A pharmaceutical composition for improving or treating bradycardia and its application

Abstract

The present application relates to a pharmaceutical composition and application for improving or treating bradycardia in the field of bradycardia drug technology. In parts by weight, the pharmaceutical composition comprises the following components: 0.1-0.5 parts of fensansan extract, 30-40 parts of dextrin, 30-40 parts of corn starch, 30-40 parts of calcium hydrogen phosphate, 1-2 parts of magnesium stearate, and 1-2 parts of sodium carboxymethyl starch. The pharmaceutical composition provided in the present application has the effect of improving or treating bradycardia. When the pharmaceutical composition or the medicament prepared by the pharmaceutical composition is used to treat bradycardia, it can significantly improve the heart rate of the subject, with good therapeutic effect, and there will be no side effects of rapid arrhythmia during the treatment process, and there is no significant effect on blood pressure, which fills the gap in the clinical treatment of bradycardia. At the same time, the pharmaceutical preparation provided has a simple prescription composition, controllable process, stable and reliable product quality, long shelf life, and good application prospects.

Description

Technical Field

[0001] The present application relates to the technical field of bradycardia drugs, and in particular to a pharmaceutical composition and application for improving or treating bradycardia. Background Art

[0002] Chronic arrhythmia, also known as bradycardia, refers to a heart rhythm in which the heart beats less than expected per minute. It can be divided into sinus bradycardia and atrioventricular block. With improvements in living standards and longer lifespans, the incidence of chronic arrhythmias has been increasing year by year, particularly among middle-aged and elderly individuals. It plays a significant role in cardiovascular disease among middle-aged and elderly individuals, with the incidence of sinus bradycardia reaching 11.61% in those over 65 years old. Its incidence increases with age, and most cases occur in the setting of organic heart disease. It can cause alterations in hemodynamics, hemorheology, and microcirculation. In severe cases, symptoms such as blackouts and dizziness, as well as inadequate perfusion of vital organs such as the heart and brain, can occur. It also presents with an insidious onset and a slow progression.

[0003] Sinus bradycardia refers to a sinus rhythm with a heart rate below 60 beats per minute. It is caused by aging or various pathophysiological processes, leading to progressive or degenerative fibrosis of the sinoatrial node and surrounding atrial tissue. This can lead to abnormalities in the formation and conduction of atrial impulses and the development of an associated bradycardia or pause syndrome. Sinus bradycardia can occur in healthy adults, especially athletes, the elderly, and during sleep. Among organic heart diseases, sinus bradycardia can be seen in coronary artery disease, acute myocardial infarction, myocarditis, cardiomyopathy, and sick sinus syndrome. A heart rate below 40 beats per minute can often cause symptoms such as angina pectoris, heart failure, or syncope.

[0004] To date, no reliable medication has been found that can correct chronic arrhythmias with minimal side effects and long-term use. In clinical emergencies, drugs such as atropine, isoproterenol, and ephedrine are used to increase heart rate. However, these drugs can induce rapid arrhythmias, including ventricular arrhythmias, lack long-term therapeutic effects, and often have significant and intolerable side effects. Furthermore, these drugs are often administered by injection, which is highly irritating and limits patient compliance. Patients with significant chronic arrhythmias accompanied by sinus arrest and syncope may consider implanting an artificial pacemaker. Although pacemaker implantation is simple and its long-term safety and efficacy in treating bradycardia have been demonstrated, it alters the activation sequence between the left and right ventricles, disrupting the balanced state of synchronous contraction between the left and right ventricles. This leads to electrical and mechanical asynchrony, resulting in cardiac remodeling, which in turn increases the risk of new-onset atrial fibrillation, right ventricular pacing-induced heart failure, and all-cause mortality.

[0005] Therefore, developing a drug that is easy to take and has a clear therapeutic effect is of great significance for clinical improvement and treatment of sinus bradycardia. Summary of the Invention

[0006] In order to address the current situation of lack of drugs for the clinical treatment of bradycardia, the present application provides a pharmaceutical composition for improving or treating bradycardia. The pharmaceutical composition, or the medicament prepared using the pharmaceutical composition, has a significant therapeutic effect on bradycardia, and will not have the side effect of rapid arrhythmia during the treatment process, and has no significant effect on blood pressure, which can fill the gap in the clinical treatment of bradycardia.

[0007] To this end, the first aspect of the present application provides a pharmaceutical composition for improving or treating bradycardia, which comprises the following components in parts by weight: 0.1 to 0.5 parts of Sanfensan extract, 30 to 40 parts of dextrin, 30 to 40 parts of corn starch, 30 to 40 parts of calcium hydrogen phosphate, 1 to 2 parts of magnesium stearate and 1 to 2 parts of sodium carboxymethyl starch.

[0008] In the present application, the effective therapeutic ingredient in the pharmaceutical composition is Sanfensan extract, which contains alkaloids that can improve the permeability of cell membranes and blood-cerebrospinal fluid barriers, promote cell metabolism, increase cell membrane calcium-magnesium ATPase activity, increase myocardial blood flow, reduce blood lipids and whole blood viscosity, dilate coronary arteries, correct hemodynamic abnormalities, improve blood flow pattern, flow rate, and flow, and increase tissue oxygen supply. For this reason, the inventors of this application attempted to use Sanfensan extract as an effective therapeutic ingredient to treat bradycardia. The results showed that Sanfensan extract had a significant therapeutic effect on bradycardia, especially sinus bradycardia, and no side effects leading to rapid arrhythmia were observed during the treatment process. There was no significant effect on blood pressure, which filled the gap in the clinical treatment of sinus bradycardia. The dextrin is a polymer compound and is used as an excipient in medicines to improve the stability of the medicines, increase the adhesion and antioxidant properties of the medicines, and reduce the irritation and side effects of the medicines. The corn starch is stable and does not react with most medicines. It is used as a medicine excipient (such as a filler, disintegrant, and adhesive) to facilitate the subsequent molding of medicines. The calcium hydrogen phosphate is a medicine excipient and is added as an excipient. In some preferred embodiments, the calcium hydrogen phosphate is specifically calcium hydrogen phosphate dihydrate, which contains water molecules and can enhance the adhesion of the various components in the medicine, making the subsequent molding of the medicine smoother and avoiding the formation of fragments and cracks. The magnesium stearate has good lubricating properties and is used to improve the fluidity, stability, and solubility of the medicine. The sodium carboxymethyl starch has strong water absorption and water swelling properties, good mobility and compressibility, and can be used as a disintegrant in the production of tablets and capsules.

[0009] The pharmaceutical composition in the present application uses Sanfensan extract as the therapeutic ingredient and dextrin, corn starch, calcium hydrogen phosphate, magnesium stearate and sodium carboxymethyl starch as pharmaceutical excipients, so that the medicine prepared using the pharmaceutical composition has an excellent bradycardia treatment effect and good stability, which can be stable for at least 24 months.

[0010] In some preferred embodiments, the pharmaceutical composition comprises the following components in parts by weight: 0.135 parts of 3 / 4 extract, 30 parts of dextrin, 40 parts of corn starch, 40 parts of calcium hydrogen phosphate, 1.1 parts of magnesium stearate and 1.1 parts of sodium carboxymethyl starch.

[0011] The present application optimizes the content of each component in the pharmaceutical composition, thereby further improving the therapeutic effect of the pharmaceutical composition on bradycardia and achieving better stability.

[0012] In some embodiments, the Sanfensan extract contains alkaloids, and the alkaloids include anisodine, scopolamine, anisodamine and hyoscyamine.

[0013] The Sanfensan extract in this application is derived from the extraction of the traditional Chinese medicine Sanfensan, which contains alkaloids. Alkaloids are the core substances that play the role of the bradycardia treatment effect. The alkaloids mainly include anisodine, scopolamine and anisodine, and also include small amounts of hyoscyamine and other alkaloids. The structural formulas of anisodine, scopolamine and anisodine are shown below:

[0014]

[0015] In some embodiments, the total content of alkaloids in the Sanfensan extract is 0.5-5.0 wt %.

[0016] The content of alkaloids in the Sanfensan extract of the present application will have a great influence on the therapeutic effect of the drug on bradycardia. Controlling the content of alkaloids within the above-mentioned range can enable the prepared pharmaceutical composition and the medicament prepared using the pharmaceutical composition to exert a good therapeutic effect on bradycardia.

[0017] In some preferred embodiments, the total content of alkaloids in the Sanfensan extract is 0.7-3.0 wt %.

[0018] The present application optimizes the content of each component in the pharmaceutical composition, thereby further improving the therapeutic effect of the pharmaceutical composition on bradycardia and achieving better stability.

[0019] The second aspect of the present application provides a use of the pharmaceutical composition as described in the first aspect of the present application in the preparation of a pharmaceutical preparation for improving or treating bradycardia.

[0020] The pharmaceutical preparation of the present application contains the pharmaceutical composition, and therefore has excellent bradycardia treatment effect without clinical side effects. In addition, the pharmaceutical preparation has a simple prescription composition, controllable process, stable and reliable product quality and a long shelf life, which fills the gap in the clinical treatment of bradycardia, is of great significance to the clinical treatment of bradycardia, especially sinus bradycardia, and has good application prospects.

[0021] In some embodiments, the pharmaceutical preparation is a tablet, and the tablet is a film-coated tablet or a sugar-coated tablet.

[0022] The pharmaceutical preparations in this application are solid preparations, such as tablets, which are convenient for oral use. However, it should be noted that the dosage form of the pharmaceutical preparations in this application is not limited to tablets, and any dosage form commonly used in clinical practice can be adopted.

[0023] In some embodiments, the preparation method of the pharmaceutical preparation comprises: preparing ingredients according to the prescribed dosage, and then granulating, tableting and coating to obtain the pharmaceutical preparation.

[0024] The pharmaceutical preparation described herein has a simple and controllable preparation process, and the resulting product has stable and reliable quality and a long shelf life. In some specific embodiments, the preparation method of the pharmaceutical preparation comprises: adding water to three-thirds of an extract, stirring, and then sieving to prepare an extract solution; premixing dextrin, corn starch, calcium hydrogen phosphate, sodium carboxymethyl starch, and magnesium stearate, and then mixing with the extract solution to prepare a wet soft material; granulating the wet soft material, followed by tableting and coating to prepare the pharmaceutical preparation.

[0025] In some embodiments, the pharmaceutical preparation is administered orally in an amount of 0.2 to 0.5 mg / day.

[0026] The pharmaceutical preparation provided herein can be administered orally, which is simple and can improve patient compliance. Furthermore, by controlling the dosage within the aforementioned range, the pharmaceutical preparation exhibits a good therapeutic effect for bradycardia, comparable to that of the clinical emergency drug atropine. Furthermore, within this dosage range, the pharmaceutical preparation does not produce the side effect of tachyarrhythmias and has no significant effect on blood pressure.

[0027] In some embodiments, the bradycardia is sinus bradycardia.

[0028] The pharmaceutical preparation provided in the present application can achieve a normal heart rate after administering an effective dose of dexmedetomidine to Beagle dogs with sinus bradycardia. The heart rate basically returns to normal 110 minutes after low-dose administration and 90 minutes after high-dose administration, showing a significant therapeutic and improvement effect on sinus bradycardia.

[0029] Beneficial technical effects of the present application: The pharmaceutical composition provided herein has the effect of improving or treating bradycardia. When the pharmaceutical composition, or a medicament prepared from the pharmaceutical composition, is used to treat bradycardia, it can significantly improve the heart rate of the subject, with good therapeutic effects, and no side effects of rapid arrhythmia during treatment, and has no significant effect on blood pressure, thus filling a gap in the clinical treatment of bradycardia. Furthermore, the pharmaceutical preparation provided herein has a simple formulation, controllable process, stable and reliable product quality, and a long shelf life. It has important reference significance for filling the gap in clinical drugs for the treatment of sinus bradycardia and has good application prospects. DETAILED DESCRIPTION

[0030] To make this application easier to understand, the following examples will be used to further illustrate this application. These examples are for illustrative purposes only and are not intended to limit the scope of application of this application. Unless otherwise specified, the raw materials or components used in this application can be obtained through commercial channels or conventional methods.

[0031] Example 1: Preparation of tablets for improving or treating bradycardia

[0032] 1. Pharmaceutical composition formula used in tablet preparation

[0033] The specific formula of the pharmaceutical composition (by weight) is: 0.135 parts of 3 / 4 extract, 30 parts of dextrin, 30 parts of corn starch, 40 parts of calcium hydrogen phosphate dihydrate, 1.1 parts of sodium carboxymethyl starch, and 1.1 parts of magnesium stearate; the total alkaloid content in the 3 / 4 extract is 0.7wt%, and the alkaloids include anisodine, scopolamine, anisodamine, and hyoscyamine.

[0034] 2. Preparation process

[0035] Dextrin, corn starch, and magnesium stearate were sieved and mixed according to the prescribed amount. Purified water was added to the 3 / 3 extract, stirred evenly, and sieved to prepare an extract solution. The weighed dextrin, corn starch, calcium hydrogen phosphate, sodium carboxymethyl starch, and magnesium stearate were added to a high-speed granulator for premixing, and then the extract solution was added to prepare a wet soft material. The wet soft material was subjected to rocking granulation, dried, and the dry granules were granulated and mixed. The granules were tableted as required, the core tablets were coated, and the coated tablets were aluminum-coated to obtain finished tablets. The weight of each tablet was 112 mg.

[0036] Example 2: Preparation of tablets for improving or treating bradycardia

[0037] 1. Pharmaceutical composition formula used in tablet preparation

[0038] The specific formula of the pharmaceutical composition is basically the same as that of Example 1, except that the total alkaloid content in the Sanfensan extract is 1.8 wt %.

[0039] 2. Preparation process

[0040] Same as Example 1.

[0041] Example 3: Preparation of tablets for improving or treating bradycardia

[0042] 1. Pharmaceutical composition formula used in tablet preparation

[0043] The specific formula of the pharmaceutical composition is basically the same as that of Example 1, except that the total alkaloid content in the Sanfensan extract is 3.0 wt%.

[0044] 2. Preparation process

[0045] Same as Example 1.

[0046] Example 4: Preparation of tablets for improving or treating bradycardia

[0047] 1. Pharmaceutical composition formula used in tablet preparation

[0048] The specific formula of the pharmaceutical composition is basically the same as that of Example 1, except that the total alkaloid content in the Sanfensan extract is 5.0 wt %.

[0049] 2. Preparation process

[0050] Same as Example 1.

[0051] Test Example 1: Stability Test

[0052] The finished tablets prepared in Examples 1-4 were stored in a sealed, dry place for 36 months. During the storage period, the properties, content, weight difference and disintegration time of the tablets were observed and tested. The test results are shown in Tables 1-4, respectively.

[0053] Table 1: Stability test results of the finished tablets prepared in Example 1

[0054]

[0055]

[0056] Table 2: Stability test results of the finished tablets prepared in Example 2

[0057]

[0058] Table 3: Stability test results of the finished tablets prepared in Example 3

[0059]

[0060] Table 4: Stability test results of the finished tablets prepared in Example 4

[0061]

[0062]

[0063] From the test results in Tables 1-4, it can be seen that the tablets for improving or treating bradycardia prepared in the present application can meet the requirements in terms of properties, content, weight difference, disintegration time, etc. after being stored in a sealed and dry place for 36 months, with no significant difference. The product has good stability within 36 months.

[0064] Test Example 2: Testing the therapeutic effect of the finished tablets prepared in Example 2 on sinus bradycardia. A physiological signal telemetry system for conscious animals was used during the testing process. Beagle dogs were fitted with vests containing electrocardiogram (ECG) and non-invasive blood pressure (NIBP) modules to monitor their heart rate and blood pressure. After 10 minutes of relative stability, the Beagle dogs were intravenously injected with a modeling agent, dexmedetomidine hydrochloride injection, at a dose of 7.5 μg / kg. Heart rate and blood pressure were monitored before (T0), 10 minutes (T1), and 20 minutes (T2) after the dexmedetomidine injection. A successful sinus bradycardia model was considered established if the heart rate decrease at both T1 and T2 was less than 30% of T0. The Beagle dogs with successful sinus bradycardia models were divided into four groups (n=6) each: a model control group, a low-dose group, a high-dose group, and an atropine control group. The drug was administered within 5 minutes after T2, and the heart rate and blood pressure were monitored at 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, and 120 minutes after administration. Among them, the model control group did not take any drugs, and the indexes were detected synchronously after the animal modeling; the low-dose group took the tablets for improving or treating bradycardia prepared in Example 2, at a dose of 2 tablets / day (224 mg / day); the high-dose group took the tablets for improving or treating bradycardia prepared in Example 2, at a dose of 4 tablets / day (448 mg / day); the atropine control group took the clinical emergency drug atropine, at a dose of 2 tablets / day. At the same time, a blank control group was set up, and the animals in the blank control group were not treated in any way, and only the indexes were detected. The test results are shown in Tables 5-9.

[0065] Table 5: Effects of tablets used to improve or treat bradycardia on heart rate in Beagle dogs

[0066]

[0067]

[0068] Note: The heart rate data listed in the table are mean ± SD, n = 6. *P < 0.05, **P < 0.01, ***P < 0.001 vs. T0 within the same group.

[0069] Table 6: Effects of tablets used to improve or treat bradycardia on heart rate reduction in Beagle dogs

[0070]

[0071]

[0072] Note: The heart rate data listed in the table are mean ± SD, n = 6. *P < 0.05, **P < 0.01, ***P < 0.001 vs. T0 within the same group.

[0073] As shown in Tables 5 and 6, after administration of dexmedetomidine hydrochloride injection, the average decrease in the heart rate of animals at T1 and T2 was 30% to 35%, both of which were above 30% (inclusive) of T0, indicating that the establishment of the animal sinus bradycardia model in the low-dose group, high-dose group, model control group, and atropine control group was effective.

[0074] As shown in Table 5, compared with T0 before modeling, there was no significant change in the heart rate of the blank control group at each time point (P>0.05); the heart rate of the model control group showed an extremely significant decrease at 90 minutes (P<0.001), a very significant decrease at 100 minutes (P<0.01), and a downward trend at 110-120 minutes (P<0.05); the heart rate of the low-dose tablet group for improving or treating bradycardia showed a very significant decrease at T1-90 minutes (P<0.01), a significant decrease at 100 minutes (P<0.05), and a downward trend at 110-120 minutes (P<0.05). The heart rate basically returned to normal after 0 minutes (P>0.05); the heart rate of the high-dose group of tablets used to improve or treat bradycardia showed a very significant decrease at 70 minutes (P<0.01), a significant decrease at 80 minutes (P<0.05), and basically returned to normal after 90 minutes (P>0.05); the heart rate of the animals in the atropine control group showed a very significant decrease at 70 minutes (P<0.01), a significant decrease at 80 minutes (P<0.05), and basically returned to normal after 90 minutes (P>0.05).

[0075] As shown in Table 6, compared with the blank control group, the heart rate reduction at T1 and T2 in the model control group was significantly increased within 90 minutes, and the heart rate reduction at 100-120 minutes was still relatively significant (P<0.05); the heart rate reduction in the low-dose tablet group for improving or treating bradycardia had no significant difference after 100 minutes (P>0.05), and the heart rate was basically restored; the heart rate reduction in the high-dose tablet group for improving or treating bradycardia had no significant difference after 80 minutes (P>0.05), and the heart rate was basically restored; the heart rate in the atropine control group was basically restored after 90 minutes.

[0076] It can be seen that the tablets for improving or treating bradycardia provided in the present application can significantly alleviate the decrease in heart rate in Beagle dogs with sinus bradycardia model at low doses, and the therapeutic effect on sinus bradycardia at high doses is equivalent to that of atropine.

[0077] Table 7: Effects of tablets used to improve or treat bradycardia on mean arterial pressure in Beagle dogs

[0078]

[0079]

[0080] Note: All data listed in the table are mean ± standard deviation, n = 6. Compared with the blank control group, there was no significant difference in each group (P>0.05).

[0081] Table 8: Effects of tablets used to improve or treat bradycardia on diastolic blood pressure in Beagle dogs

[0082]

[0083]

[0084] Note: All data listed in the table are mean ± standard deviation, n = 6. Compared with the blank control group, there was no significant difference in each group (P>0.05).

[0085] Table 9: Effects of tablets used to improve or treat bradycardia on systolic blood pressure in Beagle dogs

[0086]

[0087] Note: All data listed in the table are mean ± standard deviation, n = 6. Compared with the blank control group, there was no significant difference in each group (P>0.05).

[0088] As can be seen from Tables 7-9, after taking the tablets for improving or treating bradycardia of the present application, there was no significant effect on the mean arterial pressure, diastolic pressure and systolic pressure of Beagle dogs with sinus bradycardia model; and compared with taking atropine, after taking the tablets for improving or treating bradycardia of the present application, the mean arterial pressure, diastolic pressure and systolic pressure of Beagle dogs were closer to those of the blank control group, indicating that the agent for improving or treating bradycardia provided by the present application will not have the side effect of rapid arrhythmia during the treatment of bradycardia and has no significant effect on blood pressure.

[0089] Test Example 3: Testing of the therapeutic effect of the finished tablets prepared in Examples 1 and 3-4 on sinus bradycardia

[0090] The testing of the therapeutic effects of the finished tablets prepared in Examples 1 and 3-4 on sinus bradycardia was basically the same as that in Test Example 3, except that the tablets for improving or treating bradycardia prepared in Examples 1 and 3-4 were used to replace the tablets for improving or treating bradycardia prepared in Example 2.

[0091] The therapeutic effects of the finished tablets prepared in Example 1 were as follows: compared with the blank control group, the heart rate reductions at T1 and T2 in the model control group were significantly increased within 90 minutes, and the heart rate reduction was still significant from 100 to 120 minutes (P<0.05); after 120 minutes, the heart rate reduction in the low-dose group of tablets for improving or treating bradycardia had no significant difference (P>0.05), and the heart rate had basically recovered; after 100 minutes, the heart rate reduction in the high-dose group of tablets for improving or treating bradycardia had no significant difference (P>0.05), and the heart rate had basically recovered; after 90 minutes, the heart rate in the atropine control group had basically recovered. At the same time, after taking the tablets, there was no significant effect on the mean arterial pressure, diastolic pressure, and systolic pressure in Beagle dogs with a sinus bradycardia model.

[0092] The therapeutic effects of the finished tablets prepared in Example 3 were as follows: compared with the blank control group, the heart rate reductions at T1 and T2 in the model control group were significantly increased within 90 minutes, and the heart rate reduction was still significant from 100 to 120 minutes (P < 0.05); the heart rate reduction in the low-dose group for improving or treating bradycardia had no significant difference after 100 minutes (P > 0.05), and the heart rate had basically recovered; the heart rate reduction in the high-dose group for improving or treating bradycardia had no significant difference after 80 minutes (P > 0.05), and the heart rate had basically recovered; the heart rate in the atropine control group had basically recovered after 90 minutes. At the same time, taking the tablets had no significant effect on the mean arterial pressure, diastolic pressure, and systolic pressure of Beagle dogs with a sinus bradycardia model.

[0093] The therapeutic effect of the finished tablet prepared in Example 5 is as follows: compared with the blank control group, the heart rate reduction of T1 and T2 in the model control group was significantly increased within 90 minutes, and the heart rate reduction from 100 to 120 minutes was still relatively significant (P<0.05); the heart rate reduction of the low-dose group of tablets for improving or treating bradycardia had no significant difference after 100 minutes (P>0.05), and the heart rate was basically restored; the heart rate reduction of the high-dose group of tablets for improving or treating bradycardia had no significant difference after 80 minutes (P>0.05), and the heart rate was basically restored; the heart rate of the atropine control group was basically restored after 90 minutes. After taking the tablets, the low-dose group had no significant effect on the mean arterial pressure, diastolic pressure and systolic pressure of Beagle dogs with a sinus bradycardia model; the high-dose group had a slight effect on the mean arterial pressure, diastolic pressure and systolic pressure of Beagle dogs with a sinus bradycardia model, causing the mean arterial pressure and systolic pressure of the Beagle dogs to be slightly lower than those of the blank control group, and the diastolic pressure to be slightly higher than that of the blank control group.

[0094] It should be noted that the embodiments described above are only used to explain the present application and do not constitute any limitation to the present application. The present application has been described with reference to typical embodiments, but it should be understood that the words used therein are descriptive and explanatory words, rather than restrictive words. The present application may be modified as specified within the scope of the claims of the present application, and the invention may be revised without departing from the scope and spirit of the present application. Although the present application described therein relates to specific methods, materials and embodiments, it does not mean that the present application is limited to the specific examples disclosed therein. On the contrary, the present application can be extended to all other methods and applications with the same function.

Claims

1. Use of a pharmaceutical composition in the preparation of a pharmaceutical preparation for improving or treating sinus bradycardia; The pharmaceutical composition comprises the following components in parts by weight: 0.1-0.5 parts of Sanfensan extract, 30-40 parts of dextrin, 30-40 parts of corn starch, 30-40 parts of calcium hydrogen phosphate, 1-2 parts of magnesium stearate and 1-2 parts of sodium carboxymethyl starch; The Sanfensan extract contains alkaloids, including anisodine, scopolamine, anisodine and hyoscyamine; the total content of alkaloids in the Sanfensan extract is 0.5-5.0 wt%.

2. The use according to claim 1, characterized in that The pharmaceutical composition comprises the following components in parts by weight: 0.135 parts of sanfensan extract, 30 parts of dextrin, 40 parts of corn starch, 40 parts of calcium hydrogen phosphate, 1.1 parts of magnesium stearate and 1.1 parts of sodium carboxymethyl starch.

3. The use according to claim 1, characterized in that The total content of alkaloids in the Sanfensan extract is 0.7-3.0 wt %.

4. The use according to claim 1, characterized in that The pharmaceutical preparation is a tablet, and the tablet is a film-coated tablet or a sugar-coated tablet.

5. The use according to claim 4, characterized in that The preparation method of the pharmaceutical preparation comprises: preparing ingredients according to the prescribed dosage, and then granulating, tableting and coating to obtain the pharmaceutical preparation.

6. The use according to claim 1, characterized in that The pharmaceutical preparation is administered orally, with a dosage of 0.2-0.5 g / day.

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