A preparation method and application of a traditional Chinese medicine preparation for treating hypertension complicating pregnancy

Abstract

The invention belongs to the technical field of Chinese medicine preparation, and specifically is a preparation method and application of a Chinese medicine preparation for treating hypertension complicating pregnancy. The method comprises the following steps: washing and drying Chinese medicinal materials in a prescribed amount, crushing them respectively, and mixing them uniformly to obtain a mixed powder A; soaking the remaining components in water according to the prescribed amount, decocting, filtering, and concentrating to obtain a Chinese medicine extract with a relative density; putting the obtained extract into a vacuum dryer for fluidized drying, and crushing them to obtain a mixed powder B after combined operation; and mixing the mixed powder A and the mixed powder B uniformly and sealing them for storage to obtain a finished product, so as to give full play to the efficacy of each medicine and avoid the loss of efficacy, so as to achieve a high release rate of the effective ingredients of the medicine, and significantly improve the stability and solubility of the medicine, thereby improving the therapeutic effect and cure rate of the medicine.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a preparation method and application of a traditional Chinese medicine preparation for treating hypertension complicating pregnancy. Background Art

[0002] Hypertensive disorders complicating pregnancy seriously threaten the health and safety of mothers and infants. It is a common complication in obstetrics and the second leading cause of maternal mortality. Preeclampsia-eclampsia is one of the main causes of increased maternal and perinatal mortality. At present, the pathogenesis of hypertensive disorders complicating pregnancy is still unclear from the perspective of Western medicine. Most of the current treatment methods are single-target antagonism. The clinical effect of single-drug antihypertensive drugs is often poor. In addition, when taking single-target antagonistic Western medicine for long-term antihypertensive drugs, adverse reactions of varying degrees often occur, such as electrolyte disorders, lipid, glucose and uric acid metabolism disorders, liver and kidney function damage, insomnia, arrhythmia, etc., or blood pressure fluctuates greatly during antihypertensive treatment, and long-term use produces drug resistance. At present, the types of antihypertensive drugs suitable for pregnant women are greatly restricted, which seriously affects patients' drug selection and blood pressure control.

[0003] Traditional Chinese medicine for the treatment of hypertension is to establish an individualized diagnosis and treatment plan under the guidance of the holistic concept and syndrome differentiation theory of traditional Chinese medicine, so that the body can gradually restore the healthy state of yin and yang balance. In recent years, some studies have found that the combination of traditional Chinese medicine with Western medicine to treat hypertension complicating pregnancy has significant advantages in enhancing the antihypertensive effect, delaying the progression of the disease, protecting target organs, and reducing maternal and fetal complications. However, in the process of clinical practice, it was found that the use of traditional Chinese medicine decoctions and powders has a good effect on the treatment of hypertension complicating pregnancy, but the time-consuming decoction, inconvenience in carrying, and poor taste seriously affect the medication compliance of some patients, hindering their in-depth promotion. Summary of the invention

[0004] The purpose of this section is to summarize some aspects of the embodiments of the present invention and briefly introduce some preferred embodiments. Some simplifications or omissions may be made in this section and the specification abstract and the invention title of this application to avoid blurring the purpose of this section, the specification abstract and the invention title, and such simplifications or omissions cannot be used to limit the scope of the present invention.

[0005] Therefore, the purpose of the present invention is to provide a method for preparing a Chinese medicine preparation for treating hypertension complicating pregnancy and its application, which has a good therapeutic effect on hypertension complicating pregnancy, can enhance the antihypertensive effect of Western medicine, delay the progression of the disease, protect target organs, and reduce maternal and fetal complications.

[0006] To solve the above technical problems, according to one aspect of the present invention, the present invention provides the following technical solutions:

[0007] A Chinese medicine preparation for treating hypertension complicating pregnancy, comprising: the following components in parts by weight;

[0008] 20-30 parts of raw Rehmannia root, 15-20 parts of Eucommia bark, 20-30 parts of raw oyster, 10-15 parts of Bupleurum root, 10-15 parts of Artemisia capillaris, 15-20 parts of White Peony root, 10-15 parts of Atractylodes macrocephala, 15-20 parts of Poria, 10-15 parts of Asparagus cochinchinensis, 15-20 parts of Scrophularia ningpoensis, 20-30 parts of Houttuynia cordata, 15-20 parts of jujube, 15-20 parts of raw malt, and 5-10 parts of raw liquorice.

[0009] A method for preparing a traditional Chinese medicine preparation for treating hypertension complicating pregnancy, comprising the following steps:

[0010] Step 1, wash and dry the raw rehmannia root, eucommia bark, raw oyster, bupleurum root, artemisia capillaris, white peony root, atractylodes macrocephala, tuckahoe, asparagus root, figwort, houttuynia cordata, jujube, raw malt, and raw licorice, respectively, and mix them evenly to obtain mixed powder A;

[0011] Step 2, soak the remaining components in water according to the formula for 10-30 minutes, decoct, filter, and concentrate to obtain a Chinese medicine extract with a relative density of 1.25-1.35;

[0012] Step 3, placing the extract obtained in step 2 into a vacuum dryer for fluidized drying, and then pulverizing the extract to obtain a mixed powder B;

[0013] Step 4: Evenly mix the mixed powder A obtained in step 1 and the mixed powder B obtained in step 3, and then seal and store them to obtain a finished product.

[0014] As a preferred embodiment of the method for preparing a traditional Chinese medicine preparation for treating hypertension complicating pregnancy described in the present invention, wherein: during the decocting in step 2, first boil over high heat for 10-20 minutes, then decoct over low heat for 20 minutes, filter, and naturally cool to 55-60°C.

[0015] As a preferred embodiment of the method for preparing a traditional Chinese medicine preparation for treating hypertension complicating pregnancy described in the present invention, wherein: during fluidized drying in step (3), gradient drying is performed, first heating at 110-130°C for 30-50 minutes, then heating at 60-100°C for 20-40 minutes, and finally heating at 15-30°C for 10-30 minutes.

[0016] As a preferred embodiment of the method for preparing a traditional Chinese medicine preparation for treating hypertension complicating pregnancy described in the present invention, the finished preparation in step (4) is any one of granules, capsules, pastes, tablets, decoctions, powders or pills.

[0017] An application of a traditional Chinese medicine preparation for treating hypertension complicating pregnancy comprises the following steps: taking the medicine orally three times a day, one dose each time, half an hour after a meal, and applying the medicine externally twice a day, 30 minutes in the morning and evening respectively.

[0018] Compared with existing technologies:

[0019] 1. The Chinese medicine composition of the present invention is developed under the guidance of the holistic concept and syndrome differentiation and treatment theory of traditional Chinese medicine, targeting the pathological and physiological characteristics of women with gestational hypertension. It is a clinically effective prescription that can cover the most common syndromes of patients with gestational hypertension, such as kidney qi deficiency, liver yang hyperactivity, lung and spleen qi deficiency, etc. It has high safety and reliable efficacy.

[0020] 2. The Chinese medicine composition of the present invention can significantly enhance the antihypertensive effect of Western medicine, delay disease progression, protect target organs, and reduce maternal and fetal complications, reflecting the application advantages of combined Chinese and Western medicine treatment in the field of obstetrics and gynecology.

[0021] 3. The Chinese medicine composition of the present invention fully considers the commonalities of hypertension and the physiological characteristics of pregnant women, takes all aspects into consideration, removes the Chinese medicines that are prohibited or used with caution during pregnancy, has mild medicinal properties, few side effects, good taste, and is easy to store and take, which is beneficial to improving patients' compliance with medication and is easy to promote comprehensively.

[0022] 4. The preparation method of the present invention can give full play to the efficacy of each drug, avoid the loss of efficacy, make the release rate of the active ingredients of the drug high, and can significantly improve the stability and solubility of the drug, thereby improving the drug treatment effect and cure rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the present invention will be described in detail below in combination with the accompanying drawings and detailed embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative labor. Among them:

[0024] Figure 1 It is a schematic diagram of the steps of the method for preparing the Chinese medicine preparation of the present invention;

[0025] Figure 2 This is a comparison chart of the differences in age, gestational age and weight among samples of different groups of the present invention;

[0026] Figure 3 This is a comparison chart of the differences between systolic blood pressure before and after treatment, diastolic blood pressure before and after treatment, placental growth factor before and after treatment, renin before and after treatment, and angiotensin I before and after treatment in different groups of the present invention;

[0027] Figure 4This is a comparison chart of the differences in 24-hour urine protein levels before and after treatment and TCM syndrome scores before and after treatment in different groups of the present invention;

[0028] Figure 5 This is a comparison chart of the differences in adverse pregnancy outcomes among samples of different groups in the present invention. DETAILED DESCRIPTION

[0029] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0030] In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention may also be implemented in other ways different from those described herein, and those skilled in the art may make similar generalizations without violating the connotation of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0031] Secondly, the present invention is described in detail with reference to schematic diagrams. When describing the embodiments of the present invention in detail, for the sake of convenience, the cross-sectional diagrams showing the device structure will not be partially enlarged according to the general scale, and the schematic diagrams are only examples, which should not limit the scope of protection of the present invention. In addition, in actual production, the three-dimensional dimensions of length, width and depth should be included.

[0032] In order to make the objectives, technical solutions and advantages of the present invention more clear, the embodiments of the present invention will be further described in detail below with reference to the accompanying drawings.

[0033] The present invention provides a method for preparing a Chinese medicine preparation for treating hypertension complicating pregnancy and its application, which has a good therapeutic effect on hypertension complicating pregnancy, can enhance the antihypertensive effect of Western medicine, delay the progression of the disease, protect target organs, and reduce maternal and fetal complications. Figure 1-5 , the Chinese medicine preparation includes the following components by weight:

[0034] 20-30 parts of raw rehmannia root, 15-20 parts of eucommia bark, 20-30 parts of raw oyster, 10-15 parts of bupleurum root, 10-15 parts of artemisia capillaris, 15-20 parts of white peony root, 10-15 parts of atractylodes macrocephala, 15-20 parts of tuckahoe, 10-15 parts of asparagus root, 15-20 parts of figwort root, 20-30 parts of houttuynia cordata, 15-20 parts of jujube, 15-20 parts of raw malt, 5-10 parts of raw liquorice, wherein, raw rehmannia root: sweet, bitter, cold in nature, and enters the heart, liver, and kidney meridians. Rehmannia root is sweeter than bitter, moist and sweet, bitter and cold, and clears and drains. Enters the heart and liver meridians, clears heat and cools blood, eliminates restlessness and stops bleeding, enters the kidney meridian, nourishes yin and produces body fluid, lubricates the large intestine, quenches thirst, and relieves constipation. It takes into account both eliminating evil and strengthening the body, and is suitable for those with blood heat, yin deficiency with heat, yin-blood deficiency, and dry intestines. It is most suitable for those with excessive heat and damaged yin.

[0035] Eucommia: sweet and warm in nature, it enters the liver and kidney meridians. Eucommia is sweet, warm and nourishing, and enters the liver and kidney meridians. It has strong medicinal properties. It is good at warming and nourishing the liver and kidneys, strengthening tendons and bones, and calming the fetus, and lowering blood pressure. It is not only an important medicine for treating kidney deficiency, back pain, or weakness of tendons and bones, but also a good medicine for treating liver and kidney deficiency, fetal leakage or fetal movement.

[0036] Raw oysters: salty in nature and slightly cold, enter the liver, gallbladder, and kidney meridians. Oysters are good at calming the mind, subduing yang and replenishing yin, softening and dispersing nodules. They are used to treat dizziness, palpitations, insomnia, irritability, tinnitus caused by liver yin deficiency and liver yang hyperactivity, as well as scrofula, phlegm nodules, masses, spontaneous sweating, night sweats, metrorrhagia, enuresis, frequent urination, thirst, breast nodules and swelling, hypertension, etc.

[0037] Bupleurum: bitter, pungent, slightly cold, and enters the liver and gallbladder meridians. Bupleurum dispels wind and heat, relieves liver depression, and raises Yang Qi. It is used for exogenous fever, alternating cold and heat, chest and flank pain, irregular menstruation, uterine prolapse, rectal prolapse, etc. Modern pharmacological research shows that Bupleurum has obvious antipyretic, sedative, anticonvulsant, analgesic, and antitussive effects. Bupleurum saponins have anti-inflammatory, lipid-lowering, immune-enhancing, cholesterol-lowering, anti-tumor, anti-radiation, and liver-protecting effects.

[0038] Artemisia capillaris: bitter and pungent in nature, slightly cold in nature, and enters the spleen, stomach, liver, and gallbladder meridians. Artemisia capillaris can clear away dampness and heat, promote bile secretion and reduce jaundice, and is an essential medicine for the treatment of jaundice. Modern pharmacological studies have shown that Artemisia capillaris has the effects of antipyretic, anti-inflammatory, lipid-lowering and diuretic.

[0039] White peony root: bitter, sour, slightly cold, enters the liver and spleen meridians. White peony root calms the liver and relieves pain, nourishes blood and regulates menstruation, and restrains yin and stops sweating. It is used for headache, dizziness, flank pain, abdominal pain, cramps in the limbs, blood deficiency and sallow complexion, irregular menstruation, spontaneous sweating, and night sweats.

[0040] Atractylodes macrocephala: bitter, sweet, warm in nature, and enters the spleen and stomach meridians. Atractylodes macrocephala strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and stabilizes the fetus. It is used for spleen deficiency, poor appetite, abdominal distension and diarrhea, phlegm and fluid, dizziness and palpitations, edema, spontaneous sweating, and restless fetuses. Tubaizhu strengthens the spleen, harmonizes the stomach, and stabilizes the fetus.

[0041] Poria: sweet, light, neutral in nature, and enters the heart, lung, spleen, and kidney meridians. Poria promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind. It is used for edema, oliguria, phlegm and fluid, palpitations, spleen deficiency, poor appetite, loose stools, restlessness, palpitations, and insomnia.

[0042] Asparagus cochinchinensis: sweet, bitter, cold in nature, and enters the lung and kidney meridians. Asparagus cochinchinensis is sweet and nourishing, bitter and purgative, cold and clearing, and enters the lung and kidney meridians. It is a clearing, nourishing and smoothing product. It can moisten the lungs and relieve cough, clear the lungs and reduce fire, nourish the kidneys and nourish yin, promote fluid production and quench thirst, clear and moisten the intestines and relieve constipation, and is good at treating various symptoms of yin deficiency and hyperactivity of fire.

[0043] Scrophularia: Sweet, bitter, salty, slightly cold in nature, enters the lung, stomach, and kidney meridians. Scrophularia is good at nourishing yin, and can be used for both deficiency heat and excess heat. It is mainly used to treat fever, thirst, rash, bone steaming, fatigue, insomnia, spontaneous sweating, night sweats, body fluid loss, constipation, vomiting blood, epistaxis, sore throat, carbuncle, etc. Modern pharmacological research has confirmed that Scrophularia has cardiotonic and blood pressure lowering effects.

[0044] Houttuynia cordata: pungent in flavor, cold in nature, and enters the lung meridian. Houttuynia cordata clears away heat and detoxifies, eliminates carbuncle and discharges pus, promotes diuresis and relieves stranguria, cools blood, stops bleeding, lowers blood pressure, disperses blood stasis, clears lung heat, clears nasal passages, clears heat and detoxifies, promotes diuresis and reduces swelling. Modern pharmacological studies have shown that Houttuynia cordata has the effects of enhancing the body's immune function, anti-cancer, anti-allergic, anti-inflammatory, lowering blood pressure, and diuresis.

[0045] Jujube: sweet in nature and warm in flavor, it enters the spleen and stomach meridians. Jujube nourishes the spleen and stomach, replenishes qi and produces body fluid, regulates the Ying and Wei, and detoxifies. It is used to treat poor appetite due to weak stomach, loose stools due to weak spleen, insufficient qi, blood and body fluid, disharmony between Ying and Wei, palpitations, and irritability in women.

[0046] Raw malt: sweet in nature, neutral in nature, and enters the spleen and stomach meridians. Malt promotes qi and digestion, strengthens the spleen and stimulates appetite, and relieves bloating and swelling. It is used for indigestion, abdominal distension and pain, spleen deficiency and poor appetite, milk stagnation, breast pain, weaning in women, liver depression and flank pain, and liver and stomach qi pain.

[0047] Raw licorice: sweet in nature and flavor, neutral, enters the heart, lung, spleen, and stomach meridians. Licorice replenishes qi and nourishes the middle, clears away heat and detoxifies, removes phlegm and relieves cough, relieves pain, and harmonizes various medicines;

[0048] See also Figure 1 , prepare the above Chinese medicine components according to the following steps;

[0049] Step 1, wash and dry the raw rehmannia root, eucommia bark, raw oyster, bupleurum root, artemisia capillaris, white peony root, atractylodes macrocephala, tuckahoe, asparagus root, figwort, houttuynia cordata, jujube, raw malt, and raw licorice, respectively, and mix them evenly to obtain mixed powder A;

[0050] In the above-mentioned Chinese medicine composition, raw Rehmannia root is used, which is moist and sweet, nourishes yin and produces body fluid; Eucommia ulmoides strengthens tendons and bones, lowers blood pressure and stabilizes pregnancy, and the above are all monarch drugs. The minister uses raw oyster to suppress yang and replenish yin, Bupleurum and Artemisia capillaris to soothe the liver and promote gallbladder, clear away dampness and heat, white peony root to restrain yin and calm the liver, so that the liver qi is adjusted and comfortable, and the rise and fall are regular; Atractylodes macrocephala and Poria cocos to invigorate qi and strengthen the spleen, promote diuresis and calm the heart, Asparagus cochinchinensis and Scrophularia ningpoensis to nourish yin and moisten dryness, and Houttuynia cordata to clear heat and promote diuresis. Jujube and raw malt are adjuvants, which invigorate the spleen and stomach to prevent excessive clearing and harming the middle. Raw licorice is used as a messenger, invigorating qi and replenishing the middle, and harmonizing the various drugs. The above drugs are used together to nourish yin and moisten dryness, calm the liver and suppress yang, replenish the liver and kidney, and consolidate the foundation and prevent evil. It is suitable for patients with liver and kidney yin deficiency, liver yang hyperactivity, spleen deficiency and dampness, qi and blood deficiency type gestational hypertension, preeclampsia, eclampsia, chronic hypertension complicated with preeclampsia, and chronic hypertension. You can treat diseases when you have them, or prevent them when you don’t have them.

[0051] Step 2, soak the remaining components in water according to the formula for 10-30 minutes, decoct, filter, and concentrate to obtain a Chinese medicine extract with a relative density of 1.25-1.35;

[0052] Step 3, placing the extract obtained in step 2 into a vacuum dryer for fluidized drying, and then pulverizing the extract to obtain a mixed powder B;

[0053] Step 4, the mixed powder A obtained in step 1 and the mixed powder B obtained in step 3 are mixed evenly and sealed for storage to obtain a finished product;

[0054] Wherein, during the decocting in step 2, first boil over high heat for 10-20 minutes, then decoct over low heat for 20 minutes, filter, and naturally cool to 55-60°C;

[0055] During fluidized drying in step 3, gradient drying is performed, first heating at 110-130° C. for 30-50 minutes, then heating at 60-100° C. for 20-40 minutes, and finally heating at 15-30° C. for 10-30 minutes;

[0056] The finished preparation in step 4 is any one of granules, capsules, pastes, tablets, decoctions, powders or pills;

[0057] Embodiment 1:

[0058] The formula includes: 20-30 parts of raw Rehmannia root, 15-20 parts of Eucommia bark, 20-30 parts of raw oyster, 10-15 parts of Bupleurum root, 10-15 parts of Artemisia capillaris, 15-20 parts of White Peony root, 10-15 parts of Atractylodes macrocephala, 15-20 parts of Poria cocos, 10-15 parts of Asparagus cochinchinensis, 15-20 parts of Scrophularia ningpoensis, 20-30 parts of Houttuynia cordata, 15-20 parts of jujube, 15-20 parts of raw malt, and 5-10 parts of raw licorice.

[0059] Preparation method: The specific steps are:

[0060] (1) Wash and dry the raw rehmannia root, eucommia bark, raw oyster, bupleurum root, artemisia capillaris, white peony root, atractylodes macrocephala, poria, asparagus root, figwort, houttuynia cordata, jujube, raw malt and raw liquorice in the prescribed amount, grind them separately, and mix them evenly to obtain mixed powder A;

[0061] (2) Soak the remaining components in water according to the formula for 20 minutes; boil over high heat for 15 minutes, then simmer over low heat for 20 minutes, filter, cool naturally to 55°C, filter, and concentrate to obtain a Chinese medicine extract with a relative density of 1.3;

[0062] (3) The extract obtained in step (2) is then placed in a vacuum dryer for fluidized drying, first heated at 120° C. for 40 minutes, then heated at 80° C. for 30 minutes, and finally heated at 20° C. for 20 minutes; and then pulverized to obtain a mixed powder B;

[0063] (4) The mixed powder A obtained in step (1) and the mixed powder B obtained in step (3) are mixed evenly and then loaded into capsules to obtain a finished product;

[0064] Experimental subjects: 89 patients with hypertension complicating pregnancy who visited Zigong Maternal and Child Health Hospital from January 2022 to June 2023 were selected and divided into an experimental group and a control group according to the random number table method, with 44 cases in the experimental group and 45 cases in the control group.

[0065] Inclusion criteria: 1) Meet the diagnostic criteria for gestational hypertension in the 2020 edition of the "Guidelines for the Diagnosis and Treatment of Hypertension Complicating Pregnancy"; 2) 20 years old ≤ ≤ 35 years old; 3) 12 weeks ≤ gestational age ≤ 37 weeks; 4) Singleton pregnancy; 5) Meet the medication indications of this study; 6) Sign the informed consent form.

[0066] Exclusion criteria: 1) Those who do not meet the diagnostic criteria for hypertensive disorders complicating pregnancy; 2) Those with serious diseases of the heart, liver, kidney and hematopoietic system; 3) Those with active pulmonary tuberculosis, AIDS and other major infectious diseases; 4) Those who are unwilling to cooperate; 5) Other pathological pregnancies, such as severe pelvic infection, gestational diabetes, intrahepatic cholestasis of pregnancy, dangerous placenta previa, placenta accreta, DIC, severe coagulation abnormalities and other diseases that may seriously affect the coagulation function of the mother; 7) Those with various mental illnesses that have been diagnosed in the past; 8) Those who have been diagnosed with rheumatic diseases such as systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome; 9) Those who are allergic to or cannot tolerate Chinese medicine; 10) Those with communication barriers or poor compliance.

[0067] Medication and observation methods:

[0068] Control group: conventional western medicine antihypertensive treatment was used, including magnesium sulfate injection for spasm relief, oral labetalol hydrochloride tablets and (or) nifedipine tablets for blood pressure reduction.

[0069] Experimental group: conventional western medicine antihypertensive regimen + capsules prepared according to the examples of the present invention.

[0070] The treatment effects of the two groups were observed.

[0071] Standard of care:

[0072] The study was conducted from multiple perspectives, including TCM syndrome scores, 24-hour dynamic blood pressure, placental growth factor, renin, angiotensin levels, and adverse pregnancy outcomes in the control and experimental groups.

[0073] After treatment, the patient is considered cured if all symptoms and signs disappear completely, and blood pressure is ≤140 / 90 mmHg, and no proteinuria is detected; (2) After treatment, the patient is considered effective if symptoms and signs are significantly improved, blood pressure is ≤140 / 90 mmHg, and no proteinuria is detected; (3) After treatment, the patient is considered improved if symptoms and signs are improved, blood pressure is between 140 / 90 mmHg and 150 / 100 mmHg, and trace proteinuria is detected; (4) After treatment, the patient is considered ineffective if clinical symptoms, signs, and blood pressure do not improve or even worsen. Total effective rate = cure rate + effective rate + improvement rate.

[0074] Statistical treatment:

[0075] SPSS 22.0 statistical software was used for data analysis in this study. The measurement data that obeyed the normal distribution or approximate normal distribution were expressed as mean ± standard deviation, and the t test was used for such data. The measurement data that were not normally distributed were tested using the non-parametric rank sum test and expressed as median (lower quartile, upper quartile); Mann-Whitney test statistic z value; P value less than 0.05 indicated statistical significance;

[0076] Experimental results:

[0077] From the following table ( Figure 2 ) It can be seen that the t-test (full name: independent sample t-test) is used to study the differences in age, gestational age, and weight among groups. The samples from different groups do not show significant differences in age, gestational age, and weight (p>0.05), which means that the samples from different groups show consistency in age, gestational age, and weight, and there is no difference;

[0078] From the following table ( Figure 3 ) It can be seen that using t-test to study the differences in 10 items before and after systolic blood pressure treatment, diastolic blood pressure treatment, placental growth factor treatment, renin treatment, and angiotensin I treatment among the research groups, samples from different groups did not show significance for 5 items before systolic blood pressure treatment, diastolic blood pressure treatment, placental growth factor treatment, renin treatment, and angiotensin I treatment (p>0.05), which means that samples from different groups showed consistency before systolic blood pressure treatment, diastolic blood pressure treatment, placental growth factor treatment, renin treatment, and angiotensin I treatment, and there was no difference.

[0079] In addition, the group samples showed significant results (p<0.05) for 5 items after systolic blood pressure treatment, diastolic blood pressure treatment, placental growth factor treatment, renin treatment, and angiotensin I treatment, which means that different groups of samples have differences after systolic blood pressure treatment, diastolic blood pressure treatment, placental growth factor treatment, renin treatment, and angiotensin I treatment. The specific analysis is as follows:

[0080] ① The difference in systolic blood pressure after treatment was significant at the 0.01 level (t=-5.503, p=0.000), and the specific comparison showed that the average value of the experimental group (133.07) was significantly lower than the average value of the control group (145.04).

[0081] ② The difference in diastolic blood pressure after treatment was significant at the 0.01 level (t=-3.694, p=0.000), and the specific comparison showed that the average value of the experimental group (79.84) was significantly lower than the average value of the control group (88.20).

[0082] ③ The group showed a significant difference at the 0.01 level after placental growth factor treatment (t=7.961, p=0.000), and the specific comparison differences showed that the average value of the experimental group (187.18) was significantly higher than the average value of the control group (168.25).

[0083] ④ The group showed a significant difference at the 0.01 level after renin treatment (t=-4.647, p=0.000), and the specific comparison differences showed that the average value of the experimental group (18.14) was significantly lower than the average value of the control group (24.07).

[0084] ⑤ The group showed a significant difference at the 0.05 level after angiotensin I treatment (t=-2.392, p=0.019), and the specific comparison differences showed that the average value of the experimental group (24.41) was significantly lower than the average value of the control group (27.61).

[0085] Comparison between the experimental group and the control group: the highest blood pressure (systolic and diastolic blood pressure) of the two groups were lower than before treatment, and the highest blood pressure level of the experimental group was significantly lower than that of the control group; the placental growth factor level of the two groups was higher than before treatment, and the placental growth factor level of the experimental group was significantly higher than that of the control group; the renin and angiotensin I levels of the two groups were significantly lower in the experimental group than in the control group;

[0086] From the following table ( Figure 4 )It can be seen that the non-parametric test was used to study the differences in the 24-hour urine protein level before and after treatment, and the TCM syndrome score before and after treatment, a total of 4 items, and the MannWhitney test statistic was used for analysis. The samples of different groups did not show significant differences in 2 items before treatment of 24-hour urine protein level and TCM syndrome score before treatment (p>0.05), which means that the samples of different groups showed consistency before treatment of 24-hour urine protein level and TCM syndrome score before treatment, and there was no difference.

[0087] In addition, two items of group samples showed significant results (p<0.05) for 24-hour urine protein level and TCM syndrome score after treatment, which means that different groups of samples have differences in 24-hour urine protein level and TCM syndrome score after treatment. Specific analysis shows that: ① The group showed 0.05 level significance (p=0.016<0.05) for 24-hour urine protein level after treatment, and the specific comparison of median differences shows that the median of the experimental group (0.395) is significantly lower than the median of the control group (0.550).

[0088] ② The TCM syndrome score after treatment showed a 0.01 level of significance (p=0.000<0.01), and the specific comparison of median differences showed that the median of the experimental group (5.000) was significantly lower than that of the control group (7.000);

[0089] Comparison between the experimental group and the control group: The 24-hour urine protein level in the experimental group was significantly lower than that in the control group, and the TCM syndrome score was also significantly lower than that in the control group;

[0090] From the above table ( Figure 5 ) In summary, samples from different groups all showed significant differences in adverse pregnancy outcomes, and the incidence of adverse pregnancy outcomes in the experimental group was significantly lower than that in the control group.

[0091] Although the present invention has been described above with reference to the embodiments, various modifications may be made thereto and parts thereof may be replaced by equivalents without departing from the scope of the present invention. In particular, as long as there is no structural conflict, the various features in the embodiments disclosed in the present invention may be used in combination with each other in any manner, and the fact that these combinations are not exhaustively described in this specification is only for the sake of omitting space and saving resources. Therefore, the present invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A Chinese medicine preparation for treating hypertension complicating pregnancy, characterized in that: Made from the following raw materials in parts by weight: 20-30 parts of raw Rehmannia root, 15-20 parts of Eucommia bark, 20-30 parts of raw oyster, 10-15 parts of Bupleurum root, 10-15 parts of Artemisia capillaris, 15-20 parts of White Peony root, 10-15 parts of Atractylodes macrocephala, 15-20 parts of Poria, 10-15 parts of Asparagus cochinchinensis, 15-20 parts of Scrophularia ningpoensis, 20-30 parts of Houttuynia cordata, 15-20 parts of jujube, 15-20 parts of raw malt, and 5-10 parts of raw liquorice.

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