CN117959404A - A topical Chinese medicinal composition for treating hyperemesis gravidarum - Google Patents
A topical Chinese medicinal composition for treating hyperemesis gravidarum Download PDFInfo
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Abstract
The invention relates to the field of traditional Chinese medicines, in particular to an external traditional Chinese medicine composition for treating hyperemesis gravidarum, which consists of the following raw material medicines: 250-300g of ginger processed pinellia tuber, 250-300g of dried orange peel, 250-300g of clove, 250-300g of medicated leaven and 300-400ml of ginger juice. The external traditional Chinese medicine application treatment method is safe for a mother and a fetus, and has low reproduction toxicity. The external treatment method can invigorate the spleen and promote appetite, so that the appetite of the patients suffering from hyperemesis gravidarum can be promoted. By applying to acupoints, the composition can act on the interior of the stomach (pericardium meridian of hand jueyin) and the interior of the foot of the stomach (stomach meridian of foot of yangming), reduce adverse flow of qi, arrest vomiting, and reduce emesis times. The external application treatment of the traditional Chinese medicine is supported by intravenous fluid infusion, so that the vomiting symptom can be obviously relieved, and the hospitalization days and the treatment time can be shortened.
Description
Technical Field
The invention relates to the field of traditional Chinese medicines, in particular to an external traditional Chinese medicine composition for treating hyperemesis gravidarum.
Background
Severe vomiting (HYPEREMESIS GRAVIDARUM, HG) refers to severe sustained nausea and vomiting in pregnant women at early gestation, and causes dehydration, ketosis and even acidosis, requiring hospitalization. The data show that HG incidence is about 0.35% -0.47%. At present, the clinic mainly adopts intravenous fluid infusion to support treatment, corrects dehydration, ketoacidosis and electrolyte disorder, and uses antiemetic agent to prevent and treat complications. However, the pregnant woman patients have low acceptance due to the long hospitalization time, increased economic burden and other factors.
The traditional Chinese medicine acupoint application organically combines the meridian, acupoints and medicine effects to generate high efficacy, simultaneously plays a double role of the medicine acupoint effect, finally achieves the purpose of stopping vomiting, and has better overall curative effect.
Disclosure of Invention
The invention aims to provide an external traditional Chinese medicine composition for treating hyperemesis gravidarum.
The invention provides a first aspect of an external traditional Chinese medicine composition for treating hyperemesis gravidarum, which comprises the following raw materials: 250-300g of ginger processed pinellia tuber, 250-300g of dried orange peel, 250-300g of clove, 250-300g of medicated leaven and 300-400ml of ginger juice.
Further, the external traditional Chinese medicine composition consists of the following raw materials: 280-300g of ginger processed pinellia tuber, 280-300g of dried orange peel, 280-300g of clove, 280-300g of medicated leaven and 300-350ml of ginger juice.
Further, the external traditional Chinese medicine composition consists of the following raw materials: 300g of ginger processed pinellia tuber, 300g of dried orange peel, 300g of clove, 300g of medicated leaven and 350ml of ginger juice.
In a second aspect of the present invention, there is provided a pharmaceutical preparation comprising the topical Chinese medicinal composition as described above as an active ingredient.
Further, the medicinal preparation is applied to the acupuncture points of the traditional Chinese medicine.
Furthermore, the preparation and the usage of the traditional Chinese medicine acupoint application are as follows:
Weighing the raw materials according to the proportion, preparing into coin-sized pills, and pasting the pills in the middle of external application. When in use, the plaster is applied to the interior of a patient and the points of the patient and the patient are changed for 1 time a day for 14 days.
In a third aspect, the invention provides an application of the external traditional Chinese medicine composition in preparing a medicine for treating hyperemesis gravidarum.
In a fourth aspect of the invention, there is provided the use of a pharmaceutical formulation as described above in the manufacture of a medicament for the treatment of hyperemesis gravidarum.
The external traditional Chinese medicine composition prescription of the invention comprises the following components: ginger processed pinellia tuber is used as a monarch and is spicy; warm nature, enter spleen meridian; stomach channel; the lung meridian has the effects of lowering adverse qi and relieving vomiting. Flos Caryophylli is ministerial drug, which is pungent and warm in nature and enters spleen, stomach and kidney meridians. Has effects of warming spleen and stomach, warming kidney, and lowering adverse qi, and can be used for treating singultus, emesis, regurgitation, etc. The two herbs are mutually combined. Warming middle energizer and lowering adverse qi, harmonizing stomach and stopping vomiting, but also tonifying kidney to prevent abortion. In the recipe, medicated leaven and dried orange peel are used as adjuvant drugs, and the medicated leaven is sweet in taste, pungent and warm in nature and enters spleen and stomach meridians. Dried orange peel, pericarpium Citri Reticulatae, bitter and pungent in flavor, warm in nature, enter lung and spleen meridians, and the two herbs are mutually combined to have the actions of strengthening spleen and stomach, promoting digestion and regulating middle warmer. For treating food stagnation, chest fullness, abdominal distention, emesis, singultus, etc. Finally, ginger juice is used as a guiding drug, and is pungent in flavor and slightly warm in nature. Enter lung, spleen and stomach meridians. Has effects of warming middle energizer and relieving vomiting. The whole formula is compatible with warming middle energizer to reduce adverse qi, harmonizing stomach to arrest vomiting, and replenishing qi to invigorate spleen.
Patients with severe vomiting of pregnancy often show nausea and vomiting, poor appetite and even inability to eat, and the external treatment method of traditional Chinese medicine can be used for preparing traditional Chinese medicine acupoint application through external medicine, has the efficacy of strengthening spleen and stimulating appetite, and can promote appetite of patients.
The severe vomiting of pregnancy is clinically supported by venous fluid infusion at present, dehydration, ketoacidosis and electrolyte disorder are corrected, and antiemetic agents are used as appropriate to prevent and treat complications. However, the pregnant woman patients have low acceptance due to the long hospitalization time, increased economic burden and other factors. The traditional Chinese medicine acupoint application organically combines the meridian, acupoints and medicine effects to generate high efficacy, simultaneously plays a double role of the medicine acupoint effect, finally achieves the purpose of stopping vomiting, and has better overall curative effect.
The invention has the advantages and beneficial effects that:
1. the external traditional Chinese medicine application treatment method is safe for the mother and the fetus, and has small reproduction toxicity.
2. The external treatment method can invigorate the spleen and promote appetite, so that the appetite of the patients suffering from hyperemesis gravidarum can be promoted.
3. By applying to acupoints, the composition can act on the interior of the stomach (pericardium meridian of hand jueyin) and the interior of the foot of the stomach (stomach meridian of foot of yangming), reduce adverse flow of qi, arrest vomiting, and reduce emesis times. The external application treatment of the traditional Chinese medicine is supported by intravenous fluid infusion, so that the vomiting symptom can be obviously relieved, and the hospitalization days and the treatment time can be shortened.
Detailed Description
The following provides a detailed description of embodiments of the present invention with reference to examples.
The experimental methods, in which specific conditions are not noted in the following examples, are generally conducted under conventional conditions or under conditions recommended by the manufacturer. The medicinal materials used in the embodiment of the invention can be obtained from the selling company of the traditional Chinese medicinal materials unless otherwise noted. The obtained medicinal materials are all Chinese medicinal decoction pieces unless otherwise noted. Decoction pieces can be obtained from sales companies or processed after being obtained.
EXAMPLE 1 composition of the Chinese medicinal composition of the invention
250G of ginger processed pinellia tuber, 250g of dried orange peel, 250g of clove, 250g of medicated leaven and 300ml of ginger juice.
Example 2: composition of the Chinese medicinal composition
260G of ginger processed pinellia tuber, 260g of dried orange peel, 260g of clove, 260g of medicated leaven and 320ml of ginger juice.
EXAMPLE 3 composition of the Chinese medicinal composition of the invention
270G of ginger processed pinellia tuber, 270g of dried orange peel, 270g of clove, 270g of medicated leaven and 340ml of ginger juice.
EXAMPLE 4 composition of the Chinese medicinal composition of the invention
280G of ginger processed pinellia tuber, 280g of dried orange peel, 280g of clove, 280g of medicated leaven and 360ml of ginger juice.
Example 5: composition of the Chinese medicinal composition
290G of ginger processed pinellia tuber, 290g of dried orange peel, 290g of clove, 290g of medicated leaven and 380ml of ginger juice.
EXAMPLE 6 composition of the Chinese medicinal composition of the invention
300G of ginger processed pinellia tuber, 300g of dried orange peel, 300g of clove, 300g of medicated leaven and 400ml of ginger juice.
EXAMPLE 7 composition of the Chinese medicinal composition of the invention
300G of ginger processed pinellia tuber, 300g of dried orange peel, 300g of clove, 300g of medicated leaven and 350ml of ginger juice.
Example 5: the preparation and the use of the traditional Chinese medicine application of the invention
The bulk drugs are weighed according to the composition and the proportion in any one of the embodiments 1-4, and are prepared into coin-sized pills which are applied in the middle of external application. When in use, the plaster is applied to the interior of a patient and the points of the patient and the patient are changed for 1 time a day for 14 days.
Example 6: clinical trials
1. Study object
100 Cases of severe vomiting patients who are admitted to the department of gynaecology hospitalization in traditional Chinese medicine department of the Shanghai university of Chinese medicine in 2018 are selected, and are randomly divided into a treatment group and a control group according to admission time, wherein 50 cases are in each group. .
2. Case selection
2.1 Diagnostic criteria
Referring to the teaching material of national higher school "obstetrics and gynecology science", it is proposed that severe and persistent nausea and vomiting occur in pregnant women in early gestation period, and dehydration, ketosis and even acidosis are caused, and hospitalization is needed.
2.2 Inclusion criteria
1) Women of childbearing ages of 20-40 years old;
2) Stopping menstruation for 5-12 weeks; b ultrasonic confirmation of intrauterine pregnancy;
3) Meets the diagnosis standard of the hyperemesis gravidarum;
4) The blood ketone body is positive, or routine examination of urine for uroketone (+++, in the form of +++), with varying degrees of electrolyte turbulence;
5) Voluntarily attending the study, and signing informed consent.
2.3 Exclusion criteria
1) Grape embryo, ectopic pregnancy and other pregnancy-specific diseases;
2) Nausea and vomiting caused by other internal and surgical diseases;
3) Hypertension, heart disease, and impaired liver and kidney function;
4) Patients suffering from mental diseases and being unable to be treated by coordination;
5) Allergic to the drug used;
6) Are participating in other clinical researchers.
2.4 Reject and drop criteria
1) Those who are unable to continue treatment for various reasons;
2) Patients with adverse drug reactions;
3) Patients with concurrent diseases;
4) The test procedure is self-exited.
3. Treatment regimen
3.1 Random grouping
The selected patients with hyperemesis gravidarum are randomly divided into a traditional Chinese medicine group and a control group according to the order of admission, wherein 50 patients in each group are respectively treated.
3.2 Methods of treatment
1) Control group: about 3000mL of intravenous infusion. Commonly used drugs: 5% glucose injection, 5% glucose sodium chloride injection, 10% glucose injection and medium/long chain fat emulsion injection; and simultaneously supplements vitamin B6, vitamin B1, vitamin C and potassium chloride. Adding balance liquid for intravenous drip for patients with obvious emesis; combining metabolic acidosis patients to intravenous drip 5% sodium bicarbonate solution as appropriate; the patient with serious dehydration and urine volume reduction properly increases the fluid supplement volume, and the fluid supplement volume is adjusted according to the severity of the dehydration of the patient. Continuous infusion is performed for at least 3 days.
2) The traditional Chinese medicine group: the traditional Chinese medicine acupoint application treatment is adopted on the basis of the nutrition support treatment of the control group. The acupoint application manufacturing method comprises the following steps: 300g of ginger processed pinellia tuber, 300g of dried orange peel, 300g of clove, 300g of medicated leaven and 350ml of ginger juice are prepared into coin-sized pills, the pills are stuck in the middle of external application, and are stuck in the interior of a patient and in the Zuan acupoint and Zusanli (both sides), and the pills are replaced for 1 time a day for 14 days.
3.3 Observation index and therapeutic Effect judgment Standard
1) And (3) observing the indexes: average number of hospitalization days, number of vomiting 24h after treatment, and urinary ketone body conversion rate were compared for 2 groups of patients. Patients with severe vomiting of pregnancy frequently vomit can not eat, and under starvation condition, the organism supplies energy by using adipose tissues, so that ketone bodies, which are intermediate products of fat metabolism, are aggregated, and the patients with severe conditions are positive in urinary ketone bodies.
2) Curative effect judgment criteria: and (3) curing: the nausea and vomiting symptoms disappear, the patient can eat normally, the weight is not reduced any more, urine analysis is carried out on the urine ketone body to turn negative, and various biochemical indexes and electrolytes are recovered to be normal; the method is effective: the symptoms of nausea and vomiting are reduced, the stomach discomfort is improved, the stomach can be eaten, the weight is not reduced any more, urine analysis is carried out to reduce the uroketone body, and all biochemical indexes are basically recovered to be normal; invalidation: none of the symptoms of vomiting is improved or aggravated, urine analysis is performed to ensure that the uroketone body is continuously positive, and various biochemical indexes are not recovered or aggravated.
3.4 Statistical methods
Statistical analysis using SPSS21.0 software, the metering data satisfying normal distributionThe t test comparison is used among groups, the normal distribution is not satisfied, the median (minimum value and maximum value) is used for description, and the Wilcoxon rank sum test is used for the comparison among groups. The counting data are described by frequency numbers (composition ratios), and the groups are compared by chi-square test, wherein alpha=0.05.
4. Results
4.1 The curative effect of the two groups is higher than that of the control group by comparing the cure rate and the total effective rate of the traditional Chinese medicine group, and the difference has statistical significance (P < 0.05). See table 1.
Table 1 comparison of clinical efficacy after two groups of treatments
Note that: p <0.05 compared to the control group.
4.2 Comparison of the number of hospitalization days for the two groups of patients, average number of hospitalization days for the treated group of patients was (3.51.+ -. 0.24) d, average number of hospitalization days for the control group of patients was (4.43.+ -. 1.45) d, and statistical difference was found in the comparison of the number of average hospitalization days for the 2 groups (P < 0.05). See table 2.
Table 2 average hospital stay comparison for two groups of patients
Note that: p <0.05 compared to the control group.
4.3 There is no statistical difference in the number of vomiting 24h before treatment (P > 0.05), there is a statistical difference in the number of vomiting 24h after treatment (P < 0.05), there is a significant reduction in the number of vomiting 24h after treatment in both groups compared with the traditional Chinese medicine group and the control group, and the difference is statistically significant (P < 0.05). See table 3.
Table 3 comparison of the number of vomiting 24h before and after treatment of two groups
Note that: △ P <0.05 compared to pretreatment in this group; * P <0.05 compared to control post-treatment.
4.2 Comparison of the conversion rate of the uretdione after the treatment of two groups of patients, wherein the conversion rate of the uretdione after the treatment of the patients in the traditional Chinese medicine group is 90.0%, the conversion rate of the uretdione after the treatment of the patients in the control group is 56.0%, and the comparison difference of the conversion rate of the uretdione in the 2 groups has statistical significance (P < 0.05). See table 4.
Table 4 comparison of the conversion of urinary Ketone to negative for two groups of patients
Note that: p <0.05 compared to the control group.
While the preferred embodiments of the present application have been described in detail, the present application is not limited to the embodiments, and various equivalent modifications and substitutions can be made by those skilled in the art without departing from the spirit of the present application, and these equivalent modifications and substitutions are intended to be included in the scope of the present application as defined in the appended claims.
Claims (8)
1. An external traditional Chinese medicine composition for treating hyperemesis gravidarum is characterized by comprising the following raw material medicines: 250-300g of ginger processed pinellia tuber, 250-300g of dried orange peel, 250-300g of clove, 250-300g of medicated leaven and 300-400ml of ginger juice.
2. The external traditional Chinese medicine composition for treating hyperemesis gravidarum according to claim 1, which is characterized by comprising the following raw materials: 280-300g of ginger processed pinellia tuber, 280-300g of dried orange peel, 280-300g of clove, 280-300g of medicated leaven and 300-350ml of ginger juice.
3. The external traditional Chinese medicine composition for treating hyperemesis gravidarum according to claim 1, which is characterized by comprising the following raw materials: 300g of ginger processed pinellia tuber, 300g of dried orange peel, 300g of clove, 300g of medicated leaven and 350ml of ginger juice.
4. A pharmaceutical preparation comprising the external-use Chinese medicinal composition as claimed in any one of claims 1 to 3 as an active ingredient.
5. The pharmaceutical formulation of claim 4, wherein the pharmaceutical formulation is a traditional Chinese medicine acupoint application.
6. The pharmaceutical preparation according to claim 5, wherein the preparation method of the traditional Chinese medicine acupoint application comprises the following steps: weighing the raw materials according to the proportion, preparing into coin-sized pills, and pasting the pills in the middle of external application.
7. Use of a topical Chinese medicinal composition according to any one of claims 1-3 in the preparation of a medicament for the treatment of hyperemesis gravidarum.
8. Use of a pharmaceutical formulation according to any one of claims 4-6 for the preparation of a medicament for the treatment of hyperemesis gravidarum.
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2024
- 2024-01-10 CN CN202410034565.5A patent/CN117959404A/en active Pending
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