External traditional chinese medicine composition for treating hyperemesis gravidarum

Abstract

An external traditional Chinese medicine composition for treating hyperemesis gravidarum, comprising the following active pharmaceutical ingredients: 250-300 g of ginger processed Pinellia, 250-300 g of dried tangerine peel, 250-300 g of clove, 250-300 g of medicated leaven, and 300-400 ml of ginger juice. The external traditional Chinese medicine composition is used for preparing a traditional Chinese medicine acupoint application to treat hyperemesis gravidarum. The therapeutic method using the external traditional Chinese medicine application is safe for the maternal body and fetus, and has little reproductive toxicity. External therapy is used to enliven the spleen and whet the appetite, which can promote an increase in the appetite of a patient suffering from hyperemesis gravidarum. By means of acupoint application, the traditional Chinese medicine composition acts on a Neiguan acupoint (the Jueyin Pericardium Meridian of Hand) and a Zusanli acupoint (the Stomach Meridian of Foot-Yangming), thereby calming the adverse-rising energy and controlling nausea and vomiting, and decreasing the frequency of vomiting. The traditional Chinese medicine external application therapy, with intravenous fluid supportive therapy, can significantly relieve vomiting symptoms and shorten the length of stay and the time of therapy.

Description

External use Chinese medicine composition for treating hyperemesis gravidarum Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, in particular to an external-use traditional Chinese medicine composition for treating hyperemesis gravidarum. Background Art

[0002] Hyperemesis gravidarum (HG) refers to severe, persistent nausea and vomiting in early pregnancy, leading to dehydration, ketosis, and even acidosis, requiring hospitalization. Data indicate that the incidence of HG is approximately 0.35% to 0.47%. Currently, clinical treatment primarily involves intravenous fluid support to correct dehydration, ketoacidosis, and electrolyte imbalances, with the use of antiemetics as appropriate to prevent and treat complications. However, due to factors such as prolonged hospitalization and increased financial burden, HG is not widely accepted by pregnant patients.

[0003] Traditional Chinese medicine acupoint application organically combines the effects of meridians, acupoints and drugs to produce high drug efficacy, while also playing the dual effect of drug acupoints, ultimately achieving the purpose of stopping vomiting, with good overall therapeutic effect.

[0004] Summary of the Invention

[0005] The purpose of the present invention is to provide an external-use traditional Chinese medicine composition for treating hyperemesis gravidarum.

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition for external use for treating hyperemesis gravidarum, which is composed of the following raw materials: 250-300g of ginger and pinellia, 250-300g of tangerine peel, 250-300g of cloves, 250-300g of Shenqu, and 300-400ml of ginger juice.

[0007] Furthermore, the external Chinese medicine composition is composed of the following raw materials: 280-300g of ginger and pinellia, 280-300g of tangerine peel, 280-300g of cloves, 280-300g of Shenqu, and 300-350ml of ginger juice.

[0008] Furthermore, the external Chinese medicine composition is composed of the following raw materials: 300g of ginger and pinellia, 300g of tangerine peel, 300g of cloves, 300g of Shenqu, and 350ml of ginger juice.

[0009] The second aspect of the present invention provides a pharmaceutical preparation comprising the above-mentioned external Chinese medicine composition as an active ingredient.

[0010] Furthermore, the pharmaceutical preparation is a Chinese medicine acupoint application.

[0011] Furthermore, the preparation and usage of the Chinese medicine acupoint application:

[0012] Weigh the raw materials according to the ratio and make a coin-sized pill. Apply it to the center of the external application patch. Apply it to the patient's Neiguan and Zusanli points (bilaterally) and change it once a day for 14 days.

[0013] A third aspect of the present invention provides a use of the above-mentioned external-use Chinese medicine composition in the preparation of a medicament for treating hyperemesis gravidarum.

[0014] A fourth aspect of the present invention provides use of the pharmaceutical preparation described above in the preparation of a medicament for treating hyperemesis gravidarum.

[0015] In the external-use Chinese medicine composition of the present invention, ginger and pinellia are the main ingredients, with a pungent taste and warm nature, entering the spleen, stomach, and lung meridians, and have the effect of relieving adverse reactions and stopping vomiting. Clove is the auxiliary ingredient, with a pungent and warm nature, entering the spleen, stomach, and kidney meridians. It has the effects of warming the middle, warming the kidney, and relieving adverse reactions, and is mainly used to treat hiccups, vomiting, and nausea. The two ingredients are used together to warm the middle, reduce adverse reactions, harmonize the stomach, and stop vomiting, and can also tonify the kidney and prevent miscarriage. Shenqu and tangerine peel are used as adjuvant ingredients in the formula. Shenqu is sweet, pungent, and warm, and enters the spleen and stomach meridians. Tangerine peel is bitter, pungent, and warm, and enters the lung and spleen meridians. The two ingredients complement each other and have the effects of strengthening the spleen and stomach, promoting digestion and regulating the middle. They treat ailments such as food stagnation, chest distension, abdominal distension, vomiting, and hiccups. Finally, ginger juice is used as the auxiliary ingredient, with a pungent taste and slightly warm nature, entering the lung, spleen, and stomach meridians, and having the effect of warming the middle and stopping vomiting. The whole formula is compatible with warming the middle and relieving adverse reactions, harmonizing the stomach and stopping vomiting, and replenishing Qi and strengthening the spleen.

[0016] Patients with hyperemesis gravidarum often experience nausea and vomiting, poor appetite, or even inability to eat, and vomiting immediately after eating. External treatment with traditional Chinese medicine can be achieved by making Chinese medicine acupoint patches with external medications, which have the effect of strengthening the spleen and appetite, and can increase the patient's appetite.

[0017] Hyperemesis gravidarum is currently primarily treated with intravenous fluid support to correct dehydration, ketoacidosis, and electrolyte imbalances, with the use of antiemetics as appropriate to prevent and treat complications. However, due to factors such as prolonged hospitalization and increased financial burden, this approach is not widely accepted by pregnant patients. Traditional Chinese Medicine (TCM) acupoint application integrates the effects of meridians, acupoints, and medications, resulting in highly effective medications and a dual effect of medication and acupoints, ultimately achieving the goal of stopping vomiting and achieving good overall efficacy.

[0018] The advantages and beneficial effects of the present invention are:

[0019] 1. External use of Chinese medicine patches is safe for the mother and fetus and has low reproductive toxicity.

[0020] 2. External treatment to awaken the spleen and stimulate appetite can increase the appetite of patients with hyperemesis gravidarum.

[0021] 3. Acupoint application, acting on Neiguan (Hand Jueyin Pericardium Meridian) and Zusanli (Foot Yangming Stomach Meridian), can reduce nausea and vomiting. Applying Chinese medicine with intravenous fluid support can significantly relieve vomiting symptoms and shorten hospitalization and treatment time. DETAILED DESCRIPTION

[0022] The specific implementation methods provided by the present invention are described in detail below with reference to the examples.

[0023] In the following examples, experimental methods where specific conditions are not specified were generally performed under conventional conditions or according to the conditions recommended by the manufacturer. Unless otherwise noted, the medicinal materials used in the examples of the present invention can be obtained from Chinese medicinal material sales companies. Unless otherwise noted, the medicinal materials obtained are all Chinese medicinal material slices. The slices can be obtained from sales companies or processed after purchase.

[0024] Embodiment 1: the composition of Chinese medicine composition of the present invention

[0025] 250g ginger and pinellia, 250g tangerine peel, 250g cloves, 250g Shenqu, 300ml ginger juice.

[0026] Example 2: Composition of the Chinese medicine composition of the present invention

[0027] 260g ginger and pinellia, 260g tangerine peel, 260g cloves, 260g Shenqu, 320ml ginger juice.

[0028] Embodiment 3: the composition of Chinese medicine composition of the present invention

[0029] 270g ginger and pinellia, 270g tangerine peel, 270g cloves, 270g Shenqu, 340ml ginger juice.

[0030] Embodiment 4: the composition of Chinese medicine composition of the present invention

[0031] 280g ginger and pinellia, 280g tangerine peel, 280g cloves, 280g Shenqu, 360ml ginger juice.

[0032] Example 5: Composition of the Chinese medicine composition of the present invention

[0033] 290g ginger and pinellia, 290g tangerine peel, 290g cloves, 290g Shenqu, 380ml ginger juice.

[0034] Example 6: Composition of Chinese medicine composition of the present invention

[0035] 300g of ginger and pinellia, 300g of dried tangerine peel, 300g of cloves, 300g of Shenqu, and 400ml of ginger juice.

[0036] Example 7: Composition of Chinese medicine composition of the present invention

[0037] 300g of ginger and pinellia, 300g of dried tangerine peel, 300g of cloves, 300g of Shenqu, and 350ml of ginger juice.

[0038] Example 8: Preparation and Use of the Chinese Medicine Compress of the Present Invention

[0039] According to the composition and ratio described in any one of Examples 1-7, the raw materials were weighed and made into coin-sized pills, which were attached to the center of the external application patch. When used, the patches were applied to the patient's Neiguan and Zusanli points (bilaterally), changing them once a day for 14 days.

[0040] Example 9: Clinical Trial

[0041] 1. Research subjects

[0042] A total of 100 patients with hyperemesis gravidarum admitted to the Department of Traditional Chinese Medicine Gynecology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2018 to December 2018 were selected and randomly divided into a treatment group and a control group according to the time of admission, with 50 cases in each group.

[0043] 2. Case selection

[0044] 2.1 Diagnostic criteria

[0045] With reference to the national college textbook "Obstetrics and Gynecology", it refers to pregnant women in early pregnancy who experience severe and persistent nausea and vomiting, and develop dehydration, ketosis, or even acidosis, requiring hospitalization.

[0046] 2.2 Inclusion criteria

[0047] 1) Women of childbearing age, aged 20 to 40 years;

[0048] 2) Amenorrhea for 5 to 12 weeks; intrauterine pregnancy confirmed by ultrasound;

[0049] 3) Meet the diagnostic criteria for hyperemesis gravidarum;

[0050] 4) Positive blood ketone bodies, or urine ketone bodies (+++, ++++) on routine urine examination, accompanied by varying degrees of electrolyte imbalance;

[0051] 5) Volunteer to participate in this study and sign the informed consent.

[0052] 2.3 Exclusion criteria

[0053] 1) Patients with hydatidiform mole, ectopic pregnancy and other pregnancy-specific diseases;

[0054] 2) Nausea and vomiting caused by other internal or surgical diseases;

[0055] 3) Those with hypertension, heart disease, liver and kidney damage;

[0056] 4) Those suffering from mental illness and unable to cooperate with treatment;

[0057] 5) Those who are allergic to the drugs used;

[0058] 6) Currently participating in other clinical research studies.

[0059] 2.4 Rejection and shedding standards

[0060] 1) Those who are unable to continue treatment due to various reasons;

[0061] 2) Patients with adverse drug reactions;

[0062] 3) Patients with concurrent diseases;

[0063] 4) Those who voluntarily withdraw from the trial process.

[0064] 3. Treatment options

[0065] 3.1 Randomization

[0066] The screened patients with hyperemesis gravidarum were randomly divided into a Chinese medicine group and a control group according to the order of admission, with 50 cases in each group.

[0067] 3.2 Treatment methods

[0068] 1) Control group: Receive approximately 3000 mL of intravenous fluids. Commonly used medications include 5% glucose injection, 5% glucose and sodium chloride injection, 10% glucose injection, and medium- and long-chain triglyceride emulsion injections. Vitamin B6, vitamin B1, vitamin C, and potassium chloride should also be supplemented. Patients with significant vomiting should receive an intravenous drip of balanced fluids. Patients with concurrent metabolic acidosis should receive an intravenous drip of 5% sodium bicarbonate solution as appropriate. Patients with severe dehydration or decreased urine output should receive an appropriate increase in fluid volume, adjusted based on the severity of dehydration. Continue the infusion for at least 3 days.

[0069] 2) Traditional Chinese Medicine Group: In addition to the nutritional support treatment of the control group, patients received acupoint application with a traditional Chinese medicine patch. The patch was prepared as follows: 300g of ginger and pinellia tuber, 300g of dried tangerine peel, 300g of cloves, 300g of Shenqu (Shenqu) root, and 350ml of ginger juice were made into coin-sized pellets. These pellets were then placed in the center of the external application patch and applied to the patient's Neiguan and Zusanli points (bilaterally). The patches were changed daily for 14 days.

[0070] 3.3 Observation indicators and efficacy judgment criteria

[0071] 1) Observational indicators: The two groups were compared for average length of hospital stay, number of vomiting episodes within 24 hours of treatment, and rate of urine ketone conversion to negative. Hyperemesis gravidarum patients frequently vomit and are unable to eat. During this state of hunger, the body utilizes adipose tissue for energy, causing the accumulation of ketone bodies, an intermediate product of fat metabolism. This results in positive urine ketones and, in severe cases, positive blood ketones.

[0072] 2) Efficacy evaluation criteria: Cured: nausea and vomiting symptoms disappear, the patient can eat normally, weight no longer decreases, urine ketones turn negative in urinalysis, and all biochemical indices and electrolytes return to normal; Effective: nausea and vomiting symptoms are alleviated, stomach discomfort improves, the patient can eat normally, weight no longer decreases, urine ketones decrease in urinalysis, and all biochemical indices basically return to normal; Ineffective: vomiting symptoms do not improve or worsen, urine ketones remain positive in urinalysis, and all biochemical indices do not recover or worsen.

[0073] 3.4 Statistical methods

[0074] SPSS 21.0 software was used for statistical analysis, and the measurement data met the requirements of normal distribution. The data were described using the t-test, and the median (minimum, maximum) was used for description of data that did not meet the normal distribution. The Wilcoxon rank sum test was used for comparison between groups. Enumeration data were described using frequency (constituent ratio) and compared between groups using the chi-square test, with α = 0.05.

[0075] 4. Results

[0076] 4.1 Comparison of Efficacy between the Two Groups The cure rate and total effective rate of the TCM group were higher than those of the control group, and the differences were statistically significant (P<0.05). See Table 1.

[0077] Table 1 Comparison of clinical efficacy between the two groups after treatment Note: Compared with the control group, *P<0.05.

[0078] 4.2 Comparison of the length of hospital stay between the two groups: The average length of hospital stay in the treatment group was (3.51±0.24) days, while the average length of hospital stay in the control group was (4.43±1.45) days. There was a statistically significant difference between the two groups (P<0.05). See Table 2.

[0079] Table 2 Comparison of average hospital stays between the two groups Note: Compared with the control group, *P<0.05.

[0080] 4.3 There was no statistically significant difference in the number of vomitings in the 24 hours before treatment between the two groups (P>0.05). However, there was a statistically significant difference in the number of vomitings in the 24 hours after treatment between the two groups (P<0.05). Within the two groups, the number of vomitings in the 24 hours after treatment in both the TCM group and the control group was significantly reduced compared with that before treatment (P<0.05). See Table 3.

[0081] Table 3 Comparison of the number of vomiting in 24 hours before and after treatment between the two groups Note: Compared with the group before treatment, △ P<0.05; compared with the control group after treatment, * P<0.05.

[0082] 4.2 Comparison of the urine ketone body conversion rate between the two groups after treatment: 90.0% of the patients in the TCM group and 56.0% of the patients in the control group had a negative urine ketone body conversion rate after treatment. The difference in the urine ketone body conversion rate between the two groups was statistically significant (P < 0.05). See Table 4.

[0083] Table 4 Comparison of urine ketone body negative conversion rate between the two groups of patients Note: Compared with the control group, *P<0.05.

[0084] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the described embodiments. Those skilled in the art may make various equivalent modifications or substitutions without departing from the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. An external-use traditional Chinese medicine composition for treating hyperemesis gravidarum, characterized in that, It consists of the following raw medicinal materials: 250 - 300 g of Pinelliae Rhizoma Praeparatum, 250 - 300 g of Citri Reticulatae Pericarpium, 250 - 300 g of Caryophylli Flos, 250 - 300 g of Medicata Fermentata, and 300 - 400 ml of fresh ginger juice.

2. The external-use traditional Chinese medicine composition for treating hyperemesis gravidarum according to claim 1, wherein It consists of the following raw medicinal materials: 280 - 300 g of Pinelliae Rhizoma Praeparatum, 280 - 300 g of Citri Reticulatae Pericarpium, 280 - 300 g of Caryophylli Flos, 280 - 300 g of Medicata Fermentata, and 300 - 350 ml of fresh ginger juice.

3. The external-use traditional Chinese medicine composition for treating hyperemesis gravidarum according to claim 1, wherein It consists of the following raw medicinal materials: 300 g of Pinelliae Rhizoma Praeparatum, 300 g of Citri Reticulatae Pericarpium, 300 g of Caryophylli Flos, 300 g of Medicata Fermentata, and 350 ml of fresh ginger juice.

4. A pharmaceutical preparation using the external-use traditional Chinese medicine composition as described in any one of claims 1 - 3 as an active ingredient.

5. The pharmaceutical preparation according to claim 4, characterized in that, The pharmaceutical preparation is a traditional Chinese medicine acupoint application patch.

6. The pharmaceutical preparation according to claim 5, characterized in that, The preparation method of the traditional Chinese medicine acupoint application patch: Weigh the raw medicinal materials according to the ratio, make pills the size of a coin, and apply them in the middle of the external application patch.

7. The application of the external-use traditional Chinese medicine composition as described in any one of claims 1 - 3 in the preparation of a drug for treating hyperemesis gravidarum.

8. The application of the pharmaceutical preparation as described in any one of claims 4 - 6 in the preparation of a drug for treating hyperemesis gravidarum.

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