Traditional Chinese medicine patch as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine patch as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine patch is prepared from the following components in parts by mass: 30-50 parts of codonopsis pilosula, 30-50 parts of raw bighead atractylodes rhizome, 26-34 parts of dried ginger and 15-25 parts of fructus amomi. The traditional Chinese medicine patch provided by the invention can effectively relieve vomitus gravidarum, is adhered to Neiguan and Zhongwan acupoints on two sides during use, has extremely high safety to pregnant women, is convenient to implement, and is easily accepted by patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and in particular to a traditional Chinese medicine patch, its preparation method and application. Background Technology

[0002] Nausea and vomiting during pregnancy are common symptoms in early pregnancy, significantly impacting the quality of life and safety of pregnant women. Currently, treatment for pregnancy vomiting primarily involves medication and intravenous rehydration. However, medication often leads to side effects, resulting in low willingness among pregnant women to take it; intravenous rehydration only temporarily alleviates vomiting symptoms, making it less practical. Therefore, there is a need for a product that eliminates the need for oral medication or rehydration, offers greater feasibility, and provides effective prevention and / or treatment of pregnancy vomiting. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine patch, its preparation method and application, to solve the technical problems of poor feasibility and ineffective efficacy of existing drugs in preventing and / or treating pregnancy vomiting.

[0004] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0005] This invention provides a traditional Chinese medicine patch, which is prepared from the following components in parts by weight: 30-50 parts of Codonopsis pilosula, 30-50 parts of raw Atractylodes macrocephala, 26-34 parts of dried ginger, and 15-25 parts of Amomum villosum.

[0006] Preferably, it is prepared from the following components in parts by weight: 34-46 parts of Codonopsis pilosula, 34-46 parts of raw Atractylodes macrocephala, 28-32 parts of dried ginger, and 17-23 parts of Amomum villosum.

[0007] Preferably, it is prepared from the following components in parts by weight: 38-42 parts of Codonopsis pilosula, 38-42 parts of raw Atractylodes macrocephala, 29-31 parts of dried ginger, and 19-21 parts of Amomum villosum.

[0008] Preferably, it is prepared from the following components in parts by weight: 40 parts of Codonopsis pilosula, 40 parts of raw Atractylodes macrocephala, 30 parts of dried ginger, and 20 parts of Amomum villosum.

[0009] This invention provides a method for preparing the aforementioned traditional Chinese medicine patch, comprising the following steps:

[0010] (1) Mix the raw material components of the formula, crush them, sieve them and take the sieve material to obtain the Chinese medicine mixture;

[0011] (2) Add ginger juice to the Chinese medicine mixture, mix again, and then obtain the Chinese medicine patch.

[0012] Preferably, the sieving in step (1) is sieved through an 80-120 mesh sieve.

[0013] Preferably, the mass-to-volume ratio of the herbal mixture in step (2) to the ginger juice is 8-12 g: 1 mL.

[0014] The present invention also provides the use of the traditional Chinese medicine patch or the traditional Chinese medicine patch prepared according to the method in the preparation of products for the prevention and / or treatment of pregnancy vomiting.

[0015] The herbal patch provided by this invention is composed of Codonopsis pilosula, Atractylodes macrocephala, dried ginger, and Amomum villosum. These four herbs work synergistically to effectively relieve nausea and vomiting during pregnancy. When using the patch, apply it to the Neiguan and Zhongwan acupoints on both sides. It is highly safe for pregnant women, easy to administer, and readily accepted by patients. Detailed Implementation

[0016] This invention provides a traditional Chinese medicine patch, which is prepared from the following components in parts by weight: 30-50 parts of Codonopsis pilosula, 30-50 parts of raw Atractylodes macrocephala, 26-34 parts of dried ginger, and 15-25 parts of Amomum villosum.

[0017] Among them, Codonopsis pilosula is neutral in nature, sweet and slightly sour in taste, and enters the spleen and lung meridians. It has the effects of tonifying the middle and replenishing qi, strengthening the spleen and benefiting the lungs. It is used for spleen and lung deficiency, shortness of breath and palpitations, poor appetite and loose stools, asthmatic cough, internal heat and thirst, etc. It also has the effects of improving intelligence, calming, hypnotizing and anticonvulsant effects. Atractylodes macrocephala enters the spleen and stomach meridians. It is bitter and sweet in taste and warm in nature. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating and calming the fetus. Dried ginger is pungent and hot in nature. It enters the spleen and stomach meridians. It has the effects of warming the middle and dispelling cold, restoring yang and unblocking the meridians, and warming the lungs and resolving phlegm. Amomum villosum is pungent and warm in nature. It enters the spleen, stomach and kidney meridians. It has the effects of resolving dampness and opening the stomach, warming the spleen and stopping diarrhea, regulating qi and calming the fetus. It is used for dampness and turbidity obstructing the middle, epigastric fullness and lack of appetite, spleen and stomach deficiency and cold, vomiting and diarrhea, morning sickness, and fetal restlessness.

[0018] In this invention, the traditional Chinese medicine patch is preferably prepared from the following components in parts by weight: 34-46 parts of Codonopsis pilosula, 34-46 parts of raw Atractylodes macrocephala, 28-32 parts of dried ginger, and 17-23 parts of Amomum villosum.

[0019] In this invention, the herbal patch is further preferably prepared from the following components in parts by weight: 38-42 parts of Codonopsis pilosula, 38-42 parts of raw Atractylodes macrocephala, 29-31 parts of dried ginger, and 19-21 parts of Amomum villosum.

[0020] In this invention, the traditional Chinese medicine patch is more preferably prepared from the following components in parts by weight: 40 parts of Codonopsis pilosula, 40 parts of raw Atractylodes macrocephala, 30 parts of dried ginger, and 20 parts of Amomum villosum.

[0021] This invention provides a method for preparing the aforementioned traditional Chinese medicine patch, comprising the following steps:

[0022] (1) Mix the raw material components of the formula, crush them, sieve them and take the sieve material to obtain the Chinese medicine mixture;

[0023] (2) Add ginger juice to the Chinese medicine mixture, mix again, and then obtain the Chinese medicine patch.

[0024] In this invention, the sieving in step (1) is sieve 80 to 120 mesh, preferably sieve 90 to 115 mesh, and more preferably sieve 100 mesh.

[0025] In this invention, the mass-to-volume ratio of the herbal mixture in step (2) to the ginger juice is 8-12 g: 1 mL, preferably 9-11 g: 1 mL, and more preferably 10 g: 1 mL.

[0026] The present invention also provides the use of the traditional Chinese medicine patch or the traditional Chinese medicine patch prepared according to the method in the preparation of products for the prevention and / or treatment of pregnancy vomiting.

[0027] The present invention further provides a method for using the Chinese herbal patch or the Chinese herbal patch prepared according to the method, wherein the Chinese herbal patch is applied to the Neiguan and Zhongwan acupoints on both sides once a day for 4 to 6 hours each time.

[0028] Neiguan (PC6) is a key acupoint for treating stomach ailments, especially vomiting. Herbal patches can enhance the therapeutic effect of treating vomiting during pregnancy by stimulating the Neiguan acupoint.

[0029] The Zhongwan acupoint has the effects of harmonizing the stomach and spleen, and regulating the qi of the internal organs. Applying Chinese medicine patches to the Zhongwan acupoint can significantly enhance the effects of relieving nausea and calming the fetus by stimulating the acupoint.

[0030] 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.

[0031] Example 1

[0032] A traditional Chinese medicine patch is prepared from the following components in parts by weight: 30 parts Codonopsis pilosula, 30 parts Atractylodes macrocephala, 26 parts dried ginger, and 15 parts Amomum villosum.

[0033] Example 2

[0034] A traditional Chinese medicine patch is prepared from the following components in parts by weight: 50 parts Codonopsis pilosula, 50 parts raw Atractylodes macrocephala, 34 parts dried ginger, and 25 parts Amomum villosum.

[0035] Example 3

[0036] A traditional Chinese medicine patch is prepared from the following components in parts by weight: 40 parts Codonopsis pilosula, 40 parts raw Atractylodes macrocephala, 30 parts dried ginger, and 20 parts Amomum villosum.

[0037] Comparative Example 1

[0038] A traditional Chinese medicine patch is prepared from the following components in parts by weight: 20 parts Codonopsis pilosula, 50 parts raw Atractylodes macrocephala, 22 parts dried ginger, and 30 parts Amomum villosum.

[0039] Comparative Example 2

[0040] A traditional Chinese medicine patch is prepared from the following components in parts by weight: 40 parts Codonopsis pilosula, 40 parts Atractylodes macrocephala, 30 parts Cinnamomum cassia and 20 parts Amomum villosum.

[0041] Comparative Example 3

[0042] A traditional Chinese medicine patch is prepared from the following components in parts by weight: 40 parts Codonopsis pilosula, 40 parts raw Atractylodes macrocephala, 30 parts dried ginger, 20 parts Pinellia ternata, and 20 parts Amomum villosum.

[0043] Comparative Example 4

[0044] A traditional Chinese medicine patch is prepared from the following components in parts by weight: 40 parts Codonopsis pilosula, 40 parts Atractylodes macrocephala, 30 parts dried ginger, 20 parts Amomum villosum, and 10 parts Zingiber officinale.

[0045] Example 4

[0046] The traditional Chinese medicine patches described in Examples 1-3 and Comparative Examples 1-4 were prepared according to the following method:

[0047] (1) Mix the raw material components of the formula, crush them, pass them through a 100-mesh sieve and take the sieve material to obtain the Chinese medicine mixture;

[0048] (2) Wash the ginger and cut it into pieces. Use three layers of sterile gauze to squeeze the ginger pieces to extract the juice.

[0049] (3) Add ginger juice to the Chinese medicine mixture at a mass-volume ratio of 10g:1mL, mix again, and obtain the Chinese medicine patch.

[0050] Experimental Example 1

[0051] The traditional Chinese medicine patch prepared by this invention can effectively treat vomiting during pregnancy, and the effect is significant, which has been fully demonstrated by clinical data, the relevant clinical data of which are as follows:

[0052] 1. Case Information

[0053] The selection criteria for cases followed the diagnostic criteria for hyperemesis gravidarum in Obstetrics and Gynecology, excluding participants with congenital physiological defects and malformations of the reproductive system, as well as those experiencing vomiting due to gastroenteritis or other diseases. Seventy-two cases were selected and randomly divided into nine groups of eight participants each. There were no significant differences among the nine groups in terms of age, gestational age, or severity of the condition, making them comparable.

[0054] 2. Treatment methods

[0055] When pregnancy reactions began, the herbal patches prepared in Examples 1-3 and Comparative Examples 1-4 were applied to the bilateral Neiguan and Zhongwan acupoints of patients in Examples 1-3 and Comparative Examples 1-4, respectively, once a day for 5 hours each time. Patients in Comparative Example 5 received a total daily fluid supplement of 2000 mL, including 1000 mL of 5% glucose saline solution, 500 mL of 10% glucose injection, and 500 mL of lactated Ringer's injection (with 2 g of vitamin C and 200 mg of vitamin B6 added).

[0056] 3. Efficacy criteria

[0057] Cure: Nausea and vomiting cease, diet returns to normal, no recurrence after discontinuation of medication, and urine ketones test negative.

[0058] Significant effect: Vomiting is significantly reduced or disappears, relapse occurs after discontinuation of medication, and urinary ketone bodies improve.

[0059] Effective: Vomiting symptoms were reduced, and urine ketones were positive.

[0060] Ineffective: No improvement or worsening of vomiting symptoms, and positive urine ketones.

[0061] All groups underwent a 15-day treatment course, with one consecutive course of treatment followed up for one month after the course ended. The results of the efficacy comparison among the groups are shown in Table 1.

[0062] Table 1 Comparison of therapeutic effects among different groups

[0063] Group get well Effective efficient invalid Overall effectiveness / % Example 1 3 2 2 1 87.5 Example 2 2 3 2 1 87.5 Example 3 3 4 1 0 100 Comparative Example 1 2 2 2 2 75 Comparative Example 2 2 1 3 2 75 Comparative Example 3 1 3 1 3 62.5 Comparative Example 4 1 2 3 2 75 Comparative Example 5 3 1 2 2 75

[0064] As shown in Table 1, the total effective rate of the example group was 87.5%–100%, while the total effective rate of the comparative examples 1–4 was 62.5%–75%. The effective rates of each group in the examples were higher than those of the comparative examples 1–4, and the difference in the total effective rates between the two groups was statistically significant. In particular, the total effective rate of the herbal patch prepared in Example 3 reached 100%, indicating that the herbal patch provided by this invention, through its specific components and proportions, effectively treats pregnancy vomiting.

[0065] As can be seen from the above embodiments, the present invention provides a traditional Chinese medicine patch, its preparation method, and its application, which can effectively relieve vomiting during pregnancy. When used, the patch is applied to the bilateral Neiguan and Zhongwan acupoints, offering high safety for pregnant women, ease of implementation, and easy patient acceptance.

[0066] 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. A traditional Chinese medicine patch, characterized in that, It is prepared from the following components in parts by weight: 30-50 parts of Codonopsis pilosula, 30-50 parts of raw Atractylodes macrocephala, 26-34 parts of dried ginger, and 15-25 parts of Amomum villosum.

2. The traditional Chinese medicine patch as described in claim 1, characterized in that, It is prepared from the following components in parts by weight: Codonopsis pilosula 34-46 parts, Atractylodes macrocephala 34-46 parts, Zingiber officinale 28-32 parts and Amomum villosum 17-23 parts.

3. The traditional Chinese medicine patch as described in claim 2, characterized in that, It is prepared from the following components in parts by weight: Codonopsis pilosula 38-42 parts, Atractylodes macrocephala 38-42 parts, Zingiber officinale 29-31 parts and Amomum villosum 19-21 parts.

4. The traditional Chinese medicine patch as described in claim 3, characterized in that, It is prepared from the following components in parts by weight: 40 parts Codonopsis pilosula, 40 parts raw Atractylodes macrocephala, 30 parts dried ginger and 20 parts Amomum villosum.

5. A method for preparing the traditional Chinese medicine patch according to any one of claims 1 to 4, characterized in that, Includes the following steps: (1) Mix the raw material components of the formula, crush them, sieve them and take the sieve material to obtain the Chinese medicine mixture; (2) Add ginger juice to the Chinese medicine mixture, mix again, and then obtain the Chinese medicine patch.

6. The method as described in claim 5, characterized in that, The sieving in step (1) is to pass through an 80-120 mesh sieve.

7. The method as described in claim 6, characterized in that, The mass-to-volume ratio of the herbal mixture to the ginger juice in step (2) is 8-12 g: 1 mL.

8. The use of the traditional Chinese medicine patch according to any one of claims 1 to 4 or the traditional Chinese medicine patch prepared according to any one of claims 5 to 7 in the preparation of products for the prevention and / or treatment of vomiting during pregnancy.