A traditional Chinese medicine composition for pregnancy reaction

Abstract

The application discloses a traditional Chinese medicine composition for pregnancy reaction, which is prepared from raw materials in the following weight ratio: cyperus rotundus 10-20 parts, radix scrophulariae 10-20 parts, pinellia ternata 10-20 parts, radix paeoniae alba 5-20 parts, agastache rugosus 5-15 parts, syzygium aromaticum 5-15 parts and zingiber officinale 5-15 parts. The raw materials are matched precisely, and the traditional Chinese medicine composition has the effects of soothing liver and stomach, regulating qi, reducing phlegm, stopping vomiting, strengthening spleen and benefiting qi, and protecting fetus, and can obviously improve the pregnancy reaction symptoms of incoordination between liver and stomach, spleen deficiency and phlegm obstruction, such as nausea and vomiting, dry mouth and bitter taste or mouth-foaming phlegm, chest fullness and hypochondriac pain, abdominal distension, belching, fatigue, dizziness and anorexia, and can prevent recurrence and prevent common pregnancy vomiting from developing into severe pregnancy vomiting, and has high practical application value.

Description

Technical Field

[0001] This invention specifically relates to a traditional Chinese medicine composition for treating pregnancy reactions. Background Technology

[0002] Around six weeks after conception, about half of pregnant women experience various discomforts such as fatigue, drowsiness, loss of appetite, aversion to oily foods, nausea, and vomiting. These symptoms are known as pregnancy reactions or early pregnancy symptoms. The exact cause of pregnancy reactions is unclear, but it may be related to hormonal changes leading to digestive dysfunction and stress causing autonomic nervous system dysfunction. Although clinical manifestations vary, and most cases of pregnancy vomiting gradually lessen or disappear naturally around the 12th week of pregnancy, frequent nausea and vomiting can still interfere with daily life and work. A small number of pregnant women experience severe pregnancy reactions, progressing from ordinary morning sickness to hyperemesis gravidarum, characterized by frequent and severe nausea and vomiting, inability to eat, electrolyte imbalance, and metabolic disorders, requiring hospitalization and intravenous fluid therapy. Because women with hyperemesis gravidarum must temporarily fast, receive intravenous fluid and electrolyte replacement to correct acid-base imbalances, and are given multivitamins (both water-soluble and fat-soluble), the long-term, large-volume daily infusions place a significant psychological and physical burden on these patients. If nausea and vomiting during pregnancy and other pregnancy symptoms can be improved, and hyperemesis gravidarum can be prevented, the quality of life of pregnant women will be greatly improved.

[0003] Patent CN202011023280.X discloses an acupoint patch for relieving nausea and vomiting, which can effectively treat hyperemesis gravidarum caused by liver-stomach disharmony when combined with intravenous fluid replacement. However, because it primarily targets hyperemesis gravidarum caused by liver-stomach disharmony accompanied by vomiting of sour and bitter fluid, and focuses on relieving nausea and vomiting to address the symptoms, it is not very effective in treating hyperemesis gravidarum caused by spleen-stomach weakness accompanied by abdominal distension, fatigue, and weakness. Its indications are relatively narrow. Furthermore, its effectiveness in improving common early pregnancy reactions, such as ordinary morning sickness and its accompanying physical discomfort, preventing the development of a disease state, and preventing hyperemesis gravidarum is unclear. Therefore, the clinical benefits for pregnant women remain limited. It is necessary to develop a more effective external dressing with broader indications that can prevent hyperemesis gravidarum. Summary of the Invention

[0004] To address the above problems, this invention provides a traditional Chinese medicine composition for treating pregnancy reactions, which is prepared from raw materials in the following weight ratio:

[0005] Cyperus rotundus 10-20 parts, Scutellaria baicalensis 10-20 parts, Pinellia ternata 10-20 parts, Paeonia lactiflora 5-20 parts, Pogostemon cablin 5-15 parts, Syzygium aromaticum 5-15 parts, Zingiber officinale 5-15 parts.

[0006] Furthermore, it is prepared from raw materials containing the following weight ratio:

[0007] Cyperus rotundus 15 parts, Scutellaria baicalensis 15 parts, Pinellia ternata 10 parts, Paeonia lactiflora 10 parts, Pogostemon cablin 10 parts, Syzygium aromaticum 10 parts, Zingiber officinale 10 parts.

[0008] Furthermore, the Pinellia ternata mentioned is Pinellia ternata from Beijing; the Pogostemon cablin mentioned is Pogostemon cablin from Guangxi.

[0009] Furthermore, it is a formulation prepared by adding pharmaceutically acceptable excipients to a powdered active pharmaceutical ingredient or an aqueous or organic solvent extract of the active pharmaceutical ingredient.

[0010] Furthermore, the preparation is a topical preparation.

[0011] Furthermore, the topical preparation is a solution, ointment, emulsion, film, or patch; the topical preparation is a solution, ointment, emulsion, film, or patch; the patch is an acupoint patch.

[0012] The present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, which includes the following steps:

[0013] (1) Weigh the raw materials according to the aforementioned proportions;

[0014] (2) The active pharmaceutical ingredient is ground into powder, or the water or organic solvent extract of the active pharmaceutical ingredient is added to the excipients or auxiliary ingredients commonly used in pharmaceuticals.

[0015] Finally, this invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for pregnancy reactions.

[0016] Furthermore, the drug has the effect of improving nausea and vomiting, fatigue, abdominal distension and / or dizziness and anorexia.

[0017] The "Jing Banxia" used in this invention is obtained by processing raw Banxia with 6% Glauber's salt, 2% ginger powder, 5% ephedra, 1.5% cinnamon twig, 3% fennel, 1% Asarum heterotropoides, 15% lime, 25% licorice, 6% soapberry, and 6% alum as auxiliary materials. It is similar in appearance to raw Banxia, ​​but its outer surface is yellow or golden yellow, the granules are uniform in size, it is brittle, the inside is yellow, and it has no numbing taste.

[0018] In Traditional Chinese Medicine (TCM), the concept of "one Qi circulating, earth pivoting the four elements" is emphasized. The central Qi (or middle Qi) is the pivot of this circulation. During pregnancy, the fetus obstructs the central Qi in the mother's body, leading to dysfunction. This weakens the spleen, eventually affecting the lungs, causing abnormal Qi movement. Prolonged liver stagnation, combined with the upward flow of Qi, attacks the stomach, resulting in nausea and vomiting. Symptoms include nausea and vomiting, persistent vomiting, dry mouth, bitter taste, or clear phlegm; sometimes accompanied by chest fullness, rib pain, epigastric fullness, abdominal distension, belching, fatigue, dizziness, and loss of appetite. This syndrome is attributed to liver-stomach disharmony, spleen deficiency, and phlegm obstruction. Treatment should focus on regulating the central Qi, harmonizing its balance, nourishing the spleen to generate lung Qi, and warming and tonifying Yang. Based on the traditional Chinese medicine theory of the circulation of Qi that causes nausea and vomiting during pregnancy, this formula uses patchouli and ginger to strengthen the spleen, resolve dampness, nourish the earth element, stabilize the fetus, regulate Qi, and promote the smooth flow of Qi in the middle Jiao; Pinellia ternata to dry dampness, resolve phlegm, and relieve nausea and vomiting; clove to warm the kidneys and assist Yang, thus nourishing kidney water; Scutellaria baicalensis to clear heat, stabilize the fetus, regulate the earth element, and assist the lung Qi in descending, thus helping the spleen to recover its function; Cyperus rotundus and Paeonia lactiflora to regulate Qi, relieve depression, soothe the liver, and promote the flow of liver Qi; these seven herbs work together to harmonize the Qi, blood, Yin, and Yang in the four directions, achieving the effects of soothing the liver, harmonizing the stomach, regulating Qi, resolving phlegm, relieving nausea and vomiting, strengthening the spleen, nourishing Qi, and stabilizing the fetus.

[0019] Based on the theory of Qi circulation in Traditional Chinese Medicine, this formula addresses the main symptoms of pregnancy reactions caused by liver-stomach disharmony and spleen deficiency with phlegm obstruction. Following the principles of monarch-minister-assistant-guide formula, the formula is explained as follows: Cyperus rotundus and Scutellaria baicalensis are used as the monarch herbs. Cyperus rotundus, with its pungent flavor, soothes the liver, relieves depression, regulates Qi, and relieves chest congestion. Scutellaria baicalensis, with its bitter flavor, clears heat, dries dampness, and calms the fetus. These two herbs work together to soothe the liver, clear heat, and calm the fetus, regulating Qi and promoting smooth flow of Qi in the middle Jiao. Pinellia ternata and ginger, as assistant herbs, nourish the spleen, dry dampness, strengthen the stomach, resolve phlegm, and relieve nausea and vomiting. The fourth herb soothes the liver, harmonizes the stomach, calms the stomach, regulates Qi, resolves phlegm, and relieves vomiting, addressing the symptoms. Agastache rugosa is added to resolve dampness and invigorate the spleen, assisting in its recovery. Paeonia lactiflora softens the liver and promotes the flow of Qi. Clove is used as the guide herb to warm the middle Jiao, calm the stomach, tonify the kidneys, and support Yang. The third herb strengthens the spleen, replenishes Qi, and calms the fetus, addressing the root cause. The seven herbs work together to treat both the symptoms and the root cause, achieving the combined effects of soothing the liver, harmonizing the stomach, calming the stomach, regulating Qi, resolving phlegm, relieving vomiting, strengthening the spleen, replenishing Qi, and calming the fetus, effectively alleviating pregnancy symptoms.

[0020] The ingredients in this invention are precisely formulated, exhibiting significant effects in soothing the liver and stomach, regulating qi, resolving phlegm, and relieving nausea; strengthening the spleen, replenishing qi, and calming the fetus. It can significantly improve nausea and vomiting, persistent vomiting, dry mouth, bitter taste, or clear phlegm in the mouth; or symptoms of pregnancy reactions such as chest fullness and rib pain, epigastric fullness and abdominal distension, belching, fatigue, dizziness, and loss of appetite, which are indicative of liver and stomach disharmony and spleen deficiency with phlegm obstruction. It also prevents recurrence and prevents ordinary morning sickness from developing into hyperemesis gravidarum, thus possessing strong practical application value.

[0021] Obviously, based on the above description of the present invention, and according to common technical knowledge and conventional methods in the field, various other modifications, substitutions or alterations can be made without departing from the basic technical concept of the present invention.

[0022] The following detailed embodiments further illustrate the above-described content of the present invention. However, this should not be construed as limiting the scope of the present invention to the following examples. All technologies implemented based on the above-described content of the present invention fall within the scope of the present invention. Attached Figure Description

[0023] Figure 1 Based on the theory of traditional Chinese medicine, this invention's formula is illustrated in the diagram. Detailed Implementation

[0024] Example 1: Preparation of the traditional Chinese medicine composition of the present invention

[0025] Ingredients: 15g Cyperus rotundus, 15g Scutellaria baicalensis, 10g Pinellia ternata, 10g Paeonia lactiflora, 10g Pogostemon cablin, 10g Syzygium aromaticum, 10g fresh ginger.

[0026] Preparation method:

[0027] 1) Weigh the raw materials according to the formula, mix all raw materials except ginger evenly and grind them into powder; cut ginger into chunks, put ginger chunks and water in a 1:1 mass ratio into a juicer, grind into a paste, put it in gauze and squeeze out the ginger juice, and collect it in a container.

[0028] 2) Take the powder obtained in step 1), add ginger juice to mix, and make a round medicine cake with a diameter of 2.0cm and a thickness of 1.0cm. Add it to a blank non-woven fabric patch with a frame and film to make a total of 25 acupoint patches.

[0029] Example 2: Preparation of the traditional Chinese medicine composition of the present invention

[0030] Ingredients: 10g Cyperus rotundus, 10g Scutellaria baicalensis, 20g Pinellia ternata, 20g Paeonia lactiflora, 15g Pogostemon cablin, 15g Syzygium aromaticum, 15g fresh ginger.

[0031] Preparation method: Same as in Example 1

[0032] Example 3: Preparation of the traditional Chinese medicine composition of the present invention

[0033] Ingredients: 20g Cyperus rotundus, 20g Scutellaria baicalensis, 10g Pinellia ternata, 5g Paeonia lactiflora, 5g Pogostemon cablin, 5g Syzygium aromaticum, 5g fresh ginger.

[0034] Preparation method: Same as in Example 1

[0035] The following experimental examples further illustrate the beneficial effects of the present invention.

[0036] Example 1: Clinical therapeutic effect of the pharmaceutical composition of the present invention

[0037] 1. Clinical Data

[0038] 1.1 Data Sources

[0039] We collected data from 175 pregnant women aged 21-38 years with nausea and vomiting during pregnancy who were admitted to the Department of Gynecology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine between January 1, 2021 and June 30, 2022. Their gestational age was 5-8 weeks.

[0040] 1.2 Diagnostic criteria

[0041] (1) Western medicine diagnostic criteria: Refer to "Obstetrics and Gynecology" (People's Medical Publishing House, edited by Xie Xing) ① Medical history: History of sexual activity and amenorrhea, with the number of days of amenorrhea within 8 weeks. ② Clinical symptoms: Nausea and vomiting, dizziness and fatigue, loss of appetite. ③ Auxiliary examinations: Positive HCG in urine or blood, and ultrasound showing intrauterine pregnancy.

[0042] (2) Diagnostic criteria of traditional Chinese medicine: Refer to "Traditional Chinese Medicine Gynecology" (China Traditional Chinese Medicine Press, edited by Zhang Yuzhen): Nausea and vomiting in early pregnancy, or persistent vomiting, dry mouth, bitter taste or clear phlegm in the mouth; or accompanied by chest fullness and hypochondriac pain or epigastric fullness and abdominal distension, belching, fatigue, dizziness and loss of appetite, pale red tongue, slightly yellow or white greasy coating, and wiry and slippery or slow and slippery pulse.

[0043] 1.3 Inclusion Criteria

[0044] Those who meet the clinical manifestations of pregnancy reactions such as nausea and vomiting during pregnancy, and whose syndrome is diagnosed as liver-stomach disharmony and spleen deficiency with phlegm obstruction according to the TCM diagnostic criteria, are in early pregnancy (5-8 weeks, for those with regular menstrual cycles, the number of days of amenorrhea is used; for those with irregular cycles, the number of days indicated by color Doppler ultrasound is used); agree to receive treatment in the control group or treatment group, and voluntarily sign the informed consent form and cooperate with the research team members in the experiment.

[0045] 1.4 Exclusion and Rejection Criteria

[0046] ① Individuals with positive blood or urine HCG but unconfirmed intrauterine pregnancy by ultrasound, or those with ectopic pregnancy, hydatidiform mole, or gestational trophoblastic disease. ② Individuals with pregnancy complications such as threatened abortion, gestational diabetes, or gestational hypertension. ③ Individuals with skin diseases at the acupoint application site. ④ Individuals with a history of allergy to the treatment drugs. ⑤ Individuals with mental illness or abnormal mental state. ⑥ Individuals whose pregnancy was terminated due to incomplete data or midway through enrollment. ⑦ Individuals who experienced severe allergic reactions or serious adverse events due to treatment. ⑧ Individuals who voluntarily withdraw and request termination of the trial.

[0047] 2. Methods

[0048] 2.1 Research Methods

[0049] Patients were randomly assigned to five groups—treatment group 1, treatment group 2, treatment group 3, control group 1, and control group 2—based on their order of visit and assigned by Arabic numerals. Each group received a corresponding patch. The patches for treatment groups 1-3 and control groups 1-2 were provided and manufactured by the pharmacy department. All patches were sealed and stored in a cool, dry place. The patches for treatment groups 1-3 and control groups 1-2 were identical in appearance, color, and texture. A designated pharmacy specialist was responsible for receiving, processing, and dispensing the medication.

[0050] Treatment groups 1-3: Received general treatment, including avoiding contact with odors and foods that easily induce nausea and vomiting, avoiding fasting in the morning, and encouraging small, frequent meals. They were given acupoint patches prepared in Examples 1-3, applied to the Zhongwan, bilateral Neiguan, and bilateral Zusanli acupoints, once daily for 4 hours each time. One course of treatment lasted 5 days, and two courses were administered. During application, any discomfort such as itching or redness was observed and recorded.

[0051] Control groups 1-2 received routine treatment, avoiding exposure to odors and foods that easily induce nausea and vomiting, avoiding fasting in the morning, and being encouraged to eat small, frequent meals. Control group 1 received control drug ①, the formula of which is: 10g of costus root, 10g of amomum villosum, 10g of ginger-processed pinellia, 10g of tangerine peel, 20g of ginseng, 10g of poria cocos, 20g of atractylodes macrocephala, 10g of perilla leaf, 5g of coptis chinensis, 10g of patchouli, 10g of bamboo shavings, and 15g of loquat leaf. The preparation method was the same as that of the treatment group, and it was made into acupoint patches. The acupoints selected were Zhongwan (CV12), bilateral Neiguan (PC6), and bilateral Zusanli (ST36), applied once every 4 hours, once a day. One course of treatment was 5 days, and two courses of treatment were performed. Control group 2 received placebo patches, which were completely identical in appearance, color, and texture to those of treatment groups 1-3 and control group 1. The acupoints selected were Zhongwan (CV12), bilateral Neiguan (PC6), and bilateral Zusanli (ST36), applied once every 4 hours, once a day. One course of treatment was 5 days, and two courses of treatment were performed.

[0052] 2.2 Observation indicators and methods for evaluating efficacy

[0053] ① Traditional Chinese Medicine (TCM) syndrome scoring: Symptoms and signs in both groups before treatment, on the 5th day of treatment, and on the 10th day of treatment were scored according to severity, including improvement in symptoms such as nausea and vomiting, fatigue, abdominal distension, dizziness, and loss of appetite. The severity was divided into three levels: none, mild, moderate, and severe, and scored as 0, 1, 2, and 3 points respectively. The total score was calculated with a maximum score of 12 points. The average value of each group was calculated, and the average change rate of the TCM syndrome score was calculated using the following formula.

[0054] The average change rate of TCM syndrome scores on the 5th day of treatment = [(average syndrome score on the 5th day of treatment - average syndrome score before treatment) / average syndrome score before treatment] × 100%

[0055] The average change rate of TCM syndrome scores on the 10th day of treatment = [(average syndrome score on the 10th day of treatment - average syndrome score before treatment) / average syndrome score before treatment] × 100%

[0056] ②The Quality of Life Scale for Nausea and Vomiting During Pregnancy (NVPQOL) was used to score the quality of life before treatment, on day 5 of treatment, and on day 10 of treatment. The average value of each group was calculated, and the average rate of change of the quality of life score for nausea and vomiting during pregnancy was calculated using the following formula.

[0057] The average change rate of quality of life score for nausea and vomiting during pregnancy on day 5 of treatment = [(average score on day 5 of treatment - average score before treatment) / average score before treatment] × 100%

[0058] The average change rate of quality of life score on day 10 of treatment for nausea and vomiting during pregnancy = [(average score on day 10 of treatment - average score before treatment) / average score before treatment] × 100%

[0059] ③Efficacy evaluation criteria: formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines":

[0060] Cure: Nausea and vomiting cease, appetite returns to normal, all symptoms disappear, all examinations are normal, and the improvement rate of TCM syndrome score is ≥90%.

[0061] Significant effect: Nausea and vomiting stop or occur occasionally, appetite improves, all examinations show significant improvement, and the improvement rate of TCM syndrome score is ≥70%.

[0062] Improvement: The frequency and severity of nausea and vomiting decreased, patients were able to eat, and various examinations showed improvement. The improvement rate of TCM syndrome score was ≥30%.

[0063] Ineffective: Symptoms do not improve, nausea and vomiting continue to worsen, loss of appetite or even vomiting immediately after eating, lethargy, and improvement rate of TCM syndrome score <30%.

[0064] Effectiveness rate = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100%

[0065] ④ The improvement of symptoms before and after treatment was statistically calculated, including nausea and vomiting, fatigue, abdominal distension, dizziness and loss of appetite.

[0066] ⑤ Recurrence rate: Follow up 2 weeks after the end of treatment to understand whether the patient experienced a recurrence of pregnancy-related nausea and vomiting after stopping the medication at the end of the treatment course.

[0067] Relapse rate = (Number of relapsed cases / (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement)) × 100%

[0068] 3. Treatment Results

[0069] (1) The clinical efficacy results are shown in Table 1.

[0070] Table 1. Clinical efficacy results of the pharmaceutical compositions of the present invention

[0071]

[0072] As shown in Table 1, patients in treatment groups 1-3 and control group 1 had significantly fewer clinical symptoms of pregnancy reactions such as nausea and vomiting compared to patients in control group 2. Treatment group 1 had the highest effective rate, reaching 88.9%, which was significantly higher than that of treatment groups 2-3 and control group 1.

[0073] (2) The average change rate of TCM syndrome scores on the 5th and 10th days of treatment is shown in Table 2.

[0074] Table 2. Average change rate of TCM syndrome scores of the pharmaceutical composition of the present invention

[0075]

[0076] As shown in Table 2, the absolute value of the average change rate of TCM syndrome scores in treatment groups 1-3 and control group 1 was significantly higher than that in control group 2; the absolute value of the average change rate of TCM syndrome scores in treatment group 1 was significantly higher than that in treatment groups 2-3 and control group 1. The acupoint patches used in treatment group 1 could significantly alleviate the symptoms and signs of pregnancy reactions.

[0077] (3) The average change rate of the quality of life score of pregnancy nausea and vomiting on the 5th and 10th days of treatment is shown in Table 3.

[0078] Table 3. Average change rate of quality of life score for pregnancy-related nausea and vomiting in the pharmaceutical composition of the present invention.

[0079]

[0080] As shown in Table 3, the average change rate of quality of life scores for nausea and vomiting during pregnancy in the treatment group and the control group was similar to the average change rate of TCM syndrome scores. The acupoint patch used in treatment group 1 had the most significant improvement on the quality of life of pregnant women in the early stages.

[0081] (4) Symptom incidence rate of the pharmaceutical composition of the present invention before and after treatment

[0082] Table 4 compares the incidence of symptoms after treatment in the two groups [n(%)].

[0083]

[0084] As shown in Table 4, both the treatment group and the control group showed relief of nausea and vomiting symptoms during pregnancy. The treatment group was more effective than the control group in relieving symptoms such as fatigue, abdominal distension, dizziness, and loss of appetite. The acupoint patch used in treatment group 1 was the most effective for nausea and vomiting and its accompanying symptoms in early pregnancy.

[0085] (5) The recurrence rate results of the pharmaceutical composition of the present invention are shown in Table 5.

[0086] Table 5. Recurrence rate of the pharmaceutical compositions of the present invention

[0087] Group Treatment group 1 Treatment group 2 Treatment group 3 Control group 1 Control group 2 Number of relapsed cases 5 8 7 8 10 recurrence rate 15.6％ 29.7％ 24.1％ 25.8％ 62.5％

[0088] As shown in Table 5, the treatment group was more effective than the control group in preventing the recurrence of pregnancy reactions such as nausea and vomiting in pregnant women. Among them, the acupoint patch used in treatment group 1 had a significant advantage in treating pregnancy reactions such as nausea and vomiting in pregnant women with a low recurrence rate.

[0089] The above clinical medication statistics show that the medication used in the treatment group primarily addresses the root cause of pregnancy by strengthening the spleen and soothing the liver, targeting symptoms such as nausea and vomiting, abdominal distension, and discomfort, and also has the effect of stabilizing the pregnancy and preventing hyperemesis gravidarum. The medication used in control group 1 primarily addresses the symptoms by relieving nausea and protecting the stomach, and its effect in preventing hyperemesis gravidarum was not ideal.

[0090] Experimental Example 2, Typical Case

[0091] Patient Ms. Wang, 31 years old, married, first visit on April 22, 2022. Chief complaint: Amenorrhea for 55 days, nausea and vomiting for 9 days, worsening for 1 day. Present illness: The patient is irritable and easily angered, experiencing nausea, vomiting, dizziness, no abdominal pain, poor appetite, worsening after eating greasy food, drowsiness, fatigue, weakness in the limbs, abdominal distension, and frequent drooling with clear phlegm. Bowel movements and urination are normal. Past medical history: The patient is generally healthy and denies any history of hepatitis, tuberculosis, or gastrointestinal diseases. Auxiliary examination: Ultrasound showed early intrauterine pregnancy. Traditional Chinese medicine diagnosis: Pregnancy vomiting, syndrome differentiation: Liver-Stomach disharmony, Spleen deficiency with phlegm obstruction. The basic treatment principle is to soothe the liver and harmonize the stomach, regulate qi and resolve phlegm to stop vomiting; strengthen the spleen and replenish qi to stabilize the pregnancy. The acupoint patch made from the Chinese herbal composition of this invention (prepared according to Example 1) was applied to the Zhongwan, bilateral Neiguan, and bilateral Zusanli acupoints daily for 4 hours each time, for 10 days. After treatment, the patient had no nausea or vomiting, and had a good appetite. During the follow-up for 2 weeks, no recurrence was observed.

[0092] In summary, this invention is based on the "traditional Chinese medicine theory of Qi circulation" and the theory of syndrome differentiation and treatment in traditional Chinese medicine. Figure 1 The formula, composed of specific Chinese medicinal herbs, has significant effects in soothing the liver and stomach, regulating qi, resolving phlegm, relieving nausea and vomiting, strengthening the spleen, replenishing qi, and calming the fetus. When these herbs are combined in the specific dosage ratio of Example 1 and applied to acupoints, it can significantly improve nausea and vomiting, or persistent vomiting, dry mouth, bitter taste, or clear phlegm in the mouth; or symptoms of pregnancy reaction such as chest fullness and rib pain, epigastric fullness and abdominal distension, belching, fatigue, dizziness, and loss of appetite, which are symptoms of liver and stomach disharmony and spleen deficiency with phlegm obstruction. It can also prevent recurrence and has a significantly better effect than similar preparations. It has strong practical application value in preventing ordinary morning sickness from developing into hyperemesis gravidarum.

Claims

1. A traditional Chinese medicine composition for treating pregnancy reactions, characterized in that: It is prepared from the following raw materials in the following weight ratio: Cyperus rotundus 10-20 parts, Scutellaria baicalensis 10-20 parts, Pinellia ternata 10-20 parts, Paeonia lactiflora 5-20 parts, Pogostemon cablin 5-15 parts, Syzygium aromaticum 5-15 parts, Zingiber officinale 5-15 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: It is prepared from the following raw materials in the following weight ratio: Cyperus rotundus 15 parts, Scutellaria baicalensis 15 parts, Pinellia ternata 10 parts, Paeonia lactiflora 10 parts, Pogostemon cablin 10 parts, Syzygium aromaticum 10 parts, Zingiber officinale 10 parts.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: The Pinellia ternata mentioned is Pinellia ternata from Beijing; the Pogostemon cablin mentioned is Pogostemon cablin from Guangxi.

4. The traditional Chinese medicine composition according to claim 1, characterized in that: It is a preparation made from active pharmaceutical ingredients, such as powdered raw materials or aqueous extracts of raw materials, plus pharmaceutically acceptable excipients.

5. The traditional Chinese medicine composition according to claim 4, characterized in that: The preparation is for external use.

6. The traditional Chinese medicine composition according to claim 5, characterized in that: The topical preparation is a solution, ointment, emulsion, film, or patch.

7. The traditional Chinese medicine composition according to claim 6, characterized in that: The patch is an acupoint patch.

8. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that: It includes the following steps: (1) Weigh the raw materials according to the proportions described in claim 1; (2) The active pharmaceutical ingredient is ground into powder or an aqueous extract of the active pharmaceutical ingredient is added to the excipients or auxiliary ingredients commonly used in pharmaceuticals to obtain the product.

9. Use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for pregnancy reactions.

10. The use according to claim 9, characterized in that: The drug has the effect of improving nausea and vomiting, fatigue, abdominal distension and / or dizziness and anorexia.

Images