizziness, loss of appetite, and vomiting immediately after eating were significantly relieved in both groups of patients. The treatment group showed a greater degree of symptom relief than the control group, and the difference was statistically significant (P < 0.05).

[0127] Table 2 Comparison of clinical symptom scores among groups

[0128]

[0129] Compared with before treatment in this group, @ P < 0.05; compared with the control group after treatment, △ P < 0.05.

Claims

1. The use of a topical traditional Chinese medicine composition prepared from perilla leaves, coptis, amomum villosum, costus root, pinellia, ginger, yam, and honey in the preparation of drugs for the prevention and treatment of vomiting, characterized in that, The components of the aforementioned traditional Chinese medicine composition are as follows: Perilla leaves 40-100 parts by weight, Coptis chinensis 10-40 parts by weight, Amomum villosum 30-70 parts by weight Costus root 20-50 parts by weight, Pinellia ternata 30-60 parts by weight, Ginger 20-50 parts by weight 50-100 parts by weight of yam and 50-150 parts by weight of honey.

2. The use as described in claim 1, characterized in that, The components of the aforementioned traditional Chinese medicine composition are as follows: Perilla leaves 50-80 parts by weight, Coptis chinensis 20-35 parts by weight, Amomum villosum 40-65 parts by weight 30-40 parts by weight of costus root, 30-40 parts by weight of pinellia tuber, and 30-40 parts by weight of ginger. 80-100 parts by weight of yam and 80-120 parts by weight of honey.

3. The use as described in claim 1, characterized in that, The components of the aforementioned traditional Chinese medicine composition are as follows: Perilla leaves 60 parts by weight, Coptis chinensis 25 parts by weight, Amomum villosum 45 parts by weight 33 parts by weight of costus root, 33 parts by weight of pinellia tuber, and 33 parts by weight of ginger. 80 parts by weight of yam and 100 parts by weight of honey.

4. The use as described in any one of claims 1-3, characterized in that, The Pinellia mentioned is ginger-processed Pinellia.

5. The use as described in any one of claims 1-3, characterized in that, The preparation method of the traditional Chinese medicine composition includes the following steps: 1) Pass the Coptis chinensis powder through a 20-mesh sieve, dissolve it in hot water at 40-45°C, maintain the temperature, and then filter it through an 80-mesh sieve for later use; 2) Add 6-12 times the amount of water to the medicinal materials except for honey, decoct for 50-80 minutes, filter, add 4-8 times the amount of water to the dregs, decoct for 40-60 minutes, filter, combine the filtrates, concentrate at 70-80°C to a relative density of 1.03-1.07, let stand, take the supernatant, add Coptis chinensis powder extract, concentrate at 70-80°C to a relative density of 1.17-1.22, cool, and the extract is ready for use; 3) Dissolve gelatin in water, then mix CMC-Na, PVP and sorbitol evenly and add them to the gelatin solution. Add 5% ethanol solution to fully swell, then add the ointment from step 2) and honey, stir and fully cross-link and coat it on non-woven fabric, cover with an anti-adhesive film, and dry to obtain the plaster.

6. The use as described in claim 4, characterized in that, The vomiting mentioned refers to vomiting caused by illness and / or medication.

7. The use as described in claim 4, characterized in that, The vomiting mentioned refers to pregnancy-related vomiting.

8. The use as described in claim 4, characterized in that, The traditional Chinese medicine preparation is a topical ointment.

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