Traditional Chinese medicine preparation for improving hyperemesis gravidarum reaction and preparation method thereof

Abstract

The invention relates to the field of medicine, in particular to a traditional Chinese medicine preparation for improving hyperemesis gravidarum reaction and a preparation method thereof. The traditional Chinese medicine preparation for improving hyperemesis gravidarum reaction comprises the following components in parts by weight: 20-30 parts of clove, 15-22 parts of rhizoma curculiginis root, 13-20 parts of perilla leaf, 8-15 parts of wormwood stem, 5-10 parts of rhizoma cyperi, 5-10 parts of medicated leaven, 3-8 parts of corn stigma and 2-5 parts of fresh ginger. The whole formula is reasonable in compatibility, and the four medicines are combined to achieve the effects of reinforcing the kidney, preventing miscarriage, clearing heat, relieving restlessness, strengthening the spleen, harmonizing the stomach and arresting vomiting.

Description

Technical Field

[0001] The present invention relates to the field of medicine, and particularly to a traditional Chinese medicine preparation for improving hyperemesis gravidarum and a preparation method thereof. Background Art

[0002] Pregnancy reactions usually manifest as physical fatigue, lethargy, loss of appetite, anorexia of greasy foods, nausea and vomiting, etc. Most pregnancy vomiting reactions gradually subside or disappear naturally around 12 weeks of pregnancy, but a small number of pregnant women have severe pregnancy reactions and develop hyperemesis gravidarum from ordinary morning sickness.

[0003] Hyperemesis gravidarum refers to pregnant women who experience severe and persistent nausea and vomiting in the early stage of pregnancy, causing dehydration and electrolyte disorders in the body, mobilizing body fat, accumulating its intermediate product acetone, and causing metabolic acidosis, and thus requiring hospitalization. Such patients usually have a significant weight loss, pale complexion, dry skin, weak pulse, reduced urine output, and in severe cases, a drop in blood pressure, leading to prerenal acute renal failure.

[0004] Currently, the commonly used Western medical treatment for patients with hyperemesis gravidarum is intravenous rehydration combined with the use of antiemetics. However, the above treatment methods impose a huge psychological and physical burden on patients with hyperemesis gravidarum. Therefore, scholars have gradually focused on traditional Chinese medicine treatment, among which traditional Chinese medicine acupoint application has received much attention. Research shows that traditional Chinese medicine acupoint application organically combines meridians, acupoints, and drug effects, producing high drug efficiency and simultaneously achieving the dual effects of drug and acupoint actions. Based on this, the present invention provides a new traditional Chinese medicine preparation for improving hyperemesis gravidarum to relieve the pain of patients with hyperemesis gravidarum. Summary of the Invention

[0005] In order to overcome the deficiencies of the prior art, one of the purposes of the present invention is to provide a traditional Chinese medicine preparation for improving hyperemesis gravidarum, which can relieve hyperemesis gravidarum reactions.

[0006] Another purpose of the present invention is to provide a preparation method of a traditional Chinese medicine preparation for improving hyperemesis gravidarum, which is simple to prepare.

[0007] One of the purposes of the present invention is achieved by adopting the following technical solutions:

[0008] A traditional Chinese medicine preparation for improving hyperemesis gravidarum, calculated by weight, comprises the following components: 20 - 30 parts of cloves, 15 - 22 parts of fairy spleen roots, 13 - 20 parts of perilla leaves, 8 - 15 parts of shepherd's purse, 5 - 10 parts of nutgrass galingale rhizome, 5 - 10 parts of medicated leaven, 3 - 8 parts of corn stigma, 2 - 5 parts of ginger.

[0009] Another purpose of the present invention is achieved by adopting the following technical solutions:

[0010] The preparation method of the above traditional Chinese medicine preparation for improving hyperemesis gravidarum comprises the following steps:

[0011] (a) Weigh each raw drug according to the weight parts ratio of the prescription, mix them evenly, add water for decoction, and obtain the filtrate and residue through filtration;

[0012] (b) Add water to the residue in step (a) for decoction, and obtain the filtrate through filtration; Combine the filtrates after two decoctions and concentrate them to a thick paste, add a pharmaceutically acceptable carrier, and make a pharmaceutical preparation, then it is done.

[0013] Preferably, the amount of water used in step (a) is 6 - 12 times the total weight of the raw drugs.

[0014] Preferably, the decoction time in step (a) is 1 - 2 h.

[0015] Preferably, the amount of water used in step (b) is 4 - 8 times the total weight of the raw drugs.

[0016] Preferably, the decoction time in step (b) is 0.5 - 1 h.

[0017] Preferably, the concentration temperature in step (b) is 65 - 75 °C.

[0018] Preferably, the relative density of the thick paste in step (b) is 1.2 - 1.3.

[0019] Preferably, the pharmaceutical preparation in step (b) is a traditional Chinese medicine acupoint plaster.

[0020] The properties and effects of each raw drug in the traditional Chinese medicine preparation provided by the present invention are as follows:

[0021] Clove: [Properties and Flavors] Pungent, warm. [Meridian Tropism] Attributed to the spleen, stomach, lung, and kidney meridians. [Functions and Indications] Warming the middle and descending adverse qi, tonifying the kidney and assisting yang. Used for spleen - stomach cold deficiency, hiccups and vomiting, reduced food intake and vomiting - diarrhea, cold pain in the abdomen and chest, and impotence due to kidney deficiency.

[0022] Curculigo rhizome: [Properties and Flavors] Pungent, hot. [Meridian Tropism] Attributed to the kidney, liver, and spleen meridians. [Functions and Indications] Tonifying the kidney and strengthening tendons, dispelling cold - dampness.

[0023] Perilla leaf: [Properties and Flavors] Pungent, warm. [Meridian Tropism] Attributed to the lung, spleen, and stomach meridians. [Functions and Indications] Dispersing cold and relieving exterior syndrome, promoting qi movement and resolving phlegm. Used for wind - cold exterior syndrome, cough with profuse phlegm, fullness and distension in the chest and epigastrium, nausea and vomiting, abdominal pain and vomiting - diarrhea, fetal qi disharmony, and pregnancy - related nausea and vomiting.

[0024] Artemisia selengensis Turcz.: [Properties and Flavors] Pungent, sweet. [Meridian Tropism] Attributed to the spleen, liver, and stomach meridians. [Functions and Indications] Used for disharmony between the spleen and stomach, unobstructed defecation and urination, resolving phlegm and relieving cough.

[0025] Cyperus rotundus:

Properties and Flavors

Meridians Entered

Functions and Indications

[0026] Medicated leaven:

Properties and Flavors

Meridians Entered

Functions and Indications

[0027] Corn silk:

Properties and Flavors

Meridians Entered

Functions and Indications

[0028] Ginger:

Properties and Flavors

Meridians Entered

Functions and Indications

[0029] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0030] In the formula, cloves warm the middle and disperse cold, and arrest vomiting by descending adverse qi; rhizoma curculiginis tonifies the kidney and boosts yang. The two together serve as the monarch drugs. Perilla leaf promotes qi movement and harmonizes the stomach, and artemisia argyi stem tonifies the spleen and stomach and aids digestion. The two together serve as the minister drugs. Cyperus rotundus regulates qi and relieves distension, soothes the liver and relieves depression; medicated leaven promotes digestion and strengthens the spleen; corn silk clears the liver and promotes bile flow. The three together serve as the assistant drugs. Ginger serves as the envoy drug to harmonize the various drugs. The whole formula has a reasonable compatibility. The four drugs are used together to achieve the effects of consolidating the kidney and preventing miscarriage, clearing heat and relieving vexation, and strengthening the spleen, harmonizing the stomach and arresting vomiting. Detailed implementation mode

[0031] Next, in combination with the specific implementation mode, the present invention will be further described. It should be noted that, on the premise of no conflict, the following-described embodiments or technical features can be arbitrarily combined to form new embodiments. The specific conditions not specified in the embodiments are carried out according to the conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments used, unless otherwise specified, are all conventional products obtained through commercial channels.

[0032] Example 1

[0033] This example provides a traditional Chinese medicine preparation for improving hyperemesis gravidarum. Calculated by weight, the traditional Chinese medicine preparation includes the following components: 22 parts of cloves, 17 parts of rhizoma curculiginis, 16 parts of perilla leaf, 12 parts of artemisia argyi stem, 9 parts of cyperus rotundus, 8 parts of medicated leaven, 5 parts of corn silk, and 3 parts of ginger.

[0034] This example also provides a preparation method for the above-mentioned traditional Chinese medicine preparation for improving hyperemesis gravidarum. The detailed preparation process is as follows:

[0035] (a) Weigh each raw medicinal material according to the weight ratio of the formula, mix them evenly, use 10 times the total weight of the raw medicinal materials as the amount of water, add the raw medicinal materials to the water and decoct for 1.5 h, and obtain filtrate and residue through filtration;

[0036] (b) Use 7 times the total weight of the raw medicinal materials as the amount of water, add water to the residue in step (a) and decoct for 0.8 h, and obtain filtrate through filtration; Combine the filtrates after the two decoctions and concentrate to a thick paste with a relative density of 1.3, coat the thick paste on the surface of the adhesive tape, and then attach a release paper to make an acupoint patch.

[0037] Example 2

[0038] This example provides a traditional Chinese medicine preparation for improving hyperemesis gravidarum. Calculated by weight, the above traditional Chinese medicine preparation includes the following components: 30 parts of cloves, 22 parts of rhizoma curculiginis, 20 parts of perilla leaf, 15 parts of artemisia selengensis, 10 parts of cyperus rotundus, 10 parts of medicated leaven, 8 parts of corn stigma, and 5 parts of ginger.

[0039] This example also provides a preparation method of the above traditional Chinese medicine preparation for improving hyperemesis gravidarum. The detailed preparation process is as follows:

[0040] (a) Weigh each raw medicinal material according to the weight ratio of the formula, mix them evenly, use 12 times the total weight of the raw medicinal materials as the amount of water, add the raw medicinal materials to the water and decoct for 2 h, and obtain filtrate and residue through filtration;

[0041] (b) Use 8 times the total weight of the raw medicinal materials as the amount of water, add water to the residue in step (a) and decoct for 1 h, and obtain filtrate through filtration; Combine the filtrates after the two decoctions and concentrate to a thick paste with a relative density of 1.2, coat the thick paste on the surface of the adhesive tape, and then attach a release paper to make an acupoint patch.

[0042] Example 3

[0043] This example provides a traditional Chinese medicine preparation for improving hyperemesis gravidarum. Calculated by weight, the above traditional Chinese medicine preparation includes the following components: 20 parts of cloves, 15 parts of rhizoma curculiginis, 13 parts of perilla leaf, 8 parts of artemisia selengensis, 5 parts of cyperus rotundus, 5 parts of medicated leaven, 3 parts of corn stigma, and 2 parts of ginger.

[0044] This example also provides a preparation method of the above traditional Chinese medicine preparation for improving hyperemesis gravidarum. The detailed preparation process is as follows:

[0045] (a) Weigh each raw medicinal material according to the weight ratio of the formula, mix them evenly, use 6 times the total weight of the raw medicinal materials as the amount of water, add the raw medicinal materials to the water and decoct for 1 h, and obtain filtrate and residue through filtration;

[0046] (b) Using 4 times the weight of the raw material drug as the amount of water, add water to the filter residue in step (a) and decoct for 0.5 h, and obtain a filtrate through filtration; Combine the filtrates after the two decoctions and concentrate to a thick paste with a relative density of 1.2. Apply the thick paste on the adhesive surface of the adhesive tape, and then attach a release paper to make an acupoint patch, and that's it.

[0047] Comparative Example 1

[0048] This comparative example provides a traditional Chinese medicine preparation. By weight, the traditional Chinese medicine preparation includes the following components: 22 parts of cloves, 16 parts of perilla leaves, 12 parts of artemisia selengensis, 9 parts of cyperus rotundus, 8 parts of medicated leaven, 5 parts of corn silk, and 3 parts of ginger. For the detailed preparation method of the above traditional Chinese medicine preparation, refer to the preparation method of Example 1, and the detailed preparation conditions are the same as those of Example 1.

[0049] Comparative Example 2

[0050] This comparative example provides a traditional Chinese medicine preparation. By weight, the traditional Chinese medicine preparation includes the following components: 22 parts of cloves, 17 parts of morinda officinalis, 16 parts of perilla leaves, 12 parts of artemisia selengensis, 9 parts of cyperus rotundus, 8 parts of medicated leaven, 5 parts of corn silk, and 3 parts of ginger. For the detailed preparation method of the above traditional Chinese medicine preparation, refer to the preparation method of Example 1, and the detailed preparation conditions are the same as those of Example 1.

[0051] Comparative Example 3

[0052] This comparative example provides a traditional Chinese medicine preparation. By weight, the traditional Chinese medicine preparation includes the following components: 22 parts of cloves, 17 parts of curculigo rhizome, 16 parts of perilla leaves, 9 parts of cyperus rotundus, 8 parts of medicated leaven, 5 parts of corn silk, and 3 parts of ginger. For the detailed preparation method of the above traditional Chinese medicine preparation, refer to the preparation method of Example 1, and the detailed preparation conditions are the same as those of Example 1.

[0053] Comparative Example 4

[0054] This comparative example provides a traditional Chinese medicine preparation. By weight, the traditional Chinese medicine preparation includes the following components: 22 parts of cloves, 17 parts of curculigo rhizome, 16 parts of perilla leaves, 12 parts of chicken gizzard-membrane, 9 parts of cyperus rotundus, 8 parts of medicated leaven, 5 parts of corn silk, and 3 parts of ginger. For the detailed preparation method of the above traditional Chinese medicine preparation, refer to the preparation method of Example 1, and the detailed preparation conditions are the same as those of Example 1.

[0055] The pharmacodynamic effects of the traditional Chinese medicine preparations prepared in Example 1 and Comparative Examples 1-4 are described below.

[0056] 1. Animal experiment

[0057] 1.1 Test subjects and grouping

[0058] 80 SD rats, weighing 200 - 220 g, were randomly divided into a model group, a blank control group, Example 1, Comparative Examples 1 - 4, and a positive control group (Compound Scopolamine Hydrobromide Patch), with 10 rats in each group, and they were housed individually in cages.

[0059] 1.2 Model construction and dosing regimen

[0060] The corresponding patches were applied to the Shenque acupoint of each rat in Example 1, Comparative Examples 1 - 4, and the positive control group. After 2 days of adaptation, kaolin was fed, and kaolin and feed were fed separately. After 3 days of feeding kaolin, when it was observed that most rats no longer ate kaolin, the modeling began. Each group of rats was intraperitoneally injected with cisplatin solution at a concentration of 0.4 mg / mL (prepared with sterile normal saline), and the dose was 6 mg / kg.

[0061] Blank control group: Intraperitoneally injected with an equal volume of normal saline.

[0062] 1.3 Detection indicators

[0063] The kaolin intake, water intake, and body weight changes of each group of rats were recorded 72 hours after modeling. The results are shown in Table 1.

[0064] Table 1

[0065] Grouping Kaolin intake (mg) Body weight (g) Water intake (mL) Model group 361.42 194.50 13.25 Blank control group 20.15 246.22 36.18 Positive control group 206.33 217.48 22.51 Example 1 185.49 241.35 31.86 Comparative example 1 253.68 203.79 16.28 Comparative example 2 237.94 218.25 20.63 Comparative example 3 209.81 227.47 24.09 Comparative example 4 197.76 235.18 26.57

[0066] As can be seen from Table 1, compared with the blank control group, the kaolin intake of the rats in the model group increased significantly, indicating that the modeling was successful. 72 hours after modeling, compared with the model group, the kaolin intake of the rats in Example 1 group, positive control group, and Comparative Examples 1 - 4 group all decreased significantly. There was no significant difference between Example 1 group and the positive control group, and both were higher than Comparative Examples 1 - 4 group.

[0067] Compared with the model group, the body weight and water intake of each group of rats in the positive control group, Example 1, and Comparative Examples 1 - 4 increased significantly 72 hours after modeling. Among them, the increase in body weight and water intake of the rats in Example 1 group was particularly significant.

[0068] Compared with Example 1 group, although Comparative Examples 1 - 4 group could increase the body weight and water intake of rats, the effect was not good. The above results indicate that the traditional Chinese medicine preparation of the present invention has an obvious antiemetic effect.

[0069] 2. Clinical trials

[0070] 2.1 Test subjects

[0071] All patients with hyperemesis gravidarum were outpatients in the obstetrics and gynecology department of our hospital. And 120 patients with intrauterine pregnancy confirmed by B-ultrasound and other diseases excluded were divided into Example 1, Comparative Examples 1-4, and normal control group by the random number table method, with 20 people in each group. There were no significant differences among the 6 groups of experimental subjects in terms of age, parity, gestational week, onset time, vomiting frequency, urinary ketone body, metabolic acidosis, etc.

[0072] 2.2 Treatment methods

[0073] ① Control group

[0074] That is, routine fetal protection treatment: According to the electrolyte, carbon dioxide combining power and dehydration conditions of pregnant women, the total daily fluid supplement is 2000 mL, including 500 mL of 10% glucose injection, 1000 mL of 5% glucose saline, and 500 mL of Ringer's solution (containing 2 g of vitamin C and 200 mg of vitamin B6); 2 g of potassium is supplemented daily, and 5 days is a course of treatment.

[0075] ② Treatment group

[0076] The acupoint patches prepared in Example 1 and Comparative Examples 1-4 were applied to the navel (Shenjue point) of each group of patients with hyperemesis gravidarum once a day, and 5 days was a course of treatment. Observe the curative effect after resting for two days.

[0077] 2.3 Curative effect criteria

[0078] The curative effect criteria were formulated with reference to the Diagnostic and Curative Effect Criteria for Traditional Chinese Medical Syndromes and Diseases. The detailed judgment criteria are shown in Table 2.

[0079] Table 2

[0080] Therapeutic effect Clinical symptoms Cured Nausea and vomiting stop, clinical symptoms disappear, diet is normal, urine ketone body is negative, and there is no recurrence after drug withdrawal Markedly effective Vomiting is significantly reduced or disappeared, recurrence is seen after drug withdrawal, and urine ketone body is improved Effective Vomiting symptoms are reduced, urine ketone body is positive Ineffective All symptoms of vomiting are not improved or aggravated, urine ketone body is positive

[0081] 2.4 Treatment effect

[0082] The total effective rate = (number of cured patients + number of markedly effective patients + number of effective patients) / total number of each group × 100%. The results are shown in Table 3.

[0083] Table 3

[0084] Grouping Total number of people Number of cured people Number of markedly effective people Number of effective people Number of ineffective people Total effective rate Control group 20 4 5 3 8 60％ Example 1 20 6 8 5 1 95％ Comparative example 1 20 4 6 7 3 70％ Comparative example 2 20 5 8 5 2 80％ Comparative example 3 20 4 5 3 8 85％ Comparative example 4 20 6 8 5 1 90％

[0085] As can be seen from Table 3, compared with the control group, the traditional Chinese medicine preparations in Example 1 and Comparative Examples 1-4 can all relieve the hyperemesis gravidarum reaction.

[0086] Compared with Example 1, although the traditional Chinese medicine preparations of Comparative Examples 1-4 can relieve hyperemesis gravidarum, the effects are not satisfactory. Further analysis shows that the traditional Chinese medicine preparation of Comparative Example 1 does not add the monarch drug Curculigo rhizome, the traditional Chinese medicine preparation of Comparative Example 2 uses Morinda officinalis to replace the monarch drug Curculigo rhizome, the traditional Chinese medicine preparation of Comparative Example 3 does not add the ministerial drug Artemisia selengensis, and the traditional Chinese medicine preparation of Comparative Example 4 uses Gallus gallus domesticus gizzard-membrane to replace the ministerial drug Artemisia selengensis. The above experimental results show that the formula of the traditional Chinese medicine preparation of the present invention is reasonable, and the four drugs are used together to achieve the effects of strengthening the kidney and preventing miscarriage, clearing heat and relieving vexation, and strengthening the spleen and stomach to stop vomiting.

[0087] The above embodiments are only the preferred embodiments of the present invention, and the scope of protection of the present invention cannot be limited thereby. Any non-substantive changes and substitutions made by those skilled in the art on the basis of the present invention belong to the scope of protection required by the present invention.

Claims

1. A traditional Chinese medicine preparation for improving hyperemesis gravidarum, characterized in that, It comprises the following components in parts by weight: 20 - 30 parts of cloves, 15 - 22 parts of curculigo rhizome, 13 - 20 parts of perilla leaf, 8 - 15 parts of crown daisy stem, 5 - 10 parts of nutgrass galingale rhizome, 5 - 10 parts of medicated leaven, 3 - 8 parts of corn stigma, and 2 - 5 parts of ginger.

2. The preparation method of a traditional Chinese medicine preparation for improving hyperemesis gravidarum according to claim 1, wherein, It comprises the following steps: (a) Weigh each raw material drug according to the weight - part ratio of the formula, mix them evenly, add them to water for decoction, and obtain a filtrate and residues through filtration; (b) Add water to the residues obtained in step (a) for decoction, and obtain a filtrate through filtration; Combine the filtrates after the two - time decoction and concentrate them to a thick paste, add a pharmaceutically acceptable carrier, and prepare a pharmaceutical preparation, then it is completed.

3. The preparation method of a traditional Chinese medicine preparation for improving hyperemesis gravidarum according to claim 2, wherein, The amount of water used in step (a) is 6 - 12 times the total weight of the raw material drugs.

4. The preparation method of a traditional Chinese medicine preparation for improving hyperemesis gravidarum according to claim 2, wherein The decocting time in step (a) is 1 - 2 h.

5. The preparation method of a traditional Chinese medicine preparation for improving hyperemesis gravidarum according to claim 2, characterized in that, The amount of water used in step (b) is 4 - 8 times the total weight of the raw material drugs.

6. The preparation method of a traditional Chinese medicine preparation for improving hyperemesis gravidarum according to claim 2, wherein The decocting time in step (b) is 0.5 - 1 h.

7. The preparation method of a traditional Chinese medicine preparation for improving hyperemesis gravidarum according to claim 2, wherein, The concentration temperature in step (b) is 65 - 75 °C.

8. The preparation method of a traditional Chinese medicine preparation for improving hyperemesis gravidarum according to claim 2, wherein, The relative density of the thick paste in step (b) is 1.2 - 1.

3.

9. The preparation method of a traditional Chinese medicine preparation for improving hyperemesis gravidarum according to claim 2, wherein, The pharmaceutical preparation in step (b) is a traditional Chinese medicine acupoint patch.