TWI520739B - Pharmaceutical composition prepared from saikosaponin and the preparation method thereof - Google Patents

Description

Medicine composition prepared from saikosaponin and preparation method thereof

The present invention relates to the use of saikosaponin for the treatment and prevention of viral infections, a pharmaceutical composition comprising saikosaponin, and a method of preparing the pharmaceutical composition.

There are currently 170 million people (2% of the global population) infected with hepatitis C virus (HCV), and the liver diseases (hepatitis, cirrhosis and liver cancer) brought by it are serious worldwide. Health and medical burden. Currently, there is no preventive vaccine for hepatitis C, and the existing clinical treatment drug interferon-alpha (IFN-α) + ribavirin is not ideal for the treatment of the most common genotype first type. (about 50% cure rate) and large side effects, more need for huge medical funds, resulting in many patients can not afford the treatment and economic burden. Although in May 2011 the US Food and Drug Administration (FDA) approved two new drugs, boceprevir and telaprevir, for the treatment of genotype 1 virus-infected patients, but Can only be combined with IFN-α and ribavirin, not suitable for single treatment. Therefore, the development of therapeutic drugs for hepatitis C virus and liver diseases caused by it is a priority.

About 500,000 to 700,000 people in Taiwan are the carriers of hepatitis C, although 30% of liver cancer caused by hepatitis C virus infection in Taiwan is far less than the proportion of liver cancer caused by hepatitis B virus infection (70%). ), however, the hepatitis B vaccine has reached a fairly high preventive effect after its full implementation. In contrast, the high variability of hepatitis C virus has encountered great difficulties in vaccine development. Therefore, it is speculated that liver cancer caused by hepatitis C in Taiwan will gradually replace hepatitis B and become the number one killer. For more than a decade, virologists have been working to develop more effective hepatitis C non-structural protein inhibitors to influence viral replication, which is expected to replace or be combined with the existing clinical drug IFN-α + ribavirin. Such antiviral strategies have made many patients with hepatitis C suffer Hui, however, many problems have arisen, such as drug side effects and expensive two major problems.

In order to develop a therapeutic drug for hepatitis C which is economical, effective, and has few side effects, the present invention uses a native endemic medicinal plant, Gaoshi Bupleurum, to develop a method for treating or preventing a viral infection by using the extracted saikosaponin. Further improving the problem of poor solubility of saikosaponin, preparing a pharmaceutical composition having the above-mentioned use, not only provides another medical treatment option for hepatitis C, but also develops Taiwan native crude medicine resources.

In view of the deficiencies in the prior art, the applicant of this case, after careful experimentation and research, and a perseverance spirit, finally conceived the case and can overcome the shortcomings of the prior art. The following is a brief description of the case.

The present invention provides a use of saikosaponin for the preparation of a pharmaceutical composition for preventing or treating hepatitis C virus, measles virus, respiratory syncytial virus, vesicular stomatitis virus, dengue virus and no-coating virus. One of the infections. The present invention contemplates the development of new drugs to replace or assist existing clinical drugs (IFN-a/ribavirin) in order to achieve the benefits of reduced side effects and economic burden. At the same time, the pharmaceutical composition provided by the present invention can be used not only as a hepatitis C virus inhibitor but also as a broad-acting antiviral drug, and can be applied to the prevention and treatment of various viruses.

Further, the present invention further provides a pharmaceutical composition comprising the main component saikosaponin, and a high molecular polymer mixed with the main component. The pharmaceutical composition of the present invention enhances bioavailability and antiviral efficacy by modifying the drug to improve the poor water solubility of the drug.

The present invention further provides a method for producing a pharmaceutical composition comprising the steps of: dissolving a saikosaponin in an organic solvent; adding the organic solvent containing the saikosaponin to a solution containing a high a molecular polymer; dispersing the saikosaponin in the high molecular polymer; and removing the organic solvent to obtain the pharmaceutical composition.

The invention proves that saikosaponin can be used for treating and preventing hepatitis C virus infection, and can also prevent measles virus, respiratory syncytial virus, vesicular stomatitis virus, dengue virus and no-coating virus from invading cells, and has broad-spectrum virus suppression. The effect of the agent. The invention also successfully prepares a naphtha dosage form of saikosaponin, which can be formulated in water to improve bioavailability. In addition to transport In addition to the use of saikosaponin and its nano-preparation as a virus prevention and treatment drug, it can also be applied to masks, gloves, anti-mosquito liquids, hand-washing milk, dry-cleaning hands (disinfectants) and various cleaning products in the future to achieve resistance. The effect of virus infection makes the epidemic prevention work easier.

The first graph (A) is the result of high performance liquid chromatography (HPLC) analysis of the camphorol extract.

The first panel (B) shows the results of HPLC analysis of saikosaponin SSa.

The first graph (C) shows the results of HPLC analysis of saikosaponin SSb2.

The first panel (D) shows the results of HPLC analysis of saikosaponin SSc.

The first figure (E) is the HPLC analysis result of saikosaponin SSd.

Figure 2 (A) shows the effect of the camphor alcohol extract on the inhibition of hepatitis C virus (HCV) infection.

The second panel (B) shows the effect of saikosaponin SSa on the inhibition of hepatitis C virus infection.

The second panel (C) shows the effect of saikosaponin SSb2 on the inhibition of hepatitis C virus infection.

The second panel (D) shows the effect of saikosaponin SSc on the inhibition of hepatitis C virus infection.

The second figure (E) shows the effect of saikosaponin SSd on the inhibition of hepatitis C virus infection.

The third panel shows the time-effect of the extract of camphorol and the saikosaponins SSa, SSb2, SSc and SSd on hepatitis C virus infection.

The fourth panel shows the results of virus entry assays for the extract of camphorol and saikosaponins SSa, SSb2, SSc and SSd.

The fifth picture shows the results of saikosaponin SSb2 inhibiting the binding of virus to cells.

The sixth picture shows the results of saikosaponin SSb2 inhibiting the infection of a variety of different genotypes of hepatitis C virus.

The seventh picture shows the results of saikosaponin SSb2 inhibiting the binding of virus and cells in serum of clinical patients.

Figure 8 (A) shows the effect of SSb2 on measles virus (MV) infection.

Figure 8 (B) shows the effect of SSb2 on respiratory syncytial virus (RSV) infection.

Figure 8 (C) shows the effect of SSb2 on the inhibition of vesicular stomatitis virus (VSV) infection.

Figure 8 (D) shows the effect of SSb2 on dengue virus (DENV) infection.

Figure 8 (E) shows the effect of SSb2 on reovirus (RV) infection.

Figure 9 (A) shows the results of identifying the crystalline properties of the pharmaceutical composition of the present invention using an X-ray diffraction analyzer (XRD).

Figure 9 (B) shows the results of the intermolecular interaction of the two materials using the infrared spectrometer (FTIR) of the pharmaceutical composition of the present invention.

Figure 9 (C) shows the results of solubility determination of the pharmaceutical composition of the present invention.

Fig. 10 (A) shows the effect of the nano preparation of the present invention for inhibiting HCV infection.

Fig. 10 (B) shows the effect of the nano preparation of the present invention on inhibiting DENV infection.

The present invention can be derived from the following examples, but the embodiments of the present invention are not limited by the following examples, and those skilled in the art can still practice other embodiments in accordance with the spirit of the disclosed embodiments. These embodiments are all within the scope of the invention.

The present invention provides a use of preparing saikosaponin for the preparation of a pharmaceutical composition for preventing or treating hepatitis C virus, measles virus, respiratory syncytial virus, vesicular stomatitis virus, dengue virus and no-coating virus ( Infection including one of reovirus, enterovirus, norovirus, adenovirus.

The saikosaponin used in the present invention is extracted from the endemic species Bupleurum kaoi of Taiwan, which is an alcohol extract of Bupleurum chinense, including saikosaponin SSa, SSb2, SSc and SSd. It should be understood that the pharmaceutical composition referred to in the present invention is not limited to the alcohol extract of Bupleurum chinense, but may also be a Bupleurum from other varieties, a product obtained by any solvent or in any manner (including a synthetic product). On the other hand, although the antiviral activity of the camphorol extract, SSa, SSb2, SSc and SSd is respectively shown in the present invention, the Chinese pharmaceutical composition of the present invention can be derived from the camphor saponin extract, SSa, SSb2, SSc and SSd or any combination thereof, for example comprising only SSb2, comprising SSa and SSb2, or comprising SSa, SSb2, SSc and SSd.

In order to prepare saikosaponin as a pharmaceutical composition, the saikosaponin of the present invention can be mixed with a pharmaceutically acceptable carrier to obtain a more bioavailable preparation. The above pharmaceutically acceptable carrier, or "excipient", "bioavailable carrier or excipient", includes any solvent, dispersing agent, coating, antibacterial or antifungal agent, preserving or delaying the absorbent, and the like. It is customary to prepare suitable compounds for the dosage form. Usually such carriers or excipients do not themselves have the activity of treating diseases, and therefore, when the saikosaponin disclosed in the present invention is prepared into various dosage forms together with a pharmaceutically acceptable carrier or excipient, it is administered to an animal or a human. Do not cause adverse reactions, allergies or other inappropriate reactions. Therefore, the saikosaponin disclosed in the present invention, together with a pharmaceutically acceptable carrier or excipient, is suitable for clinical use to achieve therapeutic or prophylactic effects.

The carrier may vary depending on the dosage form, and the composition for oral administration may be in any orally acceptable dosage form, including capsules, troches, tablets, emulsifiers, liquid suspensions, dispersions, solvents. The carrier used in the oral dosage form is generally a basic additive such as lactose, corn starch, lubricant, magnesium stearate or the like. The diluent used in the capsules includes lactose and dried corn starch. In the form of a liquid suspension or emulsifier dosage form, the active substance is suspended or dissolved in an oily interface in combination with an emulsifier or a suspending agent, and a moderate sweetener, flavor or coloring agent is added as needed.

The pharmaceutical composition of the present invention can be manufactured as one of a drug, a disinfectant, a glove, a mask, a dry hand, a hand lotion, and a mosquito repellent depending on the use. Preparation examples of the pharmaceutical composition of the present invention will be described in detail below.

Confirmation of the active ingredients of Bupleurum:

Please refer to Fig. 1 (A) to (E) for the HPLC analysis results of the camphor saponin extract, saikosaponin SSa, SSb2, SSc and SSd, respectively. In the present invention, it was confirmed by HPLC that saikosaponins SSa, SSb2, SSc, and SSd were indeed present in the extract of B. sinensis (BK), and the content thereof was quantified. The quantified results in Figures 1(A) to (E) are shown in Table 1 below.

Saikosaponin has the effect of inhibiting hepatitis C virus infection:

The second panels (A) to (E) show the effects of the camphor saponin extract, saikosaponin SSa, SSb2, SSc and SSd on the inhibition of hepatitis C virus (HCV) infection. The camphorol extract (BK), saikosaponin SSa, SSb2, SSc and SSd were dissolved in dimethyl sulfoxide (DMSO) and prepared into various concentrations for screening for antiviral activity. It was found that BK, SSa, SSb2, SSc, and SSd all had the effect of inhibiting cell culture-derived hepatitis C virus (HCVcc) genotype 2a infection in a dose-dependent manner. According to the above screening results, the concentration of antiviral activity is not selected, and the antiviral activity is continued, for example, BK: 50 μg/ml, SSa: 8 μM, SSb 2: 50 μM, SSc: 200 μM, SSd: 2 μM, The above dose inhibits viral proteins by approximately 2 log (100 fold). Table 2 below shows the quantified results of the second figures (A) to (E).

The third panel shows the time-effect of the extract of camphorol and the saikosaponins SSa, SSb2, SSc and SSd on hepatitis C virus infection. Firstly, in order to explore the complete virus infection cycle, the virus and the drug were initially added in three different ways, 1) the drug was removed after 24 hours, and then the virus was added. After three days, the virus expression was detected by cold light (pre- Treatment); 2) The virus and the drug were added at the same time, removed together after 3 hours, three days later, the virus was detected by cold light (co-addition); and 3) the virus was added for 3 hours before the drug was added, three days later Cold light detects viral post-infection. In the co-addition experiment, it was observed that the extracts of Bupleurum and SSa, SSb2, and SSd all had good inhibitory effects, confirming that the drug could interfere with viral infection; in the pre-treatment experiment, all the drugs were ineffective. Therefore, it is preliminarily speculated that the role of the drug is not to protect cells against viral infection; in the results of post-infection, all drugs were found to be ineffective, confirming that the drug may not act on the stage of replication or translation of the virus, while SSc only persists in the drug. Inhibition was only observed in experiments where the entire viral infection process was present (not shown). From the above results, it is known that the antiviral mechanism of the camphorol extract and SSa, SSb2 and SSd is a stage for inhibiting the early entry of the hepatitis C virus into cells.

The fourth panel shows the results of virus entry assays for the extract of camphorol and saikosaponins SSa, SSb2, SSc and SSd. In the experiments of inactivation and attachment, it was observed that only SSb2 can neutralize virus particles and inhibit virus-attached cells, while fusion experiments found that camphorol extract and both SSa and SSb2 were available. To prevent viral fusion, the above results confirm that the main mechanism of anti-viral activity of the camphorol extract and its active components SSa and SSb2 is entry inhibition, which can be used as a virus entry inhibitor.

The fifth picture shows the results of saikosaponin SSb2 inhibiting the binding of virus to cells. Cell culture-derived hepatitis C virus or soluble glycoprotein E2 (sE2) was added to Huh-7.5 cells at 4 °C, and treated with SSb2 at the same time. After 3 hours, phosphate buffer solution (PBS) was used. Wash the SSb2 and the virus, then use the anti-E2 antibody to interact with the virus or glycoprotein on the cell membrane, and finally detect the amount of virus by enzyme immunoassay (ELISA). The results show that SSb2 can prevent viral invasion by interfering with the binding of HCVcc and sE2 to the cell membrane. According to the above experiments, the role of B. sinensis and its components (SSa, SSb2, SSc, SSd) can be used as a therapeutic drug for chronic hepatitis C, and the mechanism of action of Gaoshi Bupleurum and SSA, SSb2, and SSd. To suppress disease Early intrusion of poison, it also has a preventive function, which can be used as a drug (disinfecting drug) for preventing virus from invading new liver tissue during liver transplantation. This special use improves the shortcoming that IFN-α+ribavirin can only be used for treatment and cannot be prevented.

The sixth picture shows the results of saikosaponin SSb2 inhibiting the infection of a variety of different genotypes of hepatitis C virus. As shown in the figure, Huh-7.5 cells were infected with genotype 2b, 3a, 7a HCVcc and SSb2 was added at the same time. The results showed that SSb2 inhibited the infection of various genotypes of hepatitis C virus.

The seventh picture shows the results of saikosaponin SSb2 inhibiting the binding of virus and cells in serum of clinical patients. The virus in clinical patient serum was added to Huh-7.5 cells at 4 °C, and SSb2 was added at the same time. After 3 hours, SSb2 and virus were washed away with PBS, and then the total RNA in the cells was extracted, and finally linked by instant polymerase. The reaction (qPCR) quantifies the virus. The results showed that SSb2 inhibited the binding of hepatitis C virus to cells of genotypes 1a, 1b, 2a, and 6 in clinical patient serum. The quantified results are shown in Table 3 below.

Combining the results of the sixth and seventh graphs, the present invention demonstrates that in addition to inhibiting genotype 2a HCVcc, saikosaponin SSb2 can inhibit the infection of other genotypes 2b, 3a, 7a HCVcc and the genotype 1a of clinical patient serum. The combination of hepatitis C virus and cells of 1b, 2a, and 6 can resist the high variability of hepatitis C virus. SSb2 can inhibit the characteristics of various genotypes of hepatitis C virus, indicating that saikosaponin can improve the treatment of genotype type 1 hepatitis C virus in the past, and can improve boceprevir and telaprevir. The two new drugs are not good for genotypes other than genotype type 1 hepatitis C virus and are not suitable for treatment alone (only with IFN-α+ribavirin). question.

Saikosaponin has the effect of inhibiting multiple viral infections:

Figure 8 (A) to (E) are SSb2 inhibitors of measles virus (MV), respiratory syncytial virus (RSV), vesicular stomatitis virus (VSV), dengue virus (DENV) and reovirus (RV) infection, respectively. The effect. The quantified results are shown in Table 4 below.

As can be seen from Table 4, these viruses belong to different types, and the results show that SSb2 has both DNA or RNA virus, single or double-stranded genes, enveloped or non-enveloped viruses. The inhibitory effect confirmed that SSb2 is a broad-spectrum antiviral drug. According to the inhibitory effect of SSb2 on the no-envelope virus, it can be inferred that it also has an inhibitory effect on a no-envelope virus such as enterovirus, norovirus or adenovirus. The no-enveloped virus referred to in the present invention may include, in addition to the above-mentioned reovirus (RV), enterovirus, norovirus and adenovirus, other non-enveloped viruses well known in the art, such as human mastoid. Viruses and small RNA viruses, etc.

According to SSb2 inhibition of a variety of viral infection characteristics, in the future can also be used in masks, gloves, anti-mosquito, hand lotion, dry hands (disinfectants) and a variety of cleaning products, making epidemic prevention work easier. For example, the addition of saikosaponin to mosquito repellent can be applied to the outbreak of dengue fever in Taiwan and Southeast Asia every summer; or according to SSb2 for no-envelope virus (such as enterovirus, norovirus or adenovirus) It has the inhibiting property, and can add saikosaponin to the dry hand lotion to solve the problem that the alcohol-free dry cleaning hand has no disinfection effect on the no-coating virus, and the crisis of the worldwide epidemic outbreaks is improved.

Since saikosaponin is poor in water solubility, if it is used as a drug, there is a problem that bioavailability is low. In addition to being able to bind to the aforementioned pharmaceutically acceptable carrier, in order to improve the solubility of saikosaponin, the present invention utilizes a nanotechnology to prepare a pharmaceutical composition comprising saikosaponin as a main component and saikosaponin and high The molecular polymers were mixed to obtain nanoparticles <50 nm. Since the pharmaceutical composition of the present invention can be stored in a liquid form in a refrigerated manner or placed in a dry powder form for cryopreservation, it can be manufactured into various medical protective devices such as drugs, disinfectants, gloves, masks, dry hands, hand lotions, and mosquito repellents. And people's livelihood supplies.

In another aspect, the present invention also provides a method for producing a pharmaceutical composition comprising dissolving a saikosaponin in an organic solvent, and adding the organic solvent containing the saikosaponin to a solution containing one A high molecular polymer disperses the saikosaponin in the high molecular polymer and removes the organic solvent to obtain the pharmaceutical composition. The following examples of the present invention take SSb2 as an example to prepare a preparation of SSb2 (SSb2-NP). It should be understood that the preparation methods provided in the examples of the present invention are also applicable to the preparation of other naphtha extracts of saikosaponin SSa, SSc, SSd or camphor alcohol extract.

Preparation of SSb2 Nano Preparation

The SSb2 nanocrystallization preparation can be obtained by performing dispersion and blending reaction of SSb2 by an emulsion solvent diffusion method. The process can be carried out with a variety of high molecular polymers, such as Pluronic® polymer, polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), and the like. According to the solubility characteristics of SSb2 and taking polyvinylpyrrolidone as an example, the process first dissolves SSb2 into a 1 mg/ml solution with an appropriate amount of ethanol, dissolves polyvinylpyrrolidone in an appropriate amount of purified water to prepare a 35% aqueous solution, and then injects the SSb2 solution into the poly In the aqueous solution of vinylpyrrolidone, the dispersion and doping reaction of SSb2 and polyvinylpyrrolidone are promoted by ultrasonic waves, and then the organic solvent (in this case, ethanol) and part of water are removed by a vacuum decomposer to obtain a preliminary SSb2 nanometer preparation. . The complete SSb2 nano preparation of this example can be obtained by filtering with a qualitative filter paper to remove the precipitate of the oversized particles. The preparation may be placed in a liquid form in a refrigerated form or stored in a dry powder form, and the latter may be recovered as pure water when it is used.

According to the preparation method in the embodiment of the present invention, SSb2 is dissolved and disposed in B In alcoholic solutions, however, those of ordinary skill in the art should be able to replace the ethanol solution with other suitable organic solvents.

The particle size of the preparation was 16.57±3.88 nm by dynamic light scattering (PCS). The size of the particles was about 10 nm by electron microscopy (TEM). The results were consistent with PCS. The yield of the process was 81.45±6.14. %. Figure 9 (A) shows the results of identifying the crystalline properties of the pharmaceutical composition of the present invention using an X-ray diffraction analyzer (XRD). The crystallinity was identified by X-ray diffraction analyzer (XRD), and compared with the physiological mixture (PM) prepared by simple mixing in different proportions, it can be seen that the SSb2-NP loss of SSb2 is located at 3.7°. The crystal lattice signal indicates that the SSb2 crystal lattice of the nano preparation disappears. Figure 9 (B) shows the results of the intermolecular interaction of the two materials using the infrared spectrometer (FTIR) of the pharmaceutical composition of the present invention. The intermolecular interaction between the two materials was identified by infrared spectrometer (FTIR). The spectrum obtained from the nanoform preparation (SSb2-NP) showed hydroxyl shift (3,420 cm ^-1 ), and the degree of displacement was different from that of the simple blender (SSb2-PM). Intermolecular interactions did occur in this case of nano preparations. The interaction between the two materials can explain the disappearance of the SSb2 crystal lattice characteristics of the nano-preparation, and is beneficial to increase the solubility of SSb2. Figure 9 (C) shows the results of solubility determination of the pharmaceutical composition of the present invention. The solubility properties of the preparation were identified by the dissolution test. The SSb2 which was generally not treated with the preparation was compared with the SSb2 nano preparation of this example. The dissolution test showed that the nano preparation of this example had a significant enhancement effect on the solubility of SSb2, and improved by the nano preparation, SSb2 Approximately 50% of the dissolution has been explained within 20 minutes and the release trend is maintained during subsequent trials.

Antiviral activity of saikosaponin nano preparations

The tenth (A) and (B) are the effects of the nano preparation of the present invention for inhibiting HCV and DENV infection, respectively. SSb2-NP is characterized by active application in water only, without the need for other co-solvents (such as DMSO). In this experiment, SSb2-NP was compared with a drug substance (SSb2-DMSO) formulated with a cosolvent (DMSO) and a raw material drug SSb2-DW prepared in water to analyze its antiviral effect. The results showed that SSb2-DW had no antiviral effect at all for HCV (Fig. 10A) or DENV (Fig. 10B), and the antiviral effect of SSb2-NP was almost similar to that of the cosolvent (SSb2-DMSO). It is reflected that the present invention successfully produces saikosaponin preparation SSb2-NP which can exert its antiviral effect only in water, and improves the bioavailability of saikosaponin and Antiviral use.

Example

A pharmaceutical composition comprising: a main component comprising a saikosaponin; and a high molecular polymer mixed with the main component.

2. The pharmaceutical composition according to the preceding embodiment, wherein the pharmaceutical composition has a size of less than 50 nm.

3. The pharmaceutical composition according to the preceding embodiment, wherein the pharmaceutical composition is manufactured as one of a drug, a disinfectant, a glove, a mask, a dry hand, a hand lotion, and an anti-mosquito solution.

4. The pharmaceutical composition according to the preceding embodiment, wherein the high molecular polymer increases the solubility of the saikosaponin.

5. The pharmaceutical composition according to the preceding embodiment, wherein the high molecular polymer is selected from the group consisting of a Pluronic® polymer, a polyvinyl alcohol (PVA), and a polyvinylpyrrolidone (PVP). One of the groups formed.

A method for producing a pharmaceutical composition, comprising: dissolving a saikosaponin in an organic solvent; adding the organic solvent containing the saikosaponin to a solution containing a high molecular polymer; Dispersing the saikosaponin in the high molecular polymer; and removing the organic solvent to obtain the pharmaceutical composition.

7. A use of a saikosaponin for the preparation of a pharmaceutical composition for preventing or treating a hepatitis C virus, a measles virus, a respiratory fusion virus, a vesicular stomatitis virus, a dengue virus And infection of one of the no-canopy viruses, wherein the pharmaceutical composition comprises the saikosaponin and a high molecular polymer.

The invention is a difficult and innovative invention, and has profound industrial value, and is submitted in accordance with the law. In addition, the invention may be modified by those skilled in the art without departing from the scope of the appended claims.

Claims (6)

A pharmaceutical composition comprising: a main component comprising a saikosaponin SSb2; and a high molecular polymer mixed with the main component, wherein the high molecular polymer is selected from the group consisting of a triplet polymer and a polyvinyl alcohol (polyvinyl) Alcohol, PVA), polyvinylpyrrolidone (PVP). The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition has a size of less than 50 nm. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is one of a drug, a disinfectant, a glove, a mask, a dry hand, a hand lotion, and a mosquito repellent. The pharmaceutical composition according to claim 1, wherein the high molecular polymer increases the solubility of the saikosaponin SSb2 in an aqueous solution. A method for producing a pharmaceutical composition comprising: dissolving a saikosaponin SSb2 in an organic solvent; and adding the organic solvent containing the saikosaponin SSb2 to a solution containing a high molecular polymer, Wherein the high molecular polymer is selected from the group consisting of a triplet polymer, a polyvinyl alcohol (PVA), and a polyvinylpyrrolidone (PVP); the saikosaponin SSb2 is dispersed in the high In the molecular polymer; and removing the organic solvent to obtain the pharmaceutical composition. The method of claim 5, wherein the pharmaceutical composition is for preventing or treating a hepatitis C virus, a measles virus, a respiratory fusion virus, a vesicular stomatitis virus, a dengue virus, and a kit. Infection of one of the membrane viruses, wherein the pharmaceutical composition comprises the saikosaponin and a high molecular polymer.